UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES JAN 25 2005 Dr. Tracy Rood Associate Registration Manager Pioneer Hi Bred International, Inc. P. O. Box 552 Johnston, Iowa 50131 0552 Dear Dr. Rood:

Subject: Bacillus thuringiensis Cry34/[ 35]* Ab1 Proteins and the Genetic Material Necessary for their Production ( From the Insert of Plasmid PHP17662) in Corn / Your Amendment/ Extension Application and January 19, 2004 Revised Experimental Program Section G EPA Experimental Use Permit No. 29964 EUP 5 Effective Dates: January 25, 2005 Through April 30, 2006 and Associated Activities Such as Collection of Field Data; Harvesting & Processing of Seed After Last Planting; and Containment Activities Such as Destruction of Volunteer Corn Plants Quantity Authorized: 1813.6 grams Cry34Ab1 and 47.2 grams Cry35Ab1 in Seeds On the basis of the information furnished by the applicant and the annexed program, an experimental use permit under § 5 of the Federal Insecticide, Fungicide, and Rodenticide Act is hereby amended/ extended for Bacillus thuringiensis Cry34/[ 35]* Ab1 proteins and the genetic material necessary for their production ( from the insert of plasmid PHP17662) in corn. The temporary tolerance exemption issued under 40 CFR § 180.1242 is associated with this experimental use permit.

Prior to shipment and/ or use of the subject corn, you must consult with the pesticide regulatory officials and, if applicable, the biotechnology regulatory officials of the State( s) in which your experimental program will be conducted, and obtain a State permit or license if such is required. ( Note Hawaii's reporting requirement for genetically modified organisms under section 321 11.6 of the Hawaii revised statutes.) Issuance of this Federal permit does not negate the need for permission from individual States. Prior to initiating this experimental program in any State, you are to notify the lead Agency of the State( s) in which your experimental program will be conducted of the specific testing program ( when, where, how much, etc.). Failure to do so may result in revocation or modification of this EUP. You must comply with all requirements of the USDA/ APHIS as they apply to the proposed testing.

You must provide notice to the State pesticide regulatory Agency at least 72 hours before you begin to apply the experimental use product. You must also provide a copy of this authorization letter and stamped label, as well as the non confidential portion of the Section G ( the January 19, 2004 version of your Section G) to all cooperators, participants, and users prior to the initial pesticide application made in accordance with the amended/ extended EUP. 2 The Agency is also notifying the relevant EPA Region( s), by sending them copies of this EUP.

Conditions under which the EUP is being amended/ extended are as follows.

1. The amount of corn seed planted of ( 1) Bacillus thuringiensis Cry34/[ 35]* Ab1 proteins and the genetic material necessary for their production ( construct PHP17662, event DAS 59122 7) in corn, ( 2) Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production ( construct PHP8999, event TC1507) in corn , ( 3) stacked Bacillus thuringiensis Cry34/[ 35]* Ab1 proteins and the genetic material necessary for their production ( construct PHP17662, event DAS 59122 7) in corn X Bacillus thuringiensis Cry1F protein and the genetic material necessary for its production ( construct PHP8999, event TC1507) corn, and ( 4) any non transgenic corn to be used will not exceed the amount needed to plant a total of 5,115 acres.

2. The permittee will immediately notify the Environmental Protection Agency of any findings from the experimental uses that have a bearing on safety ( i. e., reporting to the Agency of any adverse effects from the use of, or exposure to, the pesticide is required). The permittee will also keep records of production, distribution and performance, and, on request, make the records available to any authorized officer or employee of the Environmental Protection Agency.

3. You must provide a final report within180 days of the expiration of the permit. The final report must include all of the items set forth in 40 CFR § 172.8( b) and report on:

  A state by state breakdown of acreage per protocol.   A state by state breakdown of locations per protocol.   A listing of experiments conducted within each protocol.   Average acreage per location for each experiment included within each protocol ( ideally this would be presented on a state by state basis).

4. The labeling submitted in connection with your application is acceptable and must be used for all shipments of seed subsequent to receiving this approval and be in possession of the user under this EUP. A stamped copy of the label is enclosed for your records.

5. Per 40 CFR § 17[ 2]*. 4( b)( v), you must provide the name and street address of all cooperators as soon as available and prior to planting.

6. This experimental use permit is not a limited seed increase registration under § 3 of FIFRA and plantings solely for commercial seed increase are prohibited 7. It is strongly recommended that future submissions should include the following information:

  Protocols to be conducted. 3   Experiments to be included within each protocol.   Estimated state by state breakdown of acreage per protocol.   Estimated state by state breakdown of locations per protocol.   Estimate of acreage and locations required for each experiment included within protocols ( ideally this would be presented on a state by state basis).   If an acreage increase is requested for one or more protocols, justification should be provided for those increases ( justification should be provided on a protocol by protocol basis).   Objective and brief description of each experiment included within protocols. Approximate number of hybrids/ inbreds/ isolines to be tested should also be included ( may be presented as average number of lines per location).   Clear explanation of acreage calculation, including a breakdown of EUP acreage designated for test plants, non test plants, and border rows included within experimental blocks.   It should be noted that EUP acreage designated for demonstration trials is generally considered inappropriate.

Based upon the submitted experimental program, the subject corn seed may be shipped for use under this permit to the following State( s) and be planted on the following acreage, provided that the that the agronomically justified acreage as listed below is not exceeded and States agree to the trials and all other requirements of the USDA/ APHIS have been met as they apply to the testing :

STATE or COMMONWEALTH ACREAGE Arkansas 5 California 10 Colorado 10 Delaware 5 Georgia 5 Hawaii 900 Illinois 250 Indiana 10 Iowa 300 Kansas 100 Maryland 10 Michigan 2505 Minnesota 10 STATE or COMMONWEALTH cont. ACREAGE cont. 4 Missouri 15 Nebraska 100 North Carolina 5 North Dakota 10 Ohio 10 Pennsylvania 10 Puerto Rico 550 South Dakota 10 Tennessee 5 Texas 10 Washington 260 Wisconsin 10 Total 5115 Acres EUP Protocols EUP Acres Requested/ Justified Breeding and observation nursery 750 Agronomic observation trials 515 Herbicide tolerance study 100 Efficacy trial 100 Insect resistance management studies 2,500 Non target organism studies 100 Regulatory studies 150 Research seed production 100 Inbred seed increase 800 Total Acreage 5,115 Sincerely,

/ s/

James Jones, Director Office of Pesticide Programs Enclosures * Typographical Correction


 Each refinery or importer CTA producing or importing Diesel Fuel for use in the United States per Sections 80.593 and 80.604 must submit a facility summary report. Items 15  -  23 deal with small refiner requirements. Please follow instructions when information is not applicable.

 Reports using this form must be submitted annually by August 31st.

 Please check the Diesel Fuel Reporting Forms web site for updated instructions and report form templates: http://epa.gov/otaq/regs/fuels/dieselfms.htm

 For information on submitting this report using EPA's Central Data Exchange (CDX) visit:
 http://epa.gov/otaq/regs/fuels/cdxinfo.htm

 Field
  No.

 Field Name

 Units

 Field Formats, Codes, & Special Instructions
                                       1.
 Report Form ID

 AAAAAAA; Character. Enter DSF0302 for this Diesel
 Fuel Sulfur Facility Summary Report
                                       2.
 Report Type

 A; Character. Submit only one original report, submit any corrections or updates as resubmission(s):

 O: Original
 R: Resubmission
                                       3.
 CBI

 A; Character. Specify if the data contained within the report is claimed as Confidential Business Information (CBI) under 40 CFR Part 2, subpart B:

 Y: Confidential Business Information
 N: Non-Confidential Business Information
                                       4.
 Report Date

 MM/DD/YYYY; Character. Enter the date you create this report. If resubmitting, use the current date and not the date on the original report.
                                       5.
 Report Year

 YYYY; Character. The report year is determined by the annual compliance period. If an annual compliance period spans two years, enter the second year (e.g. for the compliance year June 1, 2006 through May 31, 2007 use
 2007).
                                       6.
 Company/Entity ID

 AAAA; Character. Enter the four-digit, EPA-assigned ID
 for the company/entity (refiner, importer, etc.).
                                       7.
 Facility ID

 AAAAA; Character. Enter the five-digit, EPA-assigned ID
 for the facility. Please include any preceding zeros.

 Field
  No.

 Field Name

 Units

 Field Formats, Codes, & Special Instructions
                                       8.
 CTA

 A; Character. Credit Trading Area (CTA). For motor vehicle diesel fuel credits only, enter the appropriate credit trading area code as defined in 80.531(a)(5)  -
  Areas are numbered 1 through 7. Enter NA if not   applicable.
                                       9.
 Total Volume
 MVDF
 gallons
<PHONE_NUMBER>99; Number. Volume of motor vehicle diesel fuel produced or imported over the compliance period.
  10.
 500 ppm MVDF Volume
 gallons
<PHONE_NUMBER>99; Number. Volume of 500 ppm sulfur motor vehicle diesel fuel produced or imported over the compliance period.
  11.
 15 ppm MVDF Volume
 gallons
<PHONE_NUMBER>99; Number. Volume of 15 ppm sulfur motor vehicle diesel fuel produced or imported over the compliance period.
  12.
 500 ppm MVDF Percent of Volume
 - before credits
 percent
 999.99; Number. The percentage of production/import during the compliance year that met the 500 ppm sulfur standard before application of volume credits.
  13.
 15 ppm MVDF Percent of Volume
 - before credits
 percent
 999.99; Number. The percentage of production/import during the compliance year that met the 15 ppm sulfur standard before application of volume credits.
  14.
 15 ppm MVDF Percent of Volume
 - after credits
 percent
 999.99; Number. The percentage of production/import during the compliance year that met the 15 ppm sulfur standard after the application of volume credits.
  15.
 Small Refiner Compliance Options

 AAAA; Character. Enter the appropriate NRLM diesel fuel small refiner compliance option code. Reference 40
 CFR 80.604(a)(2) for additional information on compliance options. All parties not participating in small refiner compliance options enter NOSR.
       SRM1:  Small Refiner Motor Vehicle Option 1; 80.552(a), Volume Limits.
       SRM2:  Small Refiner Motor Vehicle Option 2; 80.552(b), Credit Generation.
       SRM3:  Small Refiner Motor Vehicle Option 3; 80.552(c), Extended Small Refiner Gasoline sulfur standard.
       SRO1:  Small Refiner Option 1; 80.554(a), NRLM Production June 1, 2007  -  May 31, 2010.
       SRO2:  Small Refiner Option 2; 80.554(b), NR Production June 1, 2010  -  May 31, 2014. And NRLM Production June1, 2012  -  May 31, 2014.
 SRO3:  Small Refiner Option 3; 80.554(c), Credit
       Generation
 SRO4:  Small Refiner Option 4; 80.554(d), Gas for Diesel
 SR13:	Small Refiner Options SRO1 & SRO3
 SR23:	Small Refiner Options SRO2 & SRO3
 TXMX:  Transmix Facility Report Flag

 Field
  No.

 Field Name

 Units

 Field Formats, Codes, & Special Instructions
  16.
 Total Volume NR
 gallons
<PHONE_NUMBER>99; Number. 80.604(b)(2). Enter The total volume of diesel fuel produced and designated as NR diesel fuel. Applicable to small refiner option 2; All other submitters enter NA
  17.
 Total LM Volume
 gallons
<PHONE_NUMBER>99; Number. 80.604(b)(2). Enter the total volume of diesel fuel produced and designated as LM diesel fuel. Applicable to small refiner option 2; All other submitters enter NA
  18.
 Total Volume 500
 PPM NR
 gallons
<PHONE_NUMBER>99; Number. 80.604(b)(2). Enter the total volume of diesel fuel produced and designated as NR diesel fuel subject to the 500 ppm sulfur standard under
 §80.510(a). Applicable to small refiner option 2; All other submitters enter NA
  19.
 Total Volume 500
 PPM LM
 gallons
<PHONE_NUMBER>99; Number. 80.604(b)(2). The total volume of diesel fuel produced and designated as LM diesel fuel subject to the 500 ppm sulfur standard under §80.510(a). Applicable to small refiner option 2; All other submitters enter NA
  20.
 Total Volume 15
 PPM NR
 gallons
<PHONE_NUMBER>99; Number. 80.604(b)(2). The total volume of diesel fuel produced and designated as NR diesel fuel having a sulfur content of 15 ppm or less. Applicable to small refiner option 2; All other submitters enter NA
  21.
 Baseline
 gallons
<PHONE_NUMBER>99; Number. 80.604(b)(2). Enter the NRLM baseline under 80.554(b)(1) - applicable to NRLM small refiner option 2. All other submitters enter NA
  22.
 Total Volume 500
 PPM NRLM
 gallons
<PHONE_NUMBER>99; Number. 80.604(b)(2). Enter the total volume of NRLM diesel fuel produced that is eligible for the sulfur standard under §80.510(a). Applicable to small refiner option 2; All other submitters enter NA
  23.
 Total Exceeded Volume NRLM Subject to 15 PPM Standard
 gallons
<PHONE_NUMBER>99; Number. 80.604(b)(2). Enter the total volume, if any, of NRLM diesel fuel subject to the 15 ppm sulfur standard that had a sulfur content in excess of 15 ppm. Applicable to small refiner option 2; All other submitters enter NA

 Electronic Submission Sample Record: DSF0302,O,Y,08/22/2011,2011,1234,81000,2,10000,2000,8000,20.00,80.00,80.00,NOSR,NA, NA,NA,NA,NA,NA,NA,NA
                           Paperwork Reduction Act Statement

 The public reporting and recordkeeping burden for this collection of information is estimated to average
 20 minutes annually. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

 Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U.S. Environmental Protection Agency (2822), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.


[Federal Register Volume 78, Number 94 (Wednesday, May 15, 2013)]
[Proposed Rules]
[Pages 28550-28551]
[FR Doc No: 2013-11454]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2013-0021;EPA-R05-OAR-2013-0022; FRL-9812-3]

Approval and Promulgation of Air Quality Implementation Plans;
Indiana; Lake and Porter Counties, Indiana, 1997 8-Hour Ozone
Maintenance Plan and 1997 Annual Fine Particulate Matter Maintenance
Plan Revisions to Approved Motor Vehicle Emissions Budgets

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: EPA is proposing to approve Indiana's request to revise the
Lake and Porter State Implementation Plans (SIPs) for the 1997 8-hour
ozone standard, and the 1997 annual fine particulate matter
(PM2.5) standard to replace the previously approved motor
vehicle emissions budgets (budgets) with budgets developed using EPA's
Motor Vehicle Emissions Simulator (MOVES) 2010a emissions model. The
Indiana Department of Environmental Management (IDEM) submitted these
requests to EPA with submittal letters dated February 1, 2013.

DATES: Comments must be received on or before June 14, 2013.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2013-0021 for the 1997 8-hour ozone maintenance plan revision or
EPA-RO5-OAR-2013-0022 for the 1997 annual PM2.5 maintenance
plan revision, by one of the following methods:
    1. www.regulations.gov: Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Fax:<PHONE_NUMBER>.
    4. Mail: Pamela Blakley, Chief, Control Strategies Section, Air
Programs Branch (AR-18J), U.S. Environmental Protection Agency, 77 West
Jackson Boulevard, Chicago, Illinois 60604.
    5. Hand Delivery: Pamela Blakley, Chief, Control Strategies
Section, Air Programs Branch (AR-18J), U.S. Environmental Protection
Agency, 77 West Jackson Boulevard, Chicago, Illinois 60604. Such
deliveries are only accepted during the Regional Office normal hours of
operation, and special arrangements should be made for deliveries of
boxed information. The Regional Office official hours of business are
Monday through Friday, 8:30 a.m. to 4:30 p.m., excluding Federal
holidays.

    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Anthony Maietta, Environmental
Protection Specialist, Control Strategies Section, Air Programs Branch
(AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson
Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because EPA views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all relevant public comments
received will be addressed in a subsequent final rule based on this
proposed rule. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time. Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule which is located in
the Rules section of this Federal Register.

    Dated: April 30, 2013.
Susan Hedman,
Regional Administrator, Region 5.
[FR Doc. 2013-11454 Filed 5-14-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 6 (Wednesday, January 9, 2013)]
[Proposed Rules]
[Pages 1792-1795]
[FR Doc No: 2013-00276]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2012-0150]
RIN 1625-AA08

Special Local Regulations, Stuart Sailfish Regatta, Indian River;
Stuart, FL

AGENCY: Coast Guard, DHS.

ACTION: Notice of Proposed Rulemaking.

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

SUMMARY: The Coast Guard is proposing to establish special local
regulations on the Indian River located northeast of Ernest F. Lyons
Bridge and south of Joes Cove, in Stuart, Florida during the Stuart
Sailfish Regatta, a series of high-speed boat races. The Stuart
Sailfish Regatta will take place from Friday, April 19, 2013 through
Sunday, April 21, 2013. Approximately 150 high-speed power boats will
be participating in the event. It is anticipated that at least 100
spectator vessels will be present during the race. These special local
regulations are necessary for the safety of race participants,
participant vessels, spectators and the general public during the
event. The special local regulations establish the following three
areas: a race area, where all persons and vessels, except those persons
and vessels participating in the high-speed boat races, are prohibited
from entering, transiting through, anchoring in, or remaining within; a
buffer zone around the race area, where all persons and vessels, except
those persons and vessels enforcing the buffer zone, or authorized
participants or vessels transiting to the race area, are prohibited
from entering, transiting through, anchoring in, or remaining within;
and a spectator area.

DATES: Comments and related material must be received by the Coast
Guard on or before February 8, 2013.
    Requests for public meetings must be received by the Coast Guard on
or before February 8, 2013.

ADDRESSES: You may submit comments identified by docket number using
any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: 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. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for further instructions
on submitting comments. To avoid duplication, please use only one of
these three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Junior Grade Mike H. Wu, Sector Miami
Prevention Department, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online at
http://www.regulations.gov, or by fax, mail, or hand delivery, but
please use only one of these means. If you submit a comment online, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as having been received by the Coast Guard when
it is received at the Docket Management Facility. We recommend that you
include your name and a mailing address, an email address, or a
telephone number in the body of your document so that we can contact
you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number USCG-2012-0150 in the ``SEARCH'' box and click
``SEARCH.'' Click on ``Submit a Comment'' on the line associated with
this rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number USCG-2012-0150 in the ``SEARCH'' box and click
``SEARCH.'' Click on Open Docket Folder on the line associated with
this rulemaking. You may also visit the Docket Management Facility in
Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one on or before February 8, 2013, using one of the methods
specified under ADDRESSES. Please explain why you believe a public
meeting would be beneficial. If we determine that one would aid this
rulemaking, we will hold one at a time and place announced by a later
notice in the Federal Register.

B. Regulatory History and Information

    Previously, temporary special local regulations regarding this
maritime event have been published in the Code of Federal Regulations
at 33 CFR 100.701. No final rule has been published in regards to this
event. The proposed special local regulations are not new in their
entirety, but merely reflect updates to certain details of the event.

C. Basis and Purpose

    The legal basis for the rule is the Coast Guard's authority to
establish special local regulations: 33 U.S.C. 1233. The purpose of the
rule is to insure safety of life on navigable waters of the United
States during the Stuart Sailfish Regatta.

D. Discussion of Proposed Rule

    From Friday, April 19, 2013 through Sunday, April 21, 2013, Stuart
Sailfish Regatta, Inc. will be hosting the Stuart Sailfish Regatta, a
series of high-speed boat races. The races will be held on the Indian
River located northeast of Ernest F. Lyons Bridge and south of Joes
Cove, in Stuart, Florida. Approximately 150 high-speed power boats will
be participating in the event. It is anticipated that at least 100
spectator vessels will be present during the race.
    The proposed rule would establish special local regulations that
will encompass certain waters of the Indian River located northeast of
Ernest F. Lyons Bridge and south of Joes Cove, in Stuart, Florida. The
special local regulations will be enforced daily from 9 a.m. until 5
p.m. from April 19, 2013 through April 21, 2013. The special local
regulations consist of the following three areas: (1) A race area,
where all persons and vessels, except those persons and vessels
participating in the high-speed boat races, are prohibited from
entering, transiting through, anchoring in, or remaining within; (2) a
buffer zone around the race area, where all persons and vessels, except
those persons and vessels enforcing the buffer zone, or authorized
participants or vessels transiting to the race area, are prohibited
from entering, transiting through, anchoring in, or remaining within;
and (3) a spectator area.
    Persons and vessels may request authorization by contacting the
Captain of the Port Miami by telephone at<PHONE_NUMBER>, or a
designated representative via VHF radio on channel 16, to enter,
transit through, anchor in, or remain within the race area or the
buffer zone. If authorization is granted by the Captain of the Port
Miami or a designated representative, all persons and vessels receiving
such authorization must comply with the instructions of the Captain of
the Port Miami or a designated representative. The Coast Guard will
provide notice of the regulated areas by Local Notice to Mariners,
Broadcast Notice to Mariners and on-scene designated representatives.

E. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes or executive orders.

1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders. The economic impact of
this proposed rule is not significant for the following reasons: (1)
The special local regulations will be enforced for a maximum of 8 hours
a day for only three days; (2) non-participant persons and vessels may
enter, transit through, anchor in, or remain within the regulated areas
during their respective enforcement periods if authorized by the
Captain of the Port Miami or a designated representative; (3) non-
participant persons and vessels not able to enter, transit through,
anchor in, or remain within the regulated areas without authorization
from the Captain of the Port Miami or a designated representative may
operate in the surrounding areas during the respective enforcement
periods; and (4) the Coast Guard will provide advance notification of
the special local regulations to the local maritime community by Local
Notice to Mariners and Broadcast Notice to Mariners.

2. Impact on Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered the impact of this proposed rule on small entities. The
Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule
will not have a significant economic impact on a substantial number of
small entities. This rule may affect the following entities, some of
which may be small entities: the owners or operators of vessels
intending to enter, transit through, anchor in, or remain within any of
the regulated areas during the respective enforcement period. For the
reasons discussed in the Regulatory Planning and Review section above,
this rule will not have a significant economic impact on a substantial
number of small entities.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION
CONTACT, above. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

4. Collection of Information

    This proposed rule will not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this proposed rule under that Order and
determined that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the ``For Further
Information Contact'' section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

8. Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

9. Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

10. Protection of Children From Environmental Health Risks

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

12. Energy Effects

    This proposed rule is not a ``significant energy action'' under
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use.

13. Technical Standards

    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f). Due to
potential environmental issues, we conducted an environmental
assessment last year for both the issuance of the marine event permit
and the establishment of this special local regulation. The same
environmental assessment is being used for this year's event as it is
substantially similar in all aspects and therefore the potential
effects and alternatives would remain unchanged. After completing the
environmental assessment for the issuance of the marine event permit,
and the establishment of these special local regulations, we have
determined these actions will not significantly affect the human
environment. The environmental assessment and finding of no significant
impact (FONSI) are available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.
    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  33 U.S.C. 1233.

0
2. Add a temporary Sec.  100.35T07-0150 to read as follows:

Sec.  100.35T07-0150  Special Local Regulations; Stuart Sailfish
Regatta, Indian River, Stuart, FL.

    (a) Regulated Areas. The following regulated areas are established
as special local regulations. All coordinates are North American Datum
1983.
    (1) Race Area. All waters of Indian River located northeast of
Ernest Lyons Bridge and south of Joes Cove that are encompassed within
an imaginary line connecting the following points: starting at Point 1
in position 27[deg]12'46'' N, 80[deg]11'09'' W; thence southeast to
Point 2 in position 27[deg]12'41'' N, 80[deg]11'08'' W; thence
southwest to Point 3 in position 27[deg]12'37'' N, 80[deg]11'11'' W;
thence southwest to Point 4 in position 27[deg]12'33'' N,
80[deg]11'18'' W; thence southwest to Point 5 in position
27[deg]12'31'' N, 80[deg]11'23'' W; thence west to Point 6 in position
27[deg]12'31'' N, 80[deg]11'27'' W; thence northwest to Point 7 in
position 27[deg]12'33'' N, 80[deg]11'31'' W; thence northwest to Point
8 in position 27[deg]12'38'' N, 80[deg]11'32'' W; thence northeast to
Point 9 in position 27[deg]12'42'' N, 80[deg]11'30'' W; thence
northeast to Point 10 in position 27[deg]12'46'' N, 80[deg]11'26'' W;
thence northeast to Point 11 in position 27[deg]12'48'' N,
80[deg]11'20'' W; thence east to Point 12 in position 27[deg]12'48'' N,
80[deg]11'15'' W; thence southeast back to origin. All persons and
vessels, except those persons and vessels participating in the high-
speed boat races, are prohibited from entering, transiting through,
anchoring in, or remaining within the race area.
    (2) Buffer Zone. All waters of Indian River located northeast of
Ernest Lyons Bridge and south of Joes Cove that are encompassed within
an imaginary line connecting the following points, with the exception
of the spectator area: starting at Point 1 in position 27[deg]12'47''
N, 80[deg]11'43'' W; thence southeast to Point 2 in position
27[deg]12'22'' N, 80[deg]11'28'' W; thence northeast to Point 3 in
position 27[deg]12'35'' N, 80[deg]11'00'' W; thence northwest to Point
4 in position 27[deg]12'47'' N, 80[deg]11'04'' W; thence northeast to
Point 5 in position 27[deg]13'05'' N, 80[deg]11'01'' W; thence
southeast back to origin. All persons and vessels, except those persons
and vessels enforcing the buffer zone, or authorized participants or
vessels transiting to the race area, are prohibited from entering,
transiting through, anchoring in, or remaining within the buffer zone.
    (3) Spectator Area. All waters of Indian River located northeast of
the Ernest Lyons Bridge and south of Joes Cove that are encompassed
within an imaginary line connecting the following

points: starting at Point 1 in position 27[deg]12'47'' N,
80[deg]11'43'' W; thence southeast to Point 2 in position
27[deg]12'40'' N, 80[deg]11'38'' W; thence northeast to Point 3 in
position 27[deg]11'52'' N, 80[deg]11'25'' W; thence northwest to Point
4 in position 27[deg]12'54'' N, 80[deg]11'26'' W; thence southwest back
to origin. On-scene designated representatives will direct spectator
vessels to the spectator area.
    (b) Definition. The term ``designated representative'' means Coast
Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, state, and local officers designated by or assisting the
Captain of the Port Miami in the enforcement of the regulated area.
    (c) Regulations.
    (1) All persons and vessels, are prohibited from:
    (A) Entering, transiting through, anchoring in, or remaining within
the race area, unless participating in the race.
    (B)Transiting through, anchoring in, or remaining within the buffer
zone, unless enforcing the buffer zone or a race participant transiting
to the race area.
    (C) Traveling in excess of no-wake speed in the spectator area.
    (2) Persons and vessels may request authorization to enter, transit
through, anchor in, or remain within the regulated area by contacting
the Captain of the Port Miami by telephone at<PHONE_NUMBER>, or a
designated representative via VHF radio on channel 16. If authorization
is granted by the Captain of the Port Miami or a designated
representative, all persons and vessels receiving such authorization
must comply with the instructions of the Captain of the Port Miami or a
designated representative.
    (3) The Coast Guard will provide notice of the regulated areas by
Local Notice to Mariners, Broadcast Notice to Mariners, and on-scene
designated representatives.
    (d) Enforcement Date. This rule will be enforced from 9:00 a.m.
until 5:00 p.m. daily from April 19, 2013 through April 21, 2013.

    Dated: December 26, 2012.
J.B. Pruett,
Captain, U.S. Coast Guard, Acting Captain of the Port Miami.
[FR Doc. 2013-00276 Filed 1-8-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Notices]
[Pages 127-128]
[FR Doc No: 2017-28250]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6753]

Joint Meeting of the Anesthetic and Analgesic Drug Products
Advisory Committee and the Drug Safety and Risk Management Advisory
Committee; Notice of Meeting; Establishment of a Public Docket; Request
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice, establishment of a public docket; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Anesthetic and Analgesic Drug
Products Advisory Committee and the Drug Safety and Risk Management
Advisory Committee. The general function of the committees is to
provide advice and recommendations to FDA on regulatory issues. The
meeting will be open to the public. FDA is establishing a docket for
public comment on this document.

DATES: The meeting will be held on February 14, 2018, from 8 a.m. to
12:30 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2017-N-6753. The docket will close on February
13, 2018. Submit either electronic or written comments on this public
meeting by February 13, 2018. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before February 13, 2018. The https://www.regulations.gov
electronic filing system will accept comments until midnight Eastern
Time at the end of February 13, 2018. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
    Comments received on or before January 31, 2018, will be provided
to the committees. Comments received after that date will be taken into
consideration by FDA.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-N-6753 for ``Joint Meeting of the Anesthetic and Analgesic
Drug Products Advisory Committee and the Drug Safety and Risk
Management Advisory Committee; Notice of Meeting; Establishment of a
Public Docket; Request for Comments.'' Received comments, those filed
in a timely manner (see ADDRESSSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at

https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify the information as ``confidential.'' Any
information marked as ``confidential'' will not be disclosed except in
accordance with 21 CFR 10.20 and other applicable disclosure law. For
more information about FDA's posting of comments to public dockets, see
80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Moon Hee V. Choi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-9001, Fax:<PHONE_NUMBER>, email: [email protected], or FDA Advisory
Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in the
Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the FDA's website at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The committees will be asked to discuss new drug
application (NDA) 209257, proposed tradename, HYDEXOR, a fixed-dose
combination oral tablet, submitted by Charleston Laboratories, Inc.,
that contains hydrocodone, acetaminophen, and promethazine, for the
short-term management of acute pain severe enough to require an opioid
analgesic while preventing and reducing opioid-induced nausea and
vomiting. The committees will also be asked to discuss the abuse
potential of this non-abuse-deterrent product and whether it should be
approved.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committees.
Written submissions may be made to the contact person on or before
January 31, 2018. Oral presentations from the public will be scheduled
between approximately 10:15 a.m. and 11:15 a.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before January 23, 2018.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by January 24, 2018.
    Persons attending FDA's advisory committee meetings are advised
that FDA is not responsible for providing access to electrical outlets.
    For press inquiries, please contact the Office of Media Affairs at
[email protected] or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Moon Hee V. Choi at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28250 Filed 12-29-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: September 15, 2008 (Volume 73, Number 179)]
[Notices]
[Page 53298-53300]
[DOCID:fr15se08-122]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58486; File No. SR-ISE-2008-36)

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule
Change Relating to Non-Displayed Penny Quotes and Orders

September 8, 2008.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is
hereby given that on August 28, 2008, the International Securities
Exchange, LLC (the ``Exchange'' or the ``ISE'') filed with the
Securities and Exchange Commission (the ``Commission'') the proposed
rule change as described in Items I, II, and III 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

    The ISE is proposing to allow non-displayed penny quotes and orders
in options that trade in minimum pricing increments greater than one
cent. The text of the proposed rule change is available on the
Exchange's Web site (http://www.ise.com), at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the 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 self-regulatory organization
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 Commission has approved rules with respect to the Nasdaq
Options

Exchange (``NOM'') and the Chicago Board Options Exchange (``CBOE'')
that permit the entry of orders and quotes in penny increments in
options series that have a minimum trading increment greater than one
cent.\3\ Under these rules, the actual firm price of the order or quote
is not displayed to market participants or the public. Rather, the
penny price is hidden on the exchange and displayed at the next closest
allowable trading increment. To avoid being competitively
disadvantaged, the ISE proposes to adopt rules that similarly permit
its members to enter orders and quotes in penny increments (``non-
displayed penny orders'' and ``non-displayed penny quotes'').
---------------------------------------------------------------------------

    \3\ Securities Exchange Act Release No. 57478 (March 12, 2008),
73 FR 14521 (March 18, 2008) (order approving SR-NASDAQ-2007-004 and
SR-NASDAQ-2007-080); Securities Exchange Act Release No. 57716
(April 25, 2008), 73 FR 24329 (May 2, 2008) (order approving SR-
CBOE-2007-39).
---------------------------------------------------------------------------

    The Exchange proposes to allow both Electronic Access Members and
market makers to enter non-displayed penny orders. In addition,
Exchange market makers will be permitted to enter non-displayed penny
quotes. Orders and quotes will be permitted in one-cent price
increments in selected options where the applicable minimum price
increment is larger than one-cent.\4\ The penny price of such orders
will be firm for incoming orders.\5\ Non-displayed penny orders and
quotes will be displayed at the nearest minimum trading increment for
the security, and the penny price of non-displayed penny orders and
quotes will not be disclosed to any market participants.
---------------------------------------------------------------------------

    \4\ The Exchange will issue a circular to notify members of the
options series in which non-displayed penny quotes and order may be
entered.
    \5\ Incoming orders will receive the firm, non-displayed penny
price. For example, if the non-displayed price of a limit order to
buy is 2.02, an incoming limit order to sell at 2.01 will be
executed at 2.02.
---------------------------------------------------------------------------

    Non-displayed penny orders will participate in executions effected
through the Block, Facilitation, Solicited Order and Price Improvement
Mechanisms. Both the Block and the Price Improvement Mechanism
currently allow members to enter orders and responses in penny
increments.\6\ Accordingly, a non-displayed penny order will
participate in executions effected through the Block and Price
Improvement Mechanisms at the penny price. However, when entering
orders and responses into the Facilitation and Solicited Order
Mechanisms, members currently are limited to the regular trading
increment for the security and the split price for the regular trading
increment.\7\ In order to be consistent with the current rule, the
proposal specifies that non-displayed penny orders also will be
executed only at the regular increment or split price, as applicable.
For example, if the displayed market is $2.00 by $2.05 and there is a
hidden penny order to buy at 2.03, the hidden penny order will
participate in the execution algorithms applied by the Facilitation and
Solicited Order Mechanisms at the split price of $2.025. If the hidden
penny price in this example is $2.02, the hidden penny order will
participate in the execution algorithms at the regular trading
increment of $2.00.
---------------------------------------------------------------------------

    \6\ ISE Rule 716, Supplementary Material .09 (regarding penny
prices in the Block Mechanism); ISE Rule 723(b)(2) and (c)(2)
(regarding penny prices in the Price Improvement Mechanism).
    \7\ ISE Rule 716, Supplementary Material .06 (regarding split
prices in the Facilitation and Solicited Order Mechanisms).
---------------------------------------------------------------------------

2. Statutory Basis
    The basis under the Exchange Act for this proposed rule change is
found in Section 6(b)(5), in that the proposed rule change is designed
to promote just and equitable principles of trade, remove impediments
to and perfect the mechanisms of a free and open market and a national
market system and, in general, to protect investors and the public
interest. This rule will enable the Exchange to remain competitive with
other options markets that permit orders and quotes to be entered and
executed in penny increments.

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

    The proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Exchange 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 written comments from members or other interested parties.

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
does not: (i) Significantly affect the protection of investors or the
public interest; (ii) impose any significant burden on competition; and
(iii) become operative for 30 days from the date on which it was filed,
or such shorter time as the Commission may designate if consistent with
the protection of investors and the public interest. The Exchange
provided the Commission with written notice of its intent to file the
proposed rule change, along with a brief description and text of the
proposed rule change, at least five business days prior to the date of
filing the proposed rule change as required by Rule 19b-4(f)(6).\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate the rule change if it
appears to the Commission that the action is necessary or appropriate
in the public interest, for the protection of investors, or would
otherwise further 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 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-ISE-2008-36 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-ISE-2008-36. 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 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-
2008-36 and should be submitted on or before October 6, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\9\
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-21391 Filed 9-12-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Proposed Rules]
[Pages 3726-3728]
[FR Doc No: 2012-1525]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 575

[Docket No. NHTSA-2011-0099]
RIN 2127-AK76

Tire Fuel Efficiency Consumer Information Program

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Notice of public workshop and agenda.

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

SUMMARY: On March 30, 2010, NHTSA published a final rule specifying the
test methods to be used for a new tire fuel efficiency consumer
information program (TFECIP) to measure three aspects of tire
performance: Rolling resistance, wet traction, and treadwear. The final
rule did not include any of the requirements for the consumer
information and education portions of the TFECIP. Instead, NHTSA
announced that, based on the comments the agency had received on the
proposal that preceded its final rule, it had decided to conduct
additional research before issuing a new proposal for these
requirements. NHTSA hopes to issue this new proposal in 2012; however,
it has decided that it would be helpful to have a public workshop to
obtain feedback on some issues that either have proved difficult to
explore effectively in the research NHTSA has conducted or have arisen
since the publication of the March 2010 final rule.
    NHTSA invites interested parties to submit written comments and to
participate in a public workshop using the instructions set forth in
this notice. As described in the Procedural Matters section of this
notice, each speaker should anticipate speaking for approximately ten
minutes, although we may need to adjust the time for each speaker if
there is a large turnout. To facilitate discussion, NHTSA has placed
documents concerning research NHTSA has finalized since the March 2010
final rule in the docket. NHTSA will consider the public comments
received in developing the new proposal regarding the remaining aspects
of the TFECIP.

DATES: Public Workshop: The public workshop will be held on Friday,
February 3, 2012 from 10 a.m. to 5 p.m. at the San Francisco Federal
Building, 90 7th Street, San Francisco, CA 94013. NHTSA notes that all
persons attending the workshop will need to clear security before
entering the meeting room and should plan their arrival time
accordingly. If you wish to attend or speak at the workshop, you must
register in advance no later than Friday, January 27, 2012, by
following the instructions in the Procedural Matters section of this
notice. NHTSA will consider late registrants to the extent time and
space allows, but NHTSA cannot ensure that late registrants will be
able to speak at the workshop.
    Comments: NHTSA must receive written comments by Friday, February
17, 2012.

ADDRESSES: You may submit comments to the docket number identified in
the heading of this document by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     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.
     Hand Delivery or Courier: U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m. Eastern
time, Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Regardless of how you submit your comments, you should mention the
docket number of this document. You may call the Docket at 1-(800) 647-
5527.
    Note that all comments received, including any personal
information,

will be posted without change to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Ms. Mary Versailles, Telephone: 1-
(202) 366-2057, Office of International Vehicle, Fuel Economy and
Consumer Standards, National Highway Traffic Safety Administration,
1200 New Jersey Avenue SE., Washington, DC 20590. Email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On June 22, 2009, NHTSA published a notice
of proposed rulemaking (NPRM) proposing a new consumer information
program for replacement tires (74 FR 29542; Docket No. NHTSA-2008-
0121). The new consumer information program responded to a requirement
in the Energy Independence and Security Act of 2007 (EISA; Pub. L. 110-
140, 121 Stat. 1492 (Dec. 18, 2007)), that directed NHTSA to develop a
national tire fuel efficiency rating system and consumer education
program for replacement tires. The program would inform consumers about
the effect of tires on fuel efficiency, safety and durability.
    On March 30, 2010, NHTSA published a final rule specifying the test
methods to be used for a new tire fuel efficiency consumer information
program (TFECIP) to measure three aspects of tire performance: rolling
resistance, wet traction, and treadwear (75 FR 15894; Docket No. NHTSA-
2010-0036). The final rule did not include any of the requirements for
the consumer information and education portions of the TFECIP. Instead,
NHTSA announced that, based on the public comments the agency had
received on its NPRM, it had decided to conduct additional research
before issuing a new proposal for these requirements. NHTSA hopes to
issue this new proposal in 2012; however, it has decided that it would
be helpful to have a public workshop to obtain feedback on some issues
that either have proved difficult to effectively explore in the
research NHTSA has conducted or have arisen since the publication of
the March 2010 final rule.
    While NHTSA welcomes the presentation of any information that
interested parties believe will assist NHTSA in issuing the
supplemental notice of proposed rulemaking (SNPRM), NHTSA is
particularly interested in presentations that address the following
topics:
    1. Rolling Resistance Coefficient (RRC) versus Rolling Resistance
Force (RRF). NHTSA's original proposal based the fuel efficiency rating
on RRF. NHTSA received numerous comments expressing the belief that the
rating should be based on RRC. NHTSA would welcome any new or
additional information on this issue.
    2. Experience in Other Countries. At the time of the previous
rulemaking, NHTSA was aware of work by Europe and Japan to implement
similar rating systems. NHTSA is aware that the Republic of Korea has
adopted a rating system since then. NHTSA would welcome a discussion of
any experience that interested parties have had with the implementation
of these other systems.
    3. Laboratory Alignment. In the March 2010 final rule, NHTSA
indicated that, because the ISO had not yet specified a reference lab
for the ISO 28580 test procedure, NHTSA would specify one or more
laboratories to operate the reference test machine(s) for the TFECIP.
This would allow tire manufacturers to know the identity of the machine
against which they would correlate their test results. While this is
still NHTSA's plan, it is aware that questions exist concerning whether
or not it is possible to meet the sigma requirements specified in the
ISO regulation. NHTSA is also aware that other countries have adopted
or are exploring other options. NHTSA has begun discussing other
options and is interested in any recommendations interested parties may
have. In particular, NHTSA would be interested in any experience with
efforts to address lab-to-lab variability under the ISO 28580
procedure.
    4. Future Production. To assist with estimating the potential
benefits of the rule and with defining the rating ranges, NHTSA would
be interested in any information manufacturers would be willing to
share about how tires are likely to change in the future because of
this pending regulation and any other new regulations. See the
Procedural Matters section on how this information could be submitted
confidentially.
    Procedural Matters: The workshop will be open to the public with
advanced registration for seating on a space-available basis.
Individuals wishing to register to assure a seat in the public seating
area should provide their name, affiliation, phone number, and email
address to Ms. Mary Versailles using the contact information in the FOR
FURTHER INFORMATION CONTACT section at the beginning of this notice no
later than Friday, January 27, 2012. Should it be necessary to cancel
the workshop due to an emergency or some other reason, NHTSA will take
all available means to notify registered participants by email or
telephone.
    The workshop will be held at a site accessible to individuals with
disabilities. Individuals who require accommodations such as sign
language interpreters should contact Ms. Mary Versailles using the
contact information in the FOR FURTHER INFORMATION CONTACT section
above no later than Friday, January 27, 2012. Any written materials
NHTSA presents at the workshop will be available electronically on the
day of the workshop to accommodate the needs of the visually impaired.
A transcript of the workshop will be created, however speakers may also
submit materials to the docket for the record.

How long will I have to speak at the public workshop?

    Once NHTSA learns how many people have registered to speak at the
public workshop, NHTSA will allocate an appropriate amount of time to
each participant, allowing time for lunch and necessary breaks
throughout the day. For planning purposes, each speaker should
anticipate speaking for approximately ten minutes, although we may need
to adjust the time for each speaker if there is a large turnout. To
accommodate as many speakers as possible, NHTSA prefers that speakers
not use technological aids (e.g., audio-visuals, computer slideshows).
However, if you plan to do so, you must let Ms. Mary Versailles know by
Friday, January 27, 2012, using the contact information in the FOR
FURTHER INFORMATION CONTACT section above. You also must make
arrangements to provide your presentation or any other aids to NHTSA in
advance of the workshop in order to facilitate set-up.

How do I prepare and submit written comments?

    It is not necessary to attend or to speak at the public workshop to
be able to comment on the issues. NHTSA invites the submission of
written comments, which the agency will consider in preparing its
SNPRM. Your comments must be written and in English. To ensure that
your comments are correctly filed in the Docket, please include the
docket number at the beginning of this notice in your comments.
    Your primary comments may not exceed 15 pages. However, you may
attach supporting documents to your primary comments. There is no limit
to the length of the attachments.
    Anyone is able to search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register at 65

FR 19477, April 11, 2000, or you may visit http://www.regulations.gov.
    If you wish Docket Management to notify you upon its receipt of
your comments, enclose a self-addressed, stamped postcard in the
envelope containing your comments. Upon receiving your comments, Docket
Management will return the postcard by mail.

How do I submit confidential business information?

    If you wish to submit any information under a claim of
confidentiality, send three copies of your complete submission,
including the information you claim to be confidential business
information, to the Chief Counsel, National Highway Traffic Safety
Administration, 1200 New Jersey Avenue SE., Washington, DC 20590.
Include a cover letter supplying the information specified in our
confidential business information regulation (49 CFR part 512).
    In addition, send two copies from which you have deleted the
claimed confidential business information to Docket Management, 1200
New Jersey Avenue SE., West Building, Room W12-140, Washington, DC
20590, or submit them electronically, in the manner described at the
beginning of this notice.

Will the agency consider late comments?

    NHTSA will consider all comments that Docket Management receives
before the close of business on the comment closing date indicated
above under DATES. To the extent the rulemaking schedule allows, NHTSA
will try to consider comments that Docket Management receives after
that date, but we cannot ensure that we will be able to do so.
    Please note that even after the comment closing date we will
continue to file relevant information in the docket as it becomes
available. Further, some commenters may submit late comments.
Accordingly, we recommend that you periodically check the docket for
new material.

Rulemaking Analyses and Notices

Executive Orders 12866 and 13563 and DOT Regulatory Policies and
Procedures

    Executive Order 12866, ``Regulatory Planning and Review,'' and
Executive Order 13563, ``Improving Regulation and Regulatory Review,''
and the Department of Transportation's regulatory policies require this
agency to make determinations as to whether a regulatory action is
``significant'' and therefore subject to OMB review and the
requirements of the aforementioned Executive Orders. Executive Order
12866 defines a ``significant regulatory action'' as one that is likely
to result in a rule that may:
    (1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or Tribal governments or
communities;
    (2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
    (4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
    We have considered the potential impact of this rulemaking under
Executive Order 12866, Executive Order 13563, and the Department of
Transportation's regulatory policies and procedures. This document
invites interested parties to submit written comments and participate
in a public meeting on topics related to the development of a SNPRM
that will propose requirements for the consumer information and
education portions of the Tire Fuel Efficiency Consumer Information
Program. We cannot now determine how the costs and benefits of the yet-
to-be-developed supplemental proposal might differ from those described
in the Preliminary Regulatory Impact Analysis that accompanied the June
22, 2009, NPRM. (Docket No. NHTSA-2008-0121-0015.) A full analysis of
the costs and benefits will be released with the SNPRM.

Other Analyses

    Because we have not yet determined the requirements that will be
proposed in the SNPRM, it would be premature to conduct any analyses
pursuant to the applicable requirements of the National Environmental
Policy Act, the Regulatory Flexibility Act, Executive Order 13132
(Federalism), Executive Order 12988 (Civil Justice Reform), the
Unfunded Mandates Reform Act, the Paperwork Reduction Act, Executive
Order 13045 (Protection of Children from Environmental Health and
Safety Risks), the National Technology Transfer and Advancement Act,
and Executive Order 13211(Energy Effects). We will provide all
necessary analyses pursuant to these regulatory requirements in the
SNPRM.

    Issued: January 19, 2012.
Christopher J. Bonanti,
Associate Administrator for Rulemaking.
[FR Doc. 2012-1525 Filed 1-20-12; 4:15 pm]
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