[Federal Register Volume 76, Number 166 (Friday, August 26, 2011)]
[Rules and Regulations]
[Pages 53328-53329]
[FR Doc No: 2011-21832]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0855; Amendment No. 71-43]

Airspace Designations; Incorporation by Reference

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Title 14 Code of Federal Regulations (14
CFR) part 71 relating to airspace designations to reflect the approval
by the Director of the Federal Register of the incorporation by
reference of FAA Order 7400.9V, Airspace Designations and Reporting
Points. This action also explains the procedures the FAA will use to
amend the listings of Class A, B, C, D, and E airspace areas; air
traffic service routes; and reporting points incorporated by reference.

DATES: These regulations are effective September 15, 2011, through
September 15, 2012. The incorporation by reference of FAA Order 7400.9V
is approved by the Director of the Federal Register as of September 15,
2011, through September 15, 2012.

FOR FURTHER INFORMATION CONTACT: Sarah A. Combs, Airspace, Regulations
and ATC Procedures Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    FAA Order 7400.9U, Airspace Designations and Reporting Points,
effective September 15, 2010, listed Class A, B, C, D and E airspace
areas; air traffic service routes; and reporting points. Due to the
length of these descriptions, the FAA requested approval from the
Office of the Federal Register to incorporate the material by reference
in the Federal Aviation Regulations section 71.1, effective September
15, 2010, through September 15, 2011. During the incorporation by
reference period, the FAA processed all proposed changes of the
airspace listings in FAA Order 7400.9U in full text as proposed rule
documents in the Federal Register. Likewise, all amendments of these
listings were published in full text as final rules in the Federal
Register. This rule reflects the periodic integration of these final
rule amendments into a revised edition of Order 7400.9V, Airspace
Designations and Reporting Points. The Director of the Federal Register
has approved the incorporation by reference of FAA Order 7400.9V in
section 71.1, as of September 15, 2011 through September 15, 2012. This
rule also explains the procedures the FAA will use to amend the
airspace designations incorporated by reference in part 71. Sections
71.5, 71.15, 71.31, 71.33, 71.41, 71.51, 71.61, 71.71, and 71.901 are
also updated to reflect the incorporation by reference of FAA Order
7400.9V.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 to reflect the approval by the Director of the Federal Register
of the incorporation by reference of FAA Order 7400.9V, effective
September 15, 2011, through September 15, 2012. During the
incorporation by reference period, the FAA will continue to process all
proposed changes of the airspace listings in FAA Order 7400.9V in full
text as proposed rule documents in the Federal Register. Likewise, all
amendments of these listings will be published in full text as final
rules in the Federal Register. The FAA will periodically integrate all
final rule amendments into a revised edition of the Order, and submit
the revised edition to the Director of the Federal Register for
approval for incorporation by reference in section 71.1.
    The FAA has determined that this action: (1) Is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under DOT Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3) does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. This
action neither places any new restrictions or requirements on the
public, nor changes the dimensions or operation requirements of the
airspace listings incorporated by reference in part 71.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR 1959-1963 Comp., p. 389.

0
2. Section 71.1 is revised to read as follows:

Sec.  71.1  Applicability.

    A listing for Class A, B, C, D, and E airspace areas; air traffic
service routes; and reporting points can be found in FAA Order 7400.9V,
Airspace Designations and Reporting Points, dated August 9, 2011. This
incorporation by reference was approved by the Director of the Federal
Register in accordance with 5 U.S.C. 552 (a) and 1 CFR part 51. The
approval to incorporate by reference FAA Order 7400.9V is effective
September 15, 2011, through September 15, 2012. During the
incorporation by reference period, proposed changes to the listings of
Class A, B, C, D, and E airspace areas; air traffic service routes; and
reporting points will be published in full text as proposed rule
documents in the Federal Register. Amendments to the listings of Class
A, B, C, D, and E airspace areas; air traffic service routes; and
reporting points will be published in full text as final rules in the
Federal Register. Periodically, the final rule amendments will be
integrated into a revised edition of the Order and submitted to the
Director of the Federal Register for approval for incorporation by
reference in this section. Copies of FAA Order 7400.9V may be obtained
from Airspace, Regulations and ATC Procedures Group, Federal Aviation
Administration, 800 Independence Avenue, SW., Washington, DC 20591,
(202) 267-8783. An electronic version of the Order is available on the
FAA Web site at http://www.faa.gov/air_traffic/publications. Copies of
FAA Order 7400.9V may be inspected in Docket No. FAA-2011-0855;
Amendment No. 71-43 on http;//www.regulations.gov. A copy of FAA Order
7400.9V may be inspected at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

Sec.  71.5  [Amended]

0
3. Section 71.5 is amended by removing the words ``FAA Order 7400.9U''
and adding, in their place, the words ``FAA Order 7400.9V.''

Sec.  71.15  [Amended]

0
4. Section 71.15 is amended by removing the words ``FAA Order 7400.9U''
and adding, in their place, the words ``FAA Order 7400.9V.''

Sec.  71.31  [Amended]

0
5. Section 71.31 is amended by removing the words ``FAA Order 7400.9U''
and adding, in their place, the words ``FAA Order 7400.9V.''

Sec.  71.33  [Amended]

0
6. Paragraph (c) of Sec.  71.33 is amended by removing the words ``FAA
Order 7400.9U'' and adding, in their place, the words ``FAA Order
7400.9V.''

Sec.  71.41  [Amended]

0
7. Section 71.41 is amended by removing the words ``FAA Order 7400.9U''
and adding, in their place, the words ``FAA Order 7400.9V.''

Sec.  71.51  [Amended]

0
8. Section 71.51 is amended by removing the words ``FAA Order 7400.9U''
and adding, in their place, the words ``FAA Order 7400.9V.''

Sec.  71.61  [Amended]

0
9. Section 71.61 is amended by removing the words ``FAA Order 7400.9U''
and adding, in their place, the words ``FAA Order 7400.9V.''

Sec.  71.71  [Amended]

0
10. Paragraphs (b), (c), (d), (e), and (f) of Sec.  71.71 are amended
by removing the words ``FAA Order 7400.9U'' and adding, in their place,
the words ``FAA Order 7400.9V.''

Sec.  71.901  [Amended]

0
11. Paragraph (a) of Sec.  71.901 is amended by removing the words
``FAA Order 7400.9U'' and adding, in their place, the words ``FAA Order
7400.9V.''

    Issued in Washington, DC, on August 22, 2011.
Gary A. Norek,
Acting Manager, Airspace, Regulations, & ATC Procedures Group.
[FR Doc. 2011-21832 Filed 8-25-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 226 (Monday, November 29, 2021)]
[Notices]
[Pages 67755-67757]
[FR Doc No: 2021-25871]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. PA-57A; File No. S7-14-21]

Privacy Act of 1974; System of Records

AGENCY: Securities and Exchange Commission.

ACTION: Notice of a new system of records.

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SUMMARY: The Securities and Exchange Commission (SEC) proposes to
establish SEC-34, Public Health and Safety Records under the Privacy
Act of 1974. This system of records maintains information collected in
response to a public health emergency. Information will be collected
from SEC personnel (political appointees, employees, consultants,
detailees, interns, and volunteers), contractors, visitors, job
applicants, and others who access or seek to access SEC facilities or
worksites to assist the SEC with maintaining a safe and healthy
workplace and to protect its workforce from risks associated with
communicable diseases.

DATES: The changes will become effective November 29, 2021, to permit
public comment on the revised routine uses. The Commission will publish
a new notice if the effective date is delayed to review comments or if
changes are made based on comments received. To assure consideration,
comments should be received on or before November 29, 2021.

ADDRESSES: Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/other.shtml); or
     Send an email to [email protected]. Please include
File Number S7-14-21 on the subject line.

Paper Comments

    Send paper comments to Vanessa A. Countryman, Secretary, U.S.
Securities and Exchange Commission, 100 F Street NE, Washington, DC
20549-1090. All submissions should refer to S7-14-21. This file number
should be included on the subject line if email is used. To help
process and review your comments more efficiently, please use only one
method. The Commission will post all comments on the Commission's
internet website (http://www.sec.gov/rules/other.shtml). Comments are
also available for website viewing and printing in the Commission's
Public Reference Room, 100 F Street NE, Washington, DC 20549, on
official business days between the hours of 10 a.m. and 3 p.m. All
comments received will be posted without change; we do not edit
personal identifying information from submissions. You should submit
only information that you wish to make publicly available.

FOR FURTHER INFORMATION CONTACT: For general and privacy related
questions please contact: Ronnette McDaniel, Privacy and Information
Assurance Branch Chief,<PHONE_NUMBER> or [email protected].

SUPPLEMENTARY INFORMATION: In order to collect and maintain contractor,
visitor and job applicant disclosures, the SEC established SEC-34,
Public Health and Safety Records, a system of records under the Privacy
Act. The SEC is committed to maintaining a safe and healthy workplace
and to protect its workforce from risks associated with a public health
emergency. To ensure and maintain the safety of all SEC personnel
(political appointees, employees, consultants, detailees, interns, and
volunteers), contractors, visitors, job applicants, and others who
access or seek to access an SEC facility, space, or worksite during a
public health emergency, the SEC may develop and institute safety
measures that require the collection of personal information. Records
may include information on individuals' vaccination status and
information to support a request for reasonable accommodation based on
disability or sincerely held religious belief. Records also may include
information on individuals who have been suspected or confirmed to have
contracted a disease or illness, or who have been exposed to an
individual who had been suspected or confirmed to have contracted a
disease or illness, related to a declared public health emergency.
Records may also include information on the individual circumstances
surrounding the disease or illness such as dates of suspected exposure,
testing results, symptoms, treatments, and other related health status
information. Any contact tracing conducted by SEC personnel will
involve collecting information about SEC personnel, contractors and
visitors who are exhibiting symptoms or who have tested positive for an
infectious disease in order to identify and notify other SEC personnel,
contractors and visitors with whom they may have come into contact and
who may have been exposed. Records may also include information on
individuals identified as emergency contacts for SEC personnel.
Information from this system of records will be collected, maintained,
and disclosed in accordance with applicable law, regulations, and
statutes, including, but not limited to; the Americans with
Disabilities Act of 1990 and regulations and guidance published by the
U.S. Occupational Safety and Health Administration, the U.S. Equal
Employment Opportunity Commission, and the U.S. Centers for Disease
Control and Prevention.

SYSTEM NAME AND NUMBER:
    SEC-34 Public Health and Safety Records.

SECURITY CLASSIFICATION:
    Non-classified.

SYSTEM LOCATION:
    Securities and Exchange Commission (SEC), 100 F Street NE,
Washington, DC 20549. Files may also be maintained in the following SEC
Regional Offices: Atlanta Regional Office (ARO), 950 East Paces Ferry
Road NE, Suite 900, Atlanta, GA 30326-1382; Boston Regional Office
(BRO), 33 Arch Street, 24th Floor, Boston, MA 02110-1424; Chicago
Regional Office (CHRO), 175 W Jackson Boulevard, Suite 1450, Chicago,
IL 60604; Denver Regional Office (DRO), Byron Rogers Federal Office
Building, 1961 Stout Street, Suite 1700, Denver, CO 80294-1961; Fort
Worth Regional Office (FWRO), Burnett Plaza, 801 Cherry Street, Suite
1900, Unit 18, Fort Worth, TX 76102; Los Angeles Regional Office
(LARO), 444 South Flower Street, Suite 900, Los Angeles, CA 90071;
Miami Regional Office (MIRO), 801 Brickell Avenue, Suite 1950, Miami,
FL 33131; New York Regional Office (NYRO), Brookfield Place, 200 Vesey
Street, Suite 400, New York, NY 10281-1022; Philadelphia Regional
Office (PLRO), One Penn Center, 1617 John F. Kennedy Boulevard, Suite
520, Philadelphia, PA 19103-1844; Salt Lake Regional Office (SLRO), 351
S West Temple St., Suite 6.100, Salt Lake City, UT 84101; and San
Francisco Regional

Office (SFRO), 44 Montgomery Street, Suite 2800, San Francisco, CA
94104.

SYSTEM MANAGER(S):
    Chief Operating Officer, Securities and Exchange Commission, 100 F
Street NE, Washington, DC 20549.

AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
    The authority to collect this information derives from General Duty
Clause, Sections 5(a)(1) and 19(a) of the Occupational Safety and
Health (OSH) Act of 1970 (29 U.S.C. 654(a)(1), 668(a)); Section 319 of
the Public Health Service Act (42 U.S.C. 247d); E.O. 12196,
Occupational Safety and Health Programs for Federal Employees (Feb. 26,
1980); Section 791 of the Rehabilitation Act of 1973 (Pub. L. 93-112),
as amended; Section 701(j) of Title VII, Civil Rights Act of 1964, as
amended (42 U.S.C. 2000e); Executive Order 13164, Requiring Federal
Agencies To Establish Procedures To Facilitate the Provision of
Reasonable Accommodation (July 26, 2000); 29 CFR 1605 and 1614; E.O
13991, Protecting the Federal Workforce and Requiring Mask-Wearing;
(Jan. 25, 2021); Executive Order on Ensuring Adequate COVID Safety
Protocols for Federal Contractors (September 9, 2021); Executive Order
on Requiring Coronavirus Disease 2019 Vaccination for Federal Employees
(September 9, 2021); OMB Memorandum M-20-23 Aligning Federal Agency
Operations with the National Guidelines for Opening Up America Again
(Apr. 20, 2020); and OMB Memorandum M-21-15 COVID-19 Safe Federal
Workplace: Agency Model Safety Principles (Jan. 24, 2021). Information
will be collected and maintained in accordance with the Americans with
Disabilities Act of 1990 (42 U.S.C. 12101 et seq.)

PURPOSE(S) OF THE SYSTEM:
    The information in the system is collected to assist the SEC with
maintaining a safe and healthy workplace and to protect its workforce
from risks associated with communicable diseases that the Secretary of
the Department of Health and Human Services has determined to be a
public health emergency pursuant to Section 319(a) of the Public Health
Service Act (42 U.S.C. 247d(a)) (``Public Health Emergency''). Records
in this system may be collected, maintained, and used to: (1) Determine
who may be allowed access to SEC facilities or worksites and what
testing or medical screening is necessary before a person may enter;
(2) respond to a significant risk of harm to SEC personnel,
contractors, and visitors, as well as to any others in SEC facilities
or worksites; (3) document reports that SEC personnel, contractors, or
any persons who have been in SEC facilities or worksites may have or
may have been exposed to a communicable disease that is the subject of
a Public Health Emergency; (4) perform contact tracing investigations
of and notifications to SEC personnel, contractors, and visitors known
or suspected of exposure to communicable diseases that are the subject
of a Public Health Emergency; (5) inform federal, state, or local
public health authorities so that these authorities may act to protect
public health as allowed or required by law; (6) implement such actions
(e.g. quarantine or isolation) as necessary to prevent the
introduction, transmission, and spread of a communicable disease that
is the subject of a Public Health Emergency by SEC personnel,
contractors, and persons who have been in SEC facilities or worksites;
(7) comply with Occupational Safety and Health Administration Act
recordkeeping requirements; and (8) process employee requests for
reasonable accommodation based on disability or sincerely held
religious belief.

CATEGORIES OF INDIVIDUALS COVERED BY THE SYSTEM:
    Individuals covered by this system include all SEC personnel
(political appointees, employees, consultants, detailees, interns, and
volunteers), contractors, visitors, job applicants, and others who
access or seek to access SEC facilities or worksites. The system also
covers individuals identified as emergency contacts for SEC staff.

CATEGORIES OF RECORDS IN THE SYSTEM:
    Information collected and maintained may include, but is not
limited to:

    --Biographical information: Name and contact information.
    --Health information: Body temperature, dates of and symptoms
relating to a potential or actual exposure to a pathogen, or
immunization and/or vaccination information.
    --Information to support a request for reasonable accommodation
based on disability or sincerely held religious belief.
    --Contact tracing information: Dates of visits to SEC facilities,
locations visited within the facility (e.g., office and cubicle
number), the duration of time spent in the facility, dates the SEC was
made aware of the exposure, and potential contacts between potentially
contagious persons and others in SEC facilities.
    --Testing Results: Negative results, confirmed or unconfirmed
positive test results, and documents related to the reasons for testing
or other aspects of test results.
    --Subsequent actions taken by the SEC to address an incident:
Identifying and contact information of individuals who have been
suspected or confirmed to have contracted a communicable disease that
is the subject of a Public Health Emergency, or who have been exposed
to an individual who has been suspected or confirmed to have contracted
a communicable disease that is the subject of a Public Health
Emergency; individual circumstances and dates of suspected exposure;
symptoms; and treatments. The SEC uses this information to maintain a
safe and healthy workplace and to protect its workforce. Although it is
not the intent for the SEC to collect family medical information, an
individual may indicate that they were exposed to specific family
members who have been diagnosed with, or are suspected to have, the
disease in question. To the extent this information may be acquired
inadvertently, such information will be kept as a confidential medical
record and maintained separately from an employee's SEC personnel file.

RECORD SOURCE CATEGORIES:
    The information in this system is collected directly from the
individual or from the individual's emergency contact. Information may
also be collected from security systems that monitor access to SEC
facilities, such as badging systems, video surveillance, human
resources systems, emergency notification systems, and federal, state,
and local agencies assisting with the response to a Public Health
Emergency. Information may also be collected from SEC contractors or
from property management companies responsible for managing office
buildings that house SEC facilities or worksites, including the General
Services Administration (GSA).

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES
OF USERS AND THE PURPOSES OF SUCH USES:
    In addition to those disclosures generally permitted under 5 U.S.C.
552a(b) of the Privacy Act, these records or information contained
therein may specifically be disclosed outside the Commission as a
routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
    1. To appropriate agencies, entities, and persons when (1) SEC
suspects or has confirmed that there has been a breach of the system of
records; (2) the SEC has determined that as a result of the suspected
or confirmed breach there is a risk of harm to individuals, the SEC

(including its information systems, programs, and operations), the
Federal Government, or national security; and (3) the disclosure made
to such agencies, entities, and the SEC's efforts to respond to the
suspected or confirmed breach or to prevent, minimize, or remedy such
harm.
    2. To a Federal, State, or local agency to the extent necessary to
comply with laws governing reporting of infectious disease.
    3. To SEC personnel, contractors, visitors, emergency contacts, or
others to notify an individual (1) who has been exposed or may have
potentially been exposed to a communicable disease that is the subject
of a Public Health Emergency of information regarding the exposure or
potential exposure, or (2) who may have reason to know of circumstances
that increase the risk of such exposure. To the extent possible, all
information will be anonymized.
    4. To another Federal agency, to a court, or a party in litigation
before a court or in an administrative proceeding being conducted by a
Federal agency when the SEC is a party to the judicial or
administrative proceeding where the information is relevant and
necessary to the proceeding.
    5. To employees, grantees, experts, contractors, and others who
have been engaged by the Commission to assist in the performance of a
service related to this system of records and who need access to the
records for the purpose of assisting the Commission in the efficient
administration of its programs, including by performing clerical,
stenographic, or data analysis functions, or by reproduction of records
by electronic or other means. Recipients of these records shall be
required to comply with the requirements of the Privacy Act of 1974, as
amended, 5 U.S.C. 552a.
    6. To a Congressional office from the record of an individual in
response to an inquiry from the Congressional office made at the
request of that individual.
    7. To another Federal agency or Federal entity, when the SEC
determines that information from this system of records is reasonably
necessary to assist the recipient agency or entity in (1) responding to
a suspected or confirmed breach or (2) preventing, minimizing, or
remedying the risk of harm to individuals, the recipient agency or
entity (including its information systems, programs, and operations),
the Federal Government, or national security, resulting from a
suspected or confirmed breach.

POLICIES AND PRACTICES FOR STORAGE OF RECORDS:
    Records in this system of records are stored electronically or on
paper in secure facilities. Electronic records are stored on the SEC's
secure network.

POLICIES AND PRACTICES FOR RETRIEVAL OF RECORDS:
    Information covered by this system of records notice may be
retrieved by the name of the individual, contact information, or by
some combination thereof.

POLICIES AND PRACTICES FOR RETENTION AND DISPOSAL OF RECORDS:
    The records will be maintained until they become inactive, at which
time they will be retired or destroyed in accordance with records
schedules of the United States Securities and Exchange Commission, and
as approved by the National Archives and Records Administration.

ADMINISTRATIVE, TECHNICAL, AND PHYSICAL SAFEGUARDS:
    Access to SEC facilities, data centers, and information or
information systems is limited to authorized personnel with official
duties requiring access. SEC facilities are equipped with security
cameras, and, at certain SEC facilities, 24-hour security guard
service. Computerized records are safeguarded in a secured environment.
Security protocols meet the promulgating guidance as established by the
National Institute of Standards and Technology (NIST) Security
Standards from Access Control to Data Encryption and Security
Assessment & Authorization (SA&A). Records are maintained in a secure,
password-protected electronic system that will utilize commensurate
safeguards that may include: Firewalls, intrusion detection and
prevention systems, and role-based access controls. Additional
safeguards will vary by program. All records are protected from
unauthorized access through appropriate administrative, operational,
and technical safeguards. These safeguards include: restricting access
to authorized personnel who have a ``need to know''; using locks; and
password protection identification features. Contractors and other
recipients providing services to the Commission shall be required to
maintain equivalent safeguards.

RECORD ACCESS PROCEDURES:
    Persons seeking to gain access to any record contained in this
system of records may inquire in writing in accordance with
instructions in SEC Privacy Act Regulations; 17 CFR 200.301 et seq.
Address such request to: FOIA/PA Officer, Securities and Exchange
Commission, 100 F Street NE, Mail Stop 5100, Washington, DC 20549-2736.

CONTESTING RECORD PROCEDURES:
    Persons seeking to contest the content of any record contained in
this system of records may inquire in writing in accordance with
instructions in SEC Privacy Act Regulations, 17 CFR 200.301 et seq.
Address such requests to: FOIA/PA Officer, Securities and Exchange
Commission, 100 F Street NE, Mail Stop 5100, Washington, DC 20549-2736.

NOTIFICATION PROCEDURES:
    See ``Record Access Procedures'' above.

EXEMPTIONS PROMULGATED FOR THE SYSTEM:
    None.

HISTORY:
    Release No. PA-57; File No. S7-14-21; 86 FR 60496, November 2,
2021.

    By the Commission.

    Dated: November 22, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-25871 Filed 11-26-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: May 16, 2006 (Volume 71, Number 94)]
[Notices]
[Page 28312-28313]
[DOCID:fr16my06-59]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-348-000]

ANR Pipeline Company; Notice of Tariff Filing

May 9, 2006.
    Take notice that on May 5, 2006, ANR Pipeline Company (ANR)
tendered for filing as part of its FERC Gas Tariff, Second Revised
Volume No. 1, Fifth Revised Sheet No. 108, with an effective date of
June 5, 2006.
    Any person desiring to intervene or to protest this filing must
file in

accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed in accordance with the provisions of Section 154.210 of
the Commission's regulations (18 CFR 154.210). Anyone filing an
intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

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

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

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-7381 Filed 5-15-06; 8:45 am]

BILLING CODE 6717-01-P


  SEQ CHAPTER \h \r 1 FILE NAME:   company.wpt   (5/11/2007) (xml)

ATTENTION:

	All commodity terms must comply with the Food and Feed Commodity
Vocabulary database (http://www.epa.gov/pesticides/foodfeed/).

	All text in blue font (instructions for preparing the document), should
be removed prior to sending the document to the Federal Register Staff.
Instructional text and prompts in green font should also be removed.

COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE

(5/11/2007)

EPA Registration Division contact: Shaja R. Brothers<PHONE_NUMBER>

INSTRUCTIONS:  Please utilize this outline in preparing tolerance
petition documents.  In cases where the outline element does not apply
please insert “NA-Remove” and maintain the outline.  The comment
notes that appear on the left margin represent hidden typesetting codes
designed to expedite the processing of the Federal Register document.
Please do not remove or alter these comment notes or change the margins,
font, or format  in your document. Simply replace the instructions that
appear in italics and brackets, i.e., “[insert company name],” with
the information specific to your action.

TEMPLATE:

Interregional Research Project Number 4

PP No.: 7E7227

	EPA has received a pesticide petition ([PP No.: 7E7227) from IR-4, 500
College Road, Suite 201 W, Princeton, NJ 08540 proposing, pursuant to
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(d), to amend 40 CFR part 180. by establishing a tolerance
for residues of bifenthrin ((2-methyl 1,1 -biphenyl-3-yl)
methyl-3-(2-chloro-3,3,3,-trifluoro-1-propenyl)-2,2-dimethylcyclopropane
carboxylate] in or on the following raw agricultural commodities:
bushberry subgroup 13-B and juneberry;  lingonberry; salal; aronia
berry; blueberry, lowbush; buffalo currant; chilean guava;  european
barberry; highbush cranberry; honeysuckle; jostaberry; native currant;
sea buckthorn at 2.0 ppm, and leafy petioles subgroup 4-B at 3.0 ppm.
EPA has determined that the petition contains data or information
regarding the elements set forth in section 408(d)(2) of the FFDCA;
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data support granting of the petition.
Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism. The metabolism of bifenthrin in plants is
adequately understood. Studies have been conducted to delineate the
metabolism of radiolabelled bifenthrin in various crops all showing
similar results. The residue of concern is the parent compound only.

	2. Analytical method. There is a practical analytical method for
detecting and measuring levels of bifenthrin in or on food with a limit
of detection that allows monitoring of food with residues at or above
the levels set in these tolerances (Gas Chromatography with Electron
Capture Detection (GC/ECD).

	3. Magnitude of residues. Field residue trials meeting EPA study
requirements have been conducted at the maximum label rate for the crops
blueberries and celery.  Results from the studies demonstrate that the
highest bifenthrin residues found will not exceed the proposed
tolerances for bushberry subgroup 13B, juneberry, lingonberry, salal,
aronia berry, blueberry, lowbush, buffalo currant, chilean guava,
european barberry, highbush cranberry, honeysuckle, jostaberry, native
currant, sea buckthorn at 2.0 ppm,  and leafy petiole subgroup 4-B at
3.0 ppm when bifenthrin is applied following the proposed use
directions.

B. Toxicological Profile

	1. Acute toxicity.  For the purposes of assessing acute dietary risk,
FMC has used the results of the 2003 EPA completed risk assessment for
bifenthrin. This acute dietary endpoint  used to determine acute dietary
risks to the general population including infants and children is from
the acute neurotoxicity study in rats, LOAEF = 70.3 mg ai/kg, NOAEL =
32.8 mg ai/kg, UF = 1000, Acute RfD = 0.033 mg/kg/day

	2. Genotoxicty.  The mouse lymphoma mutagenesis assay gave a weak
positive result; however, the weight of the evidence from short-term
mutagenicity tests indicate that bifenthrin is not mutagenic.

	3. Reproductive and developmental toxicity.  i. Rat reproduction study.
 Parental toxicity occurred as decreased body weight at 5.0 mg/kg/day
with a no observed adverse effect level (LOAEL) of 3.0 mg/kg/day.  There
were no developmental (pup) or reproductive effects up to 5.0 mg/kg/day
(highest dose tested).

	ii. Postnatal Sensitivity.  Based on the absence of pup toxicity up to
dose levels, which produced toxicity in the parental animals, there was
no evidence of special postnatal sensitivity to infants and children in
the rat reproduction study.  In a developmental neurotoxicity study,
pups were not more sensitive than the dams.  The NOELs for maternal and
developmental neurotoxicity were both 50 ppm.

	4. Subchronic toxicity.  The results of the 21-day dermal toxicity
study in rats is used for short-term (1-30 days), intermediate-term (1-6
months) and long-term (> 6 months) dermal risk calculations.  The 21-day
dermal toxicity study NOEL for systemic toxicity is 47 mg ai/kg/day
based on observations of clinical signs (exaggerated hindlimb flexion
and staggered gait).

	5. Chronic toxicity. The reference dose (RfD) has been established at
0.004 mg/kg/day.  This RfD is based on a one-year oral study in dogs
with a LOAEF of 2.7 mg ai/kg/day and a NOAEL of 1.3  mg ai/kg/day, UF =
300 based on observations of increased incidence of tremors in both
sexes.

	Bifenthrin is classified as a Group C chemical (possible human
carcinogen); No Q1* has been derived.

	6. Animal metabolism. The metabolism of bifenthrin in animals is
adequately understood.  Metabolism studies in rats with single doses
demonstrated that about 90% of the parent compound and its hydroxylated
metabolites are excreted.

	7. Metabolite toxicology. The Agency has previously determined that the
metabolites of bifenthrin are not of toxicological concern and need not
be included in the tolerance expression.

	8. Endocrine disruption.  No special studies investigating potential
estrogenic or other endocrine effects of bifenthrin have been conducted.
 However, no evidence of such effects was reported in the standard
battery of required toxicology studies, which have been completed and
found acceptable.  Based on these studies, there is no evidence to
suggest that bifenthrin has an adverse effect on the endocrine system.

C. Aggregate Exposure

	1. Dietary exposure. Tolerances have been established for the residues
of bifenthrin, in or on a variety of raw agricultural commodities.
Tolerances, in support of registrations, currently exist for residues of
bifenthrin on the following crops: hops, strawberries, corn (grain,
forage and fodder), sweet corn, eggplant, cottonseed, artichokes,
peppers (bell and non-bell), lettuce (head), grapes, spinach, cabbage,
rapeseed, tomatoes, Food Handling Establishments, banana (import),
pears, okra, cilantro .  Also for the crop groups: vegetables, cucurbit,
group 9, fruit, citrus, group 10 and nuts, tree, group 14 and the
subgroups: vegetable, legume, edible podded, subgroup 6A, pea and bean,
succulent shelled, subgroup 6B, caneberry subgroup 13A, and brassica,
head and stem, subgroup 5A, herb subgroup 19A, leaf petioles subgroup
4B, vegetables tuberous and corm, subgroup 1C, pea and bean, dried
shelled, except soybeans, subgroup 6C.  Also, for the livestock
commodities of cattle, goats, hogs, horses, sheep, poultry, eggs, and
milk.  Pending tolerances for mayhaw, peanut, soybeans, root crops
subgroup 1B, and fruiting vegetables group 8 also exist.  For the
purposes of assessing the potential dietary exposure for these existing
and pending tolerances, EPA conducted an exposure estimate using Dietary
Exposure Evaluation Model – Food Commodity Intake Database TM
(DEEM-FCIDTM) Version 2.04, results from field trials and processing
studies, monitoring data, consumption data from the 1989-1992, USDA
Continuing Surveys of Food Intakes by Individuals (CSFII), and
information on the percentages of the crops treated (where available)
with bifenthrin were utilized.

		i. Food.  a. Acute Dietary Exposure risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a 1-day or
single exposure.  For the purposes of assessing acute dietary risk, FMC
has used the results of the 2003 EPA completed risk assessment for
bifenthrin. This acute dietary endpoint  used to determine acute dietary
risks to the general population including infants and children is from
the acute neurotoxicity study in rats, LOAEF = 70.3 mg ai/kg, NOAEL =
32.8 mg ai/kg, UF = 1000, Acute RfD = 0.0328 mg/kg/day.   Available
information on anticipated residues, monitoring data and percent crop
treated (if no estimate was available the conservative estimate of 50%
crop treatment was used) were incorporated into a Tier III analysis;
using Monte Carlo modeling for commodities that may be consumed in a
single serving.  These assessments demonstrate that the MOEs at the
99.9th percentile are greater than the EPA standard of 100% aPAD for all
subpopulations.  The 99.9th percentile of exposure for the overall U.S.
Population is estimated to be 0.006225 mg/kg/day (18.9% aPAD).  The
99.9th percentile of exposure for children 3 to 5 years old (most highly
exposed population subgroup) is estimated to be 0.014898 mg/kg/day
(45.4% aPAD).  The 99.9th percentile of exposure to all infants less
than 1 year old is estimated to be 0.010252 mg/kg/day (31.25% aPAD).
Based on the conservatism used in the analyses, actual dietary exposure
will be less than that presented here.  FMC concludes that based on
adequate % aPAD for all population subgroups there is reasonable
certainty that no harm will result from the proposed additional uses of
bifenthrin.

	b. Chronic Exposure.  The reference dose (RfD) has been established at
0.004 mg/kg/day.  This RfD is based on a one-year oral study in dogs
with a LOAEF of 2.7 mg ai/kg/day and a NOAEL of 1.3  mg ai/kg/day, UF =
300 based on observations of increased incidence of tremors in both
sexes.  The chronic exposures for the U.S. Population are estimated to
be 0.000132 mg/kg/day and utilize 3.3% of the cPAD.  The chronic
exposures for Non-nursing infants (most highly exposed population
subgroup) is estimated to be 0.000322 mg/kg/day and utilizes 8.1% of the
cPAD.  Chronic dietary exposure estimates for all infants (< 1 year old)
is estimated to be 0.000276 mg/kg/day and utilizes 6.9% of the cPAD.
Therefore, FMC concludes with reasonable certainty that no harm will
result from the proposed additional uses of bifenthrin.

	ii. Drinking water. US EPA’s draft SOP for Incorporating Estimates of
Drinking Water Exposure into Aggregate Risk Assessments was used to
perform a drinking water analysis.  This SOP utilizes a variety of tools
to conduct drinking water assessment.  These tools include water models
such as FQPA Index Reservoir Screening Tool (FIRST), PRZM/EXAMS, SCIGROW
and monitoring data.  If monitoring data are not available then the
models are used to predict potential residues in surface water.  A
comparison of the calculated Drinking Water Level of Concern (DWLOC)
value to the Estimated Environmental Concentration (EEC) is made.  If
the DWLOC exceeds the EEC value then there is reasonable certainty that
no harm will result from the short- or intermediate-term aggregate
exposure.  In the case of bifenthrin, monitoring data do not exist, so
the FIRST model was used to estimate a surface water residue and SCIGROW
for the groundwater.

	Based on the analyses the acute aggregate exposures to bifenthrin
residues, the   DWLOC for all seasons for the US population was 831 ppb
while the modeled EEC, was 0.1 and 0.006 ppb for surface water and
ground water respectively.  For children (1-6 year old), the DWLOCs was
147 ppb while the modeled EEC was the same as that for the whole US
population.  For the chronic aggregate exposures to bifenthrin residues,
the   DWLOC for all seasons for the US population was 128 ppb while the
modeled EEC, was 0.1 and 0.006 ppb for surface water and ground water
respectively.  For children (1-6 year old), the DWLOCs was 35 ppb while
the modeled EEC was the same as that for the whole US population.
Since, the calculated DWLOC values for all population subgroups exceeded
the modeled EEC for surface water and ground water residues, there is
reasonable certainty that no harm will result from aggregate exposures
to bifenthrin residues.

	2. Non-dietary exposure. The aggregate residential exposure analyses
were based on conservative screening-level assumptions.  The residential
risk assessments resulted in acceptable MOEs and a clear indication of
reasonable certainty of no harm.  The short-term analyses, all of the
route- and product-specific MOEs were greater than 300 and the aggregate
MOEs were greater than 300 for all population subgroups.  Based on the
above information, FMC concludes that bifenthrin does not pose a risk
due to short- and intermediate-term aggregate exposure.

D. Cumulative Effects

	To our knowledge there are currently no available data or other
reliable information indicating that any toxic effects produced by
bifenthrin would be cumulative with those of other chemical compounds;
thus only the potential risks of bifenthrin have been considered in this
assessment of its aggregate exposure.

E. Safety Determination

	1. U.S. population. Using the conservative exposure assessment analyses
the estimated chronic exposure to the U.S. Population is 0.000132
mg/kg/day and utilizes 3.3% of the cPAD.  In addition, the chronic
exposure estimates for all population subgroups (including infants and
children) are well below the cPAD of 0.004 mg/kg/day.  The acute dietary
exposure analyses at the 99.9th percentile for the U.S. Population is
0.006225 and utilizes 18.9% of the aPAD.  In addition, the acute
exposure estimates for population subgroups of concern (infants and
children) indicate that the maximum %aPAD or %cPAD utilized is 31.25%
(aPAD) and 6.9% (cPAD) .  Based on this information FMC concludes that
there is reasonable certainty that no harm will result from acute and
chronic exposure to bifenthrin.

	2. Infants and children. i. General.  In assessing the potential for
additional sensitivity of infants and children to residues of
bifenthrin, FMC considered data from developmental toxicity studies in
the rat and rabbit, a developmental neurotoxicity study, and a
two-generation reproduction study in the rat.  The developmental
toxicity studies are designed to evaluate adverse effects on the
developing organism resulting from pesticide exposure during prenatal
development to one or both parents.  Reproduction studies provide
information relating to effects from exposure to the systemic toxicity.
FFDCA Section 408 provides that the EPA may apply an additional margin
of safety for infants and children in the case of threshold effects to
account for prenatal and postnatal toxicity and completeness of the
database.

	 ii.  Developmental toxicity studies.  In the rabbit developmental
study, there were no developmental effects observed in the fetuses
exposed to bifenthrin.  The maternal NOAEL was 2.67 mg/kg/day based on
head and forelimb twitching at the LOAEL of 4 mg/kg/day.  In the rat
developmental study, the maternal NOEL was 7.4 mg/kg/day, based on
treatment-related clinical signs and reductions in body weights,
adjusted maternal body weights, and corresponding reductions in food
consumption noted among dams receiving the LOEL of 16.3 mg/kg/day.  The
developmental NOEL was greater than 16.3 mg/kg/day based on lack of any
adverse fetal effects at levels up to and including 16.3 mg/kg/day.

	  iii.  Developmental neurotoxicity study.  In a rat developmental
neurotoxicity study, pups were not more sensitive than the dams.  The
NOEL for maternal toxicity was 50 ppm, based on tremors at the LOEL of
100 ppm.  The NOEL for developmental neurotoxicity was also 50 ppm.

	 iv.  Reproductive toxicity study.  In the rat reproduction study,
parental toxicity occurred as decreased body weight at 5.0 mg/kg/day
with a NOAEL of 3.0 mg/kg/day.  There were no developmental (pup) or
reproductive effects up to 5.0 mg/kg/day (highest dose tested).

	v. Conclusion.  Based on the absence of fetal effects and pup toxicity
in any of the referenced studies, FMC concludes that reliable data
support use of the standard 100-fold uncertainty factor, and that an
additional uncertainty factor is not needed to protect the safety of
infants and children.  As previously stated, aggregate exposure
assessments utilized no more than 45.5% of the aPAD or cPAD for either
the entire U.S. Population or any of the population subgroups including
infants and children.  Therefore, it may be concluded that there is
reasonable certainty that no harm will result to infants and children
from aggregate exposure to bifenthrin residues.

F. International Tolerances

	There are no Codex, Canadian, or Mexican residue limits for the residue
of bifenthrin in or on bushberry; juneberry; lingonberry; salal; aronia
berry; blueberry, lowbush;  buffalo currant; chilean guava; european
barberry; highbush cranberry; honeysuckle; jostaberry; native currant;
sea buckthorn; and leafy petiole subcrop 4-B.


[Federal Register Volume 80, Number 91 (Tuesday, May 12, 2015)]
[Notices]
[Page 27231]
[FR Doc No: 2015-11428]

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DEPARTMENT OF TRANSPORTATION

Intelligent Transportation Systems Connected Vehicle Reference
Implementation Architecture Workshop; Notice of Public Meeting

AGENCY: ITS Joint Program Office, Office of the Assistant Secretary for
Research and Technology, U.S. Department of Transportation.

ACTION: Notice.

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

    In continuation of ITS Connected Vehicle Reference Implementation
Architecture (CVRIA) efforts, the U.S. Department of Transportation
(USDOT) Intelligent Transportation System Joint Program Office (ITS
JPO) will present and seek input on the latest results of its Connected
Vehicle architecture developments and standards analysis at a workshop
in Cambridge, Massachusetts, June 10-12, 2015.
    The event will be held at Draper Laboratory, located in the Kendall
Square technology innovation area, and near USDOT's Volpe National
Transportation Systems Center. The event will be presented in two
parts:
     June 10: A training session on:
    [cir] The CVRIA, a consistent framework to guide the planning and
deployment of connected vehicle technologies. The architecture
identifies options for interoperable deployment of technologies from an
enterprise, physical, logical, and communications perspective. It also
facilitates the ability of jurisdictions to operate collaboratively and
to harness the benefits of a regional approach to transportation
challenges.
    [cir] The Systems Engineering Tool for Intelligent Transportation
(SET-IT) Version 1.1, which allows implementers and decision makers to
develop their own architectures for deployment.
    Both are available at: http://www.its.dot.gov/arch/index.htm and
www.iteris.com/cvria.
     June 11-12: A workshop that will provide implementers and
decision makers with:
    [cir] An update on the changes to CVRIA and SET-IT as they move
toward the release of version 2.0 in late June 2015.
    [cir] An update on the standards analysis that was performed using
the CVRIA to identify interfaces that are candidates for
standardization.
    To register for the CVRIA workshop, please visit: www.itsa.org/cvriaregistration.
    For further information, please contact Carlos Alban,
Transportation Program Specialist, Intelligent Transportation Society
of America, 1100 New Jersey Ave. SE., Suite 850 Washington, DC 20003,
202-721-4223<EMAIL_ADDRESS>    Updates will be available on the ITS Program Web site at: http://www.its.dot.gov/ under Press Room: Public Meetings and Events, and on
the ITS Standards Web site at: http://www.standards.its.dot.gov/DevelopmentActivities/CVReference.

SUPPLEMENTARY INFORMATION: The CVRIA training will be conducted on
Wednesday, June 10, 2015 from 9:00-16:00. The workshop will be
conducted on Thursday, June 11, 2015 from 9:00-16:30 and on Friday,
June 12, 2015 from 9:00-13:00. It will take place at Draper Laboratory,
555 Technology Square, Cambridge, MA 02139. Directions to Kendall
Square, local hotel options, and information for access to Draper
Laboratory will be provided to registrants.
    As the results of the CVRIA, interface analysis, and
standardization efforts are expected to affect a wide range of public
and private organizations, it is important that the analyses
incorporate, as appropriate, the needs and requirements of the CV
community. This workshop is an appropriate opportunity for external
stakeholders to engage in the standards discussion.

    Issued in Washington, DC, on the 7th day of May 2015.
Stephen Glasscock,
Program Analyst, ITS Joint Program Office.
[FR Doc. 2015-11428 Filed 5-11-15; 8:45 am]
 BILLING CODE 4910-22-P


[Federal Register Volume 80, Number 58 (Thursday, March 26, 2015)]
[Notices]
[Page 16044]
[FR Doc No: 2015-07048]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold an Open Meeting on March 30, 2015, at
10:30 a.m., in Room 10800 at the Commission's headquarters building, to
hear oral argument in cross-appeals by Francis V. Lorenzo and the
Division of Enforcement from an initial decision of an administrative
law judge.
    On December 31, 2013, the law judge found that Lorenzo violated the
antifraud provisions of Section 17(a) of the Securities Act of 1933,
Section 10(b) of the Securities Exchange Act of 1934, and Exchange Act
Rule 10b-5 when he sent two potential investors emails containing false
and misleading information about his firm's client. The law judge
ordered Lorenzo to cease and desist from violations of the antifraud
provisions, barred him from the securities industry, and ordered him to
pay a civil money penalty of $15,000.
    The issues likely to be considered at oral argument include whether
Lorenzo violated the antifraud provisions as alleged and, if so, the
extent to which he should be sanctioned for those violations.
    The duty officer determined that no earlier notice thereof was
possible. For further information, please contact the Office of the
Secretary at<PHONE_NUMBER>.

    Dated: March 24, 2015.
Brent J. Fields.
Secretary.
[FR Doc. 2015-07048 Filed 3-24-15; 4:15 pm]
 BILLING CODE 8011-01-P


[Federal Register: March 5, 2009 (Volume 74, Number 42)]
[Notices]
[Page 9654-9655]
[DOCID:fr05mr09-89]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59442; File No. SR-OCC-2009-01]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to Amended Interpretative Guidance on the New Methodology for
Adjusting Option Contracts for Cash Dividends and Distributions

February 24, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on January 6, 2009, The
Options Clearing Corporation (``OCC'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change described
in Items I, II, and III below, which items have been prepared primarily
by OCC. OCC filed the proposed rule change pursuant to Section
19(b)(3)(A)(i) of the Act \2\ and Rule 19b-4(f)(1) thereunder \3\ so
that the proposal was effective upon filing with the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested parties.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78s(b)(3)(A)(i).
    \3\ 17 CFR 240.19b-4(f)(1).
---------------------------------------------------------------------------

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

    The proposed rule change would amend previously adopted
interpretative guidance regarding the administration and application of
the new adjustment method for cash dividends and distributions (``New
Methodology'').

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

    In its filing with the Commission, OCC 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. OCC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\4\
---------------------------------------------------------------------------

    \4\ The Commission has modified the text of the summaries
prepared by OCC.
---------------------------------------------------------------------------

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

Background
    In File No. SR-OCC-2008-10, OCC adopted interpretative guidance
developed by the OCC's Securities Committee regarding the New
Methodology.\5\ In File No. SR-OCC-2008-16, OCC proposed a minor
modification to the New Methodology, which was approved by the
Commission on September 18, 2008.\6\ The purpose of this rule change is
to amend the interpretative guidance to address the approved
modification to the New Methodology.
---------------------------------------------------------------------------

    \5\ Securities Exchange Act Release No. 55258 (February 8,
2007), 72 FR 7701 (February 16, 2007).
    \6\ Securities Exchange Act Release No. 58586 (September 18,
2008), 73 FR 55582 (September 25, 2008).
---------------------------------------------------------------------------

Amendment to Interpretative Guidance
    Under the New Methodology, cash dividends paid by a company other
than pursuant to a policy or practice of paying dividends on a
quarterly or other regular basis would be deemed ``special'' and would
ordinarily trigger a contract adjustment provided the value of the
adjustment is at least $12.50 per option contract.\7\ However, certain
inconsistencies may result when the threshold of $12.50 per option
contract is applied to all options on the affected underlying security.
For example, if a $.10 special cash dividend is declared, the standard-
size 100 share option would not be adjusted (because the value is less
than $12.50). However, a previously adjusted 150 share option
(reflecting a 3 for 2 split) would be adjusted (because the value is
$15 per contract). Adjusting some but not all options of the same class
in response to the same dividend event, especially if the 100 share
option is not adjusted, could be confusing to investors, OCC's
Securities Committee (consisting of representatives of each of the
options exchanges and OCC) determined that this potential confusion
should be avoided.
---------------------------------------------------------------------------

    \7\ The New Methodology took effect beginning with dividends
announced on and after February 1, 2009, other than for certain
grandfathered options.
---------------------------------------------------------------------------

    OCC's Securities Committee believed that greater consistency across
contracts of varying sizes could be achieved by retaining the $12.50
per contract threshold in all cases but subjects the threshold amount
to a qualification providing that if a corresponding standard-size
contract exists on the underlying security, previously adjusted
contracts will be adjusted only if the corresponding standard-size
contract is also adjusted. This qualification was the subject of File
No. SR-OCC-2008-16. Implementation of the qualification will take
effect at the same time the New Methodology is effective.
    OCC's previously adopted interpretative guidance regarding the New
Methodology has been amended to address the application of the
qualified $12.50 per contract threshold, including examples of how the
threshold will work in practice. The amended interpretative guidance is
attached to the proposed rule change as Exhibit 5, and will be posted
on OCC's public Web site, made available in an information memorandum
accessible to clearing members, or otherwise made available in hard
copy form on request.\8\
---------------------------------------------------------------------------

    \8\ The proposed rule change, including Exhibit 5, can be found
on OCC's Web site at http://www.theocc.com/publications/rules/
proposed_changes/sr_occ_09_01.pdf.
---------------------------------------------------------------------------

    The proposed rule change is consistent with the requirements of
Section 17A of the Act \9\ and the rules and regulations thereunder
applicable to OCC because it provides market participants with
interpretative guidance on the application of the New Methodology which
will be applied to adjustments for cash dividends and

distributions. The proposed rule change is not inconsistent with the
existing rules of OCC, including any other rules proposed to be
amended.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

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

    OCC does not believe that the proposed rule change would impose any
burden on competition.

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

    Written comments were not and are not intended to be solicited with
respect to the proposed rule change, and none have been received.

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

    The foregoing rule change has become effective upon filing pursuant
to Section 19(b)(3)(A)(i) of the Act \10\ and Rule 19b-4(f)(1) \11\
thereunder because the proposal constitutes an interpretation with
respect to the meaning, administration, or enforcement of an existing
rule of OCC. At any time within sixty days of the filing of such 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.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A)(i).
    \11\ 17 CFR 240.19b-4(f)(1).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml) or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-OCC-2009-01 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
    All submissions should refer to File Number SR-OCC-2009-01. 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. The text of the proposed rule change is available
at OCC, the Commission's Public Reference Room, and http://
www.theocc.com/publications/rules/proposed_changes/sr_occ_09_
01.pdf. 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-OCC-
2009-01 and should be submitted on or before March 26, 2009.

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-4679 Filed 3-4-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 95 (Wednesday, May 17, 2023)]
[Rules and Regulations]
[Pages 31476-31477]
[FR Doc No: 2023-10153]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0356; FRL-9839-02-OCSPP]

Spiropidion; Pesticide Tolerances; Technical Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; technical correction and amendment.

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

SUMMARY: EPA issued a final rule in the Federal Register of July 20,
2022, establishing tolerances for residues of the insecticide
spiropidion and its metabolites and degradates in or on multiple
commodities requested by Syngenta Crop Protection, LLC under the
Federal Food, Drug, and Cosmetic Act (FIFRA). That document
inadvertently misstated the nomenclature listed for the residue
definition of the spiropidion metabolite SYN547305. This document
corrects the noted error in the referenced regulation.

DATES: This final rule correction is effective May 17, 2023.

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0356, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton 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<PHONE_NUMBER>. For the latest status information on
EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Director, Registration
Division (7505T), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. Does this action apply to me?

    The Agency included in the July 20, 2022, final rule a list of
those who may be potentially affected by this action.

II. Why is this correction issued as a final rule?

    Section 553 of the Administrative Procedure Act (APA) (5 U.S.C.
553(b)(3)(B)) provides that, when an agency for good cause finds that
notice and public procedure are impracticable, unnecessary, or contrary
to the public interest, the agency may issue a final rule without
providing notice and an opportunity for public comment since this
correction is not a substantive change at all, just a technical change.
EPA has determined that there is good cause for making this technical
correction final without prior proposal and opportunity for comment,
because EPA is correcting the inadvertent error in the listing for the
nomenclature for the residue definition of the spiropidion metabolite
SYN547305. EPA finds that this constitutes good cause under 5 U.S.C.
553(b)(3)(B). This technical change does not create any new regulatory
requirements that affected parties would need time to prepare for since
it is just a correction of a technical error.

III. Do any of the statutory and executive order reviews apply to this
action?

    No. For a detailed discussion concerning the statutory and
executive order review, refer to Unit VI. of the July 20, 2022, final
rule.

IV. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

V. What does this technical correction do?

    FR Doc. 2022-15410 published in the Federal Register of July 20,
2022 (87 FR 43214) (FRL-9389-01-OCSPP) is corrected as follows:
    1. On page 43215, first column, under the heading ``Summary of
Petitioned-For Tolerance,'' paragraph 1, lines 16-17, revise ``[3-(4-
chloro-2,6-dimethyl-phenyl)-8-methoxy-1-methyl-1,8-
diazaspiro[4.5]decane-2,4-dione; and 2-(4-chloro-2,6-dimethyl-phenyl)-
1-hydroxy-8-methoxy-4-methyl-4,8-diazaspiro[4.5]dec-1-en-3-one]'' to
read ``[3-(4-chloro-2,6-dimethylphenyl)-4-hydroxy-8-methoxy-1-methyl-
1,8-diazaspiro[4.5]dec-3-en-2-one]''.
    2. On page 43218, third column, under the heading ``Conclusion,''
paragraph 1, lines 23-25, revise ``[3-(4-chloro-2,6-dimethyl-phenyl)-8-
methoxy-1-methyl-1,8-diazaspiro[4.5]decane-2,4-dione; and 2-(4-chloro-
2,6-dimethyl-phenyl)-1-hydroxy-8-methoxy-4-methyl-4,8-
diazaspiro[4.5]dec-1-en-3-one]'' to read ``[3-(4-chloro-2,6-
dimethylphenyl)-4-hydroxy-8-methoxy-1-methyl-1,8-diazaspiro[4.5]dec-3-
en-2-one]''.
    3. On page 43218, third column, under the heading ``Conclusion,''
paragraph 1, lines 34-37, revise ``[3-(4-chloro-2,6-dimethyl-phenyl)-8-
methoxy-1-methyl-1,8-diazaspiro[4.5]decane-2,4-dione; and 2-(4-chloro-
2,6-dimethyl-phenyl)-1-hydroxy-8-methoxy-4-methyl-4,8-
diazaspiro[4.5]dec-1-en-3-one]'' to read ``[3-(4-chloro-2,6-
dimethylphenyl)-4-hydroxy-8-

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,

Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: May 9, 2023.
Charles Smith,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR part 180 is corrected by making the following
correcting amendments:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

Sec.  180.723  Spiropidion; tolerances for residues.

0
2. In Sec.  180.723:
0
a. Amend paragraph (a)(1) by revising ``SYN547305 [3-(4-chloro-2,6-
dimethyl-phenyl)-8-methoxy-1-methyl-1,8-diazaspiro[4.5]decane-2,4-
dione; and 2-(4-chloro-2,6-dimethyl-phenyl)-1-hydroxy-8-methoxy-4-
methyl-4,8-diazaspiro[4.5]dec-1-en-3-one],'' to read as ``SYN547305 [3-
(4-chloro-2,6-dimethylphenyl)-4-hydroxy-8-methoxy-1-methyl-1,8-
diazaspiro[4.5]dec-3-en-2-one]''; and
0
b. Amend paragraph (a)(2) by revising ``SYN547305 [3-(4-chloro-2,6-
dimethyl-phenyl)-8-methoxy-1-methyl- 1,8-diazaspiro[4.5]decane-2,4-
dione; and 2-(4-chloro-2,6-dimethyl-phenyl)-1- hydroxy-8-methoxy-4-
methyl-4,8- diazaspiro[4.5]dec-1-en-3-one],'' to read as ``SYN547305
[3-(4-chloro-2,6-dimethylphenyl)-4-hydroxy-8-methoxy-1-methyl-1,8-
diazaspiro[4.5]dec-3-en-2-one]''.

[FR Doc. 2023-10153 Filed 5-16-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 79 (Friday, April 24, 2015)]
[Rules and Regulations]
[Pages 22901-22903]
[FR Doc No: 2015-09580]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2015-0071]
RIN 1625-AA00

Safety Zone; 24 Mile Tampa Bay Marathon Swim, Tampa Bay; Tampa,
FL

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard establishes a temporary moving safety zone on
the waters of Tampa Bay in the vicinity of Tampa, Florida during the 24
Mile Tampa Bay Marathon Swim. The 24 Mile Tampa Bay Marathon Swim is
scheduled to take place on April 25, 2015. Approximately 30 swimmers
are anticipated to participate in the marathon swim event. No
spectators are expected to be present during the event. The safety zone
is necessary to provide for the safety of the participants, participant
vessels, and the general public on the navigable waters of the United
States during the event. The safety zone will establish a moving
protective area around safety vessels including kayaks involved in the
race. Persons and vessels, except those participating in the event,
will be prohibited from entering, transiting through, anchoring in, or
remaining within the regulated area unless authorized by the Captain of
the Port St. Petersburg or a designated representative.

DATES: This rule will be effective from April 24, 2015 through April
25, 2015. This rule will be enforced from 4 a.m. until 9 p.m. on April
25, 2015.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2015-0071]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number 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.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Tyrone J. Stafford, Sector St. Petersburg Prevention
Department, U.S. Coast Guard; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Rich Walter, 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. Regulatory History and Information

    On March 9, 2015, a notice of proposed rulemaking (NPRM) entitled
Safety Zone; 24 Mile Tampa Bay Marathon Swim; Tampa Bay; Tampa, FL was
published in the Federal Register (80 FR 12365). Only 1 comment was
received; however, the comment was provided under a separate event
(Swim Around Lido Key) comment section. The comment stated concern for
a safety zone encompassing the entire 24 mile swim route for the event.
The safety zone will be a moving zone that will not impact any other
areas of the race path while not in use by the swimmers during the
race.

    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Any delay in the effective date of
this rule would be contrary to the public interest because immediate
action is needed to minimize potential hazards associated with a
marathon swim with approximately 30 swimmers involved.

B. Basis and Purpose

    The legal basis for this rule is the Coast Guard's authority to
establish regulated navigation areas and other limited access areas: 33
U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Department of Homeland Security Delegation No. 0170.1.
    The purpose of the rule is to provide for the safety of life on
navigable waters of the United States during the swimming event.

C. Discussion of the Final Rule

    On April 25, 2015, Distance Matters, Inc. is sponsoring The 24 Mile
Tampa Bay Marathon Swim. This open water swim event will be held on the
waters of Tampa Bay, Tampa, Florida. Approximately 30 participants are
anticipated to participate in the event. No spectator vessels are
expected during the event.
    This rule will establish a temporary moving safety zone that will
encompass certain waters of Tampa Bay located in the vicinity of Tampa,
Florida. The temporary moving safety zone will be enforced from 4 a.m.
until 9 p.m. on April 25, 2015. The safety zone will establish a moving
protective area around all safety vessels involved in the race. Persons
and vessels, except those participating in the event, will be
prohibited from entering, transiting through, anchoring in, or
remaining within the regulated area unless authorized by the Captain of
the Port St. Petersburg or a designated representative.
    Persons and vessels may request authorization to enter, transit
through, anchor in, or remain within the enforcement areas by
contacting the Captain of the Port St. Petersburg by telephone at (727)
824-7506, or a designated representative via VHF radio on channel 16.
If authorization to enter, transit through, anchor in, or remain within
the event area is granted by the Captain of the Port St. Petersburg or
a designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port St. Petersburg or a designated representative. The Coast Guard
will provide notice of the safety zone by Local Notice to Mariners,
Broadcast Notice to Mariners, and/or on-scene designated
representatives.

D. Regulatory Analyses

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

1. Regulatory Planning and Review

    This 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 rule is not significant for the following reasons: (1) The safety
zone will be enforced for seventeen hours; (2) although non-participant
persons and vessels will not be able to enter, transit through, anchor
in, or remain within the safety zone without authorization from the
Captain of the Port St. Petersburg or a designated representative, they
may operate in the surrounding areas during the enforcement period; (3)
non-participant persons and vessels may still enter, transit through,
anchor in, or remain within the safety zone during the enforcement
period if authorized by the Captain of the Port St. Petersburg or a
designated representative; and (4) the Coast Guard will provide advance
notification of the safety zone to the local maritime community by
Local Notice to Mariners and/or Broadcast Notice to Mariners.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this 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 non-participant
vessels intending to enter, transit through, anchor in, or remain
within the safety zone described in this regulation 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.

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 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
section above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This 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 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 rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

8. Taking of Private Property

    This rule will 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 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

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

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does 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 action 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 rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this 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), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule is categorically excluded, under figure 2-1,
paragraph (34)(g), of the Instruction. This rule involves establishing
a temporary safety zone that will be enforced for 17 hours total. An
environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add a temporary Sec.  165.T07-0071 to read as follows:

Sec.  165.T07-0071  Safety Zone; 24 Mile Tampa Bay Marathon Swim, Tampa
Bay; Tampa, FL.

    (a) The following regulated area is a safety zone: All waters
within a 50-yard radius around safety vessels including kayaks.
    (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 St. Petersburg in the enforcement of the regulated
areas.
    (c) Regulations. (1) Non-participant persons and vessels are
prohibited from entering, transiting through, anchoring in or remaining
within the regulated area unless authorized by the Captain of the Port
St. Petersburg or a designated representative.
    (2) Non-participant persons and vessels desiring to enter, transit
through, anchor in, or remain within the regulated area may contact the
Captain of the Port St. Petersburg by telephone at<PHONE_NUMBER>, or a
designated representative via VHF radio on channel 16. If authorization
to enter, transit through, anchor in, or remain within the regulated
area is granted by the Captain of the Port St. Petersburg or a
designated representative, all persons and vessels receiving such
authorization must comply with the instructions of the Captain of the
Port St. Petersburg or a designated representative.
    (3) The Coast Guard will provide notice of the regulated area by
Local Notice to Mariners, Broadcast Notice to Mariners, and/or on-scene
designated representatives.
    (d) Enforcement date. This rule will be enforced from 4 a.m. until
9 p.m. on April 25, 2015.

    Dated: April 1, 2015.
G. D. Case,
Captain, U.S. Coast Guard, Captain of the Port St. Petersburg.
[FR Doc. 2015-09580 Filed 4-23-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 163 (Tuesday, August 23, 2011)]
[Notices]
[Pages 52667-52668]
[FR Doc No: 2011-21447]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0386]

International Conference on Harmonisation; Guidance on E2F
Development Safety Update Report; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``E2F Development Safety Update
Report.'' The guidance was prepared under the auspices of the
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH). The guidance
describes the format, content, and timing of a development safety
update report (DSUR) for an investigational drug. The DSUR will serve
as a common standard for periodic reporting on drugs under development
(including marketed drugs that are under further study) among the ICH
regions. The DSUR can be submitted in the United States in place of an
annual report for an investigational new drug application (IND). The
harmonized DSUR is intended to promote a consistent approach to annual
clinical safety reporting among the ICH regions and enhance efficiency
by reducing the number of reports generated for submission to the
regulatory authorities.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002, or the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label
to assist the office in processing your requests. The guidance may also
be obtained by mail by calling the Center for Biologics Evaluation and
Research at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov.

Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Ellis F.
Unger, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4208, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>; or Peter F. Bross, Center for
Biologics Evaluation and Research (HFM-755), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Office of International
Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, rm. 3506, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In the Federal Register of August 5, 2008 (73 FR 45462), FDA
published a notice announcing the availability of a draft guidance
entitled ``E2F Development Safety Update Report.'' The notice gave
interested persons an opportunity to submit comments by November 3,
2008.
    After consideration of the comments received and revisions to the
guidance, a final draft of the guidance was submitted to the ICH
Steering Committee and endorsed by the three participating regulatory
agencies in August 2010.
    The guidance describes the format, content, and timing of a DSUR
for an investigational drug. The DSUR will serve as a common standard
for periodic reporting on drugs under development (including marketed
drugs that are under further study) among the ICH regions. The DSUR is
patterned after the periodic safety update report (used for safety
reporting in the postmarketing environment) and can be submitted in the
United States in place of an annual report for an IND. The harmonized
DSUR is intended to promote a consistent approach to annual clinical
safety reporting among the ICH regions and enhance efficiency by
reducing the number of reports generated for submission to the
regulatory authorities.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: August 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21447 Filed 8-22-11; 8:45 am]
BILLING CODE 4160-01-P