[Federal Register Volume 80, Number 154 (Tuesday, August 11, 2015)]
[Notices]
[Pages 48097-48098]
[FR Doc No: 2015-19686]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP09-6-001; CP09-7-001; Docket No. CP13-507-000]

LNG Development Company, LLC; Oregon Pipeline Company, LLC;
Northwest Pipeline LLC; Notice of Availability of the Draft
Environmental Impact Statement for the Proposed Oregon LNG Terminal and
Pipeline Project and Washington Expansion Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared a draft environmental impact statement (EIS)
for the Oregon LNG Terminal and Pipeline Project (Oregon LNG Project)
proposed by LNG Development Company, LLC and Oregon Pipeline Company,
LLC (collectively referred to as Oregon LNG) and the Washington
Expansion Project proposed by Northwest Pipeline LLC (Northwest) in the
above-referenced dockets. Oregon LNG requests authorization under
Section 3 of the Natural Gas Act (NGA) to site, construct, and operate
an import/export liquefied natural gas (LNG) terminal in Warrenton,
Oregon. Oregon LNG also requests a Certificate of Public Convenience
and Necessity (Certificate) pursuant to Section 7(c) of the NGA to
construct and operate a natural gas pipeline from the proposed LNG
terminal to an interconnect with the interstate transmission system of
Northwest near Woodland, Washington. Northwest requests a Certificate
pursuant to Section 7(c) of the NGA to expand the capacity of its
existing natural gas transmission facilities between Woodland and
Sumas, Washington. The primary purpose of the projects is to export an
equivalent of about 456 billion cubic feet per year of natural gas to
foreign markets.
    The draft EIS assesses the potential environmental effects of the
construction and operation of the Oregon LNG and Washington Expansion
Projects in accordance with the requirements of the National
Environmental Policy Act (NEPA). The FERC staff concludes that approval
of the proposed projects would result in some adverse environmental
impacts; however, most of these impacts would be reduced to less-than-
significant levels with the implementation of Oregon LNG's and
Northwest's proposed mitigation and the additional measures recommended
in the draft EIS.
    The U.S. Environmental Protection Agency, U.S. Army Corps of
Engineers, U.S. Fish and Wildlife Service, U.S. Coast Guard, U.S.
Department of Energy, and U.S. Department of Transportation's Pipeline
and Hazardous Materials Safety Administration participated as
cooperating agencies in the preparation of the EIS. Cooperating
agencies have jurisdiction by law or special expertise with respect to
resources potentially affected by the proposal and participate in the
NEPA analysis. Although the cooperating agencies provided input to the
conclusions and recommendations presented in the draft EIS, the
agencies will present their own conclusions and recommendations in
their respective records of decision or determinations for the
projects.
    The draft EIS addresses the potential environmental effects of the
construction and operation of the following facilities associated with
the Oregon LNG Project:
     One marine terminal with a ship berth for one LNG marine
carrier;
     two full-containment storage tanks, each designed to store
160,000 cubic meters of LNG;
     natural gas pretreatment facilities;
     two liquefaction process trains, regasification
facilities, and other related terminal support structures and systems;
     an 86.8-mile-long, 36-inch-diameter bidirectional
pipeline; and
     one 40-megawatt (MW), 48,000-horsepower (hp) electrically
driven gas compressor station.
    For the Washington Expansion Project, the draft EIS addresses the
potential environmental effects of the construction and operation of:
     140.6 miles of 36-inch-diameter pipeline loop \1\ along
Northwest's existing pipeline in 10 noncontiguous segments;
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    \1\ A pipeline loop is a segment of pipe constructed parallel to
an existing pipeline to increase capacity.
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     ancillary pipeline facilities; and
     96,000 hp of additional compression at five existing
compressor stations.
    Northwest's project would also include abandonment and removal of
existing pipeline and aboveground facilities.
    The FERC staff mailed copies of the draft EIS to federal, state,
and local government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes;
potentially affected landowners; other interested individuals and
nongovernmental organizations; newspapers and libraries in the project
area; and parties to these proceedings. Paper copy versions of this EIS
were mailed to those specifically requesting them; all others received
a compact disk version. In addition, the draft EIS is available for
public viewing on the FERC's Web site (www.ferc.gov) using the eLibrary
link. A limited number of hardcopies are available for distribution and
public inspection at: Federal Energy Regulatory Commission, Public
Reference Room, 888 First Street NE., Room 2A, Washington, DC 20426,
(202) 502-8371.
    Any person wishing to comment on the draft EIS may do so. To ensure
consideration of your comments on the proposal in the final EIS, it is
important that the Commission receive your comments on or before
October 6, 2015.
    For your convenience, there are four methods you can use to submit
your comments to the Commission. In all instances, please reference the
project docket numbers (CP09-6-001, CP09-7-001, and CP13-507-000) with
your submission. The Commission encourages electronic filing of
comments and has expert staff available to assist you at<PHONE_NUMBER>
or<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project.
    (2) You can file your comments electronically by using the eFiling
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' If you are filing a comment on a particular project,

please select ``Comment on a Filing'' as the filing type.
    (3) You can file a paper copy of your comments by mailing them to
the following address: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC
20426.
    (4) In lieu of sending written or electronic comments, the
Commission invites you to attend one of the public comment meetings its
staff will conduct during the draft EIS comment period and in the
project area to receive comments on the draft EIS. We encourage
interested groups and individuals to attend and present oral comments
on the draft EIS. Transcripts of the meetings will be available for
review in eLibrary under the project docket numbers. A notice of
meeting times and locations will be sent to the environmental mailing
list and posted on the FERC eLibrary.
    Any person seeking to become a party to the proceeding must file a
motion to intervene pursuant to Rule 214 of the Commission's Rules of
Practice and Procedures (Title 18 Code of Federal Regulations Part
385.214).\2\ Only intervenors have the right to seek rehearing of the
Commission's decision. The Commission grants affected landowners and
others with environmental concerns intervenor status upon showing good
cause by stating that they have a clear and direct interest in this
proceeding that no other party can adequately represent. Simply filing
environmental comments will not give you intervenor status, but you do
not need intervenor status to have your comments considered.
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    \2\ See the previous discussion on the methods for filing
comments.
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    Questions?
    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search,'' and enter the docket
number(s) excluding the last three digits in the Docket Number field
(i.e., CP09-6-001, CP09-7-001, and CP13-507-000). Be sure you have
selected an appropriate date range. For assistance, please contact FERC
Online Support at<EMAIL_ADDRESS>or toll free at (866) 208-
3676; for TTY, contact<PHONE_NUMBER>. The eLibrary link also provides
access to the texts of formal documents issued by the Commission, such
as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription that allows you to keep track of all formal issuances and
submittals in specific dockets. This can reduce the amount of time you
spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: August 5, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-19686 Filed 8-10-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 150 (Monday, August 5, 2019)]
[Notices]
[Page 38026]
[FR Doc No: 2019-16621]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER19-2134-000.
    Applicants: Wheelabrator Shasta Energy Company Inc.
    Description: Supplemental to June 14, 2019 Wheelabrator Shasta
Energy Company Inc. tariff filing.
    Filed Date: 7/24/19.
    Accession Number: 20190724-5142.
    Comments Due: 5 p.m. ET 8/14/19.

    Docket Numbers: ER19-2329-001.
    Applicants: Midcontinent Independent System Operator, Inc., Ameren
Illinois Company.
    Description: Tariff Amendment: 2019-07-29_SA 2880 Att A-Proj Spec
No. 4 WVPA-EnerStar-West Union Substitute to be effective 6/3/2019.
    Filed Date: 7/29/19.
    Accession Number: 20190729-5090.
    Comments Due: 5 p.m. ET 8/19/19.

    Docket Numbers: ER19-2486-000.
    Applicants: Imperial Valley Solar 2, LLC.
    Description: Sec.  205(d) Rate Filing: COC LGIA CTA Filing to be
effective 7/30/2019.
    Filed Date: 7/29/19.
    Accession Number: 20190729-5126.
    Comments Due: 5 p.m. ET 8/19/19.

    Docket Numbers: ER19-2487-000.
    Applicants: Imperial Valley Solar 2, LLC.
    Description: Sec.  205(d) Rate Filing: COC New Substation Filing to
be effective 7/30/2019.
    Filed Date: 7/29/19.
    Accession Number: 20190729-5127.
    Comments Due: 5 p.m. ET 8/19/19.

    Docket Numbers: ER19-2489-000.
    Applicants: GridLiance High Plains LLC.
    Description: Compliance filing: GHP eTariff Order No. 842 Revisions
to be effective 5/15/2018.
    Filed Date: 7/30/19.
    Accession Number: 20190730-5000.
    Comments Due: 5 p.m. ET 8/20/19.

    Docket Numbers: ER19-2490-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2019-07-30_SA 3336 ATC-
Waterloo Utilities D-TIA to be effective 9/29/2019.
    Filed Date: 7/30/19.
    Accession Number: 20190730-5029.
    Comments Due: 5 p.m. ET 8/20/19.

    Docket Numbers: ER19-2491-000.
    Applicants: Interstate Power and Light Company.
    Description: Sec.  205(d) Rate Filing: Concurrence to Wholesale
Distribution Service Agreement (George) to be effective 9/1/2019.
    Filed Date: 7/30/19.
    Accession Number: 20190730-5058.
    Comments Due: 5 p.m. ET 8/20/19.

    Docket Numbers: ER19-2492-000.
    Applicants: PacifiCorp.
    Description: Sec.  205(d) Rate Filing: BPA Construction Agmt--
Conversion Ross-Lex-Swift Rev 2 to be effective 9/29/2019.
    Filed Date: 7/30/19.
    Accession Number: 20190730-5060.
    Comments Due: 5 p.m. ET 8/20/19.

    Docket Numbers: ER19-2493-000.
    Applicants: Arizona Public Service Company.
    Description: Sec.  205(d) Rate Filing: Rate Schedule No. 217 to be
effective 10/1/2019.
    Filed Date: 7/30/19.
    Accession Number: 20190730-5063.
    Comments Due: 5 p.m. ET 8/20/19.

    Docket Numbers: ER19-2494-000.
    Applicants: Arizona Public Service Company.
    Description: Sec.  205(d) Rate Filing: Revisions to Service
Agreement Nos. 218 and 335 to be effective 7/1/2019.
    Filed Date: 7/30/19.
    Accession Number: 20190730-5079.
    Comments Due: 5 p.m. ET 8/20/19.

    Docket Numbers: ER19-2495-000.
    Applicants: Wessington Springs Wind, LLC.
    Description: Baseline eTariff Filing: Wessington Springs Wind, LLC
Application for MBR Authority to be effective 9/29/2019.
    Filed Date: 7/30/19.
    Accession Number: 20190730-5090.
    Comments Due: 5 p.m. ET 8/20/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 30, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-16621 Filed 8-2-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 158 (Wednesday, August 17, 2022)]
[Notices]
[Pages 50619-50620]
[FR Doc No: 2022-17694]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP22-1115-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Sec.  4(d) Rate Filing: Non-Conforming--Atlantic
Sunrise--Chesapeake to be effective 9/1/2022.
    Filed Date: 8/9/22.
    Accession Number: 20220809-5071.
    Comment Date: 5 p.m. ET 8/22/22.

    Docket Numbers: RP22-1116-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Sec.  4(d) Rate Filing: List of Non-Conforming Service
Agreements and Negot Rate (ASR_Chief Rls to CEM) to be effective 9/1/
2022.
    Filed Date: 8/9/22.
    Accession Number: 20220809-5094.
    Comment Date: 5 p.m. ET 8/22/22.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and

385.214) on or before 5:00 p.m. Eastern time on the specified comment
date. Protests may be considered, but intervention is necessary to
become a party to the proceeding.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 10, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-17694 Filed 8-16-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Rules and Regulations]
[Pages 19858-19860]
[FR Doc No: 2016-07782]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2015-4010; Airspace Docket No. 15-ASO-11]

Establishment of Class D and Class E Airspace, and Amendment of
Class E Airspace; Lake City, FL

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class D airspace and Class E surface
area airspace at Lake City, FL, providing the controlled airspace
required for the Air Traffic Control Tower at Lake City Gateway
Airport. This action also amends existing Class E airspace by
recognizing the airport's name change. Controlled airspace is necessary
for the safety and management of instrument flight rules (IFR)
operations at the airport. A minor adjustment is made to the geographic
coordinates of the airport.

DATES: Effective 0901 UTC, May 26, 2016. The Director of the Federal
Register approves this incorporation by reference action under Title 1,
Code of Federal Regulations, part 51, subject to the annual revision of
FAA Order 7400.9 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.9Z, Airspace Designations and Reporting
Points, and subsequent amendments can

be viewed online at http://www.faa.gov/airtraffic/publications/. For
further information, you can contact the Airspace Policy Group, Federal
Aviation Administration, 800 Independence Avenue SW., Washington, DC
20591; telephone:<PHONE_NUMBER>. The Order is also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of FAA Order 7400.9Z at NARA, call
202-741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, P.O.
Box 20636, Atlanta, Georgia 30320; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes Class D and Class E airspace, and amends Class E
airspace at Lake City Gateway Airport, Lake City, FL.

History

    On January 13, 2016, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to establish Class D airspace and
Class E surface area airspace, and amend Class E airspace extending
upward from 700 feet above the surface at Lake City Gateway Airport,
Lake City, FL, providing the controlled airspace required to support
the Air Traffic Control Tower (81 FR 1590) FAA-2015-4010. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. No comments
were received. Subsequent to publication, the FAA found an error in the
geographic coordinates of Lake City Gateway Airport. This action
corrects that error.
    Class D and E airspace designations are published in paragraphs
5000, 6002, and 6005, respectively, of FAA Order 7400.9Z dated August
6, 2015, and effective September 15, 2015, which is incorporated by
reference in 14 CFR part 71.1. The Class D and E airspace designations
listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.9Z, Airspace Designations and
Reporting Points, dated August 6, 2015, and effective September 15,
2015. FAA Order 7400.9Z is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B,
C, D, and E airspace areas, air traffic service routes, and reporting
points.

The Rule

    This amendment to Title 14, Code of Federal Regulations (14 CFR)
part 71 establishes Class D airspace and Class E surface area airspace
at Lake City Gateway Airport, Lake City, FL, providing the controlled
airspace required to support the Air Traffic Control Tower. Class D
airspace extending upward from the surface up to and including 2,500
feet is established within a 4.2 mile radius of the airport. Class E
surface area airspace is established within a 4.2 mile radius of the
airport. Class E airspace extending upward from 700 feet above the
surface is amended by changing the airport's name from Lake City
Municipal Airport to Lake City Gateway Airport. Controlled airspace is
necessary for IFR operations. The geographic latitude coordinate of the
airport is adjusted from ``lat. 30[deg]10'56'' N.'', to ``lat.
30[deg]10'55'' N.'' for the Class D and E airspace areas.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (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. Since this is a routine matter that
only affects air traffic procedures and air navigation, it is certified
that this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists 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(f), 106(g); 40103, 40113, 40120, E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Z,
Airspace Designations and Reporting Points, dated August 6, 2015,
effective September 15, 2015, is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASO FL D Lake City, FL [New]

Lake City Gateway Airport, FL
    (Lat. 30[deg]10'55'' N., long. 82[deg]34'37'' W.)

    That airspace extending upward from the surface to and including
2,500 feet within a 4.2-mile radius of Lake City Gateway Airport.
This Class D airspace area is effective during the specific dates
and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Airport/Facility Directory.

Paragraph 6002 Class E Surface Area Airspace.

* * * * *

ASO FL E2 Lake City, FL [New]

Lake City Gateway Airport, FL
    (Lat. 30[deg]10'55'' N., long. 82[deg]34'37'' W.)

    Within a 4.2-mile radius of Lake City Gateway Airport. This
Class E airspace area is effective during the specific dates and
times established in advance by a Notice to Airmen. The effective
date and time will thereafter be continuously published in the
Airport/Facility Directory.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO FL E5 Lake City, FL [Amended]

Lake City Gateway Airport, FL
    (Lat. 30[deg]10'55'' N., long. 82[deg]34'37'' W.)

    That airspace extending upward from 700 feet above the surface
within a 7-mile radius of Lake City Gateway Airport.

    Issued in College Park, Georgia, on March 29, 2016.
Ryan W. Almasy,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2016-07782 Filed 4-5-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: April 24, 2008 (Volume 73, Number 80)]
[Proposed Rules]
[Page 22108-22110]
[DOCID:fr24ap08-13]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0159]
RIN 1625-AA00

Safety Zone: Langley Air Force Base Air Show, Willoughby Point,
Hampton, VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a safety zone on the
Back River in the vicinity of Hampton, VA in support of the Air Power
over Hampton Roads Air show. This action is intended to restrict vessel
traffic movement on the Back River to protect mariners from the hazards
associated with the air show.

DATES: Comments and related material must reach the Coast Guard on or
before May 27, 2008.

ADDRESSES: You may submit comments identified by Coast Guard docket
number USCG-2008-0159 to the Docket Management Facility at the U.S.
Department of Transportation. To avoid duplication, please use only one
of the following methods:
    (1) Online: http://www.regulations.gov.
    (2) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (3) Hand delivery: Room W12-140 on the Ground Floor of the West
Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays. The
telephone number is<PHONE_NUMBER>.
    (4) Fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call Lieutenant Candice Casavant, Waterways Management Division,
Sector Hampton Roads at<PHONE_NUMBER>. If you have questions on
viewing or submitting material to the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided. We have an agreement with the
Department of Transportation (DOT) to use the Docket Management
Facility. Please see DOT's ``Privacy Act'' paragraph below.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2008-0159), indicate the specific section of this
document to which each comment applies, and give the reason for each
comment. We recommend that you include your name and a mailing address,
an e-mail address, or a phone number in the body of your document so
that we can contact you if we have questions regarding your submission.
You may submit your comments and material by electronic means, mail,
fax, or delivery to the Docket Management Facility at the address under
ADDRESSES; but please submit your comments and material by only one
means. If you submit them by mail or delivery, submit them in an
unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit them by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period. We may change this
proposed rule in view of them.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov at
any time, click on ``Search for Dockets,'' and enter the docket number
for this rulemaking (USCG-2008-0159) in the Docket ID box, and click
enter. You may also visit either the Docket Management Facility in Room
W12-140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays; or the Commander, Sector
Hampton Roads, Norfolk Federal Building, 200 Granby St., 7th Floor
between 9 a.m. and 3 p.m., Monday through Friday, except Federal
holidays.

Privacy Act

    Anyone can search the electronic form of all comments received into
any of our dockets by the name of the individual submitting the comment
(or signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review the Department of
Transportation's Privacy Act Statement in the Federal Register
published on April 11, 2000 (65 FR 19477), or you may visit http://
DocketsInfo.dot.gov.

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one to the Docket Management Facility at the address under
ADDRESSES explaining why one would be beneficial. If we determine that
one would aid this rulemaking, we will hold one at a time and place
announced by a later notice in the Federal Register.

Background and Purpose

    On June 20-22, 2008 Langley Air Force Base will sponsor an air show
at Langley Air Force Base in the vicinity of Willoughby Point within
the area bounded by 37[deg]-05'-35'' N/076[deg]-20'-47'' W, 37[deg]-
05'-46'' N/076[deg]-20'-04'' W, 37[deg]-05'-12'' N/076[deg]-19'-59'' W,
37[deg]-05'-12'' N/076[deg]-20'-18'' W (NAD 1983). Due to the need to
protect mariners and spectators from the hazards associated with the
air show, access to the area

described above will be temporarily restricted.

Discussion of Proposed Rule

    The Coast Guard proposes to establish a safety zone on the Back
River in the vicinity of Willoughby Point in Hampton, VA within waters
bounded by 37[deg]-05'-35'' N/076[deg]-20'-47'' W, 37[deg]-05'-46'' N/
076[deg]-20'-04'' W, 37[deg]-05'-12'' N/076[deg]-19'-59'' W, 37[deg]-
05'-12'' N/076[deg]-20'-18'' W (NAD 1983). This safety zone will be
established in the interest of public safety during the Air Power over
Hampton Air show and will be enforced from 3 p.m. to 11:30 p.m. on June
20, 2008, 9 a.m. to 5 p.m. on June 21, 2008 and 9 a.m. to 5 p.m. on
June 22, 2008. Access to the safety zone will be restricted during the
specified date and times. Except for participants and vessels
authorized by the Captain of the Port or his Representative, no person
or vessel may enter or remain in the safety zone.

Regulatory Evaluation

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analysis based on 13 of these statutes or executive orders.

Executive Order 12866

    This proposed rule is not a ``significant regulatory action'' under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of that Order. The Office of Management and
Budget has not reviewed it under that Order.
    We expect the economic impact of this proposed rule to be so
minimal that a full Regulatory Evaluation is unnecessary. Although this
regulation restricts access to the regulated area, the effect of this
rule will not be significant because: (i) The safety zone will be in
effect for a limited duration; (ii) the Coast Guard will make
notifications via maritime advisories so mariners can adjust their
plans accordingly; and (iii) the COTP may periodically authorize
transiting vessels access through the safety zone.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. 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 proposed
rule would not have a significant economic impact on a substantial
number of small entities because the zone will only be in place for a
limited duration and maritime advisories will be issued allowing the
mariners to adjust their plans accordingly. However, this rule may
affect the following entities, some of which may be small entities: the
owners and operators of vessels intending to transit or anchor in that
portion of the Back River from 3 p.m. to 11:30 p.m. on June 20, 2008, 9
a.m. to 5 p.m. on June 21, 2008 and 9 a.m. to 5 p.m. on June 22, 2008.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
proposed rule would affect your small business, organization, or
governmental jurisdiction and you have questions concerning its
provisions or options for compliance, please contact Lieutenant Candice
Casavant, Waterways Management Division, Sector Hampton Roads at (757)
668-5580. 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.

Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

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 or more in any
one year. Though this proposed rule would not result in such an
expenditure, we do discuss the effects of this rule elsewhere in this
preamble.

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

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

Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. We
invite your comments on how this proposed rule might impact tribal
governments, even if that impact may not constitute a ``tribal
implication'' under the Order.

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because

it is not a ``significant regulatory action'' under Executive Order
12866 and is not likely to have a significant adverse effect on the
supply, distribution, or use of energy. The Administrator of the Office
of Information and Regulatory Affairs has not designated it as a
significant energy action. Therefore, it does not require a Statement
of Energy Effects under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed rule under Commandant Instruction
M16475.lD which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is not likely to
have a significant effect on the human environment. A preliminary
``Environmental Analysis Check List'' supporting this preliminary
determination is available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

List of Subjects in 33 CFR Part 165

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

Words of Issuance and Proposed Regulatory Text

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

    2. Add Sec.  165.T05-015 to read as follows:

Sec.  165.T05-015  Safety Zone: Langley Air Force Base Air Show,
Willoughby Point, Back River, Hampton, VA.

    (a) Location: The following area is a safety zone: All waters in
the vicinity of Willoughby Point on the Back River within the area
bounded by 37[deg]-05'-35'' N./076[deg]-20'-47'' W., 37[deg]-05'-46''
N./076[deg]-20'-04'' W., 37[deg]-05'-12'' N./076[deg]-19'-59'' W.,
37[deg]-05'-12'' N./076[deg]-20'-18'' W. (NAD 1983).
    (b) Definition: Captain of the Port Representative: Means any U.S.
Coast Guard commissioned, warrant or petty officer who has been
authorized by the Captain of the Port Hampton Roads, to act on his
behalf.
    (c) Regulation: (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into this zone is prohibited unless
authorized by the Captain of the Port Hampton Roads or his designated
representatives.
    (2) The operator of any vessel in the immediate vicinity of this
safety zone shall:
    (i) Stop the vessel immediately upon being directed to do so by any
commissioned, warrant or petty officer on shore or on board a vessel
that is displaying a U.S. Coast Guard Ensign.
    (ii) Proceed as directed by any commissioned, warrant or petty
officer on shore or on board a vessel that is displaying a U.S. Coast
Guard Ensign.
    (3) The Captain of the Port Hampton Roads and the Sector Duty
Officer at Sector Hampton Roads in Portsmouth, Virginia can be
contacted at telephone Number<PHONE_NUMBER> or<PHONE_NUMBER>.
    (4) The Coast Guard Representatives enforcing the safety zone can
be contacted on VHF-FM 13 and 16.
    (d) Effective Period: This regulation will be in effect from 3 p.m.
on June 20, 2008, until 5 p.m. on June 22, 2008.

    Dated: April 1, 2008.
Patrick B. Trapp,
Captain, U.S. Coast Guard, Captain of the Port, Hampton Roads.
[FR Doc. E8-8467 Filed 4-23-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 88, Number 69 (Tuesday, April 11, 2023)]
[Notices]
[Pages 21728-21729]
[FR Doc No: 2023-07496]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-485, OMB Control No. 3235-0547]

Proposed Collection; Comment Request: Extension: ``Investor
Form''

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

    Notice is hereby given pursuant to the Paperwork Reduction Act of
1995 (44 U.S.C. 3501 et seq.) that the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget (``OMB'') for extension and approval.
    Each year the Commission receives several thousand contacts from
investors who have complaints or questions on a wide range of
investment-related issues. To make it easier for the public to contact
the agency electronically, the Commission's Office of Investor
Education and Advocacy (``OIEA'') created an electronic form (the
Investor Form) that provides drop down options to choose from in order
to categorize the investor's complaint or question, and may also
provide the investor with automated information about their issue. The
Investor Form asks investors to provide information concerning, among
other things, their names, how they can be reached, the names of the
individuals or entities involved, the nature of their complaint or tip,
what documents they can provide, and what, if any, actions they have
taken. Use of the Investor Form is voluntary. Absent the forms, the
public still has several ways to contact the agency, including
telephone, facsimile, letters, and email. Investors can access the
Investor Form through the consolidated Investor Complaint and Question
web page.
    OIEA receives approximately 30,000 contacts each year through the
Investor Form. Investors who choose not to use the Investor Form
receive the same level of service as those who do. The dual purpose of
the form is to make it easier for the public to contact the agency with
complaints, questions, tips, or other feedback and to further
streamline the workflow of Commission staff that record, process, and
respond to investor contacts.
    The Commission uses the information that investors supply on the
Investor Form to review and process the contact (which may, in turn,
involve responding to questions, processing complaints, or, as
appropriate, initiating enforcement investigations), to maintain a
record of contacts, to track the volume of investor complaints, and to
analyze trends. Use of the Investor Form is voluntary. The Investor
Form asks investors to provide information concerning, among other
things, their names, how they can be reached, the names of the
individuals or entities involved, the nature of their complaint or tip,
what documents they can provide, and what, if any, actions they have
taken.
    The staff of the Commission estimates that the total reporting
burden for using the Investor Form is 7,500 hours. The calculation of
this estimate depends on the number of investors who use the forms each
year and the estimated time it takes to complete the forms: 30,000
respondents x 15 minutes = 7,500 burden hours.
    The Commission may not conduct or sponsor a collection of
information unless it displays a currently valid control number. No
person shall be subject to any penalty for failing to comply with a
collection of information subject to the PRA that does not display a
valid OMB control number.
    Written comments are invited on: (a) whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the collection of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to David Bottom, Chief
Information Officer, Securities and Exchange Commission, c/o John R.
Pezullo, 100 F St. NE, Washington, DC 20549; or send an email to:
[email protected].

    Dated: April 5, 2023.
Sherry R. Haywood,
Assistant Secretary.
[FR Doc. 2023-07496 Filed 4-10-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 28, 2005 (Volume 70, Number 248)]
[Notices]
[Page 76823-76825]
[DOCID:fr28de05-113]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2005-0478; FRL-7752-3]

Imazaquin; Tolerance Reassessment Decision for Low Risk
Pesticide; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's Tolerance
Reassessment Decision (TRED) for the pesticide Imazaquin, and opens a
public comment period on this document, related risk assessments, and
other support documents. EPA has reviewed the low risk pesticide
imazaquin through a modified, streamlined version of the public
participation process that the Agency uses to involve the public in
developing pesticide tolerance reassessment and reregistration
decisions. Through the tolerance reassessment program, EPA is ensuring
that all pesticides meet current health and food safety standards.

DATES: Comments, identified by docket ID number OPP-2005-0478, must be
received on or before February 27, 2006.

ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Wilhelmena Livingston, Special Review
and Reregistration Division (7508C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this
action under docket ID number OPP-2005-0478. The official public docket
consists of the documents specifically referenced in this action, any
public comments received, and other information related to this action.
Although a part of the official docket, the public docket does not
include Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute. The official public docket
is the collection of materials that is available for public viewing at
the Public Information and Records Integrity Branch (PIRIB), Rm. 119,
Crystal Mall 2, 1801 S. Bell St., Arlington, VA. This docket
facility is open from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The docket telephone number is (703) 305-
5805.
     2. Electronic access. You may access this Federal Register
document electronically through the EPA Internet under the ``Federal
Register'' listings at http://www.epa.gov/fedrgstr/.

    EDOCKET, EPA's electronic public docket and comment system was
replaced on November 25, 2005, by an enhanced Federal-wide electronic
docket management and comment system located at http://www.regulations.gov/.
 Follow the on-line instructions.

    An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public

comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly

available docket materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
    Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.

C. How and to Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
    1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
    i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/edocket/
, and follow the online instructions for submitting comments.

Once in the system, select ``search,'' and then key in docket ID number
OPP-2005-0478. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to<EMAIL_ADDRESS>
Attention: Docket ID Number OPP-2005-0478. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2005-0478.
    3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1801 S. Bell St., Arlington, VA, Attention: Docket ID
Number OPP-2005-0478. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.

D. How Should I Submit CBI to the Agency?

    Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide any technical information and/or data you used that
support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at your estimate.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternatives.
    7. Make sure to submit your comments by the comment period deadline
identified.
    8. To ensure proper receipt by EPA, identify the appropriate docket
ID number in the subject line on the first page of your response. It
would also be helpful if you provided the name, date, and Federal
Register citation related to your comments.

II. Background

A. What Action is the Agency Taking?

    EPA has reassessed the uses of imazaquin and the one existing
tolerances or legal residue limits. On December 20, 2005, EPA reached a
tolerance reassessment decision for this low risk pesticide. Imazaquin
is an imidazolinone herbicide which controls weeds by inhibiting the
synthesis of specific amino acids (valine, leucine and isoleucine)
necessary for plant growth. It is registered as a pre-plant,
preemergence and early postemergence herbicide for use on soybeans,
primarily across the central Midwest from Kentucky to Illinois and
across the mid-South in Arkansas, Louisiana and Mississippi. It is also
registered for pre- and postemergence weed control on ornamentals and
warm season turfgrass in both residential and non-residential settings.
The turf and ornamental uses are concentrated across the southern U.S.
because of imazaquin's lack of selectivity on cool season grasses. The
Agency is now issuing for comment the resulting Report on Food Quality
Protection Act (FQPA) Tolerance Reassessment Progress and Risk
Management Decision for imazaquin, known as a TRED, as well as related
risk assessments and technical support documents.
    EPA developed the imazaquin TRED through a modified, streamlined
version of its public process for making tolerance reassessment and
reregistration eligibility decisions. Through these programs, the
Agency is ensuring that pesticides meet current standards under the
Federal Food, Drug, and Cosmetic Act (FFDCA) and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended by
FQPA. EPA must review tolerances and tolerance exemptions that were in
effect when the FQPA was enacted, to ensure that these existing
pesticide residue limits for food and feed commodities meet the safety
standard established by the new law. Tolerances are considered
reassessed once the safety finding has been made or a revocation
occurs. EPA has reviewed and made the requisite safety finding for the
imazaquin tolerances included in this notice.
    EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and Reregistration; Public
Participation Process, published in the Federal Register of May 14,
2004 (69 FR 26819) (FRL-7357-9) explains that in conducting these
programs, the Agency is tailoring its public participation process to
be commensurate with the level of risk, extent of use, complexity of
issues, and degree of public concern associated with each pesticide.
EPA can expeditiously reach decisions for pesticides like imazaquin,
which pose no risk concerns, and require no risk mitigation. Once EPA
assesses uses and risks for such low risk pesticides, the Agency may go
directly to a decision and prepare a document summarizing its findings,
such as the imazaquin TRED.
    The tolerance reassessment program is being conducted under
Congressionally mandated time frames, and EPA recognizes the need both
to make timely decisions and to involve the public in finding ways to
effectively mitigate pesticide risks. Imazaquin, however, poses no
risks that require mitigation. The Agency therefore is issuing the
imazaquin TRED, its risk assessments, and related support documents
simultaneously for public comment. The comment period is intended to
provide an opportunity for public input and a mechanism for initiating
any necessary amendments to the TRED. All comments should be submitted
using the methods in Unit I. of the SUPPLEMENTARY INFORMATION, and must
be received by EPA on or before the closing date. These comments will
become part of the Agency Docket for imazaquin. Comments received after
the close of the comment period will be marked ``late.'' EPA is not
required to consider these late comments.
    EPA will carefully consider all comments received by the closing
date and will provide a Response to Comments Memorandum in the Docket
and electronic EDOCKET. If any comment significantly affects the
document, EPA also will publish an amendment to the TRED in the Federal
Register. In the absence of substantive comments requiring changes, the
decisions reflected in the TRED will be implemented as presented. These
decisions may be supplemented by risk mitigation measures when EPA
considers its cumulative assessment of the cumulative group pesticides.

B. What is the Agency's Authority for Taking this Action?

    Section 408(q) of the FFDCA, 21 U.S.C. 346a(q), requires EPA to
review tolerances and exemptions for pesticide residues in effect as of
August 2, 1996, to determine whether the tolerance or exemption meets
the requirements of section 408(b)(2) or (c)(2) of FFDCA. This review
is to be completed by August 3, 2006.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: December 19, 2005.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E5-7991 Filed 12-27-05; 8:45 am]

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[Federal Register Volume 88, Number 30 (Tuesday, February 14, 2023)]
[Notices]
[Pages 9522-9524]
[FR Doc No: 2023-03070]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2018-E-3051 and FDA-2018-E-3095]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ALIQOPA

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ALIQOPA and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human drug
product.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
17, 2023. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 14, 2023.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 17, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets

Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2018-E-3051 and FDA-2018-E-3095 for Determination of Regulatory
Review Period for Purposes of Patent Extension; ALIQOPA. Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with Sec.  10.20 (21 CFR 10.20) and
other applicable disclosure law. For more information about FDA's
posting of comments to public dockets, see 80 FR 56469, September 18,
2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug or biologic product, animal drug product, medical device,
food additive, or color additive) was subject to regulatory review by
FDA before the item was marketed. Under these acts, a product's
regulatory review period forms the basis for determining the amount of
extension an applicant may receive.
    A regulatory review period consists of two periods of time: a
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product, ALIQOPA
(copanlisib dihydrochloride) indicated for treatment of adult patients
with relapsed follicular lymphoma who have received at least two prior
systemic therapies. Subsequent to this approval, the USPTO received
patent term restoration applications for ALIQOPA (U.S. Patent Nos.
7,511,041 and RE46856) from Bayer Intellectual Property GmbH and the
USPTO requested FDA's assistance in determining the patents'
eligibility for patent term restoration. In a letter dated May 13,
2019, FDA advised the USPTO that this human drug product had undergone
a regulatory review period and that the approval of ALIQOPA represented
the first permitted commercial marketing or use of the product.
Thereafter, the USPTO requested that FDA determine the product's
regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ALIQOPA is 3,004 days. Of this time, 2,821 days occurred during the
testing phase of the regulatory review period, while 183 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
June 26, 2009. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on June 26,
2009.
    2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: March 16,
2017. FDA has verified the applicant's claim that the new drug
application (NDA) for ALIQOPA (NDA 209936) was initially submitted on
March 16, 2017.
    3. The date the application was approved: September 14, 2017. FDA
has verified the applicant's claim that NDA 209936 was approved on
September 14, 2017.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its applications for patent extension,
this applicant seeks 1,594 or 692 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in (21 CFR 60.30), any interested person may petition FDA for
a determination regarding whether the applicant for extension acted
with due diligence during the regulatory review period. To meet its
burden, the petition must comply with all the requirements of 60.30,
including but not limited to: must be timely (see DATES), must be filed
in accordance with Sec.  10.20, must contain sufficient facts to merit
an FDA

investigation, and must certify that a true and complete copy of the
petition has been served upon the patent applicant. (See H. Rept. 857,
part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in
the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: February 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03070 Filed 2-13-23; 8:45 am]
BILLING CODE 4164-01-P