[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Rules and Regulations]
[Pages 13203-13204]
[FR Doc No: 2015-05719]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2013-1055; Airspace Docket No. 13-ANM-27]

Establishment of Class E Airspace; Rogue Valley, OR

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action establishes Class E airspace at the Rogue Valley
VHF Omni-Directional Radio Range Tactical Air Navigation Aid (VORTAC),
Rogue Valley, OR, to facilitate vectoring of Instrument Flight Rules
(IFR) aircraft under control of Seattle and Oakland Air Route Traffic
Control Centers (ARTCCs). This action enhances the safety and
management of IFR operations within the National Airspace System (NAS).

DATES: Effective 0901 UTC, April 30, 2015. 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 7400.9Y, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed on line at http://www.faa.gov/airtraffic/publications/. The Order is also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material 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, you can contact the Airspace Policy and ATC Regulations
Group, Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC 29591; telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Steve Haga, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    On October 16, 2014 the FAA published in the Federal Register a

notice of proposed rulemaking (NPRM) to establish Class E en route
domestic airspace at the Rogue Valley VORTAC, Rogue Valley, OR (79 FR
62080). Interested parties were invited to participate in this
rulemaking effort by submitting written comments on the proposal to the
FAA. Two comments were received supporting the proposal, one from the
National Business Aviation Association, and one by an anonymous
individual. Subsequent to publication, the FAA found an inadvertent
omission of exclusionary language regarding the 12-mile offshore
territorial limit. This action makes the correction.
    Class E airspace designations are published in paragraph 6006, of
FAA Order 7400.9Y, dated August 6, 2014, and effective September 15,
2014, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation 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 7400.9Y, Airspace Designations and
Reporting Points, dated August 6, 2014, and effective September 15,
2014. FAA Order 7400.9Y is publicly available as listed in the
ADDRESSES section of this final rule. FAA Order 7400.9Y 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 E en route domestic airspace extending upward
from 1,200 feet above the surface at the Rogue Valley VORTAC navigation
aid, Rogue Valley, OR. By this action, aircraft are contained while in
IFR conditions under control of Seattle and Oakland ARTCCs by vectoring
aircraft from en route airspace to terminal areas. This action enhances
the safety and management of controlled airspace within the NAS.
    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, is
non-controversial and unlikely to result in adverse or negative
comments. 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.
    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 controlled airspace at the Rogue Valley VORTAC, Rogue
Valley, OR.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. 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(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 7400.9Y,
Airspace Designations and Reporting Points, dated August 6, 2014, and
effective September 15, 2014, is amended as follows:

Paragraph 6006 En route domestic airspace areas.

* * * * *

ANM OR E6 Rogue Valley, OR [New]

Rogue Valley VORTAC, OR
    (Lat. 42[deg]28'47'' N., long. 122[deg]54'47'' W.)

    That airspace extending upward from 1,200 feet above the surface
within an area bounded by lat. 43[deg]27'19'' N., long.
119[deg]56'31'' W.; to lat. 42[deg]39'54'' N., long. 119[deg]42'02''
W.; to lat. 41[deg]00'07'' N., long. 120[deg]10'44'' W.; to lat.
40[deg]45'47'' N., long. 120[deg]14'45'' W.; to lat. 40[deg]27'51''
N., long. 119[deg]37'10'' W.; to lat. 39[deg]33'53'' N., long.
120[deg]19'02'' W.; to lat. 39[deg]05'16'' N., long. 124[deg]05'00''
W.; to lat. 39[deg]42'30'' N., long. 124[deg]25'58'' W.; to lat.
40[deg]01'00'' N., long. 124[deg]35'00'' W.; to lat. 40[deg]25'25''
N., long. 124[deg]40'06'' W.; to lat. 42[deg]50'00'' N., long.
124[deg]50'00'' W.; thence to the point of beginning, excluding that
airspace beyond 12-miles of the shoreline.

     Issued in Seattle, Washington, on February 27, 2015.
Johanna Forkner,
Acting Manager, Operations Support Group, Western Service Center, AJV-
W2.
[FR Doc. 2015-05719 Filed 3-12-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 203 (Monday, October 23, 2023)]
[Notices]
[Page 72801]
[FR Doc No: 2023-23470]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE: 2:00 p.m. on Thursday, October 26, 2023.

PLACE: The meeting will be held via remote means and/or at the
Commission's headquarters, 100 F Street NE, Washington, DC 20549.

STATUS: This meeting will be closed to the public.

MATTERS TO BE CONSIDERED: Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    In the event that the time, date, or location of this meeting
changes, an announcement of the change, along with the new time, date,
and/or place of the meeting will be posted on the Commission's website
at https://www.sec.gov.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    The subject matter of the closed meeting will consist of the
following topics:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Resolution of litigation claims; and
    Other matters relating to examinations and enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting agenda items that may consist of
adjudicatory, examination, litigation, or regulatory matters.

CONTACT PERSON FOR MORE INFORMATION: For further information; please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.
    Authority: 5 U.S.C. 552b.

    Dated: October 19, 2023.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2023-23470 Filed 10-19-23; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 202 (Friday, October 22, 2021)]
[Proposed Rules]
[Pages 58611-58613]
[FR Doc No: 2021-22547]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2021-0817; Airspace Docket No. 20-AAL-45]
RIN 2120-AA66

Proposed Establishment of United States Area Navigation (RNAV)
Route T-308; Anvik, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish United States Area
Navigation (RNAV) route T-308 in the vicinity of Anvik, AK in support
of a large and comprehensive T-route modernization project for the
state of Alaska.

DATES: Comments must be received on or before December 6, 2021.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2021-0817; Airspace Docket No. 20-AAL-45 at the beginning of your

comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order JO 7400.11F, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/.
    For further information, you can contact the Rules and Regulations
Group, Federal Aviation Administration, 800 Independence Avenue SW,
Washington, DC, 20591; telephone:<PHONE_NUMBER>. FAA Order JO 7400.11F
is also available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of FAA Order
JO 7400.11F at NARA, email: [email protected] or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Christopher McMullin, Rules and
Regulations Group, Office of Policy, Federal Aviation Administration,
800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

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
the 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 would expand the availability of RNAV in Alaska and
improve the efficient flow of air traffic within the National Airspace
System (NAS) by lessening the dependency on ground based navigation.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2021-0817; Airspace Docket No. 20-AAL-45) and be submitted in
triplicate to the Docket Management Facility (see ADDRESSES section for
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2021-0817; Airspace Docket No. 20-AAL-45.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRM

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Western Service Center, Operations
Support Group, Federal Aviation Administration, 2200 South 216th St.,
Des Moines, WA 98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11F, Airspace
Designations and Reporting Points, dated August 10, 2021, and effective
September 15, 2021. FAA Order JO 7400.11F is publicly available as
listed in the ADDRESSES section of this document. FAA Order JO 7400.11F
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

Background

    In 2003, Congress enacted the Vision 100-Century of Aviation
Reauthorization Act (Pub. L. 108-176), which established a joint
planning and development office in the FAA to manage the work related
to the Next Generation Air Transportation System (NextGen). Today,
NextGen is an ongoing FAA-led modernization of the nation's air
transportation system to make flying safer, more efficient, and more
predictable.
    In support of NextGen, this proposal is part of a larger and
comprehensive T-route modernization project in the state of Alaska. The
project mission statement states: ``To modernize Alaska's Air Traffic
Service route structure using satellite based navigation Development of
new T-routes and optimization of existing T-routes will enhance safety,
increase efficiency and access, and will provide en route continuity
that is not subject to the restrictions associated with ground based
airway navigation.'' As part of this project, the FAA evaluated the
existing Colored Airway structure for: (a) Direct replacement (i.e.,
overlay) with a T-route that offers a similar or lower Minimum En route
Altitude (MEA) or Global Navigation Satellite System Minimum En route
Altitude (GNSS MEA); (b) the replacement of the colored airway with a
T-route in an optimized but similar geographic area, while retaining
similar or lower MEA; or (c) removal with no route structure (T-route)
restored in that area because the value was determined to be
insignificant.
    The aviation industry/users have indicated a desire for the FAA to
transition the Alaskan en route navigation structure away from
dependency on Non-Directional Beacons (NDB), and move to develop and
improve the RNAV route structure. The FAA proposes to establish RNAV
route T-308 to provide an alternate routing for Alaskan VOR Federal
airway V-510. V-510 utilizes Emmonak, AK, (ENM) VOR/DME, and ANVIK, AK,
(ANV) NDB. ANV is on the scheduled decommission list, and will force
the deletion of V-510 at that time.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 to establish
RNAV route T-308 in the vicinity of Anvik, AK in support of a large and
comprehensive T-route modernization project for the state of Alaska.
The proposed route is described below.

    T-308: The FAA proposes to establish T-308 from ENM to the WEREL,
AK, waypoint, which would be a replacement for ANV. The route would
mirror the current V-510.
    United States Area Navigation Routes are published in paragraph
6011 of FAA Order JO 7400.11F dated August 10, 2021 and effective
September 15, 2021, which is incorporated by reference in 14 CFR 71.1.
The RNAV route listed in this document would be published subsequently
in FAA Order JO 7400.11F.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed 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
Department of Transportation (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 will only affect air traffic
procedures and air navigation, it is certified that this proposed rule,
when promulgated, will not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 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 JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 6011 United States Area Navigation Routes.

* * * * *

T-308 Emmonak, AK to WEREL, AK [New]

EMMONAK, AK (ENM)             VOR/DME             (Lat. 62[deg]47'04.52'' N, long. 164[deg]29'15.12'' W)
WEREL, AK                     WP                  (Lat. 62[deg]38'29.25'' N, long. 160[deg]11'07.20'' W)

* * * * *

    Issued in Washington, DC, on October 12, 2021.
Michael R. Beckles,
Acting Manager, Rules and Regulations Group.
[FR Doc. 2021-22547 Filed 10-21-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 2 (Friday, January 3, 2020)]
[Notices]
[Pages 369-370]
[FR Doc No: 2019-28480]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meetings

TIME AND DATE:  2:00 p.m. on Wednesday, January 8, 2020.

PLACE:  The meeting will be held at the Commission's headquarters, 100
F Street NE, Washington, DC 20549.

STATUS:  This meeting will be closed to the public.

MATTERS TO BE CONSIDERED:  Commissioners, Counsel to the Commissioners,
the Secretary to the Commission, and recording secretaries will attend
the closed meeting. Certain staff members who have an interest in the
matters also may be present.
    In the event that the time, date, or location of this meeting
changes, an announcement of the change, along with the new time, date,
and/or place of the meeting will be posted on the Commission's website
at https://www.sec.gov.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10),
permit consideration of the scheduled matters at the closed meeting.
    The subject matters of the closed meeting will consist of the
following topics:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Resolution of litigation claims; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting agenda items that may consist of
adjudicatory, examination, litigation, or regulatory matters.

CONTACT PERSON FOR MORE INFORMATION:  For further information; please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

    Dated: December 31, 2019.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2019-28480 Filed 12-31-19; 11:15 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 69 (Thursday, April 9, 2020)]
[Notices]
[Pages 19936-19937]
[FR Doc No: 2020-07490]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-48-000]

Iroquois Gas Transmission System, L.P.; Notice of Schedule for
Environmental Review of the Enhancement by Compression Project

    On February 3, 2020, Iroquois Gas Transmission System, L.P.
(Iroquois) filed an application in Docket No. CP20-48-000 requesting a
Certificate of Public Convenience and Necessity pursuant to Section
7(c) of the Natural Gas Act to construct and operate certain natural
gas compression and associated facilities. The proposed project is
known as the Enhancement by Compression Project (Project), and would
add a total of 125 million cubic feet of natural gas per day of
incremental firm transportation service to existing customers in New
York.
    On February 12, 2020, the Federal Energy Regulatory Commission
(Commission or FERC) issued its Notice of Application for the Project.
Among other things, that notice alerted agencies issuing federal
authorizations of the requirement to complete all necessary reviews and
to reach a final decision on a request for a federal authorization
within 90 days of the date of issuance of the Commission staff's
Environmental Assessment (EA) for the Project. This instant notice
identifies the FERC staff's planned schedule for the completion of the
EA for the Project.

Schedule for Environmental Review

Issuance of EA--September 30, 2020
90-Day Federal Authorization Decision Deadline--December 29, 2020

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    The Project would add one new 12,000 horsepower (hp) compressor
unit and associated facilities at each of its existing Athens (Greene
County, New York) and Dover Compressor Stations (Dutchess County, New
York) and two new 12,000 hp compressor units at its existing Brookfield
Compressor Station (Fairfield County, Connecticut). Iroquois

also proposes to add cooling and related equipment at its existing
Milford Compressor Station (New Haven County, Connecticut). The Project
would add a total of 48,000 hp of new compression on Iroquois' System.

Background

    On March 25, 2020, the Commission issued a Notice of Intent to
Prepare an Environmental Assessment for the Proposed Enhancement by
Compression Project and Request for Comments on Environmental Issues
(NOI). The NOI was sent to affected landowners; federal, state, and
local government agencies; elected officials; environmental and public
interest groups; Native American tribes; other interested parties; and
local libraries and newspapers. All substantive comments will be
addressed in the EA.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. 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.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC website (www.ferc.gov). Using the eLibrary link, select General
Search from the eLibrary menu, enter the selected date range and Docket
Number excluding the last three digits (i.e., CP20-48), and follow the
instructions. For assistance with access to eLibrary, the helpline can
be reached at<PHONE_NUMBER>, TTY<PHONE_NUMBER>, or at
<EMAIL_ADDRESS>The eLibrary link on the FERC website also
provides access to the texts of formal documents issued by the
Commission, such as orders, notices, and rule makings.

    Dated: April 3, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-07490 Filed 4-8-20; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 112 (Monday, June 11, 2012)]
[Rules and Regulations]
[Pages 34212-34215]
[FR Doc No: 2012-14035]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. FDA-2007-F-0390] (Formerly 2007F-0115)

Irradiation in the Production, Processing, and Handling of Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to provide for the safe use of a carbon dioxide
laser for etching information on the surface of fresh, intact citrus
fruit. This action is in response to a petition filed by Durand-
Wayland, Inc.

DATES: This rule is effective June 11, 2012. Submit either electronic
or written objections and requests for a hearing by July 11, 2012. See
section VIII of this document for information on the filing of
objections.

ADDRESSES: You may submit either electronic or written objections and
requests for a hearing, identified by Docket No. FDA-2007-F-0390, by
any of the following methods:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written objections in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2007-F-0390 for this rulemaking. All objections
received will be posted without change to http://www.regulations.gov,
including any personal information provided. For detailed instructions
on submitting objections, see section VIII. Objections in the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
objections received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Celeste Johnston, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register of April 11, 2007 (72
FR 18263), FDA announced that a food additive petition (FAP 7M4768) had
been filed by Durand-Wayland, Inc., c/o Hyman, Phelps & McNamara, P.C.,
700 13th St. NW., suite 1200, Washington, DC 20005-5929. The petition
proposed that the food additive regulations in part 179 (21 CFR part
179) be amended to provide for the safe use of a carbon dioxide laser
for etching information on food, excluding meat and poultry. The
intended technical effect of the carbon dioxide laser is to etch
information, such as the price look-up code printed on an adhesive
label placed on the surface of individual, fresh produce items sold at
retail, directly onto the surface of food. The carbon dioxide laser
therefore obviates the need for an adhesive label.
    In a letter dated April 27, 2007, Hyman, Phelps & McNamara, P.C.,
informed FDA that Sunkist Growers, Inc., 14130 Riverside Dr., Sherman
Oaks, CA 91423-2313, had joined Durand-Wayland, Inc., as co-petitioner
of FAP 7M4768. The letter explained that Hyman, Phelps & McNamara would
represent both petitioners with regard to FAP 7M4768.
    Subsequent to the filing of the petition, the petitioners amended
the petition by requesting a response to the proposed use of the carbon
dioxide laser for etching information on the skin of fresh, intact
citrus fruit not intended for commercial juice production, while the
other requests in the petition remained

under review. The petitioners submitted a letter dated September 1,
2011, requesting withdrawal of all remaining uses of the petition other
than to etch information on the skin of fresh, intact citrus fruit not
intended for commercial juice production. On December 29, 2011, the
petitioners communicated to FDA that, generally, citrus fruit intended
solely for commercial juice production would not be laser etched, and
that laser-etched citrus fruit would generally be intended for sale in
the fresh market. However, certain circumstances (e.g., a cancelled
order, expired shelf-life) could arise that would preclude laser-etched
citrus fruit from being sold into the fresh market. In such
circumstances, laser-etched citrus fruit could be sold for commercial
juice production. To allow for this possibility, the petitioners
requested that the proposed use not be limited to fruit not intended
for nor used in commercial juice production. The petitioners assert
that this use should be allowed because they contend there is no
material difference between etched and non-etched citrus fruit. This
final rule is a complete response to the petition.

II. Evaluation of Safety

    A source of radiation used to treat food meets the definition of
``food additive'' under section 201(s) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 321(s)). While a source of
radiation such as a carbon dioxide laser is not added to the food
literally, the source is used to treat food and can affect the
characteristics of the food.
    Under section 409(c)(3)(A) of the FD&C Act (21 U.S.C.
348(c)(3)(A)), a food additive cannot be approved for a particular use
unless a fair evaluation of the data available to FDA establishes that
the additive is ``safe'' for that use. FDA's food additive regulations
in 21 CFR 170.3(i) define ``safe'' as ``a reasonable certainty in the
minds of competent scientists that the substance is not harmful under
the intended conditions of use.``
    To fairly evaluate the safety of the carbon dioxide laser used to
etch information on the skin of fresh, intact citrus fruit, the Agency
must identify the various effects that may result from etching the
fruit and assess whether any of these effects pose a public health
concern. In doing so, FDA has determined that the two primary areas of
possible public health concern are the potential chemical effects and
the potential microbiological risk from etching the food. Each of these
areas is discussed in detail within this document.

III. Evaluation of the Safety of the Petitioned Use of a Carbon Dioxide
Laser

A. Background on Carbon Dioxide Laser Etching System

    The low energy carbon dioxide laser that is the subject of this
petition emits an infrared pulsed light with a wavelength of 10.6
micrometers ([mu]m). The infrared energy produced by the carbon dioxide
laser is non-ionizing and falls within the infrared energy spectrum
that is commonly used for food processing, such as cooking, toasting,
and grilling. The carbon dioxide laser beam is integrated with a dot-
matrix type printer head that etches information by removing the
pigmented top layer from the surface of food and revealing a
contrasting sublayer. The etching penetrates the food to an average
depth of 50 [mu]m, which is about the first two to three epidermal cell
layers of the food's surface.
    To limit the etching depth (i.e., how far the laser penetrates the
fruit) and the total surface area of the fruit that is etched, the
petitioners have specified the maximum energy per laser etched area to
be 9.8 x 10-3 joules per square centimeter (J/cm\2\) and a
maximum total surface area of fruit etched by the laser to be 0.122
cm\2\. The petitioners have also proposed a limit on the total energy
to which the citrus fruit is exposed from the use of the carbon dioxide
laser to be 1.5 x 10-3 J. Studies that evaluated the
chemical and microbiological effects of the carbon dioxide laser on
fresh produce, which are discussed in section III.B and III.C of this
document, were consistent with these limits. To ensure that the use of
the carbon dioxide laser for etching information on citrus fruit is
safe, FDA is specifying these limits as conditions of safe use in the
resulting regulation.

B. Potential for Chemical Effects in Food

    One of the issues considered by FDA in evaluating the safety of a
carbon dioxide laser used to etch information on the skin of fresh,
intact citrus fruit is the potential formation of chemical products in
the fruit generated by the laser etching process. To determine whether
the use of a food additive is safe, FDA typically considers the
chemical identity and amount of the additive that will be ingested
compared to what is known regarding its toxicity. In the case of
substances added directly to food, the Agency estimates the amount of
the additive that will be ingested from the proposed use levels of the
additive in particular foods and the consumption patterns of those
foods. Information about the chemical structure of an additive, an
assessment of the likely consumption of the additive, and information
regarding the toxicity of the additive, forms the basis for evaluating
its safety. Similarly, for the petitioned use of the carbon dioxide
laser for etching the skin of fresh, intact citrus fruit, the Agency
considered the potential exposure to new chemical substances that may
be generated in the laser-etched fruit in evaluating its toxicological
safety.
    To demonstrate the safety of the laser etching process, the
petitioners provided a study that compared the chemical effects in
tomatoes, potatoes, and apples exposed to the carbon dioxide laser
etching system to those cooked with infrared heat. The study included
chemical analyses that showed that use of the carbon dioxide laser to
etch information on foods does not generate any new chemical substances
that are not also typically generated by conventional cooking. Although
this study was not conducted specifically on citrus fruit, the results
are relevant for evaluating the potential chemical effects in fruits
and vegetables exposed to laser etching in general, and therefore,
support a determination that the proposed use of a laser to etch the
skin of fresh, intact citrus fruit is safe.
    Furthermore, the dietary exposure to any substances generated in
the citrus fruit by the laser etching process is expected to be
negligible due to the insignificant amount of substances formed, the
very small portion of the surface area of the citrus fruit that is
etched (0.122 cm\2\), and the fact that the skin of citrus fruit is
normally not consumed (Refs. 1 and 2). Based on this information, FDA
concludes that any chemical effects generated by the laser etching
process leading to the formation of products in the fruit are of no
toxicological concern (Ref. 3).

C. Potential for Microbiological Risk in Food

    The petitioners submitted data from a controlled study that
evaluated whether the petitioned use of the carbon dioxide laser for
etching information on the skin of fresh, intact citrus fruit increased
the microbiological risk from changes to the surface of laser-etched
fruit compared to fruit that had not been laser etched. The study
assessed the ability of Salmonella bacteria to infiltrate, survive, or
grow on the surface of fresh Valencia oranges in the area that was
etched by the carbon dioxide laser under the proposed conditions of
use. Salmonella bacteria were inoculated on the surface of oranges
under typical conditions of commercial storage of fresh oranges. The
study utilized Salmonella because

it is a human pathogen commonly associated with fresh produce
contamination. Valencia oranges were used in the study because they are
a fresh citrus fruit and, compared to other types of citrus fruit, have
a higher hydrogen-ion concentration (pH) that is more advantageous for
Salmonella growth.
    According to the study's results, the recovery of viable Salmonella
bacteria from the oranges after etching by the carbon dioxide laser and
subsequent storage for 29 days was comparable to the recovery of
Salmonella from control oranges that were not etched by the carbon
dioxide laser. The amount of viable Salmonella bacteria decreased with
storage time and followed a similar pattern of decline over the
duration of storage under all treatment conditions. The study also
evaluated the presence of viable Salmonella in the juice portion of
inoculated and etched oranges. Salmonella was not detected in the juice
portion of any sound, decay-free oranges that had been etched by the
laser.
    FDA evaluated the results of the study and concluded that
Salmonella bacteria present on orange surfaces prior to etching by the
carbon dioxide laser, and that contaminate orange surfaces after laser
etching, do not infiltrate, survive, or grow during subsequent storage
to a level that presents a potential public health hazard significantly
greater than the survival or growth of Salmonella bacteria on oranges
that are not etched by the carbon dioxide laser (Ref. 4).
    As stated earlier, on December 29, 2011, the petitioners requested
that the proposed use not be limited to citrus fruit not intended for
nor used in commercial juice production because certain circumstances,
such as a cancelled order or expired shelf-life, may arise that would
preclude citrus fruit that is already laser etched from being sold in
the fresh market, but such fruit could still be sold for commercial
juice production. In these circumstances, the preferred alternative
would be to use the laser-etched citrus fruit for commercial juice
production. FDA concludes that no additional safety data or analysis is
necessary because the evidence submitted by the petitioners has
established that there is no material difference between etched and
non-etched citrus fruit. Specifically, the Salmonella study results
provided by the petitioners demonstrated the microbiological
similarities between the untreated and laser-etched oranges, and the
results from the same study showed no detection of Salmonella in the
juice portion of laser-etched oranges. In addition, juice processors
are required to comply with the Hazard Analysis and Critical Control
Point regulation for juice (part 120 (21 CFR part 120)) (the juice
HACCP regulation). Specifically, Sec.  120.24(a) (21 CFR 120.24(a))
requires juice processors to include in their HACCP plans control
measures that will consistently produce, at a minimum, a 5-log
reduction in the pertinent microorganism, which is the most resistant
microorganism of public health significance that is likely to occur in
the juice. Juice processors must achieve the 5-log reduction through
treatments applied directly to the juice, except that citrus juice
processors may use treatments applied to the surface of the fruit,
provided that the 5-log reduction process begins after culling and
cleaning as defined in Sec.  120.3(a) and (f), and the reduction is
accomplished within a single production facility (Sec.  120.24(b)). FDA
concludes that laser-etched citrus fruit, which has been otherwise
cleaned and culled in accordance with the requirements of part 120, can
be eligible to be used to make citrus juice where treatments applied
only to the surface of the fruits are used to achieve the 5-log
pathogen reduction control measure. In addition, Sec.  120.11(b)
requires the juice processor to validate that the HACCP plan, including
any processes used to achieve the 5-log pathogen reduction requirements
of Sec.  120.24, is adequate to control food hazards that are
reasonably likely to occur. If validation reveals that the HACCP plan
is no longer adequate to achieve the 5-log pathogen reduction and
otherwise meet the requirements of part 120, the juice processor must
modify the HACCP plan immediately. Based on the data submitted by the
petitioners demonstrating that there is no material difference between
etched and non-etched citrus fruit, and the additional controls for the
growth of pertinent microorganisms provided by the juice HACCP
regulation, FDA has no safety concerns regarding the possible use of
laser-etched citrus fruit for commercial juice production, and this use
is not excluded from the scope of the final rule.

IV. Conclusion

    Based on the data and studies submitted in the petition and other
relevant information in the Agency's files, FDA concludes that the
proposed use of a carbon dioxide laser for etching information on the
surface of fresh, intact citrus fruit is safe under the conditions
proposed in this petition. Therefore, the food additive regulations
should be amended as set forth in this document.

V. Public Disclosure

    In accordance with Sec.  171.1(h) (21 CFR 171.1(h)), the petition
and the documents that FDA considered and relied upon in reaching its
decision to approve the petition are available for inspection at the
Center for Food Safety and Applied Nutrition by appointment with the
information contact person (see FOR FURTHER INFORMATION CONTACT). As
provided in Sec.  171.1(h), the Agency will delete from the documents
any materials that are not available for public disclosure before
making the documents available for inspection.

VI. Environmental Impact

    The Agency has previously considered the environmental effects of
this rule as announced in the notice of filing for FAP 7M4768 (72 FR
18263). No new information or comments have been received that would
affect the Agency's previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.

VII. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

VIII. Objections

    Any person who will be adversely affected by this regulation may
file with the Division of Dockets Management (see ADDRESSES) either
electronic or written objections by (see DATES). Each objection shall
be separately numbered, and each numbered objection shall specify with
particularity the provisions of the regulation to which objection is
made and the grounds for the objection. Each numbered objection on
which a hearing is requested shall specifically so state. Failure to
request a hearing for any particular objection shall constitute a
waiver of the right to a hearing on that objection. Each numbered
objection for which a hearing is requested shall include a detailed
description and analysis of the specific factual information intended
to be presented in support of the objection in the event that a hearing
is held. Failure to include such a description and analysis for any
particular objection shall constitute a waiver of the right to a
hearing on the objection. It is only necessary to send one set of
documents. Identify documents with the docket number found in brackets
in the heading of this document. Any objections received in response to
the regulation may be seen in the Division of Dockets Management

between 9 a.m. and 4 p.m., Monday through Friday.

IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act

    FDA's review of this petition was limited to section 409 of the
FD&C Act. This final rule is not a statement regarding compliance with
other sections of the FD&C Act. For example, the Food and Drug
Administration Amendments Act of 2007, which was signed into law on
September 27, 2007, amended the FD&C Act to, among other things, add
section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)). Section 301(ll) of
the FD&C Act prohibits the introduction or delivery for introduction
into interstate commerce of any food that contains a drug approved
under section 505 of the FD&C Act (21 U.S.C. 355), a biological product
licensed under section 351 of the Public Health Service Act (42 U.S.C.
262), or a drug or biological product for which substantial clinical
investigations have been instituted and their existence has been made
public, unless one of the exceptions in section 301(ll)(1) to (ll)(4)
of the FD&C Act applies. In its review of this petition, FDA did not
consider whether section 301(ll) of the FD&C Act or any of its
exemptions apply to the laser-etching source. Accordingly, this final
rule should not be construed to be a statement that a food that has
been laser etched, if introduced or delivered for introduction into
interstate commerce, would not violate section 301(ll) of the FD&C Act.
Furthermore, this language is included in all food additive final rules
and therefore should not be construed to be a statement of the
likelihood that section 301(ll) of the FD&C Act applies.

X. References

The following references have been placed on display in the Division of
Dockets Management (see ADDRESSES) and may be seen by interested
persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Memorandum from Lee, Chemistry Review Group, Division of Petition
Review, to Johnston, Regulatory Group II, Division of Petition
Review, May 16, 2007.
2. Memorandum from Lee, Chemistry Review Group, Division of Petition
Review, to Johnston, Regulatory Group II, Division of Petition
Review, November 19, 2008.
3. Memorandum from Khan, Toxicology Team, Division of Petition
Review, to Johnston, Regulatory Group II, Division of Petition
Review, April 20, 2010.
4. Memorandum from Losikoff, Division of Seafood Safety, and
Mahovic, Produce Safety Staff, to Johnston, Regulatory Group II,
Division of Petition Review, August 15, 2011.

List of Subjects in 21 CFR Part 179

    Food additives, Food labeling, Food packaging, Radiation
protection, Reporting and recordkeeping requirements, Signs and
symbols.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
179 is amended as follows:

PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF
FOOD

    1. The authority citation for 21 CFR part 179 continues to read as
follows:

    Authority:  21 U.S.C. 321, 342, 343, 348, 373, 374.

0
2. Section 179.43 is added to subpart B to read as follows:

Sec.  179.43  Carbon dioxide laser for etching food.

    Carbon dioxide laser light may be safely used for etching
information on the surface of food under the following conditions:
    (a) The radiation source consists of a carbon dioxide laser
designed to emit pulsed infrared radiation with a wavelength of 10.6
micrometers such that the maximum energy output of the laser does not
exceed 9.8 x 10-3 joules per square centimeter (J/cm\2\);
    (b) The carbon dioxide laser shall be used only for etching
information on the skin of fresh, intact citrus fruit, providing the
fruit has been adequately washed and waxed prior to laser etching, and
the etched area is immediately rewaxed after treatment; and
    (c) The maximum total energy to which the etched citrus fruit is
exposed from the use of the carbon dioxide laser shall not exceed 1.5 x
10-3 J, and the maximum total etched surface area of the
citrus fruit shall not exceed 0.122 cm\2\.

    Dated: June 5, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14035 Filed 6-8-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: July 22, 2008 (Volume 73, Number 141)]
[Notices]
[Page 42570-42571]
[DOCID:fr22jy08-50]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2007-0128; FRL-8695-6]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Ferroalloys
Production: Ferromanganese and Silicomanganese (Renewal), ICR Number
1831.04, OMB Number 2060-0391

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before August 21,
2008.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2007-0128, to (1) EPA online using http://www.regulations.gov (our
preferred method), or by e-mail to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information Center, Mail Code
2201T, 1200 Pennsylvania Avenue, NW., Washington, DC 20460, and (2) OMB
at: Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street,
NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Mar[iacute]a Malav[eacute], Compliance
Assessment and Media Programs Division, Mail Code 2223A, Office of
Compliance, Environmental Protection Agency, 1200 Pennsylvania Avenue,
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On March 9, 2007 (72 FR 10735), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2007-0128, which is available for public viewing
online at http://www.regulations.gov, in person viewing at the
Enforcement and Compliance Docket in the EPA Docket Center (EPA/DC),
EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington, DC. The
EPA Docket Center 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 Reading Room is<PHONE_NUMBER>, and the telephone number
for the

Enforcement and Compliance Docket is<PHONE_NUMBER>.
    Use the EPA electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note the EPA policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing at http://www.regulations.gov, as EPA receives them
and without change, unless the comment contains copyrighted material,
Confidential Business Information (CBI), or other information whose
public disclosure is restricted by statute. For further information
about the electronic docket, go to http://www.regulations.gov.
    Title: NESHAP for Ferroalloys Production: Ferromanganese and
Silicomanganese (Renewal).
    ICR Numbers: EPA ICR Number 1831.04, OMB Number 2060-0391.
    ICR Status: This ICR is scheduled to expire on September 30, 2008.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may neither conduct nor sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid OMB control number. The OMB control numbers for the EPA
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, and displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) using Maximum Achievable Control Technology were
proposed on August 4, 1998, promulgated on May 20, 1999, and amended
most recently on March 22, 2001. The rule applies to ferroalloy
production facilities that manufacture ferromanganese and
silicomanganese that are major sources of hazardous air pollutants
(HAPs) or are co-located at major sources of HAPs.
    In general, all NESHAP standards require initial notifications,
performance tests, and periodic reports. Respondents that are not
required to conduct an initial performance test are required to notify
the EPA Administrator of the initial compliance status of the source.
Sources are also required to monitor and maintain records of its
operations including: (1) Process or control device parameters; (2) bag
leak detention systems; (3) maintenance plan for air pollution control
devices (e.g., capture system and venturi scrubbers); (4) certification
that monitoring devices are accurate; and (5) the implementation and
corrective actions taken related to the startup, shutdown and
malfunction plan and the fugitive dust control plan. The types of
periodic reports required by this regulation include: Opacity-related
reports; performance test results reports; immediate and periodic
startup/shutdown/malfunction reports, quarterly emissions reports;
capture hood inspection reports; fugitive dust operations reports; and
annual compliance status reports. These notifications, reports, and
records are essential in determining compliance, and are required of
all sources subject to NESHAP standards.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 83
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to respond to a collection of information; search data
sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Ferroalloy production facilities
that manufacture ferromanganese and silicomanganese and are either
major sources of HAPs or are co-located at major sources of HAPs.
    Estimated Number of Respondents: 1.
    Frequency of Response: Initially, annually, semiannually and
quarterly.
    Estimated Total Annual Hour Burden: 584 hours.
    Estimated Total Annual Costs: $37,129 in Labor costs exclusively.
There are no annualized capital/startup or O&M costs associated with
this ICR.
    Changes in the Estimates: There are no changes in the labor hours
and cost in this ICR compared to the previous ICR. This is due to two
considerations: (1) The regulations have not changed over the past
three years and are not anticipated to change over the next three
years; and (2) the growth rate for the industry is either very low, or
negative, or non-existent, so there are no significant changes in the
overall burden.
    Since there are no changes in the regulatory requirements and there
is no significant industry growth, the labor hours and cost figures in
the previous ICR are used in this ICR, and there is no change in burden
to industry.

    Dated: July 16, 2008.
Sara Hisel-McCoy,
Director, Collection Strategies Division.
[FR Doc. E8-16739 Filed 7-21-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: October 4, 2010 (Volume 75, Number 191)]
[Rules and Regulations]
[Page 61099-61100]
[DOCID:fr04oc10-7]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0821]
RIN 1625-AA87

Security Zones; Captain of the Port Buffalo Zone; Technical
Amendment

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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SUMMARY: The Coast Guard is revising the contact information for Marine
Safety Detachment Massena in the regulation establishing the process
for getting permission to transit the security zones at Moses-Saunders
Nuclear Power Dam, and Long Sault Spillway Dam. This action is
necessary because the telephone number is incorrect, and this action
will ensure the ability of persons or vessels to gain permission to
transit these areas.

DATES: This rule is effective October 4, 2010.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2010-0821 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-0821 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the 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, 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 e-mail MSSD2 John Maurer, Marine Safety Detachment Massena,
Coast Guard; telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
If you have questions on viewing the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this final rule without prior notice and
opportunity to comment pursuant to authority under section 4(a) of the
Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because notice and comment is unnecessary.
This rule is minor and merely technical in nature in that it simply
amends a telephone number for the point of contact at Marine Safety
Detachment Massena.
    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. Good cause exists because delaying
the effective date is unnecessary. This rule is minor and merely
technical in nature in that it simply amends a telephone number for the
point of contact at Marine Safety Detachment Massena.

Background and Purpose

    The Captain of the Port Buffalo has previously established a
security zone in the vicinity of Moses-Saunders Power Dam and the Long
Sault Spillway Dam. This security zone exists in 33 CFR 165.911.
Persons desiring to transit the area of the Moses-Saunders Power Dam
and the Long Sault Spillway Dam must contact the Supervisor, Marine
Safety Detachment Massena. Currently, 33 CFR 165.911 provides an
incorrect telephone number for the Supervisor, Marine Safety Detachment
Massena.

Discussion of Rule

    The Captain of the Port Buffalo is publishing this final rule to
correct the telephone number currently published in 33 CFR 165.911 for
the Supervisor, Marine Safety Detachment Massena. This correction is
necessary so that the public may contact the appropriate Coast Guard
office to receive permission to transit the security zones in the area
of the Moses-Saunders Power Dam and the Long Sault Spillway Dam.

Regulatory Analyses

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

Regulatory Planning and Review

    This 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.
    The Coast Guard determined that this rule is not a significant
regulatory action because it is only a correction of the contact
information in the previous rule, not a substantive change of the
regulation.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this 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 rule will
not have a significant economic impact on a substantial number of small
entities. This rule will have no effect on small entities because it is
purely minor and technical in nature in that it merely corrects the
telephone number for the point of contact at Marine Safety Detachment
Massena.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    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.

Collection of Information

    This rule calls 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 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 (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.

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.

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.

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.

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.

Energy Effects

    We have analyzed this 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 rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

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 concluded
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)(a), of
the Instruction. This rule involves an editorial revision to a
regulation to update a telephone number. 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 record
keeping requirements, Security measures, Waterways.

0
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. 1226, 1231; 46 U.S.C. Chapters 701, 3306,
3703; 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.

0
2. In Sec.  165.911, revise paragraph (b)(2) to read as follows:

Sec.  165.911  Security Zones; Captain of the Port Buffalo Zone.

* * * * *
    (b) * * *
    (2) Persons or vessels desiring to transit the area of the Nine
Mile Point and Fitzpatrick Nuclear Power Plants or Ginna Nuclear Power
Plant security zones must contact the Captain of Port Buffalo at
telephone number<PHONE_NUMBER>, or on VHF/FM channel 16 to seek
permission to transit the area. Persons desiring to transit the area of
Moses-Saunders Power Dam or Long Sault Spillway Dam security zones must
contact the Supervisor, Marine Safety Detachment Massena at telephone
number<PHONE_NUMBER>, or on VHF/FM channel 16 to seek permission to
transit the area. If permission is granted, all persons and vessels
shall comply with the instructions of the Captain of the Port or his or
her designated representative.
* * * * *

    Dated: September 16, 2010.
R.S. Burchell,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
[FR Doc. 2010-24774 Filed 10-1-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 238 (Monday, December 12, 2016)]
[Notices]
[Pages 89470-89471]
[FR Doc No: 2016-29674]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-P-1363]

Determination That SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER
(Sodium Chloride), Injectable, 234 Milligrams/Milliliter, Was Not
Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium
chloride), injectable, 234 milligrams (mg)/milliliter (mL), was not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for sodium chloride, injectable, 234 mg/mL, if all
other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: David Faranda, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-8767.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER (sodium chloride),
injectable, 234 mg/mL, is the subject of NDA 019329, held by Abraxis
Pharmaceutical Products, and initially approved on April 22, 1987.
SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER is indicated for use in
patients who have special problems of sodium electrolyte intake or
excretion, and for the treatment of sodium chloride and water
deficiencies, which commonly occur in many diseases.
    In a letter dated January 18, 1996, the original NDA holder,
Fujisawa USA, Inc., notified FDA that SODIUM CHLORIDE 23.4% IN PLASTIC
CONTAINER (sodium chloride), injectable, 234 mg/mL, was being
discontinued, and FDA moved the drug product to the ``Discontinued Drug

Product List'' section of the Orange Book.
    Gordon Johnston Regulatory Consultants, LLC, submitted a citizen
petition dated May 25, 2016 (Docket No. FDA-2016-P-1363), under 21 CFR
10.30, requesting that the Agency determine whether SODIUM CHLORIDE
23.4% IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL,
was withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER
(sodium chloride), injectable, 234 mg/mL, was not withdrawn for reasons
of safety or effectiveness. The petitioner has identified no data or
other information suggesting that SODIUM CHLORIDE 23.4% IN PLASTIC
CONTAINER (sodium chloride), injectable, 234 mg/mL, was withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of SODIUM CHLORIDE 23.4% IN
PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, from sale.
We have also independently evaluated relevant literature and data for
possible postmarketing adverse events. We have reviewed the available
evidence and determined that this drug product was not withdrawn from
sale for reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list SODIUM CHLORIDE 23.4%
IN PLASTIC CONTAINER (sodium chloride), injectable, 234 mg/mL, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to this drug product may
be approved by the Agency as long as they meet all other legal and
regulatory requirements for the approval of ANDAs. If FDA determines
that labeling for this drug product should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.

    Dated: December 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29674 Filed 12-9-16; 8:45 am]
 BILLING CODE 4164-01-P