[Federal Register Volume 80, Number 230 (Tuesday, December 1, 2015)]
[Notices]
[Pages 75094-75096]
[FR Doc No: 2015-30427]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP16-4-000]

Tennessee Gas Pipeline Company, L.L.C.; Notice Of Intent To
Prepare An Environmental Assessment For The Proposed Orion Project And
Request For Comments On Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the Orion Project involving
construction and operation of facilities by Tennessee Gas Pipeline
Company, L.L.C. (TGP) in Wayne and Pike Counties, Pennsylvania. The
Commission will use this EA in its decision-making process to determine
whether the project is in the public convenience and necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies on the project. You can make a difference by providing us with
your specific comments or concerns about the project. Your comments
should focus on the potential environmental effects, reasonable
alternatives, and measures to avoid or lessen environmental impacts.
Your input will help the Commission staff determine what issues they
need to evaluate in the EA. To ensure that your comments are timely and
properly recorded, please send your comments so that the Commission
receives them in Washington, DC on or before December 23, 2015.
    If you sent comments on this project to the Commission before the
opening of this docket on October 9, 2015, you will need to file those
comments in Docket No. CP16-4-000 to ensure they are considered as part
of this proceeding.
    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives should notify their constituents of this proposed
project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable agreement. However, if
the Commission approves the project, that approval conveys with it the
right of eminent domain. Therefore, if easement

negotiations fail to produce an agreement, the pipeline company could
initiate condemnation proceedings where compensation would be
determined in accordance with state law.
    TGP provided landowners with a fact sheet prepared by the FERC
entitled ``An Interstate Natural Gas Facility On My Land? What Do I
Need To Know?'' This fact sheet addresses a number of typically asked
questions, including the use of eminent domain and how to participate
in the Commission's proceedings. It is also available for viewing on
the FERC Web site (www.ferc.gov).

Public Participation

    For your convenience, there are three methods you can use to submit
your comments to the Commission. The Commission encourages electronic
filing of comments and has expert staff available to assist you at
(202) 502-8258 or<EMAIL_ADDRESS>Please carefully follow these
instructions so that your comments are properly recorded.
    (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; or
    (3) You can file a paper copy of your comments by mailing them to
the following address. Be sure to reference the project Docket No.
(CP16-4-000) with your submission: Kimberly D. Bose, Secretary, Fderal
Energy Regulatory Commission, 888 First Street NE., Room 1A,
Washington, DC 20426.

Summary of the Proposed Project

    TGP proposes to construct and operate pipeline facilities, to
modify existing aboveground facilities, and add new tie-in facilities
in Wayne and Pike Counties, Pennsylvania. The Orion Project would
provide about 135,000 dekatherms per day of natural gas. According to
TGP, its project would meet market needs of the Middle Atlantic and New
England regions of the United States, and to a lesser extent Canada.
    The Orion Project would consist of the following facilities:
     approximately 12.9 miles of new 36-inch-diameter looping
\1\ pipeline in Wayne and Pike Counties, Pennsylvania;
---------------------------------------------------------------------------

    \1\ A pipeline loop is a segment of pipe constructed parallel to
an existing pipeline to increase capacity.
---------------------------------------------------------------------------

     a new internal pipeline inspection (``pig'') launcher,
crossover, and connecting facilities at the beginning of the proposed
pipeline loop in Wayne County, Pennsylvania;
     a new ``pig'' receiver, crossover, and connecting
facilities at the end of the proposed pipeline loop in Pike County,
Pennsylvania;
     modifications at the existing Compressor Station 323,
including rewheeling/restaging of an existing compressor and other
piping and appurtenant modifications.
    The general location of the project facilities is shown in appendix
1.\2\
---------------------------------------------------------------------------

    \2\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of appendices were sent to all those
receiving this notice in the mail and are available at www.ferc.gov
using the link called ``eLibrary'' or from the Commission's Public
Reference Room, 888 First Street NE., Washington, DC 20426, or call
(202) 502-8371. For instructions on connecting to eLibrary, refer to
page 6 of this notice.
---------------------------------------------------------------------------

Land Requirements for Construction

    Construction of the proposed facilities would disturb about 248
acres of land for the pipeline and aboveground facilities, 62 acres of
which are associated with existing permanent TGP rights-of-way.
Following construction, TGP would maintain about 79 acres for permanent
operation of the project's facilities, 34 acres of which are associated
with existing permanent TGP rights-of-way; the remaining acreage would
be restored and revert to former uses. The majority of the proposed
pipeline route parallels TGP's existing 300 Line rights-of-way. The
majority of the aboveground facilities would be constructed within
existing facility boundaries or existing permanent easement; however,
an additional 0.1 acre of new operational right-of-way would be needed
for the proposed aboveground facilities.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
\3\ to discover and address concerns the public may have about
proposals. This process is referred to as ``scoping.'' The main goal of
the scoping process is to focus the analysis in the EA on the important
environmental issues. By this notice, the Commission requests public
comments on the scope of the issues to address in the EA. We will
consider all filed comments during the preparation of the EA.
---------------------------------------------------------------------------

    \3\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
---------------------------------------------------------------------------

    In the EA we will discuss impacts that could occur as a result of
the construction and operation of the proposed project under these
general headings:
     geology and soils;
     land use;
     water resources, fisheries, and wetlands;
     cultural resources;
     vegetation and wildlife;
     air quality and noise;
     endangered and threatened species;
     public safety; and
     cumulative impacts.
    We will also evaluate reasonable alternatives to the proposed
project or portions of the project, and make recommendations on how to
lessen or avoid impacts on the various resource areas.
    The EA will present our independent analysis of the issues. The EA
will be available in the public record through eLibrary. We will
publish and distribute the EA to the public for an allotted comment
period. We will consider all comments on the EA before making our
recommendations to the Commission. To ensure we have the opportunity to
consider and address your comments, please carefully follow the
instructions in the Public Participation section, beginning on page 2.
    With this notice, we are asking agencies with jurisdiction by law
and/or special expertise with respect to the environmental issues of
this project to formally cooperate with us in the preparation of the
EA.\4\ Agencies that would like to request cooperating agency status
should follow the instructions for filing comments provided under the
Public Participation section of this notice.
---------------------------------------------------------------------------

    \4\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Part 1501.6.
---------------------------------------------------------------------------

Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we are using this

notice to initiate consultation with the Pennsylvania State Historic
Preservation Office (SHPO), and to solicit their views and those of
other government agencies, interested Indian tribes, and the public on
the project's potential effects on historic properties.\5\ We will
define the project-specific Area of Potential Effects (APE) in
consultation with the SHPO as the project develops. On natural gas
facility projects, the APE at a minimum encompasses all areas subject
to ground disturbance (examples include construction right-of-way,
contractor/pipe storage yards, compressor stations, and access roads).
Our EA for this project will document our findings on the impacts on
historic properties and summarize the status of consultations under
section 106.
---------------------------------------------------------------------------

    \5\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
---------------------------------------------------------------------------

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the project. We will update the environmental mailing list
as the analysis proceeds to ensure that we send the information related
to this environmental review to all individuals, organizations, and
government entities interested in and/or potentially affected by the
proposed project.
    Copies of the EA will be sent to the environmental mailing list for
public review and comment. If you would prefer to receive a paper copy
of the document instead of the CD version or would like to remove your
name from the mailing list, please return the attached Information
Request (appendix 2).

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Instructions for becoming an intervenor are in
the User's Guide under the ``e-filing'' link on the Commission's Web
site.

Additional Information

    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 at www.ferc.gov using the ``eLibrary'' link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number,
excluding the last three digits in the Docket Number field (i.e., CP16-
4). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or 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 which 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.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: November 23, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-30427 Filed 11-30-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 209 (Monday, October 29, 2012)]
[Notices]
[Page 65546]
[FR Doc No: 2012-26445]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EF11-7-000]

Western Area Power Administration; Notice of Filing

    Take notice that on July 14, 2011, Western Area Power
Administration submitted its revised version of its Tariff Title for
the Western Rate Schedules database, to be effective July 14, 2011.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on November 9, 2012.

    Dated: October 19, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-26445 Filed 10-26-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 164 (Friday, August 27, 2021)]
[Rules and Regulations]
[Pages 48025-48027]
[FR Doc No: 2021-18525]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0623]
RIN 1625-AA00

Safety Zone; M/V ZHEN HUA 24, Crane Delivery Operation,
Chesapeake Bay and Coastal Virginia

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary moving safety zone
around M/V ZHEN HUA 24 during its transit through certain waters of the
Chesapeake Bay and Coastal Virginia. This action is necessary to
provide for the safety of life on these navigable waters during the
movement of the M/V ZHEN HUA 24 while it is transporting four new
Super-Post Panamax container cranes to the Port of Baltimore,
anticipated to begin transit of the Chesapeake Bay on August 31, 2021.
The Captain of the Port Virginia has determined that limited
maneuverability and unique cargo of this vessel are potential hazardous
to any person or vessel within the safety zone. This rulemaking
prohibits persons and vessels from being in the safety zone unless
authorized by the Captain of the Port Virginia or a designated
representative.

DATES: This rule is effective August 30, 2021 through September 29,
2021.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander Ashley Holm, Sector Virginia
Waterways Management division, U.S. Coast Guard; telephone 757-668-
5581, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code
CBBT Chesapeake Bay Bridge-Tunnel
COTP Captain of the Port

II. Background Information and Regulatory History

    On June 28, 2021, Ports America Chesapeake, LLC notified the Coast
Guard that the M/V ZHEN HUA 24 will be transporting four new Super-Post
Panamax container cranes from Shanghai, China, to the Port of
Baltimore. These cranes will be delivered to, and installed at, the
Seagirt Marine Terminal at Baltimore, MD. In response, on August 12,
2021, the Coast Guard published a notice of proposed rulemaking (NPRM)
titled Safety Zone: M/V ZHEN HUA 24, Crane Delivery Operation,
Chesapeake Bay and Coastal Virginia, 86 FR 44328. There we stated why
we issued the NPRM, and invited comments on our proposed regulatory
action. During the comment period that ended August 23, 2021, we
received no comments. When the NPRM was published, the M/V ZHEN HUA 24
was estimated to arrive between September 4, 2021, and September 29,
2021. This arrival date has been moved up due to changes in shipping
schedules and is now scheduled to begin its inbound transit on August
31, 2021, but this date is still subject to change.
    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. Delaying the effective date of
this rule would be impracticable and contrary to the public interest
because immediate action is needed to respond to the potential safety
hazards associated with the transit of the M/V ZHEN HUA 24 to
Baltimore, MD, which is expected to occur prior to the 30 day time
period. Actual notice of enforcement of this rule will be provided via
Broadcast Notice to Mariners and VHF-FM radio transmissions.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rulemaking under authority in 46
U.S.C. 70034 (previously 33 U.S.C. 1231). The COTP Virginia has
determined that potential hazards associated with the crane delivery
operation would be a safety concern for any vessel required to transit
the navigation channels in the Chesapeake Bay and Coastal Virginia that
would meet, pass, or overtake the M/V ZHEN HUA 24. These hazards can be
mitigated with a 500 yards radius safety zone around the vessel. The
purpose of this rule is to ensure safety of vessels and protect the
environment and critical national infrastructure such as the Chesapeake
Bay bridge-tunnel (CBBT) during the vessel's transit to Baltimore.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received no comments on our NPRM published
August 12, 2021. There are no changes in the regulatory text of this
rule from the proposed rule in the NPRM.
    This rule establishes a temporary moving safety zone with a radius
of 500 yards centered around the M/V ZHEN HUA 24 during the inbound
transit through the territorial sea and the Chesapeake Bay to
Baltimore, MD. The safety zone will be enforced when the M/V ZHEN HUA
24 enters the U.S. Territorial Sea, as defined in 33 CFR 2.22(a)(1),
and enforcement will end when the vessel crosses the Virginia- Maryland
State Line in the Chesapeake Bay. The M/V ZHEN HUA 24 is expected to
begin its inbound transit through the Chesapeake Bay on August 31,
2021, but this is subject to change. The duration of the zone is
intended to ensure the safety of vessels and these navigable waters for
the duration of the vessel's transit estimated to last 15 hours. No
vessel or person will be permitted to enter the safety zone without
obtaining permission from the COTP or a designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, this
rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on This regulatory
action determination is based on the size and duration of the safety
zone, which would impact only vessel traffic required to transit
certain navigation channels of the Chesapeake Bay and the Coastal
Virginia for an expected total no

more than 15 enforcement-hours. Although these waterways support both
commercial and recreational vessel traffic, small portions of the
waterway would be restricted for a small period of time as the M/V ZHEN
HUA 24 transits northward in the Chesapeake Bay. Moreover, the Coast
Guard would issue a Broadcast Notice to Mariners via VHF-FM marine
channel 16 about the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rulemaking. 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.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    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.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, 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.

E. 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.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of
1969(42 U.S.C. 4321-4370f), and have determined that this action is one
of a category of actions that do not individually or cumulatively have
a significant effect on the human environment. This rule involves
involves a temporary safety zone that would prohibit entry within
certain navigable waters of the Chesapeake Bay and Coastal Virginia
within a 500 yards radius of the M/V ZHEN HUA 24. It is categorically
excluded from further review under paragraph L60c of Appendix A, Table
1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Memorandum for the
Record supporting this determination is available in the docket. For
instructions on locating the docket, see the ADDRESSES section of this
preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T05-0623 to read as follows:

Sec.  165.T05-0623  Safety Zone; M/V ZHEN HUA 24, Crane Delivery
Operation, Chesapeake Bay and Coastal Virginia.

    (a) Regulated Area. The rule establishes the following regulated
area as a temporary moving safety zone: All waters within a 500 yards
radius of the M/V ZHEN HUA 24 during its inbound transit to Baltimore,
MD. Inbound transit will begin when the M/V ZHEN HUA enters the U.S.
Territorial Sea, as defined in33 CFR 2.22(a)(1), and end when the
vessel crosses the Virginia-Maryland State Line in the Chesapeake Bay,
a line starting at a point 38[deg]01'36'' N latitude, 75[deg]14'34'' W
longitude, then south east to a point 37[deg]19'14'' N latitude,
72[deg]13'13'' W longitude. These coordinates are based on WGS 84.
    (b) Definitions. As used in this section--
    Captain of the Port (COTP) means the Commander, U.S. Coast Guard
Sector Virginia.
    Designated representative means a Coast Guard Patrol Commander,
including a Coast Guard coxswain, petty officer, or other officer
operating a Coast

Guard vessel and a Federal, State, and local officer designated by or
assisting the Captain of the Port Virginia (COTP) in the enforcement of
the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by telephone at<PHONE_NUMBER> or on Marine Band Radio
VHF-FM channel 16 (156.8 MHz). Those in the safety zone must comply
with all lawful orders or directions given to them by the COTP or the
COTP's designated representative.
    (3) The Coast Guard will provide notice of the regulated area by
Marine Safety Information Bulletins, Local Notice to Mariners,
Broadcast Notice to Mariners, and on-scene designated representatives.
    (d) Enforcement officials. The U.S. Coast Guard may be assisted in
the patrol and enforcement of the safety zone by Federal, State, and
local agencies.
    (e) Enforcement period. This section will be enforced during
inbound transit of the M/V ZHEN HUA 24 through Coastal Virginia and
Chesapeake Bay on the way to the Port of Baltimore.

    Dated: August 24, 2021.
Jennifer A. Stockwell,
Captain, U.S. Coast Guard, Acting Captain of the Port Virginia.
[FR Doc. 2021-18525 Filed 8-26-21; 8:45 am]
BILLING CODE 9110-04-P


1 ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 82 [ FRL]

RIN []

Protection of Stratospheric Ozone: Allocation of Essential Use Allowances for Calendar Year 2005.

AGENCY: Environmental Protection Agency ( EPA). ACTION: Proposed rule.

SUMMARY: EPA is proposing to allocate essential use allowances for import and production of class I stratospheric ozone depleting substances ( ODSs) for calendar year 2005. Essential use allowances enable a person to obtain controlled class I ODSs as an exemption to the regulatory ban of production and import of these chemicals, which became effective on January 1, 1996. EPA allocates essential use allowances for exempted production or import of a specific quantity of class I ODS solely for the designated essential purpose. The proposed allocations total 1,524.58 metric tons of chlorofluorocarbons for use in metered dose inhalers.

DATES: Written comments on this proposed rule must be received by the EPA Docket on or before [ insert date 30 days after date of publication], unless a public hearing is requested. Comments must then be received on or before 30 days following the public hearing. Any party requesting a public hearing must notify the contact listed below under " For More Information Contact" by 5: 00 p. m. Eastern Standard Time on [ insert date 10 days after publication]. If a hearing is held, EPA will publish a document in the Federal Register announcing the hearing information.

ADDRESSES: Submit your comments, identified by Docket ID No. OAR 2004 0063, by one of the following methods:

Federal eRulemaking Portal: http:// www. regulations. gov. Follow the on line instructions for submitting comments.

Agency Website: http:// www. epa. gov/ edocket. EDOCKET, EPA's electronic public docket and comment system, is EPA's preferred method for receiving comments. Follow the on line instructions for submitting comments.

Mail: Air and Radiation Docket, Environmental Protection Agency, Mailcode 6102T, 1200 Pennsylvania Ave., NW, Washington, DC, 20460, Attention: Docket ID No. OAR 2004 2 0063.

Hand Delivery: EPA Docket Center, ( EPA/ DC) EPA West, Room B102, 1301 Constitution Ave., NW, Washington, D. C., Attention Docket ID No. OAR 2004 0063. Deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. Instructions: Direct your comments to Air Docket ID No. OAR 2004 0063. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http:// www. epa. gov/ edocket, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through EDOCKET, regulations. gov, or e mail. For instructions on how to submit CBI, see " How do I submit confidential business information to EPA?" under SUPPLEMENTARY INFORMATION. The EPA EDOCKET and the federal regulations. gov websites are " anonymous access" systems, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e mail comment directly to EPA without going through EDOCKET or regulations. gov, your e mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD ROM you submit. 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. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. Docket: All documents in the docket are listed in the EDOCKET index at http:// www. epa. gov/ edocket. Although listed in the index, some information is not publicly available, namely CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in EDOCKET or in hard copy at the Air Docket, EPA/ DC, EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is ( 202) 566 1744, and the telephone number for Docket ID No. OAR 3 2004 0063 is ( 202) 566 1742. Materials related to previous EPA actions on the essential use program are contained in EPA Air Docket No. A 93 39. Docket A 93 39 may be reviewed at the Public Reading Room.

FOR FURTHER INFORMATION CONTACT: Scott Monroe, Essential Use Program Manager, by regular mail: U. S. Environmental Protection Agency, Stratospheric Protection Division ( 6205J), 1200 Pennsylvania Avenue, NW, Washington, DC, 20460; by courier service or overnight express: 1301 L Street, N. W., Washington D. C., 20005, by telephone: 202 343 9712; or by email: monroe. scott@ epa. gov.

SUPPLEMENTARY INFORMATION: Table of Contents I. General Information A. How should I submit confidential business information to EPA? II. Basis for Allocating Essential Use Allowances A. What are essential use allowances? B. Under what authority does EPA allocate essential use allowances? C. What is the process for allocating essential use allowances? III. Essential Use Allowances for Medical Devices IV. Proposed Allocation of Essential Use Allowances for Calendar Year 2005 V. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer and Advancement Act I. General Information A. How should I submit confidential business information to EPA? Comments that contain confidential business information should be submitted in two versions, one clearly marked " Public", to be filed in the public docket, and the other clearly marked " Confidential" to be reviewed by authorized government personnel only. If the comments are not marked, EPA will assume they do 1 " Consumption" is defined as the amount of a substance produced in the United States, plus the amount imported into the United States, minus the amount exported to Parties to the Montreal Protocol ( see Section 601( 6) of the Clean Air Act). Stockpiles of class I ODSs produced or imported prior to the 1996 phase out may be used for purposes not expressly banned at 40 CFR part 82.

2 Class I ozone depleting substances are listed at 40 CFR Part 82 subpart A, appendix A.

4 not contain confidential business information and will docket them. Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. Send or deliver information identified as CBI only to the Essential Use Program Manager. 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 identified in the FOR FURTHER INFORMATION CONTACT section. II. Basis for Allocating Essential Use Allowances A. What are essential use allowances? Essential use allowances are allowances to produce or import certain ozone depleting chemicals in the U. S. for purposes that have been deemed " essential" by the Parties to the Montreal Protocol and the U. S. Government. The Montreal Protocol on Substances that Deplete the Ozone Layer ( Protocol) is the international agreement to reduce and eventually eliminate the production and consumption1 of all stratospheric ozone depleting substances ( ODSs). The elimination of production and consumption of class I ODSs is accomplished through adherence to phase out schedules for specific class I ODSs2, including: chlorofluorocarbons ( CFCs), halons, carbon 3 According to Section 614( b) of the Act, Title VI " shall be construed, interpreted, and applied as a supplement to the terms and conditions of the Montreal Protocol . . . and shall not be construed, interpreted, or applied to abrogate the responsibilities or obligations of the United States to implement fully the provisions of the Montreal Protocol. In the case of conflict between any provision of this title and any provision of the Montreal Protocol, the more stringent provision shall govern." EPA's regulations implementing the essential use provisions of the Act and the Protocol are located in 40 CFR part 82.

5 tetrachloride, and methyl chloroform. As of January 1, 1996, production and import of most class I ODSs were phased out in developed countries, including the United States. However, the Protocol and the Clean Air Act ( Act) provide exemptions that allow for the continued import and/ or production of class I ODS for specific uses. Under the Protocol, exemptions may be granted for uses that are determined by the Parties to be " essential." Decision IV/ 25, taken by the Parties to the Protocol in 1992, established criteria for determining whether a specific use should be approved as essential, and set forth the international process for making determinations of essentiality. The criteria for an essential use, as set forth in paragraph 1 of Decision IV/ 25, are the following: "( a) that a use of a controlled substance should qualify as ` essential' only if: ( i) it is necessary for the health, safety or is critical for the functioning of society ( encompassing cultural and intellectual aspects); and ( ii) there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health; ( b) that production and consumption, if any, of a controlled substance for essential uses should be permitted only if: ( i) all economically feasible steps have been taken to minimize the essential use and any associated emission of the controlled substance; and ( ii) the controlled substance is not available in sufficient quantity and quality from existing stocks of banked or recycled controlled substances, also bearing in mind the developing countries' need for controlled substances." B. Under what authority does EPA allocate essential use allowances? Title VI of the Act implements the Protocol for the United States. 3 Section 604( d) of the Act authorizes EPA to allow the production of limited quantities of class I ODSs after the phase 6 out date for the following essential uses: ( 1) Methyl Chloroform, " solely for use in essential applications ( such as nondestructive testing for metal fatigue and corrosion of existing airplane engines and airplane parts susceptible to metal fatigue) for which no safe and effective substitute is available." Decision X/ 6 by the Parties to the Protocol established that "* * * the remaining quantity of methyl chloroform authorized for the United States at previous meetings of the Parties [ will] be made available for use in manufacturing solid rocket motors until such time as the 1999 2001 quantity of 176.4 tons ( 17.6 ODP weighted tons) allowance is depleted, or until such time as safe alternatives are implemented for remaining essential uses." Prior to 2004, EPA issued allowances for production of approximately 34 metric tons of methyl chloroform out of the authorized balance of 176 metric tons. Under section 604( d)( 1) of the Act, EPA may no longer allocate essential use allowances for production and import of methyl chloroform as of January 1, 2005. Therefore, In light of this deadline, in the allocation rulemaking for calendar year 2004 ( 69 FR 4059) EPA allocated the remaining authorized production allowances for methyl chloroform, approximately 142 metric tons, to the National Aeronautics and Space Administration. in the allocation rulemaking for calendar year 2004 ( 69 FR 4059). ( 2) Medical Devices ( as defined in section 601( 8) of the Act), " if such authorization is determined by the Commissioner [ of the Food and Drug Administration], in consultation with the Administrator [ of EPA] to be necessary for use in medical devices." EPA issues allowances to manufacturers of metered dose inhalers, which use CFCs as propellant for the treatment of asthma and chronic obstructive pulmonary diseases. ( 3) Aviation Safety, for which limited quantities of halon 1211, halon 1301, and halon 2402 may be produced " if the Administrator of the Federal Aviation Administration, in consultation with the Administrator [ of EPA] determines that no safe and effective substitute has been developed and that such authorization is necessary for aviation safety purposes." Neither EPA nor the Parties have ever granted a request for essential use allowances for halon, because alternatives are available or because existing quantities of this substance are large enough to provide for any needs for which alternatives have not yet been developed. The Protocol, under Decision X/ 19, additionally allows a general exemption for laboratory and analytical uses. This exemption is reflected in EPA's regulations at 40 CFR part 82, subpart A. While the Act does not specifically provide for this exemption, EPA has determined that an allowance for essential laboratory and analytical uses is allowable under the Act as a de minimis exemption. The de minimis exemption is addressed in 7 EPA's final rule of March 13, 2001 ( 66 FR 14760 14770). The Parties to the Protocol subsequently agreed ( Decision XI/ 15) that the general exemption does not apply to the following uses: testing of oil and grease, and total petroleum hydrocarbons in water; testing of tar in road paving materials; and forensic finger printing. EPA incorporated this exclusion at Appendix G to Subpart A of 40 CFR part 82 on February 11, 2002 ( 67 FR 6352). C. What is the process for allocating essential use allowances? Before EPA may allocate essential use allowances, the Parties to the Protocol must first approve the United States' request to produce or import essential class I ODSs. The procedure set out by Decision IV/ 25 calls for individual Parties to nominate essential uses and the total amount of ODSs needed for those essential uses on an annual basis. The Protocol's Technology and Economic Assessment Panel evaluates the nominated essential uses and makes recommendations to the Protocol Parties. The Parties make the final decisions on whether to approve a Party's essential use nomination at their annual meeting. This nomination cycle occurs approximately two years before the year in which the allowances would be in effect. The allowances allocated through today's action were first nominated by the United States in January 2003. Once the U. S. nomination is approved by the Parties, EPA allocates essential use exemptions to specific entities through notice and comment rulemaking in a manner consistent with the Act. For medical devices, EPA requests information from manufacturers about the number and type of devices they plan to produce, as well as the amount of CFCs necessary for production. EPA then forwards the information to the Food and Drug Administration ( FDA), which determines the amount of CFCs necessary for metered dose inhalers in the coming calendar year. Based on FDA's assessment, EPA proposes allocations to each eligible entity. Under the Act and the Protocol, EPA may allocate essential use allowances in quantities that together are below or equal to the total amount approved by the Parties. EPA may not allocate essential use allowances in amounts higher than the total approved by the Parties. For 2005, the Parties authorized the United States to allocate up to 1,902 metric tons of CFCs for essential uses. III. Essential Use Allowances for Medical Devices The following is a step by step list of actions EPA and FDA have taken thus far to implement the exemption for medical devices found at section 604( d)( 2) of the Act for the 2005 control period. 1. On February 24, 2004, EPA sent letters to MDI manufacturers requesting the following information under section 114 of the Act (" 114 letters"): a. The MDI product where CFCs will be used. 8 b. The number of units of each MDI product produced from 1/ 1/ 03 to 12/ 31/ 03. c. The number of units anticipated to be produced in 2004. d. The gross target fill weight per unit ( grams). e. Total amount of CFCs to be contained in the MDI product for 2005. f. The additional amount of CFCs necessary for production. g. The total CFC request per MDI product for 2005. The 114 letters are available for review in the Air Docket ID No. OAR 2004 0063. The companies requested that their responses be treated as confidential business information; for this reason, EPA has not placed the responses in the docket. 2. On May 18, 2004, EPA sent FDA the information MDI manufacturers provided in response to the 114 letters with a letter requesting that FDA make a determination regarding the amount of CFCs necessary for MDIs for calendar year 2005. This letter is available for review in Air Docket ID No. OAR 2004 0063. 3. On July 28, 2004, FDA sent a letter to EPA stating the amount of CFCs determined by the Commissioner to be necessary for each MDI company in 2005. This letter is available for review in the Air Docket ID No. OAR 2004 0063. In their letter, FDA informed EPA that they had determined that 1524.58 metric tons of CFCs were necessary for use in medical devices in 2005. In accordance with the determination made by FDA, today's action proposes to allocate essential use allowances for a total of 1524.58 metric tons of CFCs for use in MDIs for calendar year 2005. The amounts listed in this proposal are subject to additional review by EPA and FDA if new information demonstrates that the proposed allocations are either too high or too low. Commentors requesting increases or decreases of essential use allowances should provide detailed information supporting their claim for additional or fewer CFCs. Any company that needs less than the full amount listed in this proposal should notify EPA of the actual amount needed. IV. Proposed Allocation of Essential Use Allowances for Calendar Year 2005 EPA proposes to allocate essential use allowances for calendar year 2005 to the entities listed in Table 1. These allowances are for the production or import of the specified quantity of class I controlled substances solely for the specified essential use. As explained in Section II. C. above, the amount of the each allocation is based on the request of the company, which was reviewed by FDA to determine the quantities necessary for use in medical devices. TABLE I.  ESSENTIAL USE ALLOCATION FOR CALENDAR YEAR 2005 9 Company Chemical Quantity ( metric tons)

( i) Metered Dose Inhalers ( for oral inhalation) for Treatment of Asthma and Chronic Obstructive Pulmonary Disease Armstrong Pharmaceuticals CFC 11 or CFC 12 or CFC 114 29 Aventis Pharmaceutical Products CFC 11 or CFC 12 or CFC 114 57 Boehringer Ingelheim Pharmaceuticals CFC 11 or CFC 12 or CFC 114 480 Schering Plough Corporation CFC 11 or CFC 12 or CFC 114 816 3M Pharmaceuticals CFC 11 or CFC 12 or CFC 114 69.18 Wyeth CFC 11 or CFC 12 or CFC 114 73.40 V. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review Under Executive Order 12866 ( 58 FR 51735, October 4, 1993), the Agency must determine whether this regulatory action is " significant" and therefore subject to review by the Office of Management and Budget ( OMB) and the requirements of the Executive Order. The Order defines " significant regulatory action" as one that is likely to result in a rule that may: ( 1) Have an annual effect on the economy of $ 100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; ( 2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; ( 3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations 10 of recipients thereof; or ( 4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Pursuant to the terms of Executive Order 12866, OMB has notified EPA that it considers this a " significant regulatory action" within the meaning of the Executive Order. EPA has submitted this action to OMB for review and incorporated changes as a result. Changes made in response to OMB suggestions or recommendations will be documented in the public record. A copy of the rule showing changes that were made is available in EPA Docket OAR 2004 0063. Under Section 6( a)( 3)( B)( ii) of Executive Order 12866, the Agency must provide to OMB's Office of Information and Regulatory Affairs an " assessment of the potential costs and benefits of the regulatory action, including an explanation of the manner in which the regulatory action is consistent with a statutory mandate and, to the extent permitted by law, promotes the President's priorities and avoids undue interference with State, local, and tribal governments in the exercise of their governmental functions." EPA is undertaking today's proposed action under the mandate established by Section 604( d) of the Clean Air Act Amendments of 1990, which directs the Administrator to authorize the production of limited quantities of class I substances solely for use in medical devices, if the Commissioner of FDA determines that the authorization is necessary. The proposed allocations in today's rule are the amounts determined by FDA to be necessary for calendar year 2005. EPA has not assessed the costs and benefits specific to today's proposed action. The Agency examined the costs and benefits associated with a related regulation. The Agency's Regulatory Impact Analysis ( RIA) for the entire Title VI phaseout program examined the projected economic costs of a complete phaseout of consumption of ozone depleting substances, as well as the projected benefits of phased reductions in total emissions of CFCs and other ozone depleting substances, including essentialuse CFCs used for metered dose inhalers ( U. S. Environmental Protection Agency, " Regulatory Impact Analysis: Compliance with Section 604 of the Clean Air Act for the Phaseout of Ozone Depleting Chemicals," July 1992). B. Paperwork Reduction Act This action does not add any information collection requirements or increase burden under the provisions of the Paperwork Reduction Act, 44 U. S. C. 3501 et. seq. OMB previously approved the information collection requirements contained in the final rule promulgated on May 10, 1995, and assigned OMB control number 2060 0170 ( EPA ICR No. 1432.21). 11 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 instruction; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An Agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR Chapter 1. C. Regulatory Flexibility Act The RFA generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impact of today's rule on small entities, small entity is defined as: ( 1) pharmaceutical preparations manufacturing businesses ( NAICS code 325412) that have less than 750 employees; ( 2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and ( 3) a small organization that is any not for profit enterprise which is independently owned and operated and is not dominant its field. After considering the economic impacts of today's proposed rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. In determining whether a rule has a significant economic impact on a substantial number of small entities, the impact of concern is any significant adverse economic impact on small entities, since the primary purpose of the regulatory flexibility analyses is to identify and address regulatory alternatives " which minimize any significant economic impact of the rule on small entities." 5 USC 603 and 604. Thus, an agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, or otherwise has a positive economic effect on all of the small entities subject to the rule. 12 This rule provides an otherwise unavailable benefit to those companies that are receiving essential use allowances by creating an exemption to the regulatory phaseout of chlorofluorocarbons. We have therefore concluded that today's proposed rule will relieve regulatory burden for all small entities. We continue to be interested in the potential impact of the proposed rule on small entities and welcome comments on issues related to such impacts. D. Unfunded Mandates Reform Act Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA), P. L. 104 4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with " Federal mandates" that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $ 100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost effective, or least burdensome alternative, if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed a small government agency plan under section 203 of the UMRA. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements. Today's rule contains no Federal mandates ( under the regulatory provisions of Title II of the UMRA) for State, local, or tribal governments or the private sector, since it merely provides exemptions from the 1996 phase out of class I ODSs. Similarly, EPA has determined that this rule contains no regulatory requirements that might significantly or uniquely affect small governments, because this rule merely allocates essential use exemptions to entities as an exemption to the ban on production and import of class I ODSs. 13 E. Executive Order 13132: Federalism Executive Order 13132, entitled " Federalism" ( 64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure " meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications." " Policies that have federalism implications" is defined in the Executive Order to include regulations that have " substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government." This proposed rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. Thus, Executive Order 13132 does not apply to this rule. F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments Executive Order 13175, entitled " Consultation and Coordination with Indian Tribal Governments" ( 65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure " meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications." This proposed rule does not have tribal implications, as specified in Executive Order 13175. Today's rule affects only the companies that requested essential use allowances. Thus, Executive Order 13175 does not apply to this rule. G. Executive Order 13045: Protection of Children from Environmental Health Risks and Safety Risks Executive Order 13045, " Protection of Children from Environmental Health risks and Safety Risks" ( 62 FR 19885, April 23, 1997), applies to any rule that ( 1) is determined to be ' economically significant" as defined under E. O. 12866, and ( 2) concerns an environmental health and safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. EPA interprets E. O. 13045 as applying only to those regulatory actions that are based on health or safety risks, such that the analysis required under section 5 501 of the Order has the potential to influence the regulation. This rule is not subject to E. O. 13045 because it implements the phase out schedule and exemptions established by Congress in Title VI of the Clean Air Act. 14 H. Executive Order 13211: Actions that Significantly Affect Energy Supply, Distribution, or Use This rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 Fed. Reg. 28355, May 22, 2001) because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The rule affects only the pharmaceutical companies that requested essential use allowances. I. National Technology Transfer and Advancement Act Section 12( d) of the National Technology Transfer and Advancement Act of 1995 (" NTTAA), Public Law No. 104 113, section 12( d) ( 15 U. S. C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e. g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This proposed rule does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards. List of Subjects in 40 CFR Part 82 Administrative practice and procedure, Air pollution control, Chemicals, Chlorofluorocarbons, Environmental protection, Imports, Methyl Chloroform, Ozone, Reporting and recordkeeping requirements.

Dated: _______________________________________

______________________________________________

Michael O. Leavitt, Administrator 40 CFR Part 82 is proposed to be amended as follows:

PART 82   PROTECTION OF STRATOSPHERIC OZONE 1. The authority citation for part 82 continues to read as follows:

Authority: 42 U. S. C. 7414, 7601,7671 7671q. 15 Subpart A   Production and Consumption Controls 2. Section 82.4 is amended by revising the table in paragraph ( n)( 2) to read as follows:

§ 82.4 Prohibitions for class I controlled substances.

* * * * *

( n) * * *

( 2) * * *

TABLE I.  ESSENTIAL USE ALLOCATION FOR CALENDAR YEAR 2005 Company Chemical Quantity ( metric tons)

( i) Metered Dose Inhalers ( for oral inhalation) for Treatment of Asthma and Chronic Obstructive Pulmonary Disease Armstrong Pharmaceuticals CFC 11 or CFC 12 or CFC 114 29 Aventis Pharmaceutical Products CFC 11 or CFC 12 or CFC 114 57 Boehringer Ingelheim Pharmaceuticals CFC 11 or CFC 12 or CFC 114 480 Schering Plough Corporation CFC 11 or CFC 12 or CFC 114 816 3M Pharmaceuticals CFC 11 or CFC 12 or CFC 114 69.18 Wyeth CFC 11 or CFC 12 or CFC 114 73.40 16 BILLING CODE 6560 50 P


[Federal Register Volume 75, Number 44 (Monday, March 8, 2010)]
[Notices]
[Page 10548]
[FR Doc No: 2010-4873]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Request Revision From the Office of
Management and Budget of a Currently Approved Information Collection
Activity, Request for Comments; Fuel Venting and Exhaust Emission
Requirements for Turbine Engine Powered Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget (OMB) to approve a current
information collection. The date of manufacture and compliance status
stamped on a nameplate of each turbojet engine permits rapid
determination by FAA inspectors, owners, and operators whether an
engine can legally be installed and operated on an aircraft in the
United States.

DATES: Please submit comments by May 7, 2010.

FOR FURTHER INFORMATION CONTACT: Carla Mauney on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Fuel Venting and Exhaust Emission Requirements for Turbine
Engine Powered Airplanes.
    Type of Request: Extension without change of an approved
collection.
    OMB Control Number: 2120-0508.
    Form(s): There are no FAA forms associated with this collection.
    Affected Public: A total of 1,200 Respondents.
    Frequency: The information is collected on occasion.
    Estimated Average Burden per Response: Approximately 5 minutes per
response.
    Estimated Annual Burden Hours: An estimated 100 hours annually.
    Abstract: The date of manufacture and compliance status stamped on
a nameplate of each turbojet engine permits rapid determination by FAA
inspectors, owners, and operators whether an engine can legally be
installed and operated on an aircraft in the United States. The
information is to be used by FAA inspectors, purchasers, owners, and
operators periodically, during the course of the year, to confirm that
the engines meet U.S. EPA pollution requirements in lieu of searching
through extensive paper records.

ADDRESSES: Send comments to the FAA at the following address: Ms. Carla
Mauney, Room 712, Federal Aviation Administration, IT Enterprises
Business Services Division, AES-200, 800 Independence Ave., SW.,
Washington, DC 20591.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

    Issued in Washington, DC, on February 25, 2010.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 2010-4873 Filed 3-5-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: June 3, 2009 (Volume 74, Number 105)]
[Notices]
[Page 26675]
[DOCID:fr03jn09-50]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EG09-19-000; EG09-20-000; EG09-23-000; EG09-24-000; EG09-
25-000; EG09-28-000; EG09-29-000; EG09-30-000; EG09-31-000; EG09-32-
000; EG09-33-000]

Hay Canyon Wind LLC; PowerSmith Cogeneration Project, LP; TXC
Green Power LLC; Evergreen Wind Power V, LLC; EcoGrove Wind, LLC; RPL
Holdings, Inc.; Reliant Energy Florida, LLC; High Lonesome Mesa, LLC;
Saranac Power Partners, L.P.; EC&R Panther Creek Wind Farm III, LLC;
Windy Flats Partners, LLC; Notice of Effectiveness of Exempt Wholesale
Generator Status

May 27, 2009.
    Take notice that during the month of April 2009, the status of the
above-captioned entities as Exempt Wholesale Generators Companies
became effective by operation of the Commission's regulations 18 CFR
366.7(a), except for Docket Nos. EG09-19-000 and EG09-20-000, which
became effective in February 2009; and Docket Nos. EG09-23-000, EG09-
24-000, and EG09-25-000, which became effective in March 2009.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-12864 Filed 6-2-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 202 (Friday, October 20, 2017)]
[Notices]
[Pages 48828-48830]
[FR Doc No: 2017-22731]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 [Docket No. FDA-2017-D-6133]

Application of the ``Solely Engaged'' Exemptions in Parts 117 and
507; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a draft guidance for industry entitled
``Application of the ``Solely Engaged'' Exemptions in Parts 117 and
507; Draft Guidance for Industry.'' The draft guidance, when finalized,
will help establishments and facilities subject to certain FDA
regulations determine whether they are ``solely engaged'' in certain
activities. Establishments and facilities ``solely engaged'' in certain
activities are exempt from some or all requirements of the regulations.

DATES: Submit either electronic or written comments on the draft
guidance by April 18, 2018, to ensure that the Agency considers your
comment on the draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-6133 for ``Application of the ``Solely Engaged'' Exemptions
in Parts 117 and 507: Guidance for Industry.'' Received comments 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 office 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 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Office of Food Safety (HFS-300), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740. Send two self-addressed adhesive labels to assist that office
in processing your request. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: For questions relating to the guidance
as it applies to human food: Jenny Scott, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>. For questions relating to the
guidance as it applies to animal food: Jeanette Murphy, Center for
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry
entitled ``Application of the ``Solely Engaged'' Exemptions in Parts
117 and 507.'' We are issuing the draft guidance consistent with our
good guidance practices regulation (21 CFR 10.115). The draft guidance,
when finalized, will represent the current thinking of the FDA on this
topic. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternate approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.
    This guidance concerns two regulations that we have established in
Title 21 of the Code of Federal Regulations as part of our
implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L.
111-353). These two regulations are part 117 (published in the Federal
Register on September 17, 2015, 80 FR 55908 and part 507 (published in
the Federal Register on September 17, 2015, 80 FR 56170). This guidance
is intended to help establishments and facilities subject to part 117
or part 507 determine whether they are ``solely engaged'' in certain
activities. Establishments and facilities ``solely engaged'' in certain
activities are exempt from some or all requirements in parts 117 or
507.
    Parts 117 and 507 contain exemptions specific to establishments and
facilities ``solely engaged'' in certain activities. The relevant
exemptions can be categorized as follows: (1) Exemption from human food
current good manufacturing practice (CGMP) requirements, (2) exemption
from human food preventive controls

requirements, (3) exemption from animal food CGMP requirements, and (4)
exemption from animal food preventive controls requirements.
    This draft guidance, when finalized, will clarify that if all of
the activities performed by an establishment are exempt under one or
more CGMP exemptions, then the establishment is not subject to the part
117 and/or part 507 CGMPs, as applicable. If all the activities
performed by a facility are exempt under one or more preventive
controls exemptions, then the facility is not subject to the part 117
and/or part 507 preventive controls requirements, as applicable. If all
the activities performed by a facility are exempt under one or more
CGMP exemptions and one or more preventive controls exemptions, then
the facility is not subject to the CGMP or preventive controls
requirements in part 117 and/or part 507, as applicable.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/FoodGuidances or https://www.fda.gov/ForIndustry/ColorAdditives/GuidanceComplianceRegulatoryInformation/ucm153033.htm (whichever is applicable) or https://www.regulations.gov.
Use the FDA Web site listed in the previous sentence to find the most
current version of the guidance.

    Dated: October 16, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22731 Filed 10-19-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 210 (Thursday, October 30, 2014)]
[Notices]
[Pages 64588-64589]
[FR Doc No: 2014-25832]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL15-10-000]

Geronimo Wind Energy, LLC; Notice of Petition for Declaratory
Order

    Take notice that on October 23, 2014, Geronimo Wind Energy, LLC
(Geronimo), pursuant to section 207(a)(2) of the Federal Energy
Regulatory Commission's (Commission) Rules of Practice and Procedure,
18 CFR 385.207(a)(2), filed a petition for declaratory order requesting
the Commission find that: (1) A 1966 Interconnection Agreement between
Otter Tail Power Co. (Otter Tail) and Minnkota Power Cooperative, Inc.
gave Otter Tail the right to provide transmission service over the 345
kV transmission line running from Center to Maple River, North Dakota;
(2) Otter Tail's transmission rights over the Center-Maple River Line
have been assigned to the Midcontinent Independent System Operator,
Inc. (MISO); and (3) the rate provided by the MISO tariff is the only
rate that may be charged for transmission service provided by MISO over
the Center-Maple River 345 kV line.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or

protests must be filed on or before the comment date. On or before the
comment date, it is not necessary to serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the Web site that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on November 24, 2014.

    Dated: October 24, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-25832 Filed 10-29-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 149 (Friday, August 4, 2017)]
[Notices]
[Pages 36391-36392]
[FR Doc No: 2017-16478]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2531-075-ME]

Brookfield White Pine Hydro LLC; Notice of Availability of
Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR part 380 (Order No. 486, 52 FR 47897), the Office
of Energy Projects has reviewed the application for a new license for
the West Buxton Hydroelectric Project, located on the Saco River in
York and Cumberland Counties, Maine, and has prepared an Environmental
Assessment (EA). The project does not occupy federal land.
    The EA contains Commission staff's analysis of the potential
effects of the project, and concludes that licensing the project, with
appropriate environmental protective measures, would not constitute a
major federal action that would significantly affect the quality of the
human environment.
    A copy of the EA is available for review at the Commission in the
Public Reference Room, or may be viewed on the Commission's Web site at
http://www.ferc.gov using the eLibrary link. Enter the docket number,
excluding the last three digits in the docket number field, to access
the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or at<PHONE_NUMBER> (toll free) or (202)
502-8659 (TTY).
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances
related to this project or other pending projects. For assistance,
contact FERC Online Support.
    Any comments should be filed within 30 days from the date of this
notice. The Commission strongly encourages electronic filing. Please
file comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the

eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support. In lieu
of electronic filing, please send a paper copy to: Secretary, Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426. The first page of any filing should include docket number P-
2531-075.
    For further information, contact Allan Creamer at<PHONE_NUMBER>,
or via email at<EMAIL_ADDRESS>
    Dated: July 31, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-16478 Filed 8-3-17; 8:45 am]
 BILLING CODE 6717-01-P