[Federal Register Volume 85, Number 189 (Tuesday, September 29, 2020)]
[Notices]
[Pages 61013-61014]
[FR Doc No: 2020-21448]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0410]

Peripheral and Central Nervous System Drugs Advisory Committee;
Notice of Meeting; Establishment of a Public Docket; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

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

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Peripheral and Central Nervous
System Drugs Advisory Committee. The general function of the committee
is to provide advice and recommendations to FDA on regulatory issues.
The meeting will be open to the public. FDA is establishing a docket
for public comment on this document.

DATES: The meeting will take place virtually on November 6, 2020, from
10 a.m. Eastern Time to 4 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2018 N-0410. The docket will close on November
5, 2020. Submit either electronic or written comments on this public
meeting by November 5, 2020. Please note that late, untimely filed
comments will not be considered. Electronic comments must be submitted
on or before November 5, 2020. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of November 5, 2020. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
    Comments received on or before October 23, 2020, will be provided
to the committee. Comments received after that date will be taken into
consideration by FDA. In the event that the meeting is cancelled, FDA
will continue to evaluate any relevant applications or information, and
consider any comments submitted to the docket, as appropriate.
    You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-0410 for ``Peripheral and Central Nervous System Drugs
Advisory Committee; Notice of Meeting; Establishment of a Public
Docket; Request for Comments.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday. Please call 240-402-
7500 ahead of the meeting time to verify access.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public

viewing and posted on https://www.regulations.gov. Submit both copies
to the Dockets Management Staff. If you do not wish your name and
contact information be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify the information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

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

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On November
6, 2020, the committee will discuss biologics license application (BLA)
761178, for aducanumab solution for intravenous infusion, submitted by
Biogen Inc., for the treatment of Alzheimer's disease.
    FDA intends to make the meeting's background material and pre-
recorded presentations available to the public no later than 2 business
days before the meeting. The pre-recorded presentations will be viewed
by the committee prior to the meeting and will not be replayed on
meeting day. If FDA is unable to post the background material and/or
pre-recorded presentations on its website prior to the meeting, the
background material and/or pre-recorded presentations will be made
publicly available on FDA's website at the time of the advisory
committee meeting. The meeting will include brief summaries of the pre-
recorded presentations. Background material and the link to the online
teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate
advisory committee meeting link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before October 23, 2020, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Those individuals interested in making
formal oral presentations should notify the contact person and submit a
brief statement of the general nature of the evidence or arguments they
wish to present, the names and addresses of proposed participants, and
an indication of the approximate time requested to make their
presentation on or before October 15, 2020. Time allotted for each
presentation may be limited. If the number of registrants requesting to
speak is greater than can be reasonably accommodated during the
scheduled open public hearing session, FDA may conduct a lottery to
determine the speakers for the scheduled open public hearing session.
The contact person will notify interested persons regarding their
request to speak by October 16, 2020.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact LaToya Bonner (see FOR FURTHER INFORMATION CONTACT) at least 7
days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: September 22, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21448 Filed 9-28-20; 8:45 am]
BILLING CODE 4164-01-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.

I smoked 2 packs a day of tobacco cigarettes for 37 years.  I had tried numerous times to quit smoking using patches, lozenges, prescriptions, “cold turkey”, and even nicotine inhalers.  None of them worked.  I always went back to tobacco.  I have now been vaping for almost 5 years.  I started vaping to merely cut down on my tobacco use to save money.  By the end of my first week I was down to 5 cigarettes a day from 40.  By the end of 6 weeks, I had completely quit tobacco.  I LOVED to smoke prior to vaping e-cigarettes.  I also have dramatically improved my health.  My doctor is amazed at how clear my lungs sound now.  I used to get really bad bronchitis about 4 times a year.  Now I don’t have that problem.  I can smell and taste much better.  I realize we need a lot more research in this area.  But please give us the extra time to make our voices heard.  Tobacco use has been proven to cause many lung diseases including Cancer.  Many homes are burned down and lives have been lost due to the use of tobacco and children playing with lighters.  As a nurse I realize anything we put into our bodies is  “at your own risk.”  But I feel from interacting with many people that have quit tobacco completely,  with the assistance of vaping e-cigarettes that they are definitely a reduced harm alternative.  I would ask you to allow us to continue vaping e-cigarettes while medical trials are conducted.  The same way tobacco had the same opportunity before the surgeon general’s warnings went on the cigarette packs.  And still, we now know the dangers of smoking tobacco, and they are still allowed to be sold.


[Federal Register: May 18, 2010 (Volume 75, Number 95)]
[Rules and Regulations]
[Page 27644-27647]
[DOCID:fr18my10-7]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2010-0148; FRL-9151-6]

Approval and Promulgation of Air Quality Implementation Plans;
Texas; Revisions to the Discrete Emission Credit Banking and Trading
Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is approving severable portions of two revisions to the
Texas State Implementation Plan (SIP) submitted by the State of Texas
on October 24, 2006, and August 16, 2007. These revisions amend
existing sections and create a new section in Title 30 of the Texas
Administrative Code (TAC), Chapter 101--General Air Quality Rules,
Subchapter H--Emissions Banking and Trading, Division 4--Discrete
Emission Credit Banking and Trading, referred to elsewhere in this
notice as the Discrete Emission Reduction Credit (DERC) Program. The
October 24, 2006, submittal creates a new section for international
emission reduction provisions and amends existing sections to prohibit
the generation and use of DERCs from shutdown activities and further
clarify procedures for using emission protocols. The August 16, 2007,
submittal amends two sections of the DERC program to update cross-
references to recently recodified 30 TAC Chapter 117 provisions.
Additionally, EPA finds that the Texas Commission on Environmental
Quality (TCEQ) has satisfied all elements of our September 6, 2006,
final conditional approval of the DERC program with the submittal of
the October 24, 2006, SIP submittal; and as such, the DERC program
conditional approval is converted to a full approval. EPA has
determined that these SIP revisions comply with the Clean Air Act and
EPA regulations, are consistent with EPA policies, and will improve air
quality. This action is being taken under section 110 and parts C and D
of the Federal Clean Air Act (the Act or CAA).

DATES: This final rule will be effective June 17, 2010.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R06-OAR-2010-0148. All documents in the docket are listed in
the http://www.regulations.gov index. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available either
electronically in http://www.regulations.gov or in hard copy at the Air
Planning Section (6PD-L), Environmental Protection Agency, 1445 Ross
Avenue, Suite 700, Dallas, Texas 75202-2733. The file will be made
available by appointment for public inspection in the Region 6 FOIA
Review Room between the hours of 8:30 a.m. and 4:30 p.m. weekdays
except for legal holidays. Contact the person listed in the FOR FURTHER
INFORMATION CONTACT paragraph below or Mr. Bill Deese at<PHONE_NUMBER>
to make an appointment. If possible, please make the

appointment at least two working days in advance of your visit. There
will be a 15 cent per page fee for making photocopies of documents. On
the day of the visit, please check in at the EPA Region 6 reception
area at 1445 Ross Avenue, Suite 700, Dallas, Texas.
    The State submittal related to this SIP revision, and which is part
of the EPA docket, is also available for public inspection at the State
Air Agency listed below during official business hours by appointment:
    Texas Commission on Environmental Quality, Office of Air Quality,
12124 Park 35 Circle, Austin, Texas 78753.

FOR FURTHER INFORMATION CONTACT: If you have questions concerning
today's final rule, please contact Ms. Adina Wiley (6PD-R), Air Permits
Section, Environmental Protection Agency, Region 6, 1445 Ross Avenue
(6PD-R), Suite 1200, Dallas, TX 75202-2733. The telephone number is
(214) 665-2115. Ms. Wiley can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, whenever ``we'',
``us'', or ``our'' is used, we mean the EPA.

Table of Contents

I. What final action is EPA taking?
II. What is the background for this action?
III. What are EPA's responses to comments received on the proposed
action?
IV. Statutory and Executive Order Reviews

I. What final action is EPA taking?

    We are fully approving severable portions of two revisions to the
Texas SIP submitted by the TCEQ on October 24, 2006, and August 16,
2007, specific to the DERC Program. The revisions we are approving
amend existing sections and create a new section in the DERC Program at
Title 30 of the Texas Administrative Code (TAC), Chapter 101--General
Air Quality Rules, Subchapter H--Emissions Banking and Trading,
Division 4--Discrete Emission Credit Banking and Trading. The October
24, 2006, submittal creates a new section for international emission
reduction provisions and amends existing sections to prohibit the
generation and use of discrete emission reduction credits from shutdown
activities and further clarify procedures for using emission protocols.
Additionally, EPA finds that the TCEQ has satisfied all elements of our
September 6, 2006, final conditional approval of the DERC program with
the submittal of the October 24, 2006, SIP submittal; and as such, the
DERC program conditional approval is converted to full SIP approval.
The severable portions of the August 16, 2007, submittal that we are
approving non-substantively revise the DERC Program to correctly update
the cross-references to the stationary source nitrogen oxide (NOX)
rules found in the Texas SIP at 30 TAC Chapter 117 as a result of the
non-substantive recodification of Chapter 117 approved by EPA as part
of the Texas SIP on December 3, 2008 (see 73 FR 73562). Additionally,
in both the October 24, 2006, and August 16, 2007, SIP submittals TCEQ
has made several non-substantive revisions to update grammar and
document style. Consequently, we are approving the revisions to the
Texas SIP at 30 TAC sections 101.372(a), 101.372(d), 101.372(f),
101.372(j), 101.373(a), 101.376(c)(4), and 101.378(b) and the creation
of new section 101.375 submitted on October 24, 2006. Additionally, we
are approving revisions to the Texas SIP at 30 TAC sections 101.372(d)
and 101.376(d) submitted on August 16, 2007, by the TCEQ.
    EPA proposed the above action on March 30, 2010, at 75 FR 15648-
15655. Today, we are approving the DERC program revisions as proposed
and find that they comply with the CAA and EPA regulations, are
consistent with EPA policies, and will improve air quality. This final
approval is being taken under parts C and D of the CAA.
    In a separate rulemaking, EPA is approving the severable Emission
Credit Banking and Trading Program (referred to elsewhere in this
notice as the Emission Reduction Credit (ERC) Program) revisions at 30
TAC sections 101.302, 101.305, and 101.306 submitted on October 24,
2006, and 30 TAC sections 101.302 and 101.306 submitted on August 16,
2007 (see EPA-R06-OAR-2010-0417).
    At this time, EPA is not taking action on the revisions to the
Emissions Banking and Trading of Allowances Program at 30 TAC sections
101.338 and 101.339 submitted on October 24, 2006. EPA is also not
taking action at this time on the revisions to the general air quality
definitions at 30 TAC Section 101.1 or the revisions to the System Cap
Trading Program at 30 TAC sections 101.383, and 101.385 submitted on
August 16, 2007. These severable revisions remain under review by EPA
and will be addressed in separate actions.

II. What is the background for this action?

    The DERC Program, conditionally approved by EPA on September 6,
2006, establishes an open market trading program to provide flexibility
for sources in complying with certain State and Federal requirements.
In an open market trading program, a source generates emission credits
by reducing its emissions during a discrete period of time. These
credits, called discrete emission credits, or DECs, in the Texas
program, are quantified in units of mass. Discrete emission credit
(DEC) is a generic term that encompasses reductions from stationary
sources (discrete emission reduction credits, or DERCs) and reductions
from mobile sources (mobile discrete emission reduction credits, or
MDERCs).\1\ Generally, discrete emission reductions of criteria
pollutants (excluding lead) or precursors of criteria pollutants may be
banked and used as DERCs. EPA's September 6, 2006, final conditional
approval of the DERC program addressed the original submission of the
program on December 23, 1997, and the subsequent revisions on January
18, 2001; April 14, 2002; January 17, 2003; and December 6, 2004.
---------------------------------------------------------------------------

    \1\ In this action, when we refer to the program as the ``DERC
Rule'' or the ``DERC Program'' we are speaking of the entire
Discrete Emission Credit Banking and Trading Program, which
encompasses both DERCs and MDERCs.
---------------------------------------------------------------------------

    Since our September 6, 2006, final conditional approval, TCEQ has
revised the DERC program to address the commitments of the DERC
conditional approval. Additionally, the TCEQ adopted revisions to the
DERC program consistent with the requirements of Senate Bill 784,
adopted during regular session, 2005, of the 79th Texas Legislature.
Senate Bill 784 allows for greater flexibility in the generation and
use of international emission reductions. These revisions were adopted
by the TCEQ on October 4, 2006, and became effective on October 26,
2006. The adopted regulations were submitted to EPA as a SIP revision
on October 24, 2006. TCEQ has also promulgated revisions to the DERC
program that update the cross-references to the new numbering structure
in 30 TAC Chapter 117. These revisions were adopted on July 25, 2007,
and became effective on August 16, 2007. The adopted regulations were
submitted to EPA as a SIP revision on August 16, 2007.

III. What are EPA's responses to comments received on the proposed
action?

    EPA received no comments on our proposed rulemaking.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the

provisions of the Act and applicable Federal regulations. 42 U.S.C.
7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's
role is to approve State choices, provided that they meet the criteria
of the Clean Air Act. Accordingly, this action merely approves State
law as meeting Federal requirements and does not impose additional
requirements beyond those imposed by State law. For that reason, this
action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have Tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on Tribal governments or preempt Tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by July 19, 2010. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental Relations, Nitrogen oxides, Ozone,
Volatile organic compounds.

    Dated: April 30, 2010.
Lawrence E. Starfield,
Acting Regional Administrator, Region 6.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart SS--Texas

0
2. The table in Sec.  52.2270(c) entitled ``EPA Approved Regulations in
the Texas SIP'' under Chapter 101 is amended by:
0
a. Revising the entries for Sections 101.372, 101.373, 101.376, and
101.378 under Subchapter H--Emissions Banking and Trading, Division 4--
Discrete Emission Credit Banking and Trading.
0
b. Adding an entry for Section 101.375 under Subchapter H--Emissions
Banking and Trading, Division 4--Discrete Emission Credit Banking and
Trading, in numerical order.
    The revisions and additions read as follows:

Sec.  52.2270  Identification of plan.

* * * * *
    (c) * * *

                                    EPA-Approved Regulations in the Texas SIP
----------------------------------------------------------------------------------------------------------------
                                                      State approval/
         State citation             Title/subject     submittal date    EPA approval date        Explanation
----------------------------------------------------------------------------------------------------------------
                                     Chapter 101--General Air Quality Rules
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                   Subchapter H--Emissions Banking and Trading
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                            Division 4--Discrete Emission Credit Banking and Trading
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
Section 101.372................  General Provisions.       7/25/2007  5/18/2010 [Insert FR  ....................
                                                                       page number where
                                                                       document begins].
Section 101.373................  Discrete Emission         10/4/2006  5/18/2010 [Insert FR  ....................
                                  Reduction Credit                     page number where
                                  Generation and                       document begins].
                                  Certification.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
Section 101.375................  Emission Reductions       10/4/2006  5/18/2010 [Insert FR  ....................
                                  Achieved Outside                     page number where
                                  the United States.                   document begins].
Section 101.376................  Discrete Emission         7/25/2007  5/18/2010 [Insert FR  ....................
                                  Credit Use.                          page number where
                                                                       document begins].
Section 101.378................  Discrete Emission         10/4/2006  5/18/2010 [Insert FR  ....................
                                  Credit Banking and                   page number where
                                  Trading.                             document begins].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2010-11681 Filed 5-17-10; 8:45 am]
BILLING CODE 6560-50-P


Significant New Alternatives Policy Program

Refrigeration and Air Conditioning Sector

Risk Screen on Substitutes for CFC-113 in

Non-Mechanical Heat Transfer

Substitute: Novec™ 649

This risk screen does not contain Clean Air Act (CAA) Confidential
Business Information (CBI) and, therefore, may be disclosed to the
public.

INTRODUCTION

Ozone-depleting substances (ODS) are being phased out of production in
response to a series of diplomatic and legislative efforts that have
taken place over the past decade, including the Montreal Protocol and
the Clean Air Act Amendments of 1990 (CAAA).  The U.S. Environmental
Protection Agency (EPA), as authorized by Section 612 of the CAAA, is
developing a program to evaluate the human health and environmental
risks posed by alternatives to ODS.  The main purpose of EPA's program,
called the Significant New Alternatives Policy (SNAP) Program, is to
identify acceptable and unacceptable substitutes for ODS in specific end
uses.

EPA’s decision on the acceptability of a substitute is based largely
on the findings of a screening assessment of potential human health and
environmental risks posed by the substitute in specific applications.
EPA has already screened a large number of substitutes in many end uses
within all of the major ODS-using sectors, including refrigeration and
air conditioning, solvent cleaning, foam blowing, aerosols, fire
suppression, adhesives, coatings and inks, and sterilization. The
results of these risk screens are presented in a series of Background
Documents that are available in EPA's docket.

The purpose of this report is to supplement EPA’s Background Document
on the refrigeration and air conditioning sector (EPA 1994) (hereinafter
referred to as the Background Document). This risk screen evaluates the
potential use of Novec™ 649, a C6 fluoroketone, as a substitute for
CFC-113 to be used as a non-mechanical heat transfer fluid for a small
class of electrical transformers.   REF _Ref173102842 \h  \* MERGEFORMAT
 Table 1  presents information on the proposed substitute.

Table   SEQ Table \* ARABIC  1 . Chemical Information for Proposed
Substitute.

Proposed Substitute	Chemical Name	CAS Number	Chemical Formula

Novec™ 649	1,1,1,2,2,4,5,5,5,
-Nonafluoro-4-(trifluoromethyl)-3-pentanone	756-13-8	C6F12O

This risk screen addresses potential toxicity risks to workers during
equipment use.  Consumer or general population exposures are not
expected to occur.  Novec™ 649 is not flammable, so a flammability
analysis was not conducted.

Section 2 of this report summarizes the results of the risk screen for
the proposed substitute.  The remainder of the report is organized into
the following sections:

Section 3: Atmospheric Assessment

Section 4: Toxicity Assessment

Section 5: Volatile Organic Compound Assessment

Section 6: References

SUMMARY OF RESULTS

™ 649 is recommended for SNAP approval for use as a non-mechanical
heat transfer fluid.  EPA's risk screen indicates that the use of the
proposed substitute will be less harmful to the atmosphere than the
continued use of CFC-113.   No significant toxicity risks to workers,
consumers or the general population are expected.

ATMOSPHERIC ASSESSMENT

This section presents an assessment of the potential risks to
atmospheric integrity posed by the use of Novec™ 649 as a
non-mechanical heat transfer fluid.  The ODP, GWP, and atmospheric
lifetime (ALT) of the proposed substitute are presented in   REF
_Ref175036149 \h  \* MERGEFORMAT  Table 1 .  The substitute is
substantially less harmful to the ozone layer and has less climate
impact than CFC-113.

Novec™ 649 Compared to CFC-113.

Heat Transfer Fluid	Ozone Depleting Potential (ODP)	Global Warming
Potential (GWP)	Atmospheric Lifetime years (ALT)

Novec™ 649	0a	0.6-1.8a	0.04a

CFC-113	0.8b	6,130c	85c

a  ICF 2003

b Available at: http://www.epa.gov/ozone/ods.html.

c IPCC 4th Assessment Report (Forster et al. 2007).

TOXICITY ASSESSMENT

4. 1.  Toxicity Reference Values

To assess potential health risks from exposure to this substitute, ICF
(2009) evaluated available toxicity data for this substitute and
developed a recommended acceptable exposure limit.   The long-term
exposure limit developed in ICF (2009) is presented in   REF
_Ref222734171 \h  \* MERGEFORMAT  Table 3 .  The reader is referred to
Attachment 1 for a detailed explanation of the development of the AEL
(note that in the attachment the substitute is referred to as
“C6-perfluoroketone”).

Table   SEQ Table \* ARABIC  3 .  Recommended Toxicity Limit for
Novec™ 649

Substance	Long-Term Exposure Limit

(ppm)

Novec™ 649	250

4. 2.  Occupational Exposure

Novec™ 649 are expected to be minimal.  To further minimize potential
exposures, it is recommended that all technicians be properly trained in
working with the transformers and related recovery equipment and that
the requirement of possessing EPA 608 certification be strictly
enforced.

4. 3.  Consumer Exposure

Consumer exposure to the substitute is not expected.

4. 4.  General Population Exposure

Chronic exposures to the substitute are not expected for the general
population.

VOLATILE ORGANIC COMPOUND (V䍏
十䕓卓䕍呎

Novec™ 649 produced in one year were to leak to the atmosphere over
the course of the year (extremely unlikely given the hermetic seals on
the transformers and the caution used during recovery to minimize
emissions), the resulting annual VOC emissions would be only about
2x10-5 percent of all annual anthropogenic VOC emissions.  As these
emissions of Novec™ 649 are several orders of magnitude less than
other anthropogenic emissions, the environmental impacts of these VOCs
are not considered a threat.

REFERENCES

3M. 2009a. Significant New Alternatives Policy (SNAP) Approval for C6
Perfluoroketone in Non-mechanical Heat Transfer Use.  June 2009.

3M.  2009b.  Follow-Up Email Regarding Significant New Alternatives
Policy (SNAP) Approval for C6 Perfluoroketone in Non-mechanical Heat
Transfer Use.  July 2009.

EPA 2008.  Volatile Organic Compounds – National Summary of VOC
Emissions.  Last updated 21 October 2008.  Accessed 4 March 2009.
Available at <http://www.epa.gov/air/emissions/voc.htm>.

EPA. 1994.  Significant New Alternatives Policy Technical Background
Document:  Risk Screen on the Use of Substitutes for Class I
Ozone-depleting Substances: Refrigeration and Air Conditioning.
Stratospheric Protection Division.  March 1994.

Forster, P., V. Ramaswamy, P. Artaxo, T. Berntsen, R. Betts, D.W. Fahey,
J. Haywood, J. Lean, D.C. Lowe, G. Myhre, J. Nganga, R. Prinn, G. Raga,
M. Schulz and R. Van Dorland. 2007.  Changes in Atmospheric Constituents
and in Radiative Forcing. In: Climate Change 2007:The Physical Science
Basis. Contribution of Working Group I to the Fourth Assessment Report
of the Intergovernmental Panel on Climate Change [Solomon, S., D. Qin,
M. Manning, Z. Chen, M. Marquis, K.B. Averyt, M.Tignor and H.L. Miller
(eds.)]. Cambridge University Press, Cambridge, United Kingdom and New
York, NY, USA.

ICF.  2009.  Recommendation for an Acceptable Exposure Limit for
C6-Perflouroketone.  Deliverable under EPA Contract EP-W-06-008, TO 038,
Task 6.  September 2009.

ICF.  2003.  Re-evaluation of a C-6 Oxyfluorocarbon (trade name Novec™
1230) and References.  Deliverable under EPA Contract Number
68-3-00-266, Work Assignment 2-05 Task 03.  Available online at: <
http://www.regulations.gov/search/Regs/contentStreamer?objectId=09000064
800bb086&disposition=attachment&contentType=pdf>.Development of AEL
for C6-Perfluoroketone

ICF has developed a revised AEL for C6-perfluoroketone based on a review
of recent additional studies in the C6-perfluoroketone toxicity
database.  These studies are

Sub-chronic (13-week) inhalation toxicity study with MTDID 5789 in rats
(TNO, 2007)

Reproduction/ developmental toxicity screening text after inhalatory
exposure to MTDID 5789 in rats (TNO, 2007)

In the subchronic inhalation study, groups of 10 each male and female
Wistar rats were exposed to 0, 300, 1000 or 3000 ppm (target
concentrations) C6-perfluoroketone for 6 hours/day, 5 days/week for 13
weeks.  In addition, two recovery groups of 10 each male and female rats
were exposed to 0 or 3000 ppm of the test compound as with the main
groups of the study and were allowed to recover for 28-days post
exposure.  This recovery period was intended to investigate the
reversibility of noted adverse effects.

The study evaluated typical parameters for subchronic toxicity studies
including clinical/cageside observations, food consumption/efficiency,
body weight changes, hematology/clinical chemistry, localized effects,
gross necropsy, organ changes, and organ histopathology.  No
exposure-related effects were noted in the following parameters:
clinical/cage side observations, food consumption/efficiency, body
weight, food consumption or opthalmoscopy.  In addition, no local
effects were noted.

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ctivity (acyl CoA-oxidase) related to peroxisomal proliferation,
predominantly in males at all exposure concentrations, but also in
females in the high-concentration group.   The liver effects were not
noted in recovery rats after 28 days post-exposure, with the exception
of the persistence of slight or very slight increased eosinophilic
granulation in 4/10 male rats at 3000 ppm.  The study authors identified
a NOEL of 1000 ppm for female rats, were unable to define a NOEL for
male rats, and identified a NOAEL/LOAEL of 300 ppm for male rats.

The subchronic study essentially validated the results of the previous
28-day inhalation study in rats using C6-perfluoroketone, which
indicated that peroxisomal proliferation resulted from rat exposure to
concentrations of 1000 ppm and higher.

As stated in the 13-week study report, peroxisomal proliferation is a
liver response observed in rodents, predominantly male rats, in response
to exposure to certain compounds.  Responses in humans are poor or
absent following exposure to peroxisomal proliferators, due to genetic
differences in the elements necessary to respond to these compounds.
For this reason, peroxisomal proliferation is considered to be a
species-specific response with more limited application to humans.  For
this reason, ICF has chosen the 1000 ppm exposure concentration in the
13-week study as the point of departure for developing the AEL for
C6-perfluoroketone.

A revised AEL has been developed as follows:

	1000 ppm x 6 hours (exposure of rats)/8 hours (workday) = 750 ppm (HEC)

750/3 (UF) = 250 ppm (AEL)

One uncertainty factor of 3 has been applied to account for interspecies
differences between rats and humans.  No other UFs have been applied.
The database is comprehensive, including a one-generation reproductive
and developmental toxicity study in rats which showed no adverse effects
at any concentration tested up to 3000 ppm.  Therefore, the original UF
of 10 applied for database limitations in the initial AEL development
has been removed.

We are aware that we have chosen as a point of departure an exposure
concentration that results in liver effects in the male rat (e.g.,
histopathological changes in the liver and increased relative liver
weight).  Studies show that rats and mice appear to be more sensitive
than humans to peroxisomal proliferators.  That is not to say that
humans are not responsive; they are responsive, for example, to a
certain class of pharmaceuticals known as hypolipidemic fibrates, such
as clofibrate, via activation of the peroxisome proliferator activated
receptor (PPAR).  There has been concern in the past with peroxisomal
proliferation in compounds that induce liver cancer in rodents and the
possibility that cancer induction is a concern with regard to humans
(e.g., DEHP, TCE, etc.; Melnick, 2001; Keshava and Caldwell, 2006).
However, these compounds are much less potent as PPAR receptor agonists
than the hypolipidemic fibrates.  Further, these agents also induce
biological effects in animal models that appear to occur independently
of peroxisome proliferation.  It does not appear that C6-perfluoroketone
induces any other relevant toxicological effects in the rat other than
peroxisome proliferation in the liver and its associated effects.
Therefore, we feel that establishing the AEL for C6-perfluoroketone at a
maximum of 250 ppm is appropriate and supported by the science.

Attachment 1 References

Keshava N and JC Caldwell (2006) Key issues in the role of peroxisome
proliferator-activated receptor agonism and cell signaling in
trichloroethylene toxicity.  Environ Health Perspect 114(9):1464-1470.

Melnick RL (2001) Is peroxisome proliferation an obligatory precursor
step in the carcinogenicity of di(2-ethylhexyl)phthalate (DEHP)? Environ
Health Perspect 109(5):437-442.

 This figure was calculated using expected annual production levels from
3M (2009a) and 2002 annual VOC emissions data from EPA (2008).

Novec 649 Risk Screen

September 17, 2009

Page   PAGE  1

Novec 649 Risk Screen – Heat Transfer End-Use 	       Attachment 1

Recommendation for an Acceptable Exposure Limit for C6- Perflouroketone

September 11, 2009

Page   PAGE  1


[Federal Register Volume 80, Number 214 (Thursday, November 5, 2015)]
[Notices]
[Pages 68521-68523]
[FR Doc No: 2015-28204]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PF15-29-000]

Dominion Carolina Gas Transmission, LLC; Notice of Intent To
Prepare an Environmental Assessment for the Planned Transco to
Charleston Project, Request for Comments on Environmental Issues, and
Notice of Public Scoping Meetings

    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 Transco to Charleston Project
involving construction and operation of facilities by Dominion Carolina
Gas Transmission, LLC (DCG) in Aiken, Charleston, Dillon, Dorchester,
Greenwood, Laurens, Newberry, and Spartanburg Counties, South Carolina.
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 November 30, 2015.
    If you sent comments on this project to the Commission before the
opening of this docket on September 2, 2015, you will need to file
those comments in Docket No. PF15-29-000 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 planned
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 planned 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.
    A fact sheet prepared by the FERC entitled ``An Interstate Natural
Gas Facility On My Land? What Do I Need To Know?'' is available for
viewing on the FERC Web site (www.ferc.gov). 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.

Public Participation

    For your convenience, there are four methods you can use to submit
your comments to the Commission. The Commission will provide equal
consideration to all comments received, whether filed in written form
or provided verbally. The Commission encourages electronic filing of
comments and has expert staff available to assist you at<PHONE_NUMBER>
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 number
(PF15-29-000) with your submission: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street NE., Room 1A,
Washington, DC 20426.
    (4) In lieu of sending written or electronic comments, the
Commission invites you to attend one of the public scoping meetings its
staff will conduct in the project area, scheduled as follows.

------------------------------------------------------------------------
           Date and time                          Location
------------------------------------------------------------------------
Wednesday, November 18, 2015, 4-7   Spartanburg Community College--Tyger
 p.m.                                River Campus, 1875 East Main
                                     Street, Duncan, SC 29334.
Thursday, November 19, 2015, 4-7    Family YMCA of Greater Laurens, 410
 p.m.                                Anderson Drive, Laurens, SC 29360.
------------------------------------------------------------------------

    You may attend at any time during the scoping meeting. There will
not be a formal presentation by Commission staff, but you will be
provided information about the FERC process. Commission staff will be
available to take verbal comments. Representatives of DCG will be
present to answer questions about its planned project.
    Comments will be recorded by a stenographer and transcripts will be
placed into the project docket and made available for public viewing on
FERC's eLibrary system (see page 7 ``Additional Information'' for
instructions on using eLibrary). We believe it is important to note
that verbal comments hold the same weight as written or electronically

submitted comments. If a significant number of people are interested in
providing verbal comments, a time limit of 3 to 5 minutes may be
implemented for each commenter to ensure all those wishing to comment
have the opportunity to do so within the designated meeting time. Time
limits will be strictly enforced if they are implemented.
    Please note this is not your only public input opportunity; please
refer to the review process flow chart in appendix 1.\1\
---------------------------------------------------------------------------

    \1\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of the 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<PHONE_NUMBER>. For instructions on
connecting to eLibrary, refer to the last page of this notice.
---------------------------------------------------------------------------

Summary of the Planned Project

    The planned project would provide 80,000 dekatherms of natural gas
per day of firm transportation service that has been fully subscribed
by three customers.
    The Transco to Charleston Project would consist of the following
facilities:
     Approximately 55 miles of 12-inch-diameter pipeline in
Spartanburg, Laurens, Newberry, and Greenwood Counties (Moore to
Chappells pipeline);
     approximately 5 miles of 4-inch-diameter pipeline in
Dillon County (Dillon pipeline);
     installation of two new 1,400-horsepower (hp) compressor
units at the existing Moore Compressor Station in Spartanburg County;
     construction of a new 3,150-hp compressor station
(Dorchester Compressor Station) in Dorchester County;
     conversion of an existing 1,050-hp compressor unit from
standby to base load at the existing Southern Compressor Station in
Aiken County;
     upgrades to the existing Charleston Town Border Station in
Charleston County; and
     associated pipeline support facilities (metering and
regulating stations, launcher and receiver assemblies, valves, and
pipeline interconnects).
    The general location of the project facilities is shown in appendix
2.

Land Requirements for Construction

    Construction of the planned facilities would disturb about 781.6
acres of land for the pipelines and 28.9 acres of land for the
aboveground facilities. Following construction, DCG would maintain
about 488.0 acres for permanent operation of the project's pipelines
and 12.9 acres for the aboveground facilities; the remaining acreage
would be restored and revert to former uses. About 6 percent of the
planned Moore to Chappells pipeline route and 28 percent of the Dillon
pipeline route parallels existing pipeline, utility, or road rights-of-
way.

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
\2\ 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.
---------------------------------------------------------------------------

    \2\ ``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 planned 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 possible alternatives to the planned project
or portions of the project, and make recommendations on how to lessen
or avoid impacts on the various resource areas.
    Although no formal application has been filed, we have already
initiated our NEPA review under the Commission's pre-filing process.
The purpose of the pre-filing process is to encourage early involvement
of interested stakeholders and to identify and resolve issues before
the FERC receives an application. As part of our pre-filing review, we
have begun to contact some federal and state agencies to discuss their
involvement in the scoping process and the preparation of the EA.
    The EA will present our independent analysis of the issues. The EA
will be available in the public record through eLibrary. Depending on
the comments received during the scoping process, we may also publish
and distribute the EA to the public for an allotted comment period. We
will consider all comments on the EA before we make 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
related to this project to formally cooperate with us in the
preparation of the EA.\3\ 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.
---------------------------------------------------------------------------

    \3\ 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 applicable State Historic Preservation Office, 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.\4\ We will define the project-specific Area of Potential
Effects (APE) in consultation with the State Historic Preservation
Office 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.
---------------------------------------------------------------------------

    \4\ The Advisory Council on Historic Preservation 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 planned project.
    If we publish and distribute the EA, copies 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 3).

Becoming an Intervenor

    Once DCG files its application with the Commission, 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. Motions to intervene are more fully described at http://www.ferc.gov/resources/guides/how-to/intervene.asp. Instructions for
becoming an intervenor are in the ``Document-less Intervention Guide''
under the ``e-filing'' link on the Commission's Web site. Please note
that the Commission will not accept requests for intervenor status at
this time. You must wait until the Commission receives a formal
application for the project.

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 (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., PF15-
29). 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: October 30, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-28204 Filed 11-4-15; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: November 15, 2005 (Volume 70, Number 219)]
[Notices]
[Page 69329]
[DOCID:fr15no05-41]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Filing

November 7, 2005.
    In the matter of: ER97-4281-014, ER99-2161-005, ER99-3000-004,
ER02-1572-002, ER02-1571-002, ER99-1115-008, ER99-1116-008, ER98-
4515-004, ER00-2810-003, ER99-4359-002, ER99-4358-002, ER99-2168-
005, ER98-1127-008, ER99-2162-005, ER00-2807-003, ER00-2809-003,
ER98-1796-007, ER00-1259-004, ER99-4355-002, ER99-4356-002, ER01-
1558-002, ER00-3160-004, ER99-4357-002, ER01-2969-003, ER00-2313-
004, ER02-1395-002, ER03-955-004, ER02-2032-002, ER02-1396-002,
ER02-1412-002, ER00-3718-003, ER99-3637-003, ER99-2157-005, ER99-
1712-005, ER00-1250-002, and ER00-2808-003; NRG Power Marketing
Inc., Arthur Kill Power LLC, Astoria Gas Turbines Power LLC, Bayou
Cover Peaking Power LLC, Big Cajun I Peaking Power LLC, Cabrillo
Power I LLC, Cabrillo Power II LLC, Cadillac Renewale Energy LLC,
Conemaugh Power LLC, Connecticut Jet Power LLC, Devon Power LLC,
Dunkirk Power LLC, El Segundo Power, LLC, Huntley Power LLC, Indian
River Power LLC, Keystone Power LLC, Long Beach Generation LLC,
Louisiana Generating LLC, Middletown Power LLC, Montville Power LLC,
NEO California Power LLC, Neo Chester-Gen LLC, et al., Norwalk Power
LLC, NRG Audrain Generating LLC, NRG Energy Center Paxton LLC, NRG
Ilion Limited Partnership, NRG Marketing Services LLC, NRG New
Jersey Energy Sales LLC, NRG Rockford LLC, NRG Rockford II LLC, NRG
Sterlington Power LLC, Oswego Harbor Power LLC, Rocky Road Power
LLC, Somerset Power LLC, Tacoma Energy Recovery Company, and Vienna
Power LLC.

    Take notice that on October 28, 2005, the direct and indirect
subsidiaries of NRG Energy, Inc. (NRG) tendered for filing a joint
notification of change in status with respect to the proposed
acquisition by NRG of Texas Genco LLC, (Texas Genco) including the
receipt by the owners of Texas Genco of certain amounts of NRG's common
stock as part of the consideration for the transfer of in Texas Genco
to NRG.
    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.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

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

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

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. eastern time on November 18, 2005.

Magalie R. Salas,
Secretary.
[FR Doc. E5-6281 Filed 11-14-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 245 (Monday, December 27, 2021)]
[Notices]
[Page 73274]
[FR Doc No: 2021-28029]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 10198-031]

City of Pelican, Pelican Utility District; Notice of Intent To
File License Application, Filing of Pre-Application Document, Approving
Use of the Traditional Licensing Process

    a. Type of Filing: Notice of Intent to File License Application and
Request to Use the Traditional Licensing Process.
    b. Project No.: 10198-031.
    c. Date Filed: September 27, 2021 (Notice of Intent); November 12,
2021 (Pre-Application Document and Request to Use the TLP).
    d. Submitted By: City of Pelican, Pelican Utility District.
    e. Name of Project: Pelican Hydroelectric Project.
    f. Location: On the Pelican Creek in the City of Pelican, Alaska.
No federal lands are occupied by the project.
    g. Filed Pursuant to: 18 CFR 5.3 of the Commission's regulations.
    h. Potential Applicant Contact: Patricia Phillips, Mayor, City of
Pelican, Box 737 Pelican, AK 99832;<PHONE_NUMBER>;
[email protected].
    i. FERC Contact: Ingrid Brofman at<PHONE_NUMBER>; or email at
[email protected].
    j. Pelican Utility District filed its request to use the
Traditional Licensing Process on November 12, 2021. Pelican Utility
District provided public notice of its request on November 14, 2021. In
a letter dated December 20, 2021, the Director of the Division of
Hydropower Licensing approved Pelican Utility District's request to use
the Traditional Licensing Process.
    k. With this notice, we are initiating informal consultation with
the U.S. Fish and Wildlife Service and NOAA Fisheries under section 7
of the Endangered Species Act and the joint agency regulations
thereunder at 50 CFR, Part 402; and NOAA Fisheries under section 305(b)
of the Magnuson-Stevens Fishery Conservation and Management Act and
implementing regulations at 50 CFR 600.920. We are also initiating
consultation with the Alaska State Historic Preservation Officer, as
required by section 106, National Historic Preservation Act, and the
implementing regulations of the Advisory Council on Historic
Preservation at 36 CFR 800.2.
    l. With this notice, we are designating the City of Pelican,
Pelican Utility District as the Commission's non-federal representative
for carrying out informal consultation pursuant to section 7 of the
Endangered Species Act and section 305(b) of the Magnuson-Stevens
Fishery Conservation and Management Act; and consultation pursuant to
section 106 of the National Historic Preservation Act.
    m. Pelican Utility District filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations.
    n. A copy of the PAD may be viewed and/or printed on the
Commission's website (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 protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY).
    o. The licensee states its unequivocal intent to submit an
application for a new license for Project No. 10198. Pursuant to 18 CFR
16.8, 16.9, and 16.10, each application for a new license and any
competing license applications must be filed with the Commission at
least 24 months prior to the expiration of the existing license. All
applications for license for this project must be filed by September
16, 2024.
    p. Register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filing and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. 2021-28029 Filed 12-23-21; 8:45 am]
BILLING CODE 6717-01-P