[Federal Register Volume 83, Number 235 (Friday, December 7, 2018)]
[Notices]
[Pages 63166-63167]
[FR Doc No: 2018-26554]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-3380]

Developing and Labeling In vitro Companion Diagnostic Devices for
a Specific Group or Class of Oncology Therapeutic Products; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Developing
and Labeling In vitro Companion Diagnostic Devices for a Specific Group
or Class of Oncology Therapeutic Products.'' This draft guidance
describes considerations for the development and labeling of in vitro
companion diagnostic devices (referred to as companion diagnostics in
this document) to support the indicated uses of multiple drug or
biologic oncology products (referred to as therapeutic products or
oncology therapeutic products in this document), when appropriate. The
draft guidance includes factors for considering when broader labeling
(i.e., labeling that is expanded) of a companion diagnostic would be
appropriate. Oncology companion diagnostics with broader evidence-based
indications will optimally facilitate clinical use.

DATES: Submit either electronic or written comments on the draft
guidance by February 5, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-2018-D-3380 for ``Developing and Labeling In vitro Companion
Diagnostic Devices for a Specific Group or Class of Oncology
Therapeutic Products.'' 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 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 Communication, Outreach and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002;
the Office of the Center Director, Guidance and Policy Development,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver
Spring, MD 20993-0002; or the Division of Drug Information, Center for
Drug Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993-0002. Send one self-addressed adhesive label to assist that
office in processing your requests. The draft guidance may also be
obtained by mail by calling FDA's Center for Biologics Evaluation and
Research (CBER) at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911; Reena Philip, Center for

Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5680, Silver Spring, MD 20993-0002,
301-796-6179; or Julie Schneider, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
22, Rm. 2208, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Developing and Labeling In vitro Companion Diagnostic
Devices for a Specific Group or Class of Oncology Therapeutic
Products.'' This draft guidance describes considerations for the
development and labeling of companion diagnostics to support the
indicated uses of multiple therapeutic oncology products, when
appropriate. This draft guidance expands on existing policy,
surrounding broader labeling, which notes that in some cases, if
evidence is sufficient to conclude that the companion diagnostic is
appropriate for use with a specific group or class of therapeutic
products (as discussed in the draft guidance), the companion
diagnostic's intended use/indications for use should name the specific
group or class of therapeutic products, rather than specific products.
To describe FDA's thinking on the topic, the draft guidance discusses a
specific example of companion diagnostics for a specific biomarker,
disease, and specimen type (specific epidermal growth factor receptor
mutations in tumors of patients with nonsmall cell lung cancer in
tissue specimens).
    Trials designed to support approval of a specific therapeutic
product and a specific companion diagnostic have led to companion
diagnostic labels that reference only a specific therapeutic
product(s). Such specificity in labeling can limit a potentially
broader use of a companion diagnostic that may be scientifically
appropriate. In clinical practice, an oncologist generally considers
the mutation profile of the tumor along with other factors when
determining the treatment for a patient, such as the toxicity profile
of the therapeutic product, the patient's preference, and formulary
options. When a companion diagnostic is labeled for use with a specific
therapeutic product, the clinician may need to order a different
companion diagnostic (i.e., one that includes other therapeutic
products in the labeling), obtain an additional biopsy(ies) from a
patient, or both, to have additional therapy treatment options.
    The draft guidance describes considerations for when broader
labeling may be scientifically appropriate and when it may not. FDA
recommends developers of therapeutic oncology products and associated
companion diagnostics collaboratively consider development programs
that may result in broader labeling of companion diagnostics that are
most clinically useful. Developers are encouraged to discuss
development programs that could result in broader labeling with the
CBER, Center for Devices and Radiological Health (CDRH), or Center for
Drug Evaluation and Research, in coordination with the Oncology Center
of Excellence, as appropriate, early to determine if the approach
described in this guidance is appropriate for consideration. Developers
whose approved companion diagnostics may be appropriate for broader
labeling are encouraged to contact CDRH or CBER, as appropriate, to
discuss.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Developing
and Labeling In vitro Companion Diagnostic Devices for a Specific Group
or Class of Oncology Therapeutic Products.'' It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

II. Other Issues for Consideration

    In addition to providing stakeholders an opportunity to comment on
the draft guidance, the Agency is interested in responses from
stakeholders to the following:
    1. Please describe any specific challenges with developing the
evidence needed to identify in labeling a companion diagnostic for use
with a specific group or class of oncology therapeutic products, rather
than a specific therapeutic product. For example, please describe any
challenges resulting from industry or business practices, including
business agreements. What actions can FDA take to address the
challenge(s)?
    2. Please describe any specific challenges with submitting a
premarket approval (PMA) supplement to FDA to expand the labeling for
an approved companion diagnostic for use with a specific group or class
of oncology therapeutic products. What actions can FDA take to address
the challenge(s)?
    3. Please describe any additional actions FDA can take to
facilitate or encourage broader, evidence-based labeling that supports
the use of a specific group or class of oncology therapeutic products
with a companion diagnostic.
    4. The guidance notes that variations in defined cut-points
established for specific biomarkers for companion diagnostics can lead
to challenges in implementing broader labeling for a specific group or
class of oncology therapeutic products. Are there actions that FDA, or
the broader scientific community, can take to facilitate
standardization in this area?

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations and guidance. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 801 and 809 have
been approved under OMB control number 0910-0485; the collections of
information in 21 CFR part 807, subpart E, have been approved under OMB
control number 0910-0120; the collections of information in 21 CFR part
814, subparts A through E, have been approved under OMB control number
0910-0231; the collections of information in 21 CFR part 814, subpart
H, have been approved under OMB control number 0910-0332; the
collections of information in the guidance document ``Requests for
Feedback on Medical Device Submissions: The Pre-Submission Program and
Meetings with Food and Drug Administration Staff'' have been approved
under OMB control number 0910-0756; and the collections of information
in the guidance ``De Novo Classification Process (Evaluation of
Automatic Class III Designation)'' have been approved under OMB control
number 0910-0844.

IV. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: December 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26554 Filed 12-6-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 211 (Thursday, November 4, 2021)]
[Rules and Regulations]
[Pages 60773-60775]
[FR Doc No: 2021-23798]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R01-OAR-2021-0381; FRL-8782-02-R1]

Air Plan Approval; Maine; Chapter 100 Definitions and Chapter 113
Growth Offset Regulations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the State of Maine.
This revision amends the definition of ``Ozone Transport Region'' in
the State's Chapter 100 Definitions Regulation and revises language in
the State's Chapter 113 Growth Offset Regulation regarding
applicability of Nonattainment New Source Review in areas that, at a
future date, may not be within the Ozone Transport Region. The intended
effect of this action is to approve the submittal

into the Maine SIP. This action is being taken under the Clean Air Act
(CAA).

DATES: This rule is effective on December 6, 2021.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R01-OAR-2021-0381. All documents in the docket
are listed on the https://www.regulations.gov website. Although listed
in the index, some information is not publicly available, i.e.,
confidential business information (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 at https://www.regulations.gov or at the U.S.
Environmental Protection Agency, EPA Region 1 Regional Office, Air and
Radiation Division, 5 Post Office Square--Suite 100, Boston, MA. EPA
requests that, if at all possible, you contact the contact listed in
the FOR FURTHER INFORMATION CONTACT section to schedule your
inspection. The Regional Office's official hours of business are Monday
through Friday, 8:30 a.m. to 4:30 p.m., excluding legal holidays and
facility closures due to COVID-19.

FOR FURTHER INFORMATION CONTACT: John Creilson, Air Quality Branch,
U.S. Environmental Protection Agency, EPA Region 1, 5 Post Office
Square--Suite 100, (Mail code 05-2), Boston, MA 02109, tel. (617) 918-
1688, email [email protected].

SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA.

Table of Contents

I. Background and Purpose
II. Response to Comments
III. Final Action
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. Background and Purpose

    On July 29, 2021 (86 FR 40793), EPA published a notice of proposed
rulemaking (NPRM) for the State of Maine, proposing to approve two SIP
revision submitted by the State on February 10 and 24, 2021. The SIP
revision proposed to: (1) Amend the definition of ``Ozone Transport
Region'' in their existing Code of Maine Rules (C.M.R.) Chapter 100
Definitions Regulation; and (2) revise language in Sections 1 and 2 of
the existing C.M.R. Chapter 113 Growth Offset Regulation regarding
applicability of Nonattainment New Source Review (NNSR) in areas that,
at a future date, may not be within the Ozone Transport Region (OTR).
The proposed SIP revisions in the NPRM are consistent with the State's
pending petition to remove certain portions of the State from the OTR.
However, Maine's rule language was structured such that no such changes
in the application of NNSR would occur until removal of portions of the
State from the OTR was approved by the EPA Administrator. In addition,
the NPRM addressed codification issues between the existing SIP and the
amended portions of Maine's current regulations submitted as proposed
SIP revisions.
    The rationale for EPA's proposed action is explained in the NPRM
and will not be restated here.

II. Response to Comments

    EPA received one public comment during the comment period. The one
comment received supported EPA's proposed action. This comment is
included in the docket of this action.

III. Final Action

    EPA is approving Maine's February 10 and 24, 2021, SIP revision
requests pertaining to its Chapter 113 Growth Offset and Chapter 100
Definitions Regulations, respectively.

IV. Incorporation by Reference

    In this rule, EPA is finalizing regulatory text that includes
incorporation by reference. In accordance with requirements of 1 CFR
51.5, EPA is finalizing the incorporation by reference of C.M.R.
Chapters 100 and 113 described in the amendments to 40 CFR part 52 set
forth below. EPA has made, and will continue to make, these documents
generally available through https://www.regulations.gov and at the EPA
Region 1 Office (please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of this preamble for more
information). Therefore, these materials have been approved by EPA for
inclusion in the State Implementation Plan, have been incorporated by
reference by EPA into that plan, are fully federally enforceable under
sections 110 and 113 of the CAA as of the effective date of the final
rulemaking of EPA's approval, and will be incorporated by reference in
the next update to the SIP compilation.\1\
---------------------------------------------------------------------------

    \1\ 62 FR 27968 (May 22, 1997).
---------------------------------------------------------------------------

V. 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 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 Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     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, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

    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 January 3, 2022. 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, Nitrogen dioxide, Nitrogen oxides, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

    Dated: October 26, 2021.
Deborah Szaro,
Acting Regional Administrator, EPA Region 1.

    Part 52 of chapter I, title 40 of the Code of Federal Regulations
is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

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

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

Subpart U--Maine

0
2. In Sec.  52.1020(c), amend the table by revising the entries for
``Chapter 100'' and ``Chapter 113'' to read as follows:

Sec.  52.1020  Identification of plan.

* * * * *
    (c) * * *

                                         EPA-Approved Maine Regulations
----------------------------------------------------------------------------------------------------------------
                                                        State effective    EPA approval date
      Maine state citation           Title/subject           date                 \1\            Explanations
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Chapter 100.....................  Definitions.......  February 9, 2021..  November 4, 2021,   Amend the
                                                                           [Insert Federal     definition of
                                                                           Register            Ozone Transport
                                                                           citation].          Region.

                                                  * * * * * * *
Chapter 113.....................  Growth Offset       January 14, 2019..  November 4, 2021,   Revisions to
                                   Regulation.                             [Insert Federal     Sections 1 and 2
                                                                           Register            of the previously
                                                                           citation].          approved rule.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ In order to determine the EPA effective date for a specific provision listed in this table, consult the
  Federal Register notice cited in this column for the particular provision.

* * * * *
[FR Doc. 2021-23798 Filed 11-3-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: January 3, 2006 (Volume 71, Number 1)]
[Notices]
[Page 104-105]
[DOCID:fr03ja06-63]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP06-41-000]

Regent Resources Ltd. and Sword Energy Limited; Notice of
Application To Transfer Natural Gas Act Section 3 Authorization and
Presidential Permit

December 27, 2005.
    On December 19, 2005, Regent Resources Ltd. (Regent) and Sword
Energy Limited (Sword) filed an application pursuant to section 3 of
the Natural Gas Act (NGA) and section 153 of the Commission's
Regulations and Executive Order No. 10485, as amended by Executive
Order No. 12038, and the Secretary of Energy's Delegation Order No.
0204-112, seeking authorization to transfer Regent's existing NGA
section 3 authorization and Presidential Permit to Sword, all as more
fully set forth in the application which is on file with the Commission
and open to the public for inspection. This filing is available for
review at the Commission 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, please contact FERC Online Support
at<EMAIL_ADDRESS>or toll-free at<PHONE_NUMBER>, or for
TTY, contact<PHONE_NUMBER>.
    Any questions regarding the application may be directed to: Shaun
Hedges, Vice President, Operations, Regent Resources Ltd., 1200, 603-
7th Avenue, SW., Calgary, Alberta T2P 2T5 or call<PHONE_NUMBER> or
Richard Mellis, Vice President, Land, Sword

Energy Limited, 3400, 205-5th Avenue, SW., Calgary, Alberta T2P 2V7 or
call<PHONE_NUMBER>.
    Specifically, Regent and Sword request the Commission to issue an
order: (1) Transferring Regent's NGA section 3 authorization to Sword
for the operation and maintenance of facilities for the importation of
natural gas from the Province of Alberta, Canada, into Glacier County,
Montana; and (2) authorizing the assignment of Regent's March 19, 2003,
Presidential Permit for the operation and maintenance of facilities at
the Alberta, Canada/Montana import point.
    The import facilities consist of (1) a gas meter station in LSD 8-
4-1-16 W4M in the Province of Alberta; (2) a 4-inch (114.3 mm) diameter
pipeline located directly south of this meter station across the
Canada-United States border at Section 1 T37N R5W, extending a distance
of approximately 2,300 feet. The pipeline crosses the International
Boundary for a distance of 30 feet (the Coutts Gas Export Pipeline) and
interconnects with a 4-inch (114.3 mm) diameter pipeline (the Connector
Pipeline) operated by Regent Resources Inc., a Montana incorporated
company that is a wholly owned subsidiary of Regent Resources Ltd. The
Connector Pipeline connects with an existing North Western-operated
gathering system in northern Montana at SE. \1/4\ Section 8, Township
37N, Range 4W downstream of the North Western-operated North Moulton
compressor station.
    Regent and Sword state that the border facilities will remain in
place and operation following the requested transfer and assignment.
Regent and Sword also state that there are no current third party
service agreements associated with the Regent pipeline, although Sword
would be prepared to offer transportation services to any other
shipper.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date, file with the Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426, a motion to
intervene in accordance with the requirements of the Commission's Rules
of Practice and Procedure (18 CFR 385.214 or 385.211) and the
Regulations under the NGA (18 CFR 157.10). A person obtaining party
status will be placed on the service list maintained by the Secretary
of the Commission and will receive copies of all documents filed by the
applicant and by all other parties. A party must submit 14 copies of
filings made with the Commission and must mail a copy to the applicant
and to every other party in the proceeding. Only parties to the
proceeding can ask for court review of Commission orders in the
proceeding.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.

    Comment Date: January 17, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-8174 Filed 12-30-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 126 (Tuesday, July 1, 2014)]
[Notices]
[Page 37308]
[FR Doc No: 2014-15403]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER14-2240-000]

Yasmin Partners LLC; Supplemental Notice that Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Yasmin Partners LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR Part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability, is July 15, 2014.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also 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>.

    Dated: June 25, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-15403 Filed 6-30-14; 8:45 am]
BILLING CODE 6717-01-P


From:
David Ailor<EMAIL_ADDRESS>Sent:
Monday, April 26, 2021 5:13 PM
To:
Jones, DonnaLee<EMAIL_ADDRESS>Cc:
Paul A. Saffrin<EMAIL_ADDRESS>Subject:
INFORMATION ON ERIE COKE'S STATUS

Hello again, Donna Lee.

This e-mail is to follow up on your request last Thursday for "...'official' documentation that Erie Coke is permanently shut down."  As I mentioned in my e-mail response that day, I know the owner  -  Paul Saffrin - and contacted him to see if he could assist with such information.

What Paul provided today is included with this e-mail, including the two attached ".pdfs" (i.e., the ECC PADEP Case Closure and the January 2021 EPA CIP, respectively) and the contact information on the EPA representative who is and has been onsite, Chris Guzzetti:

Chris Guzzetti
On-Scene Coordinator
EPA Region 3
1650 Arch Street  -  3SD32
Philadelphia, PA 19103
(215) 814-5261
<EMAIL_ADDRESS>
I've cc'ed Paul on this e-mail, should you have further questions.  DCA

David C. Ailor, P.E.
President
American Coke and Coal Chemicals Institute
25 Massachusetts Avenue, N.W.
Suite 800
Washington, D.C. 20001
Phone:<PHONE_NUMBER>
eFax.:<PHONE_NUMBER>
<EMAIL_ADDRESS>www.accci.org

<< Erie-Coke-ECC PADEP Case Closure  060920.pdf >>
<< Erie Coke CIP March2021-superfund.pdf >>

From: David Ailor<EMAIL_ADDRESS>Sent: Thursday, April 22, 2021 5:48 PM
To: 'Jones, DonnaLee'<EMAIL_ADDRESS>Subject: RE: [SPAM-Sender] RE: coke modeling issues and potential meeting times

Yes, he does.  DCA

David C. Ailor, P.E.
President
American Coke and Coal Chemicals Institute
25 Massachusetts Avenue, N.W.
Suite 800
Washington, D.C. 20001
Phone:<PHONE_NUMBER>
eFax.:<PHONE_NUMBER>
<EMAIL_ADDRESS>www.accci.org

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Thursday, April 22, 2021 5:41 PM
To: David Ailor<EMAIL_ADDRESS>Subject: RE: [SPAM-Sender] RE: coke modeling issues and potential meeting times

Thanks. I guess the owner has other facilities or businesses?

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.

From: David Ailor<EMAIL_ADDRESS>Sent: Thursday, April 22, 2021 5:34 PM
To: Jones, DonnaLee<EMAIL_ADDRESS>Subject: RE: [SPAM-Sender] RE: coke modeling issues and potential meeting times

I know the owner.  I can contact him and see if he can provide it.  DCA

David C. Ailor, P.E.
President
American Coke and Coal Chemicals Institute
25 Massachusetts Avenue, N.W.
Suite 800
Washington, D.C. 20001
Phone:<PHONE_NUMBER>
eFax.:<PHONE_NUMBER>
<EMAIL_ADDRESS>www.accci.org

From: Jones, DonnaLee<EMAIL_ADDRESS>Sent: Thursday, April 22, 2021 5:31 PM
To: David Ailor<EMAIL_ADDRESS>Subject: RE: [SPAM-Sender] RE: coke modeling issues and potential meeting times

Thank you! On another subject, I need to get "official" documentation that Erie Coke is permanently shut down. Proof that the facility was dismantled would be one form of proof. Another is revoking permit or, lastly, removal of battery stack and/or quench tower or other obvious piece of equipment. Do you have any way to get this or should I just go through state/region?

Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Group (D243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

Pronouns - She/Her/Hers
Salutation - Dr./Ms.


[Federal Register Volume 76, Number 154 (Wednesday, August 10, 2011)]
[Proposed Rules]
[Pages 49383-49384]
[FR Doc No: 2011-20305]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0625; Airspace Docket No. 11-AEA-16]

Proposed Amendment of Class D and E Airspace; North Philadelphia,
PA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to amend Class D and Class E airspace at
Northeast Philadelphia Airport, North Philadelphia, PA, due to the
closing of Willow Grove Naval Air Station and Warminster NAWC. This
action would enhance the safety and airspace management of Instrument
Flight Rules (IFR) operations in the North Philadelphia, PA airspace
area.

DATES: Comments must be received on or before September 26, 2011. The
Director of the Federal Register approves this incorporation by
reference action under title 1, Code of Federal Regulations, part 51,
subject to the annual revision of FAA, Order 7400.9 and publication of
conforming amendments.

ADDRESSES: Send comments on this rule to: U. S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New JerseyAvenue, SE., Washington, DC 20590-0001;
Telephone: 1-800-647-5527; Fax:<PHONE_NUMBER>. You must identify the
Docket Number FAA-2011-0625; Airspace Docket No. 11-AEA-16, at the
beginning of your comments. You may also submit and review received
comments through the Internet at http://www.regulations.gov.
    You may review the public docket containing the rule, any comments
received, and any final disposition in person in the Dockets Office
(see ADDRESSES section for address and phone number) between 9 a.m. and
5 p.m., Monday through Friday, except Federal Holidays.
    An informal docket may also be examined during normal business
hours at the office of the Eastern Service Center, Federal Aviation
Administration, Room 210, 1701 Columbia Avenue, College Park, Georgia
30337.

FOR FURTHER INFORMATION CONTACT: John Fornito, Airspace Specialist,
Operations Support Group, Eastern Service Center, Air Traffic
Organization, Federal

Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320;
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested persons are invited to comment on this rule by
submitting such written data, views, or arguments, as they may desire.
Comments that provide the factual basis supporting the views and
suggestions presented are particularly helpful in developing reasoned
regulatory decisions on the proposal. Comments are specifically invited
on the overall regulatory, aeronautical, economic, environmental, and
energy-related aspects of the proposal. Communications should identify
both docket numbers and be submitted in triplicate to the address
listed above. Those wishing the FAA to acknowledge receipt of their
comments on this notice must submit with those comments a self-
addressed, stamped postcard on which the following statement is made:
``Comments to Docket No. FAA-2011-0625; Airspace Docket No. 11-AEA-
16.'' The postcard will be date/time stamped and returned to the
commenter. All communications received before the specified closing
date for comments will be considered before taking action on the
proposed rule. The proposal contained in this notice may be changed in
light of the comments received. A report summarizing each substantive
public contact with FAA personnel concerned with this rulemaking will
be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded from and
comments submitted through http://www.regulations.gov. Recently
published rulemaking documents can also be accessed through the FAA's
Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/. Additionally, any person may obtain
a copy of this notice by submitting a request to the Federal Aviation
Administration (FAA), Office of Air Traffic Airspace Management, ATA-
400, 800 Independence Avenue, SW., Washington, DC 20591, or by calling
(202) 267-8783. Communications must identify both docket numbers for
this notice. Persons interested in being placed on a mailing list for
future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-
9677, to request a copy of Advisory Circular No. 11-2A, Notice of
Proposed Rulemaking Distribution System, which describes the
application procedure.

The Proposal

    The FAA is considering an amendment to Title 14, Code of Federal
Regulations (14 CFR) part 71 to amend Class D and E airspace at
Northeast Philadelphia Airport, North Philadelphia, PA. Class D and
Class E airspace designated as surface area would be reconfigured due
to the closing of Willow Grove Naval Air Station and Warminster NAWC.
    Class D and Class E airspace designations are published in
Paragraphs 5000 and 6002, respectively, of FAA Order 7400.9U, dated
August 18, 2010, and effective September 15, 2010, which is
incorporated by reference in 14 CFR 71.1. The Class D and E airspace
designations listed in this document would be published subsequently in
the Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore, (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This proposed rulemaking is promulgated under the authority
described in Subtitle VII, Part A, Subpart I, Section 40103. Under that
section, the FAA is charged with prescribing regulations to assign the
use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This proposed regulation is within the scope
of that authority as it proposes to amend Class D and E airspace in the
North Philadelphia, PA area.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR Part 71 as follows:

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

    1. The authority citation for Part 71 will continue to read as
follows:

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of Federal
Aviation Administration Order 7400.9U, Airspace Designations and
Reporting Points, dated August 18, 2010, and effective September 15,
2010, is amended as follows:

Paragraph 5000 Class D airspace.

* * * * *

AEA PA D North Philadelphia, PA [Amended]

Northeast Philadelphia Airport, Philadelphia, PA
    (Lat. 40[deg]04'55''; N long. 75[deg]00'39'' W.)

    That airspace extending upward from the surface to and including
2,600 feet MSL within a 5.6-mile radius of the Northeast
Philadelphia Airport. This Class D airspace area is effective during
the specific dates and times established in advance by a Notice to
Airmen. The effective date and time will thereafter be continuously
published in the Airport/Facility Directory.
* * * * *

Paragraph 6002 Class E airspace designated as surface areas.

* * * * *

AEA PA E2 North Philadelphia, PA [Amended]

Northeast Philadelphia Airport, Philadelphia, PA
    (Lat. 40[deg]04'55'' N., long. 75[deg]00'39'' W.)

    That airspace extending upward from the surface to and including
2,600 feet MSL within a 5-mile radius of the Northeast Philadelphia
Airport. This Class E airspace area is effective during the specific
dates and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously purblished
in the Airport/Facility Directory.

    Issued in College Park, Georgia, on August 1, 2011.
Mark D. Ward,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2011-20305 Filed 8-9-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 63 (Wednesday, April 1, 2020)]
[Notices]
[Pages 18327-18328]
[FR Doc No: 2020-06796]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2020-14]

Petition for Exemption; Summary of Petition Received; Old Abe
Aviation LLC

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Federal Aviation Regulations. The
purpose of this notice is to improve the public's awareness of, and
participation in, the FAA's exemption process. Neither publication of
this notice nor the inclusion or omission of information in the summary
is intended to affect the legal status of the petition or its final
disposition.

DATES: Comments on this petition must identify the petition docket
number and must be received on or before April 21, 2020.

ADDRESSES: Send comments identified by docket number FAA-2020-0056
using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30; U.S.
Department of Transportation, 1200 New Jersey Avenue SE, Room W12-140,
West Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE, Washington, DC 20590-0001, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the

public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
http://www.dot.gov/privacy.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC 20590-0001, between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jake Troutman,<PHONE_NUMBER>, Office
of Rulemaking, Federal Aviation Administration, 800 Independence Avenue
SW, Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on March 20, 2020.
Brandon Roberts,
Acting Executive Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2020-0056.
    Petitioner: Old Abe Aviation LLC.
    Section(s) of 14 CFR Affected: Sec.  61.56(a)(1) & (2).
    Description of Relief Sought: The proposed exemption, if granted,
would allow the petitioner, and all part 61 certificated pilots other
than student pilots, relief from the aeronautical knowledge test
requirement in Sec.  107.63(a)(1), provided the person applying for a
remote pilot certificate has met the following requirements:
    (a) The applicant must hold a part 61 pilot certificate other than
a student pilot certificate.
    (b) The applicant has received at least two hours of ground
instruction from an authorized instructor using a curriculum approved
by the FAA.
    (c) The authorized instructor described in #2 must hold: (1) A
ground instructor or flight instructor certificate (2) a part 61 pilot
certificate other than a student pilot certificate, and (3) a part 107
remote pilot certificate.
    (d) The curriculum, described in #2, must include review of all
areas of knowledge included in Sec.  107.74(a).
    (e) The authorized instructor must provide the applicant with an
endorsement in the applicant's pilot logbook attesting that the
training was provided in accordance with the conditions and limitations
of the exemption.

[FR Doc. 2020-06796 Filed 3-31-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 77 (Friday, April 20, 2012)]
[Notices]
[Pages 23709-23710]
[FR Doc No: 2012-9561]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 3

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

    Docket Numbers: ER11-4157-001.
    Applicants: Entergy Arkansas, Inc.
    Description: SRW IOA Compliance Filing to be effective 9/27/2011.
    Filed Date: 4/12/12.
    Accession Number: 20120412-5054.
    Comments Due: 5 p.m. ET 5/3/12.

    Docket Numbers: ER12-1347-001.
    Applicants: Carolina Power & Light Company.
    Description: Amendment to Rate Schedule No. 190 of Carolina Power
and Light Company to be effective 12/31/9998.
    Filed Date: 4/12/12.
    Accession Number: 20120412-5129.
    Comments Due: 5 p.m. ET 4/19/12.

    Docket Numbers: ER12-1524-000.
    Applicants: Kleantricity, Inc.
    Description: Kleantricity MBRA Application to be effective 7/1/
2012.
    Filed Date: 4/12/12.
    Accession Number: 20120412-5081.
    Comments Due: 5 p.m. ET 5/3/12.

    Docket Numbers: ER12-1525-000.
    Applicants: NRG Solar Alpine LLC.

    Description: Application for Market-Based Rate Authority to be
effective 6/11/2012.
    Filed Date: 4/12/12.
    Accession Number: 20120412-5124.
    Comments Due: 5 p.m. ET 5/3/12.

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

    Dated: April 12, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-9561 Filed 4-19-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 137 (Friday, July 17, 2015)]
[Proposed Rules]
[Pages 42443-42446]
[FR Doc No: 2015-17468]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2010-0283; FRL-9930-68-Region 6]

Approval and Promulgation of Implementation Plans; Texas;
Revisions to the Minor New Source Review (NSR) State Implementation
Plan (SIP) for Portable Facilities

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the Texas State Implementation Plan (SIP)
submitted by the Texas Commission on Environmental Quality (TCEQ) on
March 19, 2010 and July 2, 2010. These revisions to the Texas SIP
revise the minor New Source Review (NSR)

program to provide for the relocation and change of location of
permitted portable facilities, establish definitions related to
portable facilities, and establish public participation for changes of
location to portable facilities. The EPA proposes to find that these
revisions to the Texas SIP comply with the Federal Clean Air Act (the
Act or CAA) and are consistent with our regulations and policy for
minor NSR. The EPA is proposing these actions under section 110 of the
Act.

DATES: Written comments must be received on or before August 17, 2015.

ADDRESSES: Submit your comments, identified by Docket No. EPA-R06-OAR-
2010-0283, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitted comments.
     Email: Ms. Aimee Wilson at<EMAIL_ADDRESS>     Mail or delivery: Ms. Aimee Wilson, Air Permits Section
(6PD-R), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200,
Dallas, Texas 75202-2733.
    Instructions: Direct your comments to Docket ID No. EPA-R06-OAR-
2010-0283. The 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.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be Confidential Business Information (CBI) or other information the
disclosure of which is restricted by statute. Do not submit information
through http://www.regulations.gov or email, if you believe that it is
CBI or otherwise protected from disclosure. The http://www.regulations.gov Web site is an ``anonymous access'' system, which
means that the EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to the EPA without going through http://www.regulations.gov, your email 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, the EPA recommends that you include your name and other
contact information in the body of your comment along with any disk or
CD-ROM submitted. If the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the EPA may not
be able to consider your comment. Electronic files should avoid the use
of special characters and any form of encryption and should be free of
any defects or viruses.
    Docket: The index to the docket for this action is available
electronically at www.regulations.gov and in hard copy at the EPA
Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas. While all
documents in the docket are listed in the index, some information may
be publicly available only at the hard copy location (e.g., copyrighted
material), and some may not be publicly available at either location
(e.g., CBI).

FOR FURTHER INFORMATION CONTACT: Ms. Aimee Wilson,<PHONE_NUMBER>;
email<EMAIL_ADDRESS>To inspect the hard copy materials, please
schedule an appointment with Ms. Wilson or contact Mr. Bill Deese at
(214) 665-7253.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we,''
``us,'' or ``our'' is used, we mean the EPA.

I. Background

A. CAA and SIPs

    The Act at section 110(a)(2)(C) requires states to develop and
submit to the EPA for approval into the state SIP, preconstruction
review and permitting programs applicable to certain new and modified
stationary sources of air pollutants for attainment and nonattainment
areas that cover both major and minor new sources and modifications,
collectively referred to as the NSR SIP. The CAA NSR SIP program is
composed of three separate programs: Prevention of Significant
Deterioration (PSD), Nonattainment New Source Review (NNSR), and minor
NSR.
    The minor NSR SIP program addresses construction or modification
activities that do not emit, or have the potential to emit, beyond
certain major source/major modification thresholds and thus do not
qualify as ``major'' and applies regardless of the designation of the
area in which a source is located. Any submitted SIP revision,
including revisions to a minor NSR program, must meet the applicable
requirements for SIP elements in section 110 of the Act, and be
consistent with all applicable statutory and regulatory requirements.
    The EPA is proposing to approve portions of the March 19, 2010 and
July 2, 2010 Texas SIP submittals as revisions to the Texas minor NSR
SIP for portable facilities. This action only addresses the provisions
relevant to the portable facilities program--30 Texas Administrative
Code (TAC) sections 116.120 and 116.178 submitted on March 19, 2010 and
30 TAC section 39.402(a)(12) submitted on July 2, 2010. These
provisions collectively establish the definitions applicable to
portable facilities, criteria for relocating and changing the location
of portable facilities, and public notice requirements for portable
facilities.

B. Overview of the Portable Facilities Program

1. March 19, 2010 SIP Submittal
    The TCEQ submitted to the EPA revisions to the State Implementation
Plan (SIP) to address definitions related to portable facilities and
rules regarding the relocation and changes of location of portable
facilities on March 19, 2010. Texas previously adopted the revisions to
the SIP on February 12, 2010; specifically definitions pertaining to
portable facilities at 30 TAC section 116.20 and provisions for the
relocation and change of location of portable facilities at 30 TAC
section 116.178.
2. July 2, 2010 SIP Submittal
    On June 2, 2010, the TCEQ adopted revisions to the State
Implementation Plan to adopt amendments made to the 30 TAC Chapter 39
Public Notice provisions for NSR permits, including provisions specific
to portable facilities at 30 TAC section 39.402(a)(12). The revisions
were submitted to the EPA on July 2, 2010. As detailed in the Technical
Support Document (TSD), this action will only address 30 TAC section
39.402(a)(12); all other portions of this SIP submittal have been
addressed by the EPA in separate actions.

II. The EPA's Evaluation

    The SIP submittals being evaluated as part of this rulemaking
provide for the movement of existing portable facilities permitted
under the Texas minor NSR program; therefore, the provisions for the
change of location or relocation of portable facilities are evaluated
against the federal requirements for minor NSR at 40 CFR 51.160-51.164
and in conjunction with the existing SIP-approved provisions of the
Texas minor NSR permitting program. All portable facilities are
permitted under the existing minor NSR SIP provisions in Chapter 116.
The portable facilities are either permitted through a case-by case
minor NSR permit subject to the requirements under 30 TAC sections
116.110-116.115 or through a Standard Permit issued under 30 TAC
Chapter 116, Subchapter F. The EPA has previously approved these minor
NSR permitting mechanisms as consistent with Federal minor NSR
requirements.

    The TCEQ issues the underlying minor NSR portable facility permits
to be protective of the NAAQS and increment. 30 TAC sections 116.20 and
116.178 provide that once a permit has been issued to a portable
facility, the facility can be moved either through a change of location
or a relocation. A change of location occurs when a portable facility
is moved to a new location and is required to go through the SIP-
approved minor NSR public notice requirements of Chapter 39. A
relocation of a portable facility is movement of the portable facility
without public notice under Chapter 39. Relocations occur in one of two
scenarios. First, portable facilities can be relocated to a location in
support of a public works project in which the new site is located in
or contiguous to the right-of way of the public works project. The
second possibility, is that a portable facility relocates to a site in
which a portable facility has previously been located at any time
during the previous two years and the site was subject Chapter 39
public notice requirements. Public notice requirements for the change
of location or relocation of a portable facility are established at 30
TAC section 39.402(a)(12). Our evaluation summarized below, and
detailed more fully in our accompanying TSD, demonstrates that the
portable facilities program satisfies applicable requirements for minor
NSR programs.
    The change of location or relocation of a portable facility permit
does not change the underlying portable facility permit requirements
and does not establish a new minor NSR permit. Rather, these provisions
enable an existing permitted facility to move as provided under the
portable designation. Under both a change of location or relocation,
the minor NSR permit (either a case-by-case minor NSR permit issued
under 30 TAC sections 116.110-116.115 or a Standard Permit issued under
30 TAC Chapter 116, Subchapter F) was required to conduct a health
impact and air quality analysis prior to issuance. The TCEQ's record
demonstrates that emissions associated with portable facilities are
typically minimal and the underlying permit contains the appropriate
emission limits, permit terms, and conditions to ensure that the
portable facility will have minimal environmental impacts at the
property line. Additionally, the TCEQ has the responsibility to review
each request for a change of location or relocation of a portable
facility; the TCEQ will deny a request for a change of location or
relocation if movement will result in adverse impacts on attainment or
maintenance of the NAAQS or increment violations.
    The EPA's minor NSR regulations require public notice for each
minor NSR permit. Because neither the change of location nor relocation
of a portable facility results in a new minor NSR permit than the
permit that was originally public noticed, there is no specific federal
requirement for a new public notice. Relocations of portable facilities
with minor NSR permits can occur since there is no underlying change to
the permit terms and conditions and the TCEQ evaluates each requested
relocation for adverse environmental impacts on attainment or
maintenance of the NAAQS or increment violations.
    The EPA has also evaluated the March 19, 2010 and July 2, 2010
revisions pertaining to Portable Facilities under section 110(l) of the
Act. We have preliminarily determined that the TCEQ satisfied all
procedural requirements pursuant to section 110(l) as detailed in our
accompanying TSD. Further, the EPA has preliminarily determined that
the Portable Facilities SIP revisions satisfy the minimum requirements
for a minor NSR program, including adequate provisions for legal
enforceability and public participation to ensure protection of the
control strategy and any applicable NAAQS. The Portable Facilities
program also contains sufficient safeguards to prevent circumvention of
Major NSR permitting requirements. Therefore, we find that the Portable
Facilities program is protective of the NAAQS, increment, attainment
and reasonable further progress, and any other applicable control
strategy requirements and will therefore satisfy the requirements of
section 110(l) of the Act.

III. Proposed Action

    The EPA is proposing to approve portions of the March 19, 2010 and
July 2, 2010, revisions to the Texas SIP to revise the minor NSR
program for portable facilities. We have evaluated the SIP submissions
for whether they meet the Act and 40 CFR part 51, and are consistent
with EPA's interpretation of the relevant provisions. Based upon our
evaluation, the EPA is preliminarily concluding that the March 9, 2010
and July 2, 2010, SIP revision submittals for portable facilities and
public participation for portable facilities meet the applicable
requirements of the Act and 40 CFR part 51. Therefore, EPA is proposing
to approve the following provisions pertaining to portable facilities
into the Texas minor NSR SIP:
     30 TAC section 116.20 adopted on February 10, 2010,
submitted on March 19, 2010;
     30 TAC section 116.178 adopted on February 10, 2010,
submitted on March 19, 2010; and
     30 TAC section 39.402(a)(12) adopted on June 2, 2010,
submitted on July 2, 2010.
    The EPA is proposing this action under section 110 of the Clean Air
Act (CAA). After review and consideration of public comments, we will
take final action on the SIP revisions that are identified herein.

IV. Incorporation by Reference

    In this action, we are proposing to include in a final rule
regulatory text that includes incorporation by reference. In accordance
with the requirements of 1 CFR 51.5, we are proposing to incorporate by
reference revisions to the Texas regulations as described in the
Proposed Action section above. We have made, and will continue to make,
these documents generally available electronically through
www.regulations.gov and/or in hard copy at the EPA Region 6 office.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Clean Air 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 CAA. Accordingly,
this document merely proposes to approve 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 (Public Law 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 CAA; 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.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon Monoxide,
Hydrocarbons, Incorporation by reference, Intergovernmental relations,
Lead, Nitrogen oxides, Ozone, Particulate matter, Portable facilities,
Reporting and recordkeeping requirements, Sulfur oxides, Volatile
organic compounds.

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

    Dated: July 8, 2015.
Ron Curry,
Regional Administrator, Region 6.
[FR Doc. 2015-17468 Filed 7-16-15; 8:45 am]
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[Federal Register Volume 85, Number 21 (Friday, January 31, 2020)]
[Notices]
[Page 5683]
[FR Doc No: 2020-01883]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4471-DR; Docket ID FEMA-2020-0001]

Tennessee; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for State of Tennessee (FEMA-4471-DR), dated December 6, 2019, and
related determinations.

DATES: This change occurred on January 7, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Myra M. Shird,
of FEMA is appointed to act as the Federal Coordinating Officer for
this disaster.
    This action terminates the appointment of Manny J. Toro as Federal
Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-01883 Filed 1-30-20; 8:45 am]
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[Federal Register: May 6, 2009 (Volume 74, Number 86)]
[Notices]
[Page 20972]
[DOCID:fr06my09-96]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1829-DR; Docket ID FEMA-2008-0018]

North Dakota; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of North Dakota (FEMA-1829-DR), dated March 24, 2009, and
related determinations.

DATES: Effective Date: April 23, 2009.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of North Dakota is hereby amended to include Hazard
Mitigation for the following areas among those areas determined to have
been adversely affected by the event declared a major disaster by the
President in his declaration of March 24, 2009.

    McHenry, Pierce, and Ward Counties for Individual Assistance.
    Grant, Oliver, Stark, and Walsh Counties and the Spirit Lake and
Standing Rock Indian Reservations for Individual Assistance (already
designated for emergency protective measures [Category B], including
direct Federal assistance, under the Public Assistance program).
    Bottineau, Bowman, Eddy, McHenry, Mountrail, Pierce, Ward, and
Wells Counties and the Sisseton-Wahpeton Oyate of the Lake Traverse
Reservation for Public Assistance.
    Griggs, Steele, Towner, and Traill Counties for Public
Assistance (already designated for Individual Assistance).
    Adams, Barnes, Benson, Burleigh, Cass, Cavalier, Dickey, Dunn,
Emmons, Foster, Grand Forks, Grant, Hettinger, Kidder, LaMoure,
Logan, McIntosh, McKenzie, McLean, Mercer, Morton, Nelson, Oliver,
Pembina, Ramsey, Ransom, Richland, Sargent, Sioux, Stutsman, and
Walsh Counties and the Spirit Lake and Standing Rock Indian
Reservations for Public Assistance [Categories A and C-G] (already
designated for emergency protective measures [Category B], including
direct Federal assistance, under the Public Assistance program).
    All counties in the State of North Dakota are eligible to apply
for assistance under the Hazard Mitigation Grant Program.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

Nancy Ward,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. E9-10436 Filed 5-5-09; 8:45 am]

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