[Federal Register Volume 77, Number 104 (Wednesday, May 30, 2012)]
[Notices]
[Pages 31858-31859]
[FR Doc No: 2012-12928]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0432]

Draft Guidance for Industry on Pathologic Complete Response in
Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an
Endpoint To Support Accelerated Approval; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Pathologic
Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage
Breast Cancer: Use as an Endpoint to Support Accelerated Approval.''
FDA's accelerated approval regulations permit approval of a new drug to
treat a serious disease on the basis of an effect on a surrogate
endpoint reasonably likely to predict the clinical benefit of the drug.
This draft guidance is intended to assist applicants in designing
trials to support marketing approval of drugs to treat breast cancer in
the neoadjuvant (preoperative) setting using pathologic complete
response (pCR) as a surrogate endpoint that could support approval
under the accelerated approval regulations. Despite advances in
systemic therapy of early-stage breast cancer over the past few
decades, there remains a significant unmet medical need for certain
high-risk or poor prognosis populations of early-stage breast cancer
patients. This guidance is intended to encourage industry innovation
and expedite the development of breakthrough therapies to treat high-
risk early-stage breast cancer.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by July 30, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Tatiana Prowell, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5249, Silver Spring, MD 20993-0002, 301-
796-2330.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Pathologic Complete Response in Neoadjuvant Treatment of
High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support
Accelerated Approval.'' Under the accelerated approval regulations (21
CFR part 314, subpart H, and 21 CFR part 601, subpart E), FDA may grant
marketing approval for a new drug on the basis of adequate and well-
controlled trials establishing that the drug has an effect on a
surrogate endpoint that is reasonably likely to predict clinical
benefit (e.g., an effect on survival or irreversible morbidity),
provided that the applicant conducts additional trials after approval
to verify and describe the predicted clinical benefit. This draft
guidance is intended to assist applicants in designing trials to
support marketing approval of drugs to treat breast cancer in the
neoadjuvant (preoperative) setting using pCR as a surrogate endpoint
that could support approval under the accelerated approval regulations.
The guidance proposes a uniform definition of pCR for regulatory
purposes. The guidance also advises on appropriate patient populations
for inclusion and on the trial designs intended to verify the predicted
clinical benefit associated with pCR to support conversion to full
approval.
    FDA recognizes that despite advances in adjuvant systemic therapy
of breast cancer over the past few decades, there remains a significant
unmet medical need for certain high-risk or poor prognosis populations
of early-stage breast cancer patients. Developing highly effective new
drugs for these populations is an FDA priority. In providing guidance
on the use of pCR as a surrogate endpoint that could support
accelerated approval in the neoadjuvant setting, FDA hopes to encourage
industry innovation and expedite the development of breakthrough
therapies to treat high-risk early-stage breast cancer.
    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 Agency's current thinking on the use of
pCR in neoadjuvant treatment of high-risk early-stage breast cancer as
an endpoint to support accelerated approval. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that 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 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively. The collections of information for special protocol
assessments have been approved under OMB control number 0910-0470.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the

docket number found in brackets in the heading of this document.
Received comments may be seen in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: May 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-12928 Filed 5-29-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 55 (Tuesday, March 22, 2011)]
[Notices]
[Page 15985]
[FR Doc No: 2011-6624]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1991-F-0203] (Formerly Docket No. 91F-0111)

Hartech Corporation; Denial Without Prejudice of Food Additive
Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is denying a food
additive petition (FAP 1M4246) proposing that the food additive
regulations be amended to provide for the safe use of a source of
ionizing radiation to treat shellfish, including crustaceans.

DATES: This order is effective June 20, 2011; except as to any
provisions that may be stayed by the filing of proper objections.
Submit either electronic or written objections and requests for a
hearing by April 21, 2011.

ADDRESSES: You may submit either electronic or written objections and
requests for a hearing identified by Docket No. FDA-1991-F-0203, by any
of the following methods:
    Electronic Submissions
    Submit electronic objections in the following way:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments.
    Written Submissions
    Submit written objections in the following ways:
    Fax:<PHONE_NUMBER>.
    Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Richard E. Bonnette, Center for Food
Safety and Applied Nutrition (HFS-255), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of April 16, 1991 (56 FR 15373), FDA announced that a food
additive petition (FAP 1M4246) had been filed by Hartech Corp.
(formerly United States Harvest Technologies, Inc., One East Chase St.,
suites 1112 and 1113, Baltimore, MD). The petition proposed to amend
the food additive regulations in Sec.  179.26 Ionizing radiation for
the treatment of food (21 CFR 179.26) to provide for the safe use of a
source of ionizing radiation to treat shellfish, including crustaceans.
    For any food additive petition, the burden is on the petitioner to
submit to FDA data and information that are adequate for the Agency to
determine that the proposed use of the additive under the specified
conditions of use is safe (21 U.S.C. 348(c)(3)(A), 21 CFR 171.1).
Hartech Corp. was notified of significant deficiencies in the
information supporting its petition by letters from the Agency dated
May 28, 1992, February 5, 1999, December 15, 2004, March 19, 2009, and
May 22, 2009. The deficiencies related primarily to concerns about the
possibility of Clostridium botulinum outgrowth in irradiated products,
especially where the normal growth pattern of typical spoilage
organisms could be changed by irradiation, thus reducing perception of
spoilage. FDA had therefore requested information on typical spoilage
and pathogenic microbial populations of shellfish irradiated at the
maximum dose requested. FDA also requested additional data on the
efficacy of the proposed doses of irradiation in reducing pathogens in
crustaceans because the petition only included data on the efficacy of
irradiation in reducing the levels of Vibrio species in oysters.
    Hartech Corp. has not provided information to address these
deficiencies, and the Agency's most recent letters to Hartech Corp.'s
last known address were returned as undeliverable. Additional efforts
to contact this petitioner have been unsuccessful. The petitioner has
not provided sufficient data and information for the Agency to conclude
that the proposed use of the food additive is safe in accordance with
section 409 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
348). FDA is therefore denying the petition without prejudice to a
future filing (21 U.S.C. 348(c)(1)(B), 21 CFR 171.100(a)).
    This order is effective as shown in the DATES section of this
document; except as to any provisions that may be stayed by the filing
of proper objections. Any person who will be adversely affected by this
order may file with the Division of Dockets Management (see ADDRESSES)
either electronic or written objections. Each objection shall be
separately numbered, and each numbered objection shall specify with
particularity the provisions of the regulation to which objection is
made and the grounds for the objection. Each numbered objection on
which a hearing is requested shall specifically so state. Failure to
request a hearing for any particular objection shall constitute a
waiver of the right to a hearing on that objection. Each numbered
objection for which a hearing is requested shall include a detailed
description and analysis of the specific factual information intended
to be presented in support of the objection in the event that a hearing
is held. Failure to include such a description and analysis for any
particular objection shall constitute a waiver of the right to a
hearing on the objection. It is only necessary to send one set of
documents. It is no longer necessary to send three copies of all
documents. Identify documents with the docket number found in brackets
in the heading of this document. Any objections received in response to
the order may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday. FDA will publish notice of the
objections that the Agency has received or lack thereof in the Federal
Register.

    Dated: March 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6624 Filed 3-21-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 98 (Monday, May 21, 2012)]
[Rules and Regulations]
[Pages 29865-29866]
[FR Doc No: 2012-12084]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2011-0608; Airspace Docket No. 11-ASW-6]

Amendment of Class E Airspace; Leesville, LA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace at Leesville, LA.
Additional controlled airspace is necessary to

accommodate new Area Navigation (RNAV) Standard Instrument Approach
Procedures at Leesville Airport. The FAA is taking this action to
enhance the safety and management of Instrument Flight Rule (IFR)
operations at the airport.

DATES: Effective date: 0901 UTC, July 26, 2012. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone 817-321-
7716.

SUPPLEMENTARY INFORMATION:

History

    On January 31, 2012, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to amend Class E airspace for the
Leesville, LA, area, creating additional controlled airspace at
Leesville Airport (77 FR 4702) Docket No. FAA-2011-0608. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. No comments
were received. Class E airspace designations are published in paragraph
6005 of FAA Order 7400.9V dated August 9, 2011, and effective September
15, 2011, which is incorporated by reference in 14 CFR Part 71.1. The
Class E airspace designations listed in this document will be published
subsequently in the Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
part 71 by amending Class E airspace extending upward from 700 feet
above the surface to accommodate new standard instrument approach
procedures at Leesville Airport, Leesville, LA. This action is
necessary for the safety and management of IFR operations at the
airport. Geographic coordinates are also updated to coincide with the
FAA's aeronautical database.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (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 rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends controlled airspace at Leesville Airport, Leesville, LA.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

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

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR part 71.1 of the Federal
Aviation Administration Order 7400.9V, Airspace Designations and
Reporting Points, dated August 9, 2011, and effective September 15,
2011, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface.

* * * * *

ASW LA E5 Leesville, LA [Amended]

Leesville Airport, LA
    (Lat. 31[deg]10'06'' N., long. 93[deg]20'33'' W.)
Leesville NDB
    (Lat. 31[deg]06'08'' N., long. 93[deg]20'31'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Leesville Airport, and within 3.6 miles
each side of the 345[deg] bearing from the airport extending from
the 6.5-mile radius to 12.2 miles north of the airport, and within
2.5 miles each side of the 000[deg] bearing of the Leesville NDB
extending from the 6.5-mile radius to 7.3 miles north of the
airport, excluding that airspace within the Fort Polk, LA, Class D
airspace area, and excluding that airspace within restricted area R-
3803A.

    Issued in Fort Worth, Texas, on May 10, 2012.
Walter L. Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2012-12084 Filed 5-18-12; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 232 (Tuesday, December 5, 2023)]
[Notices]
[Pages 84314-84315]
[FR Doc No: 2023-26648]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG24-42-000.
    Applicants: Cutlass Solar II, LLC.
    Description: Cutlass Solar II, LLC submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 11/28/23.
    Accession Number: 20231128-5143.
    Comment Date: 5 p.m. ET 12/19/23.

    Docket Numbers: EG24-43-000.
    Applicants: Grimes County Solar Project LLC.
    Description: Grimes County Solar Project LLC submits Notice of
Self-Certification of Exempt Wholesale Generator Status.
    Filed Date: 11/28/23.
    Accession Number: 20231128-5146.
    Comment Date: 5 p.m. ET 12/19/23.

    Docket Numbers: EG24-44-000.
    Applicants: Ben Milam Solar 2 LLC.
    Description: Ben Milam Solar 2 LLC submits Notice of Self-
Certification of Exempt Wholesale Generator Status.
    Filed Date: 11/29/23.
    Accession Number: 20231129-5052.
    Comment Date: 5 p.m. ET 12/20/23.

    Docket Numbers: EG24-45-000.
    Applicants: Quartz Solar, LLC.
    Description: Quartz Solar, LLC submits Notice of Self-Certification
of Exempt Wholesale Generator Status.
    Filed Date: 11/29/23.
    Accession Number: 20231129-5147.
    Comment Date: 5 p.m. ET 12/20/23

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

    Docket Numbers: ER10-2721-009; ER10-2721-011; ER10-2721-015.
    Applicants: El Paso Electric Company.
    Description: Amendment to July 31, 2023, Notice of Non-Material
Change in Status of El Paso Electric Company.
    Filed Date: 11/20/23.
    Accession Number: 20231120-5235.
    Comment Date: 5 p.m. ET 12/11/23.

    Docket Numbers: ER10-2861-007; ER13-1504-008.
    Applicants: SWG Arapahoe, LLC, Fountain Valley Power, L.L.C.
    Description: Supplement to December 20, 2019, Updated Market Power
Analysis for the Northwest Region of Fountain Valley Power, L.L.C., et
al.
    Filed Date: 11/20/23.
    Accession Number: 20231120-5239.
    Comment Date: 5 p.m. ET 12/11/23.

    Docket Numbers: ER15-1471-011; ER15-632-011; ER16-915-004; ER15-
634-011; ER10-2721-010; ER15-1672-010; ER10-2861-009; ER19-2287-002;
ER16-2010-005; ER14-2939-009; ER10-1874-012; ER19-9-006; ER15-2728-011;
ER19-2294-002; ER14-2140-011; ER12-1308-012; ER15-1952-009; ER16-711-
008; ER14-2466-012; ER14-2465-012; ER14-2141-011; ER16-2561-005; ER13-
1504-010; ER19-2305-002.
    Applicants: Valencia Power, LLC, SWG Arapahoe, LLC, Sunflower Wind
Project, LLC, Selmer Farm, LLC, RE Columbia Two LLC, RE Camelot LLC,
Pio Pico Energy Center, LLC, Pavant Solar LLC, Palouse Wind, LLC,
Mulberry Farm, LLC, Mesquite Power, LLC, Maricopa West Solar PV, LLC,
Mankato Energy Center II, LLC, Mankato Energy Center, LLC, Imperial
Valley Solar Company (IVSC) 2, LLC, Hancock Wind, LLC, Goal Line L.P.,
Fountain Valley Power, L.L.C., Evergreen Wind Power II, LLC, El Paso
Electric Company, Cottonwood Solar, LLC, Comanche Solar PV, LLC, CID
Solar, LLC, Blue Sky West, LLC
    Description: Supplement to January 19, 2021, Notice of Non-Material
Change in Status of Blue Sky West, LLC, et al.
    Filed Date: 11/20/23.
    Accession Number: 20231120-5236.
    Comment Date: 5 p.m. ET 12/11/23.

    Docket Numbers: ER23-2510-001.
    Applicants: California Independent System Operator Corporation.
    Description: Compliance filing: 2023-11-29 Short-Term Wheeling
Through Compliance Filing to be effective 6/1/2024.
    Filed Date: 11/29/23.
    Accession Number: 20231129-5080.
    Comment Date: 5 p.m. ET 12/20/23.

    Docket Numbers: ER24-55-000.
    Applicants: Silver Peak Energy, LLC.
    Description: Silver Peak Energy, LLC submits Request for Shortened
Comment Period of Ten Days re Supplement to Application.
    Filed Date: 11/14/23.
    Accession Number: 20231114-5141.
    Comment Date: 5 p.m. ET 12/5/23.

    Docket Numbers: ER24-171-000.
    Applicants: Skysol, LLC.
    Description: Supplement to October 20, 2023, Skysol, LLC tariff
filing.
    Filed Date: 11/29/23.
    Accession Number: 20231129-5150.
    Comment Date: 5 p.m. ET 12/13/23.

    Docket Numbers: ER24-492-000.
    Applicants: ISO New England Inc., New England Power Pool
Participants Committee.
    Description: Compliance filing: ISO New England Inc. submits tariff
filing per 35: ISO/NEPOOL; EL23-89--Comp Filing (Rev. to IEP Making
Pumped Storage Eligible) to be effective 8/2/2023.
    Filed Date: 11/29/23.
    Accession Number: 20231129-5062.
    Comment Date: 5 p.m. ET 12/20/23.

    Docket Numbers: ER24-493-000.
    Applicants: AEP Texas Inc.
    Description: 205(d) Rate Filing: AEPTX-Sun Cactus Solar Project
Generation Interconnection Agreement to be effective 11/6/2023.
    Filed Date: 11/29/23.
    Accession Number: 20231129-5067.
    Comment Date: 5 p.m. ET 12/20/23.

    Docket Numbers: ER24-494-000.
    Applicants: California Independent System Operator Corporation.
    Description: Petition for Approval of Disposition of Penalty
Assessment Proceeds of the California Independent System Operator
Corporation.
    Filed Date: 11/29/23.
    Accession Number: 20231129-5152.
    Comment Date: 5 p.m. ET 12/20/23.

    Docket Numbers: ER24-495-000
    Applicants: Duke Energy Florida, LLC
    Description: 205(d) Rate Filing: DEF-Harmony Florida Solar II--ASAO
SA No. 401 to be effective 10/30/2023.
    Filed Date: 11/29/23.
    Accession Number: 20231129-5173.
    Comment Date: 5 p.m. ET 12/20/23.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene, to protest, or to answer a
complaint in any of the above proceedings must file in accordance with
Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211,
385.214, or 385.206) on or before 5:00 p.m. Eastern time on the
specified comment date. Protests may be considered, but intervention is
necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in

Commission proceedings. OPP can help members of the public, including
landowners, environmental justice communities, Tribal members and
others, access publicly available information and navigate Commission
processes. For public inquiries and assistance with making filings such
as interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].

    Dated: November 29, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-26648 Filed 12-4-23; 8:45 am]
BILLING CODE 6717-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on April 21, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST-2000-7003

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  TAP Air Portugal						Date Filed:  April 2, 2004

Relief requested:  Renew exemption from 49 U.S.C. § 41301 to engage in
scheduled foreign air transportation of persons, property and mail from
points behind Portugal, via Portugal and intermediate points, to a point
or points in the United States, and beyond; and charter foreign air
transportation pursuant to Annex II of the U.S.-Portugal Air Transport
Agreement.

If renewal, date and citation of last action:  April 5, 2002, in this
docket

Applicant representative:  William Karas & Carol Gosain<PHONE_NUMBER>

DOT Analyst:  Gordon H. Bingham<PHONE_NUMBER>

Responsive pleadings:  None filed

	DISPOSITION

Action:  Approved								Action date:  April 21, 2004

Effective dates of the authority granted:  April 21, 2004-April 21, 2006

Basis for approval (bilateral agreement/reciprocity):  U.S.-Portugal Air
Transport Agreement

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

X  Standard exemption conditions (attached) and TAP’s foreign air
carrier permit (Order 79-8-47)

Special conditions/Partial grant/Denial basis/Remarks

Action taken by:  Paul L. Gretch, Director

		      Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) the applicant was qualified to perform the
proposed operations; (2) our action was consistent with Department
policy; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied all requests in
the referenced Docket.  We may amend, modify, or revoke the authority
granted in this Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

											Attachment

Foreign Carrier Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its Principal Security Inspector (PSI) to advise the PSI of its
plans and to find out whether the Transportation Security Administration
has determined that security is adequate to allow such airport(s) to be
served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.


[Federal Register Volume 80, Number 187 (Monday, September 28, 2015)]
[Notices]
[Pages 58272-58273]
[FR Doc No: 2015-24497]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket No. FEMA-2015-0001; Internal Agency Docket No. FEMA-B-1511]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency; DHS.

ACTION: Notice; correction.

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

SUMMARY: On June 8, 2015, FEMA published in the Federal Register a
proposed flood hazard determination notice that contained an erroneous
table. This notice provides corrections to that table, to be used in
lieu of the information published at 80 FR 32396. The table provided
here represents the proposed flood hazard determinations and
communities affected for Humboldt County, California, and Incorporated
Areas.

DATES: Comments are to be submitted on or before December 28, 2015.

ADDRESSES: The Preliminary Flood Insurance Rate Map (FIRM), and where
applicable, the Flood Insurance Study (FIS) report for each community
are available for inspection at both the online location and the
respective Community Map Repository address listed in the table below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
www.msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1511, to
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER> or (email)
<EMAIL_ADDRESS>or visit

the FEMA Map Information eXchange (FMIX) online at
www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed in the table below, in
accordance with Section 110 of the Flood Disaster Protection Act of
1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own, or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and are also used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP may only be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at http://floodsrp.org/pdfs/srp_fact_sheet.pdf.
    The communities affected by the flood hazard determinations are
provided in the table below. Any request for reconsideration of the
revised flood hazard determinations shown on the Preliminary FIRM and
FIS report that satisfies the data requirements outlined in 44 CFR
67.6(b) is considered an appeal. Comments unrelated to the flood hazard
determinations will also be considered before the FIRM and FIS report
are made final.

Correction

    In the proposed flood hazard determination notice published at 80
FR 32396 in the June 8, 2015, issue of the Federal Register, FEMA
published a table titled ``Humboldt County, CA and Incorporated
Areas''. This table contained inaccurate information as to the
communities affected by the proposed flood hazard determinations
featured in the table. The Cities of Eureka and Ferndale were not
included in the previous notice.
    In this document, FEMA is publishing a table containing the
accurate information. The information provided below should be used in
lieu of that previously published.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: September 11, 2015.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
           Humboldt County, California, and Incorporated Areas
------------------------------------------------------------------------
      Maps available for inspection online at: http://www.fema.gov/preliminaryfloodhazarddata preliminaryfloodhazarddata
 Project: 07-09-0269S Preliminary Dates: August 7, 2009, March 19, 2010,
                             January 9, 2015
City of Arcata.........................  City of Arcata, 525 9th Street,
                                          Arcata, CA 95521.
City of Blue Lake......................  City of Blue Lake, 111
                                          Greenwood Avenue, Blue Lake,
                                          CA 95525.
City of Eureka.........................  City Hall, 531 K Street,
                                          Eureka, CA 95501.
City of Ferndale.......................  Public Works Department, 834
                                          Main Street, Ferndale, CA
                                          95536.
City of Fortuna........................  City of Fortuna City Hall, 621
                                          11th Street, Fortuna, CA
                                          95540.
Unincorporated Areas of Humboldt County  Clark Complex, 3015 H Street,
                                          Eureka, CA 95501.
------------------------------------------------------------------------

[FR Doc. 2015-24497 Filed 9-25-15; 8:45 am]
BILLING CODE 9110-12-P


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 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
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REGION 8
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1595 Wynkoop Street
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Denver, CO   80202-1129
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Phone<PHONE_NUMBER>
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www.epa.gov/region8

Ref: 8ARD-PM

Mr. Bernie Fox
      Thunder Butte Petroleum Services, Chief Executive Officer
      Mandan, Hidatsa, and Arikara (MHA) Nation dba
Thunder Butte Petroleum Services, Inc.
      Tribal Administration Building
330 Main Street, P.O. Box 1227
New Town, North Dakota 58763

Re:Application Incompleteness Determination for the Synthetic Minor New Source Review Permit Thunder Butte Petroleum Services, Inc., Crude Oil Topping Plant

Dear Mr. Bernie Fox:

The Environmental Protection Agency Region 8 has completed its review of Thunder Butte Petroleum Services, Inc.'s (TBPS) May 2, 2023 application for a tribal Synthetic Minor New Source Review permit (SMNSR). This action was requested in accordance with the Federal Minor New Source Review (MNSR) Permit Program in Indian Country at 40 CFR part 49 for a proposed modification at the existing TBPS Crude Oil Storage and Transfer Facility, located on the Fort Berthold Reservation in Ward County, North Dakota. TBPS is proposing to construct a crude oil Topping Plant and is requesting synthetic minor restrictions to maintain allowable emissions for the facility below the major source thresholds of the Title V Operating Permit Program (title V) at 40 CFR part 71 and the major source thresholds of the major New Source Review Program (NSR) at 40 CFR part 52.21.

Pursuant to 40 CFR 49.154(b) and (d) and 49.158, EPA has determined that the application submitted in support of permitting the proposed TBPS Topping Plant is incomplete. As drafted, the application discusses the integration of eight previously permitted crude oil storage tanks at the Crude Oil Storage Facility into the Topping Plant. Six of these tanks were most recently permitted in the tribal synthetic minor NSR permit SMNSR-TAT-000781-2021.002 issued in June 2022. As the current version of the application makes clear, these six tanks are proposed to be integrated into the Topping Plant operations and are integral to the successful operation of the proposed facility. In previous conversations with TBPS's consultant on December 8, 2022, EPA noted that if the intent was to integrate the six tanks into a Topping Plant, that it would require the entirety of the project to be integrated into and approved as one permitting action.

Accordingly, Region 8 has determined that all activities listed in the June 2022 permit and the proposed Topping Plant application, as submitted, should be permitted in a single permit. As discussed in the 2009 Project Aggregation rule, the proposed Topping Plant and activities permitted in the June 2022 SMNSR permit are substantially related and as such, EPA is requesting the following:

TBPS notify Region 8 by July 24, 2023 if it intends to proceed with the Topping Plant that incorporates the six tanks into its operations.
If TBPS wishes to continue the Topping Plant project, Region 8 requests that TBPS stop all construction activities related to the June 2022 SMNSR permit until a permit is issued aggregating the six tanks and the Topping Plant. If EPA determines that an SMNSR is still appropriate for the Topping Plant, EPA will reopen the June 2022 permit to correct the material defect of omitting the Topping Plant from that permit and proceed to re-issue the permit according to the requirements of 40 CFR §49.159(a) and 40 CFR §49.159(e). This reopening and reissuing of an SMNSR permit will require a public notice and comment period under the provisions of 40 CFR §49.157.
If TBPS does not wish to continue with the Topping Plant project, construction on the six tanks under the June 2022 permit may continue.

This permit action has been assigned to Mr. Donald Law and has been given permit number SMNSR-TAT-000781-2023.003. If you have any questions, or if you'd like to schedule a meeting to discuss this matter further, please contact him at<EMAIL_ADDRESS>or<PHONE_NUMBER>. A copy of the application provided by TBPS may be reviewed electronically online through Docket #EPA-R08-OAR-2023-0274 at https://www.regulations.gov. We look forward to hearing from you and working with you and your company as you consider pursuing the Topping Plant permit.

Sincerely,

Adrienne Sandoval
Director
Air and Radiation Division

cc:Chairman Mark Fox  -  MHA Nation
Mr. John Fredericks, Legal Counsel  -  MHA Nation
Mr. Edmund Baker, Environmental Director  -  MHA Nation
Ms. Lisa Lone Fight, Senior Scientific Advisor  -  MHA Nation
Mr. Kenny Lyson, Director  -  MHA Energy Department
Ms. Catherine Everett  -  MHA Energy Liaison