[Federal Register Volume 78, Number 152 (Wednesday, August 7, 2013)]
[Notices]
[Pages 48173-48174]
[FR Doc No: 2013-19004]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0597]

Guidance for Industry on Oversight of Clinical Investigations--A
Risk-Based Approach to Monitoring; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Oversight of
Clinical Investigations--A Risk-Based Approach to Monitoring.'' This
guidance assists sponsors in developing risk-based monitoring
strategies and plans for clinical investigations of human drugs,
biologics, medical devices, and combinations thereof. The overarching
goal of this guidance is to enhance human subject protection and the
quality of clinical trial data by focusing sponsor oversight on the
most important aspects of study conduct and reporting. The guidance
makes clear that sponsors can use a variety of approaches to meet their
responsibilities for monitoring investigational new drug or
investigational device exemption studies.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this 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; the Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448; or the Office of
Communication and Education, Division of Small Manufacturers,
International and Consumer Assistance, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4613, 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 guidance document.
    Submit electronic comments on the 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: Ann Meeker-O'Connell, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 5356, Silver Spring, MD 20993-0002, 301-
796-7615; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>; or Linda Godfrey,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3446, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Oversight of Clinical Investigations--A Risk-Based Approach
to Monitoring.'' FDA is publishing this guidance to assist sponsors of
clinical investigations in developing risk-based monitoring strategies
and plans for clinical investigations of human drug and biological
products, medical devices, and combinations thereof. This guidance is
intended to make clear that sponsors can use a variety of approaches to
meet their responsibilities for monitoring clinical investigations
under 21 CFR parts 312 and 812.

    In the Federal Register of August 29, 2011 (76 FR 53683), FDA
announced the availability of the draft guidance entitled ``Oversight
of Clinical Investigations: A Risk-Based Approach to Monitoring,''
dated August 2011, and the public was provided with an opportunity to
comment on it until November 28, 2011. FDA carefully considered all of
the comments received in developing the final guidance. The final
guidance includes clarifications and additional detail on some topics.
For example, the final guidance includes additional detail on how to
perform risk-based monitoring and examples of monitoring techniques.
    The final guidance describes strategies for monitoring activities
that reflect a modern, risk-based approach that focuses on critical
study parameters and relies on a combination of monitoring activities
to oversee a study effectively. The guidance also makes recommendations
about how to develop monitoring plans and document monitoring
activities and includes additional strategies to ensure study quality.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on oversight of clinical investigations--a
risk-based approach to monitoring. 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. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions 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 this guidance were approved under OMB
control numbers 0910-0078, 0910-0014, and 0910-0733.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

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

    Dated: August 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19004 Filed 8-6-13; 8:45 am]
BILLING CODE 4160-01-P


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

General Comment:Dear Mr. Zeller:

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

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

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. As a consumer that tried every FDA approved cessation/ Tobacco Harm reduction product to break a nearly 30 year use of combustible cigarettes; I have only been able to stop said use of combustible cigarettes using one of the products included in the Food and Drug Administration's Proposed Rule. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

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

Respectfully yours, Concerned consumer


This appendix is only available from MassDEP as an electronic file
entitled “CMAQ Model Statistics for the OTR States”


[Federal Register: October 25, 2010 (Volume 75, Number 205)]
[Notices]
[Page 65521-65523]
[DOCID:fr25oc10-114]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2007-0041]

FM Approvals; Expansion of Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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

SUMMARY: This notice announces the Occupational Safety and Health
Administration's final decision expanding the recognition of FM
Approvals LLC as a Nationally Recognized Testing Laboratory under 29
CFR 1910.7.

DATES: The expansion of recognition becomes effective on October 25,
2010.

FOR FURTHER INFORMATION CONTACT: MaryAnn Garrahan, Director, Office of
Technical Programs and Coordination Activities, NRTL Program,
Occupational Safety and Health Administration, U.S. Department of
Labor, 200 Constitution Avenue, NW., Room N-3655, Washington, DC 20210,
or phone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Notice of Final Decision

    The Occupational Safety and Health Administration (OSHA) hereby
gives notice that it is expanding the recognition of FM Approvals LLC
(FM) as a Nationally Recognized Testing Laboratory (NRTL). FM's
expansion covers the use of additional test standards. OSHA's current
scope of recognition for FM may be found in the following informational
Web page: http://www.osha.gov/dts/otpca/nrtl/fm.html.
    OSHA recognition of an NRTL signifies that the organization meets
the legal requirements specified in 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within its
scope of recognition, and is not a delegation or grant of government
authority. As a result of

recognition, employers may use products approved by the NRTL to meet
OSHA standards that require product testing and certification.
    The Agency processes applications by an NRTL for initial
recognition, or for expansion or renewal of this recognition, following
requirements in Appendix A to 29 CFR 1910.7. This appendix requires
that the Agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides its preliminary finding and, in the second
notice, the Agency provides its final decision on the application.
These notices set forth the NRTL's scope of recognition or
modifications of that scope. OSHA maintains an informational Web page
for each NRTL that details its scope of recognition. These pages are
available from the Web site at http://www.osha.gov/dts/otpca/nrtl/
index.html. Each NRTL's scope of recognition has three elements: (1)
The type of products the NRTL may test, with each type specified by its
applicable test standard; (2) the recognized site(s) that has/have the
technical capability to perform the testing and certification
activities for test standards within the NRTL's scope; and (3) the
supplemental program(s) that the NRTL may use, each of which allows the
NRTL to rely on other parties to perform activities necessary for
product testing and certification.
    FM submitted an application, dated July 18, 2007, to expand its
recognition to include 31 additional test standards. The NRTL Program
staff deferred action on 20 of these standards pending resolution of
technical issues. The staff determined that ten of the remaining 11
standards are ``appropriate test standards'' within the meaning of 29
CFR 1910.7(c). In connection with this request, NRTL Program staff did
not perform an onsite review of FM's recognized sites. The staff only
performed a comparability analysis,\1\ which determined that FM has the
capabilities to perform the testing related to the ten standards (see
list below). The Agency subsequently accepted this recommendation, and
published a preliminary notice announcing the expansion application in
the Federal Register on March 2, 2010 (75 FR 9439). Comments were
requested by March 17, 2010, but OSHA received no comments in response
to this notice. OSHA is now proceeding with this final notice to grant
FM's expansion application.
---------------------------------------------------------------------------

    \1\ This analysis involves determining whether the testing and
evaluation requirements of test standards already in an NRTL's scope
are comparable to the requirements in the standards requested by the
NRTL.
---------------------------------------------------------------------------

    All public documents pertaining to the FM application are available
for review by contacting the Docket Office, Occupational Safety and
Health Administration, U.S. Department of Labor, 200 Constitution
Avenue, NW., Room N-2625, Washington, DC 20210. These materials also
are available online at http://www.regulations.gov under Docket No.
OSHA-2007-0041.

Final Decision and Order

    NRTL Program staff examined FM's application, the comparability
analysis, and other pertinent information. Based on this examination
and the analysis, OSHA finds that FM meets the requirements of 29 CFR
1910.7 for expansion of its recognition, subject to the limitation and
conditions specified below. Pursuant to the authority in 29 CFR 1910.7,
OSHA hereby expands the recognition of FM, subject to this limitation
and these conditions.

Limitation

    OSHA limits the expansion of FM's recognition to testing and
certification of products for demonstration of conformance to the
following test standards, each of which OSHA determines is an
appropriate test standard, within the meaning of 29 CFR 1910.7(c):

UL 153 Portable Electric Luminaires \2\
---------------------------------------------------------------------------

    \2\ FM requested recognition for UL 298--Portable Electric Hand
Lamps, but this standard has been withdrawn and was superseded by UL
153.
---------------------------------------------------------------------------

UL 268A Smoke Detectors for Duct Application
UL 484 Room Air Conditioners
UL 521 Heat Detectors for Fire Protective Signaling Systems
UL 1480 Speakers for Fire Alarm, Emergency, and Commercial and
Professional Use
UL 1638 Visual Signaling Appliances--Private Mode Emergency and General
Utility Signaling
FM 3210 Heat Detectors for Automatic Fire Alarm Signaling
FM 7260 Electrostatic Finishing Equipment
UL 61010A-1 Electrical Equipment for Laboratory Use; Part 1: General
Requirements
UL 61010B-1 Electrical Measuring and Test Equipment; Part 1: General
Requirements

    The designations and titles of these test standards were current at
the time of the preparation of this notice.
    OSHA's recognition of any NRTL for a particular test standard is
limited to equipment or materials (i.e., products) for which OSHA
standards require third-party testing and certification before use in
the workplace. Consequently, if a test standard also covers any product
for which OSHA does not require such testing and certification, an
NRTL's scope of recognition does not include that product.
    The American National Standards Institute (ANSI) may approve the
test standards listed above as American National Standards. However,
for convenience, we may use the designation of the standards-developing
organization for the standard as opposed to the ANSI designation. Under
the NRTL Program's policy, any NRTL recognized for a particular test
standard may use either the proprietary version of the test standard or
the ANSI version of that standard. Contact ANSI to determine whether a
test standard is currently ANSI-approved.

Conditions

    FM also must abide by the following conditions of the recognition,
in addition to those conditions already required by 29 CFR 1910.7:
    1. FM must allow OSHA access to its facilities and records to
ascertain continuing compliance with the terms of its recognition, and
to perform investigations as OSHA deems necessary;
    2. If FM has reason to doubt the efficacy of any test standard it
is using under this program, it must promptly inform the test standard-
developing organization of this concern, and provide that organization
with appropriate relevant information upon which its concern is based;
    3. FM must not engage in, or permit others to engage in, any
misrepresentation of the scope or conditions of its recognition. As
part of this condition, FM agrees that it will allow no representation
that it is either a recognized or an accredited Nationally Recognized
Testing Laboratory (NRTL) without clearly indicating the specific
equipment or material to which this recognition applies and that its
recognition is limited to certain products;
    4. FM must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
changes in its operations as an NRTL, including details of these
changes;
    5. FM will meet all the terms of its recognition and will always
comply with all OSHA policies pertaining to this recognition; and
    6. FM will continue to meet the requirements for recognition in all
areas to which this recognition applies.

Authority and Signature

    David Michaels, PhD, MPH, Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue, NW.,
Washington, DC 20210, directed the preparation of this notice.
Accordingly, the Agency is issuing this notice pursuant to Sections
6(b) and 8(g) of the Occupational Safety and Health Act of 1970 (29
U.S.C. 655 and 657), Secretary of Labor's Order No. 4-2010 (75 FR
55355), and 29 CFR part 1911.

    Signed at Washington, DC, on October 20, 2010.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2010-26894 Filed 10-22-10; 8:45 am]
BILLING CODE 4510-26-P


41789 Federal Register / Vol. 68, No. 135 / Tuesday, July 15, 2003 / Notices Amendment No. 1 which provides for the addition of one point of interconnection. Midwest states that a copy of this filing was served upon the Kansas Corporation Commission and Aquila. Comment Date: July 21, 2003.

8. Midwest Energy, Inc.

[ Docket No. ER03   1008   000]

Take notice that on June 30, 2003, Midwest Energy, Inc. ( Midwest) submitted for filing an Electric Interconnection Contract ( Contract) between Central Kansas Power Company, Inc., now known as Midwest Energy, Inc. and Westar Energy ( Westar). This Interconnection Contract was previously filed by Westar Energy and designated as FPC No. 123 as revised and amended. Midwest states that a copy of this filing was served upon the Kansas Corporation Commission and Westar. Comment Date: July 21, 2003.

9. American Transmission Systems, Inc.

[ Docket No. ER03   1009   000]

Take notice that on June 30, 2003, American Transmission Systems, Inc. ( ATSI) tendered for filing its Service Agreement No. 337, an executed Network Integration Transmission Service Agreement with Buckeye Power, Inc. ( Buckeye) under ATSI's Open Access Transmission Tariff, FERC Electric Tariff, Second Revised Volume No. 1. ATSI requests that the agreement be placed in effect on July 1, 2003. ATSI states that copies of the filing were served upon Buckeye and the Public Utilities Commission of Ohio. Comment Date: July 21, 2003.

10. NEO California Power LLC [ Docket No. ER03   1010   000]

Take notice that on July 1, 2003, NEO California Power LLC ( NEO California) filed with the Federal Energy Regulatory Commission a Must Run Service Agreement dated June 30, 2003 with the California Independent System Operator Corporation. Comment Date: July 22, 2003.

11. Southern California Edison Company [ Docket No. ER03   1011   000]

Take notice that on July 1, 2003, Southern California Edison Company ( SCE) tendered for filing revised rate sheets ( Revised Sheets) to the Agreement For Interconnection Service and the Interconnection Facilities Agreement between SCE and Harbor Cogeneration Company ( Harbor), Service Agreement Nos. 2 and 9 under SCE's FERC Electric Tariff, First Revised Volume No. 6. SCE respectfully requests an effective date of June 30, 2003. SCE states that the Revised Sheets to these agreements reflect an extension of their terms and conditions to provide interconnection service to Harbor's 110 MW generating facility through August 31, 2003. SCE also states that copies of this filing were served upon the Public Utilities Commission of the State of California and Harbor. Comment Date: July 22, 2003.

12. RAM Energy Products, L. L. C.

[ Docket No. ER03   1012   000] Take notice that on July 1, 2003, RAM Energy Products, L. L. C. submitted for filing, pursuant to Section 205 of the Federal Power Act, and part 35 of the Commission's regulations, an application for authorization to make sales, as a power marketer, of capacity, energy, and certain Ancillary Services at market based rates; to reassign transmission capacity; and to resell firm transmission rights. Comment Date: July 22, 2003.

13. New England Power Pool [ Docket No. ER03   1014   000] Take notice that on July 1, 2003, the New England Power Pool ( NEPOOL) Participants Committee filed for acceptance materials to permit NEPOOL to expand its membership to include El Cap II, LLC ( El Cap), Split Rock Energy, LLC ( Split Rock), and New Hampshire Industries, Inc., ( NHI). The Participants Committee requests an effective date of July 1, 2003, for the commencement of participation in NEPOOL by El Cap and Split Rock, and September 1, 2003 for the commencement of participation in NEPOOL as a Governance Only Member by NHI. The Participants Committee states that copies of these materials were sent to the New England state governors and regulatory commissions and the Participants in NEPOOL. Comment Date: July 22, 2003.

Standard Paragraph Any person desiring to intervene or to protest this filing 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). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a motion to intervene. All such motions or protests should be filed on or before the comment date, and, to the extent applicable, must be served on the applicant and on any other person designated on the official service list. 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 `` FERRIS'' link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC Online Support at FERCOnlineSupport@ ferc. gov or tollfree at ( 866) 208   3676, or for TTY, contact ( 202) 502   8659. Protests and interventions may be filed electronically via the Internet in lieu of paper; see 18 CFR 385.2001( a)( 1)( iii) and the instructions on the Commission's Web site under the `` e Filing'' link. The Commission strongly encourages electronic filings.

Magalie R. Salas, Secretary. [ FR Doc. 03   17848 Filed 7   14   03; 8: 45 am]

BILLING CODE 6717   01   P ENVIRONMENTAL PROTECTION AGENCY [ OPP   2002   0296; FRL   7318   4]

Pesticides; Data Submitter Rights for Data Submitted in Support of Tolerance Actions; Notice of Availability; Extension of Comment Period AGENCY: Evironmental Protection Agency ( EPA). ACTION: Notice; extension of comment period.

SUMMARY: On April 17, 2003, EPA announced the availability for comment on a proposal discussing a program to enable the Agency to appropriately implement the new provisions contained in section 408( i) of the Federal Food, Drug, and Cosmetic Act ( FFDCA) to address exclusive use and compensation rights for data submitted to EPA in support of tolerance and tolerance exemption actions. The Agency received a request to extend the comment period and this notice announces the extension of the comment period for 60 days. DATES: Comments, identified by the docket ID number OPP   2002   0296, must be received on or before September 16, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in VerDate Jan< 31> 2003 16: 59 Jul 14, 2003 Jkt 200001 PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 15JYN1. SGM 15JYN1 41790 Federal Register / Vol. 68, No. 135 / Tuesday, July 15, 2003 / Notices Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Cameo G. Smoot, Field and External Affairs Division ( 7506C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   5454; fax number: ( 703) 308   5884; email address: smoot. cameo@ epa. gov. SUPPLEMENTARY INFORMATION:

I. General Information A. Does This Action Apply to Me? You may be potentially affected by this action if you submit data to EPA in support of establishing, maintaining or exempting tolerances for pesticides under the FFDCA, or are a pesticide registrant or a person applying for pesticide registration under the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). Potentially affected entities may include, but are not limited to:   Pesticide manufacturing ( NAICS code 32532) e. g., individuals or entities engaged in activities related to the registration of a pesticide product. This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions in 40 CFR part 152 Pesticide Registration and Classification Procedures and section 408( i) of the FFDCA. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of This Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket ID number OPP   2002   0296. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although, a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA dockets. You may use EPA dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although, not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also, include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties, or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket/, and follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP   2002   0296. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to opp docket@ epa. gov, Attention: Docket ID number OPP   2002   0296. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your e mail address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB) ( 7502C), Office of Pesticide Programs ( OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001, Attention: Docket ID number OPP   2002   0296. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID number OPP   2002   0296. Such deliveries are only accepted VerDate Jan< 31> 2003 16: 59 Jul 14, 2003 Jkt 200001 PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 15JYN1. SGM 15JYN1 41791 Federal Register / Vol. 68, No. 135 / Tuesday, July 15, 2003 / Notices during the docket's normal hours of operation as identified in Unit I. A. 1.

D. How Should I Submit CBI to the Agency?

Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed, except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

II. What Action Is EPA Taking?

This document extends the public comment period established in the Federal Register issued on April 17, 2003 ( 68 FR 18977) ( FRL   7279   9). In that document, EPA sought comment on a proposal for implementing a data compensation program under FFDCA. EPA is hereby extending the comment period, which was set to end on July 16, 2003, to September 16, 2003.

III. What Is the Agency's Authority for Taking This Action?

As part of the Food Quality Protection Act of ( FQPA) 1996, Congress amended the FFDCA to address exclusive use and compensation rights for data submitted to EPA in support of tolerance and tolerance exemption actions, and to amend treatment of confidential information under the statute. This proposal addresses the implementation of the statutory requirement.

Lists of Subjects Environmental protection, Pesticides, Tolerance, and Data compensation. Dated: July 7, 2003. Jim Jones, Director, Office of Pesticide Programs.

[ FR Doc. 03   17901 Filed 7   14   03; 8: 45 am]

BILLING CODE 6560   50   S FEDERAL COMMUNICATIONS COMMISSION [ DA 03   2057]

ITFS, MDS, and MMDS Pending Applications AGENCY: Federal Communications Commission. ACTION: Notice.

SUMMARY: In this document, the Federal Communications Commission's ( FCC's) Public Safety and Private Wireless Division of the Wireless Telecommunications Bureau dismisses applications where the applicants did not respond to an October 18, 2002 public notice requiring applicants to affirm their interest in those applications. The public notice also dismisses legal matters relating to applications that are being dismissed in the public notice.

FOR FURTHER INFORMATION CONTACT: For questions relating to legal matters dismissed as a result of this public notice, please contact John J. Schauble, Chief, Policy and Rules Branch, Public Safety and Private Wireless Division at 202   418   0797. For all other questions relating to this Public Notice, contact Mary Shultz, Branch Chief, or Ruth Taylor, Chief, Microwave Section, Licensing and Technical Analysis Branch at 717   338   2646.

SUPPLEMENTARY INFORMATION: This is a summary of the FCC's Public Notice, DA 03   2057, released on June 20, 2003. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center, 445 12th Street, SW., Washington, DC 20554. The complete text may be purchased from the FCC's copy contractor, Qualex International, 445 12th Street SW., Room CY   B402, Washington, DC 20554. The full text may also be downloaded at: http:// www. fcc. gov. Alternative formats are available to persons with disabilities by contacting Brian Millin at ( 202) 418   7426 or TTY ( 202) 418   7365 or at bmillin@ fcc. gov. 1. On October 18, 2002, the Wireless Telecommunications Bureau ( WTB) released a Public Notice ( October Public Notice), 67 FR 69010, November 14, 2002, in which it sought to ensure that it had a complete and accurate listing of all licenses and pending applications in the Instructional Television Fixed Service ( ITFS), the Multipoint Distribution Service ( MDS), and the Multichannel Multipoint Distribution Service ( MMDS). The Public Notice referenced six different tables of licensing information. Specifically, Table E listed all pending applications for ITFS and Table F listed all pending applications for MDS and MMDS. Tables E and F contained the following information for each pending application: licensee name, file number, application purpose, call sign, facility ID, transmitter city/ state, BTA and channel. The WTB required that all ITFS, MDS and MMDS licensees and applicants review and verify the information contained in these tables. For pending applications filed prior to March 25, 2002, the WTB required that the applicant respond in writing by December 18, 2002 if continued processing was desired. The time for licensees and applicants in these services to respond to the October Public Notice was extended to February 3, 2003. This deadline was further extended to February 21, 2003. 2. Appendix A to this Public Notice contains a list of those pending ITFS applications with a filing date prior to March 25, 2002 where the applicant/ licensee has not responded to the October Public Notice. Appendix B to this Public Notice contains a list of those pending MDS and MMDS applications for with a filing date prior to March 25, 2002 where the applicant/ licensee has not responded to the October Public Notice. In the October Public Notice, WTB indicated, `` For any applications for which written affirmations requesting further processing have not been received, those applications will be dismissed without prejudice.'' Accordingly, it is ordered, pursuant to section 4( i) of the Communications Act of 1934, as amended, 47 U. S. C. 154( i) and § § 21.28( d) and 73.3568( a)( 1) of the Commission's Rules, 47 CFR 21.28( d), 73.3568( a)( 1), the applications listed in Appendix A and Appendix B to this Public Notice are hereby dismissed without prejudice. 3. In addition, as a result of the dismissal of the applications listed in Appendices A and B, certain legal matters are now moot. Those legal matters consist of petitions to deny or petitions for reconsideration filed with respect to those applications, or complaints filed with respect to licenses that have now expired or been forfeited because of the dismissal of renewal applications for those licenses. Since the underlying applications have now VerDate Jan< 31> 2003 16: 59 Jul 14, 2003 Jkt 200001 PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 15JYN1. SGM 15JYN1


[Federal Register Volume 79, Number 178 (Monday, September 15, 2014)]
[Rules and Regulations]
[Pages 54901-54902]
[FR Doc No: 2014-21801]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

Docket No. FAA-2014-0273; Airspace Docket No. 14-ANE-2
RIN 2120-AA66

Amendment of Air Traffic Service (ATS) Routes; Northeast ME

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action modifies VOR Federal airways V-93, V-314, and V-
471; and RNAV route T-295 in northeastern Maine due to the scheduled
decommissioning of the Princeton, ME, VOR facility. In addition, an
analysis of the airway structure in that area found that some segments
of the affected routes are rarely utilized and are therefore being
removed.

DATES: Effective date 0901 UTC, November 13, 2014. 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.

ADDRESSES: FAA Order 7400.9X, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://
www.faa.gov/airtraffic/publications/. The Order is also
available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call<PHONE_NUMBER> or go to http://archives.gov/
federalregister/codeoffederal-regulations/
ibrlocations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15. For further
information, you can contact the Airspace Policy and Regulations Group,
Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC 20591; telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Paul Gallant, Airspace Policy and
Regulations Group, Office of Airspace Services, Federal Aviation
Administration, 800 Independence Avenue SW., Washington, DC 20591;
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    The FAA published in the Federal Register a notice of proposed
rulemaking (NPRM) to amend three VOR Federal airways and one area
navigation route in northeastern Maine (79 FR 29138, May 21, 2014).
Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal. No comments were
received.

The Rule

    This action amends Title 14, Code of Federal Regulations (14 CFR)
part 71 by modifying the descriptions of VOR Federal airways V-93, V-
314, V-471 and RNAV route T-295 due to the planned decommissioning of
the Princeton VOR in Maine.
    An analysis of the airway structure in northeastern Maine found
that some segments of the affected routes airways are rarely utilized.
After coordination with Boston Air Route Traffic Control Center, Bangor
Airport Traffic Control Tower, and Moncton Center (Canada), the FAA is
removing the underutilized segments of the affected routes. The changes
are described below.
    V-93 extends between Patuxent River, MD, and the intersection of
the Princeton, ME, 157[deg] radial and the United States/Canadian
border. The FAA is terminating the route at the Bangor, ME, VORTAC
(BGR), eliminating the route segments between BGR and the United
States/Canadian border.
    V-314 extends from Quebec, PQ, Canada, through United States
airspace, to St. John, NB, Canada. This action terminates the route at
Millinocket, ME, and eliminates the segments between Millinocket,
Princeton, ME, and St. John, NB, Canada.
    V-471 extends between the intersection of the Princeton, ME,
208[deg] and the Bangor, ME, 132[deg] radials (i.e., the charted BARHA
fix) and the intersection of the Houlton, ME, 085[deg] radial and the
United States/Canadian border. This action removes the route segment
between the Bangor VORTAC and the BARHA fix.
    T-295 extends between the LOUIE, MD, fix and the Princeton, ME,
VOR. The amended route terminates at Bangor, ME, eliminating the
segment between Bangor and Princeton, ME.
    VOR Federal airways are published in paragraph 6010(a); and low
altitude RNAV routes are published in paragraph 6011, respectively, of
FAA Order 7400.9X dated August 7, 2013, and effective September 15,
2013, which is incorporated by reference in 14 CFR 71.1. The VOR
Federal airways and area navigation route listed in this document will
be subsequently published in the Order.
    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 Department of Transportation (DOT) Regulatory Policies and
Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant
preparation of a regulatory evaluation because the anticipated impact
is so minimal. Since this is a routine matter that only affects air
traffic procedures and air navigation, it is certified that this rule
does not have a significant economic impact on a substantial number of
small entities under the criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority.
    This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of the
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
because it modifies the route structure as required to preserve the
safe and efficient flow of air traffic in northeastern Maine.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures,'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist

that warrant preparation of an environmental assessment.

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 part 71 continues to read as follows:

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9X,
Airspace Designations and Reporting Points, dated August 7, 2013 and
effective September 15, 2013, is amended as follows:

Paragraph 6010(a)--VOR Federal Airways

V-93 [Amended]

    From Patuxent River, MD, INT Patuxent 013[deg] and Baltimore,
MD, 122[deg] radials; Baltimore; INT Baltimore 004[deg] and
Lancaster, PA, 214[deg] radials; Lancaster; Wilkes-Barre, PA; to INT
Wilkes-Barre 037[deg] and Sparta, NJ 300[deg] radials. From INT
Sparta 018[deg] and Kingston, NY, 270[deg] radials; Kingston;
Pawling, NY; Chester, MA, 12 miles 7 miles wide (4 miles E and 3
miles W of centerline); Keene, NH; Concord, NH; Kennebunk, ME; INT
Kennebunk 045[deg] and Bangor, ME, 220[deg] radials; to Bangor.

V-314 [Amended]

    From Quebec, PQ, Canada, 99 miles 55 MSL, to Millinocket, ME,
excluding the airspace within Canada.

V-471 [Amended]

    From Bangor, ME; Millinocket, ME; Houlton, ME; INT Houlton
085[deg] radial and the United States/Canadian border.
* * * * *

Paragraph 6011 United States Area Navigation Routes

T-295 LOUIE, MD to Bangor, ME (BGR) [Amended]
LOUIE, MD                     FIX                 (Lat. 38[deg]36'44'' N., long. 076[deg]18'04'' W.)
BAABS, MD                     WP                  (Lat. 39[deg]19'51'' N., long. 076[deg]24'41'' W.)
Lancaster, PA (LRP)           VORTAC              (Lat. 40[deg]07'12'' N., long. 076[deg]17'29'' W.)
Wilkes-Barre, PA (LVZ)        VORTAC              (Lat. 41[deg]16'22'' N., long. 075[deg]41'22'' W.)
LAAYK, PA                     FIX                 (Lat. 41[deg]28'33'' N., long. 075[deg]28'57'' W.)
SAGES, NY                     FIX                 (Lat. 42[deg]02'46'' N., long. 074[deg]19'10'' W.)
SASHA, MA                     FIX                 (Lat. 42[deg]07'59'' N., long. 073[deg]08'55'' W.)
Keene, NH (EEN)               VORTAC              (Lat. 42[deg]47'39'' N., long. 072[deg]17'30'' W.)
Concord, NH (CON)             VORTAC              (Lat. 43[deg]13'11'' N., long. 071[deg]34'32'' W.)
Kennebunk, ME (ENE)           VOR/DME             (Lat. 43[deg]25'32'' N., long. 070[deg]36'49'' W.)
BRNNS, ME                     FIX                 (Lat. 43[deg]54'09'' N., long. 069[deg]56'43'' W.)
Bangor, ME (BGR)              VORTAC              (Lat. 44[deg]50'30'' N., long. 068[deg]52'26'' W.)

    Issued in Washington, DC, on September 8, 2014.
Ellen Crum,
Acting Manager, Airspace Policy and Regulations Group.
[FR Doc. 2014-21801 Filed 9-12-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 95 (Monday, May 18, 2015)]
[Notices]
[Pages 28340-28341]
[FR Doc No: 2015-11882]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. 2015-23]

Petition for Exemption; Summary of Petition Received; American
Airlines, Inc.

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14 of the Code of Federal
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 June 8, 2015.

ADDRESSES: Send comments identified by docket number FAA-2015-0409
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 (DOT), 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, 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, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Valentine Castaneda<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 May 12, 2015.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2015-0409.
    Petitioner: American Airlines, Inc.
    Section(s) of 14 CFR Affected: 14 CFR part 121.
    Description of Relief Sought: American Airlines, Inc. is seeking
relief from the requirements of 14 CFR 121.311(b), to the extent
required for infants/children traveling on American Airlines to be able
to use an FAA-approved Child Restraint System (CRS) in an obliquely
oriented seat (not forward facing) on Boeing 777 and Boeing 787
aircraft during all phases of flight.

[FR Doc. 2015-11882 Filed 5-15-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: September 22, 2010 (Volume 75, Number 183)]
[Notices]
[Page 57766-57767]
[DOCID:fr22se10-61]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP10-498-000]

Ryckman Creek Resources, LLC; Notice of Petition

September 15, 2010.
    Take notice that on September 3, 2010, Ryckman Creek Resources, LLC
(Petitioner), 3 Riverway, Suite 1110, Houston, Texas 77056, filed in
Docket No. CP10-498-000, a petition for an Exemption of Temporary Acts
and Operations and Request for Expedited Approval, pursuant to Rule
207(a)(5) of the Commission's Rules of Practice and Procedure, 18 CFR
385.207(a)(5) and section 7(c)1(B) of the Natural Gas Act, to perform
specific temporary activities related to drill site preparation and the
drilling of a stratigraphic test well. Specifically, Petitioner
proposes to drill the 9-H Test Well located in Uinta County, WY to
obtain cores in the Gypsum Springs and upper Nugget formations to
verify certain characteristics of the reservoir in order to develop a
proposed underground natural gas storage facility, all as more fully
set forth in the application, which is on file with the Commission and
open to public inspection. The filing may also be viewed on the Web at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Any questions regarding this application should be directed to
Thomas Wynne, Ryckman Creek Resources, LLC, 3 Riverway, Suite 1110,
Houston, TX 77056, telephone no. (713)

974-5600, facsimile no.<PHONE_NUMBER>, and e-mail:
<EMAIL_ADDRESS>    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    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 stated below, 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.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and 14 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: September 29, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-23623 Filed 9-21-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 86 (Thursday, May 4, 2023)]
[Notices]
[Pages 28562-28563]
[FR Doc No: 2023-09401]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2022-N-1894; FDA-2018-N-3303; FDA-2022-N-0576; FDA-
2022-N-1794; FDA-2011-N-0902; FDA-2009-N-0545; FDA-2016-N-2474; FDA-
2010-D-0350; FDA-2012-D-0530; FDA-2016-N-2683; FDA-2013-N-0403; FDA-
2013-N-0134; FDA-2022-N-2440; FDA-2013-N-0879; and FDA-2014-N-1048]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a

list of information collections that have been approved by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of
1995.

FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: The following is a list of FDA information
collections recently approved by OMB under section 3507 of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control
number and expiration date of OMB approval for each information
collection are shown in table 1. Copies of the supporting statements
for the information collections are available on the internet at
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Yale-Mayo Clinic Centers of Excellence         0910-0912       3/31/2024
 in Regulatory Science and Innovation
 B12 Pediatric Device Survey............
Electronic Products Requirements........       0910-0025       2/28/2026
Investigational Device Exemptions.......       0910-0078       2/28/2026
General Drug Labeling Provisions and OTC       0910-0340       2/28/2026
 Monograph Drug User Fee Submissions....
Prescription Drug Product Labeling;            0910-0393       2/28/2026
 Medication Guide Requirements..........
Reporting of Biological Product                0910-0458       2/28/2026
 Deviations and Human Cells, Tissues,
 and Cellular and Tissue-Based Product
 Deviations in Manufacturing............
Designation of New Animal Drugs for            0910-0605       2/28/2026
 Minor Use or Minor Species.............
Tobacco Retailer Training Programs......       0910-0745       2/28/2026
Q-Submission and Early Payor Feedback          0910-0756       2/28/2026
 Request Programs for Medical Devices...
Data To Support Social and Behavioral          0910-0847       2/28/2026
 Research as Used by the Food and Drug
 Administration.........................
Protection of Human Subjects and               0910-0130       3/31/2026
 Institutional Review Boards............
Mammography Standards Quality Act              0910-0309       3/31/2026
 Requirements...........................
Biologics License Applications;                0910-0338       3/31/2026
 Procedures & Requirements..............
Procedures for the Safe Processing and         0910-0354       3/31/2026
 Importing of Fish and Fishery Products.
Medical Device Labeling Regulations;           0910-0485       3/31/2026
 Unique Device Identification...........
------------------------------------------------------------------------

    Dated: April 28, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09401 Filed 5-3-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 140 (Monday, July 22, 2013)]
[Notices]
[Pages 43947-43950]
[FR Doc No: 2013-17471]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-69992; File No. SR-NYSE-2013-51]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Amending Its Price List To Revise the Credits for Certain Designated
Market Maker Transactions and Revise the Annual Trading License Fees

July 16, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on July 3, 2013, New York Stock Exchange LLC (the ``Exchange'' or
``NYSE'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been prepared by the Exchange. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its Price List to revise the credits
for certain Designated Market Maker (``DMM'') transactions and revise
the annual trading license fees. The Exchange proposes to implement the
fee changes effective July 3, 2013. The text of the proposed rule
change is available on the Exchange's Web site at www.nyse.com, at the
principal office of the Exchange, and at the Commission's Public
Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend its Price List to revise the credits
for certain DMM transactions and revise the annual trading license
fees. The Exchange proposes to implement the fee changes effective July
3, 2013.
DMM Rebates \3\
---------------------------------------------------------------------------

    \3\ Rebates are applied when (i) posting displayed and non-
displayed orders on Display Book, including s-quote and s-quote
reserve orders; (ii) when providing liquidity on non-displayed
interest using the Capital Commitment Schedule; or, prior to the
implementation of the Capital Commitment Schedule, using the
following message activities: price improvement, size improvement
(PRIN FILL), matching away market quotes; and (iii) when executing
trades in the crowd and at Liquidity Replenishment Points. Rebates
do not apply to executions at the open. See Price List at n.6.
---------------------------------------------------------------------------

    DMMs are currently eligible for a per share rebate when adding
liquidity in shares of each More Active Security \4\ if the More Active
Security has a stock price of $1.00 or more, the DMM meets both the
More Active Securities Quoting Requirement \5\ and the More Active
Securities Quoted Size Ratio Requirement,\6\ and the DMM's providing
liquidity meets certain thresholds, as follows:
---------------------------------------------------------------------------

    \4\ A ``More Active Security'' is one with an average daily
trading volume in the previous month equal to or greater than one
million shares. See Price List.
    \5\ A DMM meets the ``More Active Securities Quoting
Requirement'' when a More Active Security has a stock price of $1.00
or more and the DMM quotes at the National Best Bid or Offer
(``NBBO'') in the applicable security at least 10% of the time in
the applicable month. See Price List.
    \6\ A DMM meets the ``More Active Securities Quoted Size Ratio
Requirement'' when the DMM Quoted Size for an applicable month is at
least 15% of the NYSE Quoted Size. The ``NYSE Quoted Size'' is
calculated by multiplying the average number of shares quoted on the
NYSE at the NBBO by the percentage of time the NYSE had a quote
posted at the NBBO. The ``DMM Quoted Size'' is calculated by
multiplying the average number of shares of the applicable security
quoted at the NBBO by the DMM by the percentage of time during which
the DMM quoted at the NBBO. See Price List at n.7.
---------------------------------------------------------------------------

     $0.0026 per share if the DMM's providing liquidity is 15%
or less of the NYSE's total intraday adding liquidity in each such
security for that month; \7\
---------------------------------------------------------------------------

    \7\ The NYSE total intraday adding liquidity is totaled monthly
and includes all NYSE adding liquidity, excluding NYSE open and NYSE
close volume, by all NYSE participants, including Supplemental
Liquidity Providers, customers, Floor brokers and DMMs. See Price
List.
---------------------------------------------------------------------------

     $0.0030 per share if the DMM's providing liquidity is more
than 15% but less than or equal to 30% of the NYSE's total intraday
adding liquidity in each such security for that month; and
     $0.0029 per share if the DMM's providing liquidity is more
than 30% of the NYSE's total intraday adding liquidity in each such
security for that month.
    The $0.0029 per share rebate is applicable to all of the member
organization's adding liquidity in each such security for that month,
not just the incremental liquidity that is more than 30% of the NYSE's
total intraday adding liquidity.\8\ The Exchange proposes to eliminate
the third pricing threshold and modify the second pricing threshold so
that a DMM will receive a rebate of $0.0030 per share if the DMM's
providing liquidity is more than 15% of the NYSE's total intraday
adding liquidity in each such security for that month. The $0.0030 per
share rebate is applicable to all of the member organization's adding
liquidity in each such security for that month, not just the
incremental liquidity that is more than 15% of the NYSE's total
intraday adding liquidity. For example, if a DMM meets both the More
Active Securities Quoting Requirement and the More Active Securities
Quoted Size Ratio Requirement, and the DMM's providing liquidity is 1.6
million shares in a security with NYSE total intraday adding liquidity
of 10 million shares, then the DMM will be eligible for a rebate of
$0.0030 per share for all 1.6 million shares. Otherwise, the DMM will
receive a per share rebate of $0.0026.
---------------------------------------------------------------------------

    \8\ See Exchange Act Release No. 68021 (Oct. 9, 2012), 77 FR
63406, 63407 n.9 (Oct. 16, 2012) (SR-NYSE-2012-50).
---------------------------------------------------------------------------

Trading Licenses
    Currently, the Exchange charges an annual fee of $40,000 per
license for the first two trading licenses held by a member
organization and $25,000 per license for each additional trading
license held by a member organization. The fee for trading licenses
issued after January 1, 2013 is prorated for the portion of the year
during which the trading license will be outstanding. If a trading
license is in place for 15 or fewer calendar days in a calendar month,
proration for that month is at a flat rate of $100 per day with no tier
pricing involved.\9\ If a trading license is in place for 16 or more
calendar days in a calendar month, proration for that month is computed
based on the number of days as applied to the applicable annual fee for
the license.\10\
---------------------------------------------------------------------------

    \9\ See Price List at n.16.
    \10\ Id.
---------------------------------------------------------------------------

    The Exchange proposes to amend its trading license fees for
additional trading licenses issued to a member organization between
July 1, 2013 and December 31, 2013. If a member organization is issued
additional trading licenses between July 1, 2013 and December 31, 2013,
and the total number of trading licenses held by the member
organization between July 1, 2013 and December 31, 2013 is greater than
the total number of trading licenses held by the member organization on
July 1, 2013, then the member organization will not be charged a
prorated fee for the period from July 3, 2013 to December 31, 2013 for
those additional trading licenses above the number the member
organization held on July 1, 2013. For example, if a member
organization holds 30 trading licenses on July 1, 2013 and between July
3, 2013 and December 31, 2013, the member organization holds 33 trading
licenses, the member organization will not be charged a prorated fee
for those three additional trading licenses. For a firm that becomes a
member organization after July 1, 2013, the firm will be assigned a
baseline of one trading license and charged a prorated fee for that
license for the remainder of 2013; any trading licenses in addition to
the first trading license will not be charged a prorated fee for the
period from July 3, 2013 to December 31, 2013.
    If a member organization merges with another member organization on
or after July 1, 2013, the total combined number of trading licenses
held by each member organization on July 1, 2013 will be considered the
baseline number of trading licenses for the successor member
organization. For example, if Firm A holds five trading licenses on
July 1, 2013 and Firm B holds eight trading licenses on July 1, 2013,
and Firm B acquires Firm A on August 1, 2013, then Firm B, as the
successor member organization, will have a baseline of 13 trading
licenses as of August 1, 2013.
    The Exchange also proposes to correct a typographical error in
footnote 15 of the Pricing List, which relates to a credit for floor
broker licenses. The footnote should refer to November and December
2012, not November and December 2013.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\11\ in general, and furthers the
objectives of Sections 6(b)(4) and 6(b)(5) of the Act,\12\ in
particular, because it provides for the equitable allocation of
reasonable dues, fees, and other charges among its

members, issuers and other persons using its facilities and does not
unfairly discriminate between customers, issuers, brokers or dealers.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f(b).
    \12\ 15 U.S.C. 78f(b)(4) and (5).
---------------------------------------------------------------------------

    The Exchange believes that with respect to the DMM rebate for
providing liquidity, eliminating the third pricing threshold and
modifying the second pricing threshold is reasonable because the
Exchange believes the rebate for the third pricing threshold did not
incent DMMs to reach that level of providing liquidity as intended.\13\
The Exchange believes that the remaining two pricing thresholds, as
modified, are at a level that will encourage greater liquidity and
competition in actively traded securities on the Exchange. The Exchange
believes that the proposed change is equitable and not unfairly
discriminatory because all DMMs will be eligible for the higher rebate.
The Exchange believes it is equitable and not unfairly discriminatory
to allocate a higher rebate to DMMs than other member organizations
because DMMs have higher quoting obligations, and in turn provide
higher volumes of liquidity, which contributes to price discovery and
benefits all market participants.
---------------------------------------------------------------------------

    \13\ See supra note 8.
---------------------------------------------------------------------------

    The Exchange believes it is reasonable to offer a temporary
reduction in the prorated fees for annual trading licenses because it
will encourage member organizations to hold additional trading
licenses, which will increase the number of market participants trading
on the floor of the Exchange, which will promote liquidity, price
discovery, and the opportunity for price improvement for the benefit of
all market participants. The Exchange also believes it is reasonable to
offer a temporary fee reduction because it will provide member
organizations with greater flexibility in managing their personnel,
especially in summer months when member organizations tend to
experience greater staff rotation. The Exchange further believes that
the July 1 date selected by the Exchange as a baseline for calculating
additional licenses is reasonable because it is the day before the
effective date of the fee change. The Exchange believes the proposed
change is equitable and not unfairly discriminatory because all member
organizations will be able to take advantage of the temporary fee
reduction.
    The Exchange believes that it is reasonable to assign new member
organizations a baseline of one trading license because this will
incent firms to become Exchange member organizations, thereby
encouraging trading activity on the Exchange, which benefits all market
participants. The Exchange believes that the proposed change is
equitable and not unfairly discriminatory because the discount is
temporary and firms that become member organizations in the latter half
of 2013 will be subject to the same trading license fees as other
member organizations beginning in 2014.
    The Exchange believes that, in the case of a merger of member
organizations, it is reasonable to assign the successor member
organization a baseline of the combined number of trading licenses held
by each member organization on July 1, 2013, effective as of the date
of the merger, so that the successor member organization's baseline
reflects the combined operations. The Exchange believes that the
alternative--i.e., counting only the number of trading licenses held by
the successor member organization on July 1, 2013 prior to the merger--
would give such member organization an unfair advantage over a member
organization that had not undergone a business combination, in that the
successor member organization would not have to pay additional fees for
the trading licenses gained through the merger for the remainder of the
year. The Exchange notes that trading licenses effectively acquired
through a merger would not increase the total number of trading
licenses on the Exchange, and therefore would not necessarily
contribute additional trading activity. Moreover, the successor member
organization will be free to eliminate any trading licenses not needed
after the merger. Therefore, the Exchange believes its proposed
approach to merging member organizations is equitable and not unfairly
discriminatory.
    The Exchange believes that correcting the typographical error in
the Price List will add greater clarity for member organizations in
understanding the annual trading license fees.
    Finally, the Exchange believes that it is subject to significant
competitive forces in setting its fees and credits, as described below
in the Exchange's statement regarding the burden on competition. For
these reasons, the Exchange believes that the proposal is consistent
with the Act.

B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,\14\ the Exchange
does not believe that the proposed rule change will impose any burden
on competition that is not necessary or appropriate in furtherance of
the purposes of the Act.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78f(b)(8).
---------------------------------------------------------------------------

    Specifically, the Exchange believes the revised pricing tiers for
DMMs reflect the need for the Exchange to adjust financial incentives
to attract order flow. In addition, the modification to the annual
trading license fees will help to remove a burden on competition by
making it easier for member organizations to appropriately staff the
Floor, which is a key feature of the Exchange's structure for offering
a fair and orderly market and competing with other exchanges. It will
also make it more economical to become a member organization in the
remainder of 2013. In addition, the Exchange does not believe the
proposed approach to merging member organizations will burden
competition because it is designed to avoid any unfair advantage a
successor member organization could have in the absence of resetting
the baseline of licenses under the proposed fee structure.
    The Exchange notes that it operates in a highly competitive market
in which market participants can readily favor competing venues if they
deem fee levels at a particular venue to be excessive or rebate
opportunities available at other venues to be more favorable. In such
an environment, the Exchange must continually adjust its fees and
rebates to remain competitive with other exchanges and with alternative
trading systems that have been exempted from compliance with the
statutory standards applicable to exchanges. Because competitors are
free to modify their own fees and credits in response, and because
market participants may readily adjust their trading practices, the
Exchange believes that the degree to which fee or rebate changes in
this market may impose any burden on competition is extremely limited.
As a result of all of these considerations, the Exchange does not
believe that the proposed changes will impair the ability of member
organizations or competing order execution venues to maintain their
competitive standing in the financial markets.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \15\ of the Act and subparagraph (f)(2) of Rule
19b-4 \16\ thereunder, because it establishes a due, fee, or other
charge imposed by the Exchange.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings under
Section 19(b)(2)(B) \17\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
---------------------------------------------------------------------------

    \17\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2013-51 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSE-2013-51. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2013-51 and should be
submitted on or before August 12, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\18\
---------------------------------------------------------------------------

    \18\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-17471 Filed 7-19-13; 8:45 am]
BILLING CODE 8011-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

	    Issued by the Department of Transportation on October 1, 2002

NOTICE OF ACTION TAKEN -- DOCKETS OST-2002-13426 & OST-2002-13461

________________________________________________________________________
________________________________________________________

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:  Volga-Dnepr J.S. Cargo Airline

Relief requested:  Exemptions pursuant to 49 U.S.C. section 40109(g) to
operate the following cargo charter flights using its AN-124 aircraft:
(a) one one-way flight from Philadelphia, PA, to Moffet Field, CA, to
transport outsized cargo consisting of a Rainbow Satellite payload and
associated equipment on/about September 28, 2002,  on behalf of Lockheed
Martin Commercial Space Systems (Docket OST-2002-13425, filed September
23, 2002);  and (b) three one-way flights from Denver, CO, to Cape
Canaveral/Skid Strip, FL, October 3-10, 2002, to transport outsized
cargo consisting of a Centaur III upper stage payload, an Atlas and
Centaur launch vehicle payload, and an Atlas V booster payload, on
behalf of Lockheed Martin Astronautics (Docket OST-2002-13461, filed
September 26, 2002).  The applicant stated that Lockheed Martin needed
urgent delivery of the equipment in order to meet a schedule that
requires final assembly of the Rainbow Satellite payload and subsequent
shipment to Cape Canaveral for scheduled initial launch capability and
in order to complete mission integration activities involving the other
equipment and subsequent launch processing.  It also stated that the
cargo is too large for transportation on U.S. carrier aircraft, and that
surface transportation was not feasible because of the time involved,
the delicate nature and high value of the cargo, and conditions
unsuitable to maintaining system integrity compliance.

Applicant representative:  Glenn Wicks<PHONE_NUMBER>

Responsive pleadings:  Volga Dnepr served its applications on those U.S.
carriers operating large all-cargo aircraft.  Each carrier indicated
that it did not have aircraft available to conduct the proposed
operations and that it had no comment or did not oppose grant of the
requested authority to Volga-Dnepr.

Statutory Standards:  Under 49 U.S.C. section 40109(g), we may authorize
a foreign air carrier to carry commercial traffic between U.S. points
(i.e., cabotage traffic) under limited circumstances.  Specifically, we
must find that the authority is required in the public interest; that
because of an emergency created by unusual circumstances not arising in
the normal course of business the traffic cannot be accommodated by U.S.
carriers holding certificates under 49 U.S.C. section 41102; that all
possible efforts have been made to place the traffic on U.S. carriers;
and that the transportation is necessary to avoid unreasonable hardship
to the traffic involved (an additional required finding, concerning
emergency transportation during labor disputes, was not relevant here).
For examples of earlier grants of authority of this type, see, e.g.,
Order 2001-5-23.

	DISPOSITION

Action:  Approved								Action date:  October 1, 2002

Effective dates of authority granted:  October 1-13, 2002

Basis for approval:  We found that the applications met all the relevant
criteria of 49 U.S.C. section 40109(g) for the grant of an exemption of
this type and that the grant was required in the public interest.
Specifically, we were persuaded that the need to move the cargo promptly
in order to complete scheduled assembly and mission integration
activities and subsequent launch deadlines; the fact that the cargo
could not be transported by surface either in time to meet that schedule
or without the risk of damage; the potential negative impact of delivery
delays; and the unique, outsized nature of the cargo, constituted an
emergency not arising in the normal course of business.  Moreover, based
on the

Page 2  -  Dockets OST-2002-13426 & OST-2002-13461

representations of the U.S. carriers, we concluded that no U.S. carrier
had aircraft available which could be used to conduct the operations at
issue here.  We also found that grant of Volga-Dnepr’s requests would
prevent undue hardship to the cargo and Lockheed Martin.  Finally, we
found that the applicant was qualified to perform its proposed
operations (see, e.g., Order 94-10-13).

Except to the extent exempted/waived, this authority is subject to our
standard exemption conditions (attached) and to the condition that
Volga-Dnepr comply with an FAA-approved flight routing for the
authorized flights.

Action taken by:   	Read C. Van de Water

			Assistant Secretary for Aviation

			   and International Affairs

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

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

												        Appendix A

FOREIGN AIR CARRIER CONDITIONS OF AUTHORITY

In the conduct of the operations authorized, the holder 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;

(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 (formerly the
Federal Aviation Act of 1958, as amended).

U.S. Department of Transportation

Office of the Secretary of Transportation									        (41301/40109)
7/2002

  The applicant subsequently advised us informally that this flight had
been delayed until on/about October 3, 2002.