[Federal Register Volume 78, Number 28 (Monday, February 11, 2013)]
[Notices]
[Page 9717]
[FR Doc No: 2013-03002]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4091-DR; Docket ID FEMA-2012-0002]

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

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Maryland (FEMA-4091-DR), dated November 20, 2012, and
related determinations.

DATES: Effective Date: December 17, 2012.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Maryland is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of November 20, 2012.

    Carroll and Montgomery Counties for Public Assistance, including
direct federal assistance.

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

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2013-03002 Filed 2-8-13; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 76, Number 224 (Monday, November 21, 2011)]
[Notices]
[Page 71991]
[FR Doc No: 2011-29948]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2011-0033; OMB No. 1660-0024]

Agency Information Collection Activities: Proposed Collection;
Comment Request, Federal Assistance for Offsite Radiological Emergency
Planning

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a revision of a currently approved collection. In
accordance with the Paperwork Reduction Act of 1995, this notice seeks
comments concerning the Federal Emergency Management Agency's request
for information from the licensee of a nuclear power plant that is
needed in order form a decision as to whether or not a condition of
``decline or fail'' exists at the State and local government level in
the preparation of emergency planning responses.

DATES: Comments must be submitted on or before January 20, 2012.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at http://www.regulations.gov under
Docket ID FEMA-2011-0033. Follow the instructions for submitting
comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street, SW., Room 835, Washington, DC
20472-3100.
    (3) Facsimile. Submit comments to<PHONE_NUMBER>.
    (4) Email. Submit comments to<EMAIL_ADDRESS>Include Docket
ID FEMA-2011-0033 in the subject line.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Deborah J. Mauldin, Policy Specialist,
Technological Hazards Division, Radiological Emergency Preparedness
Branch, at<PHONE_NUMBER> for additional information. You may contact
the Records Management Division for copies of the proposed collection
of information at facsimile number<PHONE_NUMBER> or email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Executive Order 12657, dated November 18,
1988, charged the Federal Emergency Management Agency (FEMA) and other
Federal agencies with emergency planning response in cases where State
and local governments have declined or failed to prepare emergency
plans. To implement Executive Order 12657, FEMA worked with the Nuclear
Regulatory Commission (NRC) and other Federal agencies on the Federal
Radiological Preparedness Coordinating Committee to develop 44 CFR part
352, Commercial Nuclear Power Plants: Emergency Preparedness Planning.
This regulation establishes policies and procedures for a licensee
submission of a certification of ``decline or fail'', and for FEMA
determination concerning Federal assistance to the licensee; and also
establishes policies and procedures for providing Federal support for
offsite planning and preparedness.

Collection of Information

    Title: Federal Assistance for Offsite Radiological Emergency
Planning.
    Type of Information Collection: Revision of a currently approved
collection.
    OMB Number: 1660-0024.
    FEMA Forms: No form.
    Abstract: This collection of information establishes policies and
procedures for submission by a commercial nuclear power plant licensee
of a certification for Federal assistance under Executive Order 12657.
It contains policies and procedures for FEMA's determinations, with
respect to a certification. It also establishes a framework for
providing Federal assistance to licensees, and procedures for review
and evaluation of the adequacy of licensee offsite radiological
emergency planning and preparedness.
    Affected Public: Business and other for profits.
    Number of Respondents: 1.
    Number of Responses: 1.
    Estimated Total Annual Burden Hours: 40.
    Estimated Cost: There are no annual record keeping, capital,
startup, nor maintenance costs associated with this information
collection.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) Evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

Gary L. Anderson,
Acting Chief Administrative Officer, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2011-29948 Filed 11-18-11; 8:45 am]
BILLING CODE 9110-21-P


[Federal Register Volume 83, Number 114 (Wednesday, June 13, 2018)]
[Notices]
[Page 27624]
[FR Doc No: 2018-12638]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4361-DR; Docket ID FEMA-2018-0001]

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

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the Commonwealth of Kentucky (FEMA-4361-DR), dated April 26, 2018,
and related determinations.

DATE: This amendment was issued May 25, 2018.

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

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the Commonwealth of Kentucky is hereby amended to include the
following area among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of April 26, 2018.

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

Brock Long,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2018-12638 Filed 6-12-18; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 51 (Friday, March 15, 2019)]
[Notices]
[Page 9513]
[FR Doc No: 2019-04841]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Number: PR19-48-000.
    Applicants: Kinder Morgan Keystone Gas Storage LLC.
    Description: Tariff filing per 284.123(b), (e)+(g): Operating
Statement Update (Payments and Loaning Overrun Rate) to be effective 5/
6/2019.
    Filed Date: 3/6/19.
    Accession Number:<PHONE_NUMBER>92.
    Comments Due: 5 p.m. ET 3/27/19.
    284.123(g) Protests Due: 5 p.m. ET 5/6/19.

    Docket Number: PR19-49-000.
    Applicants: Columbia Gas of Ohio, Inc.
    Description: Tariff filing per 284.123(b), (e)/: COH Rates
effective March 1 2019 to be effective 3/1/2019.
    Filed Date: 3/7/19.
    Accession Number:<PHONE_NUMBER>59.
    Comments/Protests Due: 5 p.m. ET 3/28/19.

    Docket Number: PR19-50-000.
    Applicants: Banquete Hub LLC.
    Description: Tariff filing per 284.123(b), (e)/: Revised Compliance
Filing SOC for Banquete Hub LLC to be effective 9/19/2018.
    Filed Date: 3/7/19.
    Accession Number:<PHONE_NUMBER>78.
    Comments/Protests Due: 5 p.m. ET 3/28/19.

    Docket Numbers: RP18-536-001.
    Applicants: American Midstream (Midla), LLC.
    Description: Report Filing: Annual Unaccounted for Gas Retention
Percentage Filing.
    Filed Date: 3/1/19.
    Accession Number: 20190301-5022.
    Comments Due: 5 p.m. ET 3/15/19.

    Docket Numbers: RP19-813-000.
    Applicants: Midcontinent Express Pipeline LLC.
    Description: Compliance filing Annual Report of Operational
Purchases and Sales 2019.
    Filed Date: 3/7/19.
    Accession Number: 20190307-5030.
    Comments Due: 5 p.m. ET 3/19/19.

    Docket Numbers: RP19-814-000.
    Applicants: Millennium Pipeline Company, LLC.
    Description: Sec.  4(d) Rate Filing: Negotiated Rate Svc Agmts--ESU
to be effective 3/11/2019.
    Filed Date: 3/7/19.
    Accession Number: 20190307-5123.
    Comments Due: 5 p.m. ET 3/19/19.

    Docket Numbers: RP19-815-000.
    Applicants: Nautilus Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Nautilus--Processing tariff
changes to be effective 4/8/2019.
    Filed Date: 3/8/19.
    Accession Number: 20190308-5064.
    Comments Due: 5 p.m. ET 3/20/19.

    Docket Numbers: RP19-816-000.
    Applicants: Portland Natural Gas Transmission System.
    Description: Sec.  4(d) Rate Filing: Bay State Neg Rate Amendment
to be effective 3/10/2019.
    Filed Date: 3/8/19.
    Accession Number: 20190308-5178.
    Comments Due: 5 p.m. ET 3/20/19.

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

    Dated: March 11, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-04841 Filed 3-14-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2659-2660]
[FR Doc No: 2019-01493]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Release From Federal Surplus Property and Grant
Assurance Obligations at Lost Hills Airport, Lost Hills, California

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice of request to release airport land and permanently close
airport.

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SUMMARY: The Federal Aviation Administration (FAA) proposes to rule and
invites public comment for the release of approximately 336 acres of
airport property at the Lost Hills Airport (Airport) in Lost Hills,
California from all conditions contained in the Surplus Property Deed
and Grant Assurances because the Airport land is not needed for airport
purposes. The land requested to be released is located at the northeast
corner of State Route 46 and Lost Hills Road in Lost Hills California.
The subject land is adjacent to offsite agricultural uses, sewage
treatment ponds and residential and commercial development. On the west
side of the Airport there is a small industrial lease area and one
water well. Whereas, on the southwest portion of the Airport there is a
soccer complex, County public park and fire station. The Airport land
will be sold via County public auction at Fair Market Value (FMV) for
either its existing use as industrial/public facility or conversion to
agricultural use. The County public park and fire station currently
located on Airport land will be sold at its FMV for continued
uninterrupted use. The proceeds from the sale of airport land will be
reinvested into Meadows Field and Kern Valley airports, therefore
benefitting general aviation. Unamortized Airport Improvement Program
Grant funds in the amount of $426,289 will be reinvested into general
aviation grant projects at either Meadows Field Airport or Kern Valley
Airport, both located in Kern County, California.

DATES: Comments must be received on or before March 11, 2019.

FOR FURTHER INFORMATION CONTACT: Comments on the request must be mailed
or delivered to the FAA at the following address: George Aiken, Federal
Aviation Administration, Office of Airports, Western-Pacific Region,
AWP-610.1, Federal Register Comment, 777 S Aviation Boulevard, Suite
150, El Segundo, CA 90245. Phone:<PHONE_NUMBER>. Additionally, one
copy of the comment submitted to the FAA must be mailed or delivered to
Mark Witsoe, Director of Airports, County of Kern, 3701 Wings Way,
Bakersfield, CA 93308.

SUPPLEMENTARY INFORMATION: In accordance with the Wendell H. Ford
Aviation Investment and Reform Act for the 21st Century (AIR 21),
Public Law 106-181 (Apr. 5, 2000; 114 Stat. 61), this notice must be
published in the Federal Register 30 days before the Secretary may
waive any condition imposed on a federally obligated airport by surplus
property conveyance deeds or grant agreements.

The Following Is a Brief Overview of the Request

    The County of Kern, Department of Airports, requested a release
from Federal surplus property and grant assurance obligations for
approximately 336 acres of airport land, at Lost Hills Airport (L84),
to allow for its permanent closure and sale and reinvestment into
Meadows Field and Kern Valley Airports. The property was originally
acquired pursuant to the Surplus Property Act of 1944 and was deeded to
the County of Kern on October 25, 1948. The property is located in the
rural community of Lost Hills, in Kern County, California,
approximately 46 miles northwest of downtown Bakersfield. The Airport
land is not needed for airport purposes, has zero based aircraft and no
aviation services are currently available.
    The Airport land area includes an industrial lease area, soccer
complex, County public park and fire station. The soccer complex lease
has been terminated and will be sold as part of the airport land
auction. The County park and fire station will be released separately
based on Fair Market Value to the County for continued public use.
Basic utilities are available in the area for future capital
improvements, however, there are no irrigation water rights with the
property for agricultural use.
    The County of Kern will sell the land at fair market value. The
sales proceeds will provide general aviation improvements at Meadows
Field and Kern Valley airports, thereby serving the interests of
general aviation.

    Issued in El Segundo, California, on January 30, 2019.
Brian Q. Armstrong,
Manager, Safety and Standards Branch, Office of Airports, Western-
Pacific Region.
[FR Doc. 2019-01493 Filed 2-6-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: September 4, 2009 (Volume 74, Number 171)]
[Notices]
[Page 45851-45852]
[DOCID:fr04se09-55]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8953-5]

Proposed Settlement Agreement

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of proposed settlement agreement; request for public
comment.

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SUMMARY: In accordance with section 113(g) of the Clean Air Act, as
amended (``Act''), 42 U.S.C. 7413(g), notice is hereby given of a
proposed settlement agreement to address a lawsuit filed by Colorado
Citizens Against ToxicWaste and Rocky Mountain Clean Air Action
(collectively ``Plaintiffs'') in the United States District Court for
the District of Colorado: Colorado Citizens Against ToxicWaste et al.
v. Jackson, No. 08-cv-1787 (D. Colo). On or about August 21, 2008,
Plaintiffs filed a Complaint alleging that EPA failed to perform a non-
discretionary duty to review, and if appropriate revise, 40 CFR Part
61, Subpart W, National Emission Standards for Radon Emissions from
Operating Mill Tailings, to comply with the requirements of CAA section
112(d). Under the terms of the proposed settlement agreement,
Plaintiffs shall file a motion for voluntary dismissal of the
Complaint, with prejudice, within 10 business days after publication in
the Federal Register of either: EPA's issuance of a final determination
not to revise Subpart W; or EPA's promulgation of a final revision of
Subpart W.

DATES: Written comments on the proposed settlement agreement must be
received by October 5, 2009.

ADDRESSES: Submit your comments, identified by Docket ID number EPA-HQ-
OGC-2009-0679, online at http://www.regulations.gov (EPA's preferred
method); by e-mail to<EMAIL_ADDRESS>by mail to EPA Docket Center,
Environmental Protection Agency, Mailcode: 2822T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; or by hand delivery or courier to
EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC, between 8:30 a.m. and 4:30 p.m. Monday through Friday,
excluding legal holidays. Comments on a disk or CD-ROM should be
formatted in Word or ASCII file, avoiding the use of special characters
and any form of encryption, and may be mailed to the mailing address
above.

FOR FURTHER INFORMATION CONTACT: Susan Stahle, Air and Radiation Law
Office (2344A), Office of General Counsel, U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone:<PHONE_NUMBER>; fax number<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Additional Information About the Proposed Settlement Agreement

    This proposed settlement agreement would settle a deadline suit
filed by Plaintiffs for EPA's failure to review, and if appropriate
revise, 40 CFR Part 61, Subpart W, National Emission Standards for
Radon Emissions from Operating Mill Tailings, to comply with the
requirements of CAA section 112(d). Under the terms of the proposed
settlement agreement, within 10 business days after Plaintiffs and EPA
have signed this agreement, the Parties shall file a joint motion with
the Court notifying it of this agreement and request that this case be
stayed pending completion of the process under section 113(g) of the
CAA as set forth in Paragraph 12 of this agreement. Within 10 business
days of the date this agreement becomes final, Plaintiffs shall file a
motion to administratively close this case. If EPA signs and submits
for publication in the Federal Register EPA's promulgation of either
(1) EPA's issuance of a final determination not to revise Subpart W or
(2) EPA's promulgation of a final revision of Subpart W, Plaintiffs
shall file a motion for voluntary dismissal of the Complaint, with
prejudice, pursuant to Fed. R. Civ. P. 41(a), within 10 business days
of such publication. Paragraph 3 contains additional steps that EPA
will complete under the agreement.
    For a period of thirty (30) days following the date of publication
of this notice, the Agency will accept written comments relating to the
proposed settlement agreement from persons who were not named as
parties or intervenors to the litigation in question. EPA or the
Department of Justice may withdraw or withhold consent to the proposed
settlement agreement if the comments disclose facts or considerations
that indicate that such consent is inappropriate, improper, inadequate,
or inconsistent with the requirements of the Act. Unless EPA or the
Department of Justice determines, based on any comment submitted, that
consent to this settlement agreement should be withdrawn, the terms of
the agreement will be affirmed.

II. Additional Information About Commenting on the Proposed Settlement
Agreement

A. How Can I Get a Copy of the Settlement Agreement?

    The official public docket for this action (identified by Docket ID
No. EPA-HQ-OGC-2009-0679) contains a copy of the proposed settlement
agreement. The official public docket is available for public viewing
at the Office of Environmental Information (OEI) Docket in the EPA
Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW.,
Washington, DC. The EPA Docket Center Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OEI Docket is (202) 566-
1752.
    An electronic version of the public docket is available through
http://www.regulations.gov. You may use http://www.regulations.gov 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. Once in the
system, select ``search,'' then key in the appropriate docket
identification number.

    It is important to note that EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing online at http://www.regulations.gov without change,
unless the comment contains copyrighted material, CBI, or other
information whose disclosure is restricted by statute. Information
claimed as CBI and other information whose disclosure is restricted by
statute is not included in the official public docket or in the
electronic public docket. EPA's policy is that copyrighted material,
including copyrighted material contained in a public comment, will not
be placed in EPA's electronic public docket but will be available only
in printed, paper form in the official public docket. Although not all
docket materials may be available electronically, you may still access
any of the publicly available docket materials through the EPA Docket
Center.

B. How and to Whom Do I Submit Comments?

    You may submit comments as provided in the ADDRESSES section.
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 submit an electronic comment, EPA recommends that you
include your name, mailing address, and an e-mail address or other
contact information in the body of your comment and with any disk or
CD-ROM you submit. 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. 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.
    Use of the http://www.regulations.gov Web site to submit comments
to EPA electronically is EPA's preferred method for receiving comments.
The electronic public docket 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.
In contrast to EPA's electronic public docket, EPA's electronic mail
(e-mail) system is not an ``anonymous access'' system. If you send an
e-mail comment directly to the Docket without going through http://
www.regulations.gov, your e-mail address is automatically captured and
included as part of the comment that is placed in the official public
docket, and made available in EPA's electronic public docket.

    Dated: September 1, 2009.
Richard B. Ossias,
Associate General Counsel.
[FR Doc. E9-21400 Filed 9-3-09; 8:45 am]

BILLING CODE 6560-50-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on April 21, 2006

NOTICE OF ACTION TAKEN -- DOCKET OST-1998-4031

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).

Application of ATLAS AIR, INC. (Atlas) filed 3/10/06 for:

XX	Renewal of exemption for two years under 49 U.S.C. 40109 to provide
the following service:

Scheduled foreign air transportation of property and mail between points
in the United States and Prestwick/Glasgow, Scotland and to integrate
this authority with its existing certificate and exemption authority.

Applicant rep: Russell Pommer<PHONE_NUMBER>			DOT Analyst: Tretha
Chromey<PHONE_NUMBER>

D I S P O S I T I O N

XX	Granted, in part (subject to conditions, see below)

XX	Dismissed, in part (request for route integration authority)

The above action was effective when taken: April 21, 2006 through April
21, 2008.

Action taken by:	Paul L. Gretch, Director

Office of International Aviation

XX	The authority granted is consistent with the aviation agreement
between the United States and the United Kingdom.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:	XX Holder’s
certificates of public convenience and necessity

XX Standard exemption conditions (attached)

On the basis of data officially noticeable under Rule 24(g) of the
Department’s regulations, we found the applicant qualified to provide
the services authorized.

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

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

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

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

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

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

(6)  Comply with all applicable requirements of the Federal Aviation
Administration and with all applicable U.S. Government requirements
concerning security, including, but not limited to, 49 CFR Part 1544.
To assure compliance with all applicable U.S. Government requirements
concerning security, the holder shall, before commencing any new service
(including charter flights) to or from a foreign airport, contact its
International Principal Security Inspector (IPSI) to advise the IPSI of
its plans and to find out whether the Transportation Security
Administration has determined that security is adequate to allow such
airport(s) to be served; and

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

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

05/2004

 The carrier’s request for route integration authority has been
superseded by Order 2006-1-1, where the Department awarded the carrier a
blanket route integration certificate.


Conference Call with DuPont for Docket

December 20, 2005

On Tuesday December 20, 2005, Environmental Protection Agency (EPA) had
a conference call with Joseph Peterpaul of DuPont from 2:00 pm to 3:00
pm. The purpose of the call was to learn about DuPont’s practices for
recycling secondary materials they produce and auditing waste and
recycling facilities. This information will be used to facilitate an
analysis of overall good hazardous waste recycling practices for a DSW
rulemaking. The call focused on what information DuPont examines in a
waste or recycling audit, such as the facility’s processing
capacities, its compliance history, the history of the site, and the
company’s financial profile; the reasons why DuPont performs audits;
tracking procedures; and the general workings of “sourcing”
agreements between DuPont and recyclers that accept secondary materials,
reclaim them, and send them back to DuPont to be used again.

Kathy Blanton	Environmental Protection Agency

Joseph Peterpaul	DuPont


[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Notices]
[Pages 1342-1343]
[FR Doc No: 2016-31998]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-4461]

Draft Guidance for Industry: Study Design Recommendations for
Residue Studies in Honey for Establishing Maximum Residue Limits and
Withdrawal Periods; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry (GFI) #243 entitled
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary
Drugs in Food-Producing Species: Study Design Recommendations for
Residue Studies in Honey for Establishing MRLs and Withdrawal Periods''
(VICH GL56). This guidance has been developed for veterinary use by the
International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products (VICH). This VICH
guidance document is intended to provide study design recommendations
which will facilitate the universal acceptance of the generated residue
depletion data to fulfill the national/regional requirements in order
to establish appropriate Maximum Residue Limits (MRLs) or other safe
limits in honey following the treatment of honeybees with veterinary
drug products, or to justify withdrawal periods in honey for
registration purposes when an MRL already exists. Use of veterinary
drug products in honeybee production is considered as a minor use in
minor species in most jurisdictions.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 6, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-D-4461 for ``Studies to Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in Food-Producing Species: Study Design
Recommendations for Residue Studies in Honey for Establishing MRLs and
Withdrawal Periods'' (VICH GL56). Received comments will be placed in
the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Julia Oriani, Center for Veterinary
Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft GFI #243 entitled
``Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary
Drugs in Food-Producing Species: Study Design Recommendations for
Residue Studies in Honey for Establishing MRLs and Withdrawal Periods''
(VICH GL56). In recent years, many important initiatives have been
undertaken by regulatory authorities and industry associations to
promote the international harmonization of regulatory

requirements. FDA has participated in efforts to enhance harmonization
and has expressed its commitment to seek scientifically based,
harmonized technical procedures for the development of pharmaceutical
products. One of the goals of harmonization is to identify, and then
reduce, differences in technical requirements for drug development
among regulatory agencies in different countries.
    FDA has actively participated in the International Council for
Harmonisation of Technical Requirements for Pharmaceuticals for Human
Use for several years to develop harmonized technical requirements for
the approval of human pharmaceutical and biological products among the
European Union, Japan, and the United States. The VICH is a parallel
initiative for veterinary medicinal products. The VICH is concerned
with developing harmonized technical requirements for the approval of
veterinary medicinal products in the European Union, Japan, and the
United States, and includes input from both regulatory and industry
representatives.
    The VICH Steering Committee is composed of member representatives
from the European Commission and European Medicines Agency,
International Federation for Animal Health--Europe, FDA, the U.S.
Department of Agriculture, the U.S. Animal Health Institute, the
Japanese Ministry of Agriculture, Forestry, and Fisheries, and the
Japanese Veterinary Products Association.
    Six observers are eligible to participate in the VICH Steering
Committee: One representative from the government of Australia/New
Zealand, one representative from the industry in Australia/New Zealand,
one representative from the government of Canada, one representative
from the industry of Canada, one representative from the government of
South Africa, and one representative from the industry of South Africa.
The VICH Secretariat, which coordinates the preparation of
documentation, is provided by the International Federation for Animal
Health.

II. Draft Guidance on Studies To Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in Food-Producing Species: Study Design
Recommendations for Residue Studies in Honey for Establishing MRLs and
Withdrawal Periods

    The VICH Steering Committee held a meeting in June 2016 and agreed
that the draft guidance document entitled ``Studies to Evaluate the
Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing
Species: Study Design Recommendations for Residue Studies in Honey for
Establishing MRLs and Withdrawal Periods'' (VICH GL56) should be made
available for public comment. This draft VICH guidance document is
intended to provide study design recommendations which will facilitate
the universal acceptance of the generated residue depletion data to
fulfill the national/regional requirements in order to establish
appropriate MRLs or other safe limits in honey following the treatment
of honeybees with veterinary drug products, or to justify withdrawal
periods in honey for registration purposes when an MRL already exists.
Use of veterinary drug products in honeybee production is considered as
a minor use in minor species in most jurisdictions.
    FDA and the VICH Expert Working Group will consider comments about
the draft guidance document.

III. Significance of Guidance

    This level 1 draft guidance, developed under the VICH process, has
been revised to conform to FDA's good guidance practices regulation (21
CFR 10.115). For example, the document has been designated ``guidance''
rather than ``guideline.'' In addition, guidance documents do not
include mandatory language such as ``shall,'' ``must,'' ``require,'' or
``requirement,'' unless FDA is using these words to describe a
statutory or regulatory requirement.
    The draft guidance, when finalized, will represent the current
thinking of FDA on this topic. It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Action of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 514 have been approved under
OMB control number 0910-0032.

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: December 30, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31998 Filed 1-4-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)]
[Notices]
[Pages 45942-45944]
[FR Doc No: 2018-19674]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0286]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for
Industry: Formal Meetings Between the Food and Drug Administration and
Biosimilar Biological Product Sponsors or Applicants

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that a proposed collection of information has been submitted to the
Office of Management and Budget (OMB) for review and clearance under
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by October
11, 2018.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0802.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
    Guidance for Industry: Formal Meetings between the Food and Drug
Administration and Biosimilar Biological Product Sponsors or
Applicants.
    OMB Control No. 0910-0802--Extension.

    This information collection supports the above captioned Agency
guidance. The Biologics Price Competition and Innovation Act of 2009,
the Biosimilar User Fee Act of 2012, and the recent passage of the
Biosimilar User Fee Amendments of 2017 (BsUFA II) under Title IV of the
FDA Reauthorization Act of 2017, authorize user fees for biosimilar
biological products. FDA has committed to meeting certain performance
goals in connection with the reauthorized biosimilar user fee program.
To provide recommendations to industry on formal meetings between FDA
and sponsors or applicants relating to the development and review of
biosimilar biological products regulated by the Center for Drug
Evaluation and Research (CDER) or the Center for Biologics Evaluation
and Research (CBER) and assist sponsors and applicants in generating
and submitting meeting requests and the associated meeting packages to
FDA for biosimilar biological products, we developed guidance for
industry entitled ``Formal Meetings Between FDA and Biosimilar
Biological Products Sponsors or Applicants.'' The guidance describes
our current thinking on how we intend to interpret and apply certain
provisions of BsUFA II and provides information on specific performance
goals for the management of meetings associated with the development
and review of biosimilar biological products. The guidance document
includes two types of information collection: (1) The submission of a
meeting request containing certain information and (2) the submission
of the information package(s) that accompany the meeting request.

A. Request for a Meeting

    Under the guidance, a sponsor or applicant interested in meeting
with CDER or CBER should submit a meeting request to the sponsor's or
applicant's application (i.e., investigational new drug application,
biologics license application). If there is no application, a sponsor
or applicant should submit the request to either the appropriate CDER
division director, with a copy sent to the division's chief of project
management staff, or to the division director of the appropriate
product office within CBER, but only after first contacting the
appropriate review division or the Biosimilars Program staff, CDER,
Office of New Drugs to determine to whom the request should be
directed, how it should be submitted, and the appropriate format for
the request and to arrange for confirmation of receipt of the request.
Under the guidance, FDA requests that sponsors and applicants
incorporate certain information in the meeting request, including:
    1. Product name,
    2. application number (if applicable), proposed proper name or
proper name (post licensure),
    4. structure,
    5. reference product name,
    6. proposed indication(s) or context of product development,
    7. meeting type being requested (the rationale for requesting the
meeting type should be included),
    8. a brief statement of the purpose of the meeting, including a
brief background of the issues underlying the agenda. It can also
include a brief summary of completed or planned studies and clinical
trials or data the sponsor or applicant intends to discuss at the
meeting, the general nature of the critical questions to be asked, and
where the meeting fits in the overall development plans.
    9. a list of specific objectives/outcomes expected from the
meeting,
    10. a proposed agenda, including times required for each agenda
item,
    11. a list of questions grouped by discipline and a brief
explanation of the context and purpose of each question,
    12. a list of all individuals with their titles and affiliations
who will attend the requested meeting from the requestor's organization
and consultants,
    13. a list of FDA staff, if known, or disciplines asked to
participate in the requested meeting,
    14. suggested dates and times for the meeting, and
    15. the proposed format of the meeting (i.e., face to face meeting,
teleconference, or videoconference).
    This information will be used by FDA to determine the utility of
the meeting, to identify FDA staff necessary to discuss proposed agenda
items, and to schedule the meeting.

B. Information Package

    FDA requests that a sponsor or applicant submit a meeting package
to the appropriate review division with the meeting request. FDA
recommends that the information packages generally include:
    1. Product name and application number (if applicable),
    2. proposed proper name or proper name (post licensure),
    3. structure,
    4. reference product name,
    5. proposed indication(s) or context of product development,
    6. dosage form, route of administration, dosing regimen (frequency
and duration), and presentation(s),
    7. a list of all sponsor's or applicant's attendees and consultants
with their titles and affiliations who will attend the requested
meeting,
    8. background that includes a brief history of the development
program and the status of product development (e.g., chemistry,
manufacturing, and controls; nonclinical; and clinical, including any
development outside the United States, as applicable),
    9. a brief statement summarizing the purpose of the meeting,
    10. the proposed agenda,
    11. a list of questions for discussion grouped by discipline and
with a brief summary for each question to explain the need or context
for the question, and
    12. data to support discussion organized by discipline and
question.
    The purpose of the meeting package is to provide FDA staff the
opportunity to adequately prepare for the meeting, including the review
of relevant data concerning the product.
    Description of Respondents: A sponsor or applicant for a biosimilar
biological product who requests a formal meeting with FDA regarding the
development and review of a biosimilar biological product.
    In the Federal Register of June 18, 2018 (83 FR 28234), we
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
    We estimate the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
GFI: Formal meetings between FDA                     Number of
    and biosimilar biological        Number of     responses per   Total annual   Average burden    Total hours
 product sponsors or applicants     respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
CDER Meeting Requests...........              36             2.5              89              15           1,335
CBER Meeting Requests...........               2               1               2              15              30
CDER Information Packages.......              29             2.2              64              30           1,920

CBER Information Packages.......               2               2               4              30             120
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           3,405
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Since last OMB approval, there has been an increase in meeting
requests with CDER and a corresponding increase in the number of
information packages. Accordingly, we have adjusted our estimate upward
by six respondents to CDER meeting requests. We attribute this change
to an increase in biosimilar product development.

    Dated: September 4, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19674 Filed 9-10-18; 8:45 am]
 BILLING CODE 4164-01-P


1 1. IDENTIFICATION OF THE INFORMATION COLLECTION ( a) Title of the Information Collection This information collection request is for the new Environmental Protection Agency ( EPA) clause entitled " Background Checks for Contractors Performing Services On site for the Environmental Protection Agency." This new clause requires background checks for all EPA contractors performing services on or within federally owned or leased facilities, commercial space primarily occupied by Federal employees and Superfund, Oil Pollution Act, and Stafford Act sites.

( b) Short Characterization The EPA uses contractors to perform services on or within federally owned or leased facilities, commercial space primarily occupied by Federal employees and Superfund, Oil Pollution Act, and Stafford Act sites. All contractor employees who perform work on site shall be subject to a background check and suitability determination prior to on site entry. The contractor is responsible for conducting background checks and for screening unacceptable candidates from the proposed pool of on site workers. The Background checks and suitability determinations must be performed within the 30 calendar days prior to the on site entry date. The contractor shall maintain records associated with all background checks.

2. NEED FOR AND USE OF THE COLLECTION ( a) Need/ authority for the Collection The legal authority for this collection is Title 5, Code of Federal Regulations, Parts 731, 732, and 736. The EPA has a responsibility to protect its employees and contractors working onsite through a background check and suitability determination to ensure reliability, trustworthiness, and good conduct and character. This process is necessary to allow the EPA to meet its responsibilities and mitigate the threat to the public health, welfare and the environment.

( b) Uses/ users of the Data Information collected by on site contractors for performing background checks is necessary for making suitability determinations on contract employees before the individual employees perform on site contractual services for the EPA.

3. NONDUPLICATION, CONSULTATION, AND OTHER COLLECTION CRITERIA ( a) Nonduplication 2 Information requested from a contractor's employee to determine suitability to work onsite is unique to a specific individual; this information cannot be obtained from any other source.

( b) Public Notice Required Prior to ICR submission to OMB The information collection request has been published with the proposed rule in the Federal Register on January 22, 2003.

( c) Consultations To determine contractor burden associated with the information collection identified in this request, the following vendors were contacted:

Representative Firm Phone Ms Rena Kieval Eastern Research Group, Inc. ( 703) 841 0500 Mr. Edward Fadullon ICF. Consulting Group, Inc. ( 703) 934 3667 Mr. Kevin Cooley Resource Management Concepts ( 301) 862 7501 Mr. Charles Singley Earth Tech, Inc. ( 804) 515 8515 Each individual consulted indicated that he/ she understood the need for the information collection and did not find the collection excessively burdensome. Estimated time to complete the information collection is described in section 6. " Estimating the Burden and Cost of the Collection."

( d) Effects of Less Frequent Collection The information provided by the contractors' employees is collected once prior to the employee performing work on site for the EPA. The requirement for a background check and suitability determination cannot be met with a less frequent collection.

( e) General Guidelines The information contained in this ICR is in accordance with the Office of Management and Budget's general guidelines for federal data collection, except that small entities have to follow the same collection procedures as other respondents.

( f) Confidentiality The EPA contractor is responsible for collecting and maintaining information under this proposed rule; therefore, each contractor will have their own procedures for ensuring confidentiality. 3 ( g) Sensitive Questions Information requested is commonly collected as a normal business practice and is not unduly sensitive. The contractor will collect and maintain employee information. The EPA will not collect contractor employee information nor maintain it. The Agency is responsible for receiving the suitability notification from contractors.

4. THE RESPONDENTS AND THE INFORMATION RECEIVED ( a) Respondents/ North American Industry Classification System Codes Information is collected for employees of the contractor and subcontractor who perform services on or within federally owned or leased facilities, commercial space primarily occupied by federal employees and Superfund, Oil Pollution Act, and Stafford Act sites. All contractor employees who will perform work on site are subject to a background check and suitability determination prior to their entry on site. Typically, these contractor respondents fall into one of the following North American Industry Classification System codes: 23493 Industrial Nonbuilding Structure Construction, 23499 All Other Heavy Construction , 339111 Laboratory Apparatus and Furniture Manufacturing, 541513, 811212, 541512 Computer Related Services, 54169 Other Scientific and Technical Consulting Services, 54133 Engineering Services, 41618 Other Management Consulting Services, and 23332 Commercial and Institutional Building Construction.

( b) Information Requested The contractor's employees will be required to provide information such as name, social security number, proof of US citizenship or legal resident status, employment history, education, military service, and address of residence.

After performing a background check and determining suitability of an employee, the contractor must notify the contracting officer that the background checks and suitability determinations have been completed.

5. THE INFORMATION COLLECTED: AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT ( a) Agency Activities The EPA contracting officers are responsible for ensuring that they have received notification from the contractor that all of its employees working on an EPA site have undergone a background check and a suitability determination. 4 ( b) Collection Methodology and Management The information is collected by each contractor from each employee who will be working on site. Submissions are accepted in any format so long as they include the requested data. Submissions are mandatory; no employee may work on site without a background check and a suitability determination unless the requirement has been waived by the contracting officer. Contracting officers, on a case by case basis, may, either temporarily or permanently, waive the requirements, if they determine, in writing, that background checks and suitability determinations are not necessary at a specific location, or for a specific individual, in order to protect the Government's interests and national security. The suitability determination is a determination that there are reasonable grounds to believe that an individual will likely be able to perform the contract requirements on site without undue risk to the interests of the Government and the national security. Once this determination is made, contractors must notify the EPA contracting officer. Contractors must maintain the records of their background checks and suitability determinations for 4 years from the date completed.

( c) Small Entity Flexibility Separate or further simplified requirements for small entities are not practical because the stated objectives cannot be met under such alternatives. Reasonable expense associated with the EPA background checks is reimbursable; therefore, small businesses are not expected to experience financial difficulties in fulfilling these requirements. There are numerous commercial sources that perform background checks.

( d) Collection Schedule Information will be collected periodically as individuals are requested to work on site locations under new or existing contracts.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION ( a) Estimation of Respondent Burden Respondent burden estimates for this collection are based upon interviews with the contractors identified in 3( b) above and discussions with Agency personnel. The Agency anticipates that the contractor burden for complying with this requirement includes the time it takes for employees to provide the required information, the administrative time to make the suitability determination, the time to notify the Agency, and the effort to maintain the records for 4 years. 5 ( b) Estimation of Respondent Costs ( i) Estimating Labor Costs Respondent Cost Estimate Burden Loaded Collection Activity Labor Cat. Hours Rate Cost 1. Time to fill out information Employees .5 hour $ 51.27 $ 25.64 2. Review/ make determination Manager .5 hour $ 96.25 $ 48.13 3. Submit notification Manager .25 hour $ 96.25 $ 24.06 4. Maintain files Amin. Support .25 hour $ 42.24 $ 10.56 1.5 hours $ 108.39 Step 1 of the information collection is completed by an employee at any level working onsite Steps 2 and 3 of the collection activity is performed by an administrative manager responsible for personnel management. Administrative support personnel are responsible for completing step 4. The cost associated with this effort was estimated using a loaded hourly rate based upon the National Compensation Survey: Occupational Wages in the United States, 2001 published by the U. S. Department of Labor, Bureau of Labor Statistics. This data was published in August of 2002, based on year end 2001 reporting, and represents the most current survey data available.

Since the labor rates used in this estimate are from 2001, an escalation factor of 4% ( based upon Defense Contract Audit Agency) was applied for each year to determine an average wage for the respective year. The cost for each labor category was determined by multiplying the escalated hourly labor rate by an estimated loading factor of 2.95 (* see below) to reflect industries' over head, fringe benefits, and general and administrative costs for each year ( 2003 thru 2005) that the ICR will be in effect. These loaded labor cost for 2003 thru 2005 are then divided by three ( number of years for the ICR) to arrive at an annualized labor cost for each labor category.

The following are the loaded labor rates used in the calculations in the table above:

Employees: 2001 = $ 15.46 2002 = ($ 15.46 x 1.04) $ 16.08 2003 = ($ 16.08 x 1.04) $ 16.72 x 2.95 = $ 49.32 2004 = ($ 16.72 x 1.04) $ 17.39 x 2.95 = $ 51.13 6 2005 = ($ 17.39 x 1.04) $ 18.09 x 2.95 = $ 53.37 $ 153.82/ 3 = $ 51.27 Administrative Manager: 2001 = $ 28.99 2002 = ($ 28.99 x 1.04) $ 30.15 2003 = ($ 30.15 x 1.04) $ 31.36 x 2.95 = $ 92.51 2004 = ($ 31.36 x 1.04) $ 32.61 x 2.95 = $ 96.20 2005 = ($ 32.61 x 1.04) $ 33.91 x 2.95 = $ 100.04 $ 288.75 = $ 96.25 Administrative Support: 2001 = $ 12.72 2002 = ($ 12.72 x 1.04) $ 13.23 2003 = ($ 13.23 x 1.04) $ 13.76 x 2.95 = $ 40.59 2004 = ($ 13.76 x 1.04) $ 14.31 x 2.95 = $ 42.22 2005 = ($ 14.31 x 1.04) $ 14.88 x 2.95 = $ 43.90 $ 126.71/ 3 = $ 42.24 * 2.95 is a factor recommended by EPA cost analyst as representative of labor related burdens experienced by EPA contractors.

( ii) Capital/ Start up Costs Respondents will not be required to acquire capital goods to provide the requested information; therefore, capital start up costs have not been included in this estimate.

( iii) Operating and Maintenance Costs Operating and maintenance costs, which include such items as file storage, photocopying, and postage, will be nominal.

( c) Estimating Agency Burden and Cost Agency burden for responses to background check and suitability determinations.

Agency Burden, Cost Estimate Labor Loaded Collection Activity Category Burden Hours Rate Cost 1. Ensure Compliance GS 13 5 .25 hour $ 39.79 $ 9.95 7 2. Document contractors' GS 13 5 .25 hour $ 39.79 $ 9.95 notifications .5 hour $ 19.90 Background checks and suitability determinations are the responsibility of the EPA on site contractor. The Agency is primarily responsible for ensuring that contractors notify the Agency that a background check and suitability determination has been completed for all employees working on site. The Agency's effort is estimated to be at the GS 13 level. The estimate includes GS 13 salary at $ 39.79 per hour. This wage is the FY2003 base wage for a GS 13 step 5 of $ 33.26. The base wage was escalated by an estimated factor of 3.1% ( compounded), based upon historical cost of living increases for federal worker, to arrive at the estimated wage for the two outlying years that the ICR is in effect. These wage rates were then multiplied by a factor of * 1.16 to reflect Federal employee benefits and then divided by three for an annualized loaded rate of $ 39.79.

FY 03' = $ 33.26 x 1.16 = $ 38.58 FY 04' = ($ 33.26x1.03) $ 34.29 x 1.16 = $ 39.78 FY 05' = ($ 34.29x1.03) $ 35.35 x 1.16 = $ 41.01 $ 119.37 / 3 = $ 39.79 * 1.16 is a factor recommended by EPA cost analyst as representative of employee related benefits.

( d) Estimating the Respondent Universe and Total Burden All EPA contractor personnel performing on site must provide the required background information unless this requirement is waived by the contracting officer. The number of nonfederal employees expected to submit the requested information for background checks for the life of this ICR is 14,000. This number was derived by estimating that 12,000 individuals will be required to respond when this requirement is initially implemented because all employees currently working on site will be required to have background checks and suitability determinations for the first year. Additionally, an estimated 1,000 employees will respond for the second year and 1,000 for the third year that the ICR is effective for a total of 14,000 employees for the three years of the ICR.

The above assessment is based on an FY2002 review performed by the EPA Federal Facilities Office. The review states that there are 5,000 contract employees estimated to be currently working under EPA contract within a federally owned or leased facility, including laboratories. Added to this number is an estimated 1,000 non Federal employees working on site through other non EPA contractual arrangements such as GSA Federal Supply Schedules and Government Wide Agency Contracts. The EPA also has contractors working out in the field on Superfund, Oil Pollution Act, and Stafford Act sites. We estimate another 6,000 contract employees working on these types of sites for a total of 12,000 employees presently working on 8 site for the EPA.

There are both small and large businesses working in the field with diverse on site situations that require large variations in the number of on site employees. Contractors may be on site for a few days or many years depending on the situation. There are currently 73 Superfund contracts that do on site work under the authority of The Comprehensive Environmental Response, Compensation and Liability Act ( CERCLA). The number of these contracts changes depending on program needs and environmental circumstances. Many Superfund contracts require employees to be prepared to report to work locations. Therefore, these employees must have background checks and suitability determinations even if not continuously located on site.

Finally, there are situations in which contracting officers may waive this background check requirement, making it difficult to precisely determine the number of respondents. For these reasons, this initial request represents our best estimate given current information. Future estimates will be more accurate and based on historical data monitored through the Agency's contractual systems on the use of the subject clause.

( e) Bottom Line Burden Hours and Costs ( i) Respondent Tally Total annual respondent hours for this collection request is 7,000.5 hours. This is derived by taking the total number of background checks and suitability determinations, 14,000, divided by 3 ( the number of years the ICR is effective) for a total of 4,667 occurrences per year. Then the number of annual occurrences, 4,667, is multiplied by the respondent burden effort of 1.5 hours to collect information to arrive at the total of 7,000.5 hours per year.

Total annual respondent cost for this collection request is $ 505,856.13. This is calculated by multiplying the number of annual occurrences, 4,667, by the respondent cost of one collection, $ 108.39.

( ii) The Agency Tally The average Agency annual burden cost is estimated at $ 92,873.30. This is calculated by multiplying the estimated burden hours, .5, by the estimated hourly rate of $ 39.79 for a total of $ 19.90 for one collection request. Then the $ 19.90 is multiplied by the estimated number of annual occurrences, 4,667, for a total of $ 92,873.30.

( f) Burden Statement 9 The annual public reporting and record keeping burden for this collection of information is estimated to average 1.5 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. OARM 2002 0001, which is available for public viewing at the Office of Environmental Information Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Office of Environmental Information Docket is ( 202) 566 1752.. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. OARM 2002 0001 in any correspondence.


Public Hearing

Tennessee Division of Air Pollution Control

9th Floor Conference Room L & C Annex

401 Church Street

Nashville, TN 37243-1531

9:30 A.M.

March 20, 2006

Opening Statement For Hearing

I would like to call this hearing to order.  It is 9:30 a.m March 20,
2006.  We are in the 9th Floor Conference Room at the L & C Annex, 401
Church Street, Nashville, Tn. My name is Malcolm Butler, I'm an
Environmental Protection Specialist V with the Division of Air Pollution
Control and I'm the Hearing Officer for this meeting. This hearing is
being held under the authority of the Tennessee Air Pollution Control
Board.

This public hearing has been called to consider the proposed amendments
to the Tennessee Air Pollution Control Regulations and the State
Implementation Plan pursuant to Tennessee Code Annotated, Section
68-201-105.

This hearing is a requirement of the Uniform Administrative Procedures
Act, and the Federal Clean Air Act.

I want to emphasize (1) that we are not here to debate any testimony
presented, but to listen and only ask questions for clarification and
(2) that written statements or transcripts of comments are requested and
will be considered as a part of this record if received in the office of
the Technical Secretary, Tennessee Air Pollution Control Division, 9th
Floor L & C Annex, 401 Church Street, Nashville, Tennessee 37243-1531 by
close of business Friday, March 11, 2005.

Notice of this hearing was publicized in newspapers of general
circulation as required by T.C.A. Section 68-201-105.  Copies of the
proposed regulatory amendments were available for public inspection at
various locations detailed in the public notice.  A copy of these
notices will be made a permanent part of the record.

The proceedings of this hearing are being recorded and copies of the
hearing record will be available for the cost of reproduction. Requests
for such copies should be sent to the Technical Secretary at the
previously mentioned address.

Compilers of the testimony presented at this hearing reserve the right
to include extensive or bulky testimony by reference only.

Verbal or written testimony, either for or against matters under
discussion, may be presented at this hearing.

Is there any one here who would like to make a oral comment?

Comments________________________________

Is there anyone else here who would like to make an oral comment for the
hearing record?   I declare a recess until 10:00 a.m.

It is 10:00 a.m., the recess is ended. The public hearing will  come to
order.

Is there anyone else here who would like to make an oral comment for the
hearing record?

Since there is no one else here desiring to make an oral comment for the
hearing record, the hearing is adjourned.

C:/ohs\2a.doc

Page   PAGE  2  of   NUMPAGES  \* MERGEFORMAT  2  Pages


[Federal Register Volume 76, Number 161 (Friday, August 19, 2011)]
[Notices]
[Pages 51993-51994]
[FR Doc No: 2011-21244]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0586]

Draft Guidance for Industry on Standards for Clinical Trial
Imaging Endpoints; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Standards for
Clinical Trial Imaging Endpoints.'' The purpose of this draft guidance
is to assist sponsors in the use of imaging endpoints in clinical
trials of therapeutic drugs and biological products. The draft guidance
describes standards sponsors can use to ensure that clinical trial
imaging data are obtained in a manner that complies with a trial's
protocol, maintains imaging data quality, and provides a verifiable
record of the imaging process.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 18, 2011.

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

FOR FURTHER INFORMATION CONTACT: Rafel Dwaine Rieves, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 2354, Silver Spring, MD 20993 -0002, 301-
796-2050; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Standards for Clinical Trial Imaging Endpoints.'' This draft
guidance is intended to assist sponsors in the standardization of
imaging procedures when an important imaging endpoint is used in a
clinical trial of a therapeutic drug or biological product, especially
for an efficacy endpoint. As part of the reauthorization of the
Prescription Drug User Fee Act (PDUFA 4), FDA committed to certain
performance goals (see letters from the Secretary of Health and Human
Services to the Chairman of

the Committee on Health, Education, Labor, and Pensions of the Senate
and the Chairman of the Committee on Energy and Commerce of the House
of Representatives, as set forth in the Congressional Record).\1\ This
draft guidance addresses one of these goals with the creation of a
guidance document that addresses the ``imaging standards for use as an
endpoint in clinical trials.'' This draft guidance also follows the
April 13, 2010, public workshop ``Standards for Imaging Endpoints in
Clinical Trials'' cosponsored by FDA, the Society of Nuclear Medicine,
and the Radiological Society of North America.\2\
---------------------------------------------------------------------------

    \1\ See ``Section A: PDUFA Reauthorization Performance Goals and
Procedures Fiscal Years 2008 Through 2012'' (http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm).
    \2\ See http://www.rsna.org/snm/index.html.
---------------------------------------------------------------------------

    This draft guidance outlines the major considerations for
standardization of image acquisition, image interpretation methods, and
other procedures to help ensure imaging data quality. The draft
guidance describes two categories of image acquisition and
interpretation standardization, a medical practice standard and a
clinical trial standard, and provides guidance on the role of each
standard in a clinical trial. With a medical practice standard, the
image acquisition and interpretation methods in the trial do not exceed
those used in medical practice. In contrast, a clinical trial standard
involves imaging methods that exceed those used in medical practice.
The draft guidance focuses on the methods important for image
acquisition and interpretation and provides a detailed outline of other
procedures important for optimizing clinical trial imaging data
quality.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on standards
for clinical trial imaging endpoints. It does not create or confer any
rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR parts 312 and 314 have been
approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

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

    Dated: August 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21244 Filed 8-18-11; 8:45 am]
BILLING CODE 4160-01-P


Emission Reduction Strategy Description and analysis of how the strategy will be implemented Estimate of emission reductions ( if available/ details on status Date of Implementation Resource Concerns/ Constraints Geographic area and/ or local government 1. Local governments join and participate with the private sector in the NC Air Awareness Program Division of Air Quality ( DAQ) and WPCOG will encourage local governments and the private sector to join the Air Awareness Program. Not quantifiable, but effective 2003/ ongoing Need the Division of Air Quality's support and coordination assistance Unifour Areas All stakeholders 2. Enhanced Ozone Awareness ( Outreach Communication): assign a local agency to develop and implement an aggressive program to educate and motivate individuals and businesses/ organizations, to take actions to minimize ozone pollution. Can include a wider distribution of educational materials, increased media alerts, promoting NC Air Awareness program,

etc. All EAC members will coordinate program. Not quantifiable, but effective 2003/ ongoing WPCOG will need education materials Unifour Areas All stakeholders 3. Evaluate the benefits of participation in the Clean Cities program WPCOG will coordinate program if UAQC desires to participate Not quantifiable, but effective 2003/ ongoing None Unifour Areas All stakeholders 4. City and County Energy Plan ( Energy Conservation Plan): An energy plan could be developed that directs city & county departments to reduce energy use. This could include new construction standards for new buildings,

retrofitting city/ county buildings, schools, & street lights for energy efficiency, and energy renewable sources i. e. Sustainable Building Design Stds. " Energy Star" Program, white roofs, etc., promoting transportation alternatives, and encouraging recycling & composting. Local governments will develop their own energy plan ( possibly involve Cooperative Extension Service) Not quantifiable, but effective 2005/ ongoing Need outside expertise to develop plans Unifour Areas All stakeholders 5. Assign staff to become air quality contact Local governments will designate staff member as air quality contact person Not quantifiable, but effective 2003/ ongoing None Unifour Areas All stakeholders 6. Adopt a local clean air policy & appoint a stakeholder group to identify &

recommend locally feasible air improvement actions Unifour Air Quality Committee ( UAQC) will continue to serve as this group Not quantifiable, but effective 2003/ ongoing None Unifour Areas All stakeholders 7. Landscaping Standards: Planted trees and vegetative landscaping reduce the need for air conditioning, reduce the heat island effect in urban areas, and reduce energy usage. Landscaping and tree ordinances could be drafted to establish minimum tree planting standards for new development; and to promoted strategic tree planting, street trees, and parking lot trees " Urban Forests Program" All local governments should develop tree and landscaping ordinances.

Local governments should educate and encourage citizen participation with tree and other vegetative plantings. Riparian buffer regulations should also be supported Not quantifiable, but effective 2005 ( Some in 2003) None Unifour Areas All stakeholders 8. Implement Smart Growth, mixed use, and infill development policies. Encourage compact development to reduce travel and promote Smart Growth concepts and redevelopment activities Not quantifiable, but effective 2005 ( Some in 2003) None Unifour Areas All stakeholders 9. Develop plans to encourage bicycle and pedestrian usage. Each EAC member will develop plans within a regional context. Not quantifiable, but effective 2005 ( Some in 2003) None Unifour Areas All stakeholders 10. Discourage Open Burning on Ozone Action Days ( Pledge Program) Request all major land development and grading businesses to sign pledges to not engage in open burning activities on high ozone days. Will survey participants for #

of days that open burning did not occur 2003/ ongoing None Unifour Areas All stakeholders 11. Support Coordination of Metropolitan Planning Organization ( MPO) and Rural Planning Organization ( RPO) efforts MPO and RPO will coordinate transportation and air quality planning efforts Not quantifiable, but effective 2003 None Unifour Areas All stakeholders 12. Encourage the use of compressed work weeks or flexible work hours, which helps reduce traffic congestion during the peak driving hours by spreading out the number of vehicles on the roadway over a longer period of time MPO and RPO will promote benefits of telecommuting, flexible work hours and staggered work schedules Will determine # of participants and estimate reduction in VMT 2004 None Unifour Areas All stakeholders 13. Expand Transit and Ridesharing programs ( carpooling/ vanpooling). These are options where employers living in the same area agree to ride to work together rather than to drive their individual vehicles to work. MPO and RPO and local governments will educate and promote these benefits Produce Maps to locate employees to assist with ridesharing programs Will determine # of participants and estimate reduction in VMT 2004 None Unifour Areas All stakeholders 14. Improve traffic operational planning, engineering and maintenance for existing and future transportation infrastructure. MPO, RPO, NCDOT, and municipalities, will expand traffic operational and engineering technologies ( signal timing, signing, message boards, etc., and other intelligent transportation strategies) Not quantifiable, but effective 2004 None Unifour Area Municipalities & NC DOT


[Federal Register Volume 83, Number 45 (Wednesday, March 7, 2018)]
[Notices]
[Page 9732]
[FR Doc No: 2018-04603]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 10482-118]

Eagle Creek Hydro Power, LLC, Eagle Creek Water Resources, LLC,
Eagle Creek Land Resources, LLC; Notice of Application Accepted for
Filing, Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Non-capacity amendment of license.
    b. Project No.: 10482-118.
    c. Date Filed: January 26, 2018.
    d. Applicants: Eagle Creek Hydro Power, LLC, Eagle Creek Water
Resources, LLC, and Eagle Creek Land Resources, LLC.
    e. Name of Project: Swinging Bridge Hydroelectric Project.
    f. Location: Mongaup River in Sullivan County, New York.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Mr. Robert Gates, Executive Vice President
Operations, Eagle Creek Renewable Energy, LLC, 65 Madison Avenue, Suite
500, Morristown, NJ 07960,<PHONE_NUMBER>, [email protected].
    i. FERC Contact: Mr. Jeremy Jessup,<PHONE_NUMBER>,
[email protected].
    j. Deadline for filing comments, motions to intervene, and protests
is 30 days from the issuance of this notice by the Commission.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, please
send a paper copy to: Secretary, Federal Energy Regulatory Commission,
888 First Street NE, Washington, DC 20426. The first page of any filing
should include docket number P-10482-118.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person on the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Request: The applicant proposes to install a new
minimum base flow turbine-generator unit (Unit No. 3) in a new
approximately 30-foot-long by 30-foot-wide powerhouse directly adjacent
to the existing powerhouse for Unit No. 2 at the Swinging Bridge
Development. The installed capacity of Unit No. 3 will replace the
inoperable turbine-generator unit (Unit No. 1). The authorized
installed capacity of the project will decrease from 11.75 MW to 7.85
MW with the proposed amendment and the licensee does not propose any
modifications to reservoir elevations or flows.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE, Room 2A, Washington, DC
20426, or by calling<PHONE_NUMBER>. This filing may also be viewed on
the Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number excluding the last three digits
in the docket number field to access the document. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
[email protected], for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Motions to Intervene, or Protests: Anyone may submit
comments, a motion to intervene, or a protest in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, motions to
intervene, or protests must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE,'' (2) set forth in the heading, the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person protesting or intervening; and (4) otherwise comply with the
requirements of 18 CFR 385.2001 through 385.2005. All comments, motions
to intervene, or protests must set forth their evidentiary basis and
otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may
obtain copies of the application directly from the applicant. A copy of
any protest or motion to intervene must be served upon each
representative of the applicant specified in the particular
application. If an intervener files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.

    Dated: March 1, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-04603 Filed 3-6-18; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 210 (Tuesday, October 30, 2012)]
[Notices]
[Pages 65762-65763]
[FR Doc No: 2012-26584]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2012-44]

Petition for Exemption; Summary of Petition Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petition for exemption received.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of Title 14, Code of Federal Regulations
(14 CFR). The purpose of this notice is to improve the public's
awareness of, and participation in, this aspect of the FAA's regulatory
activities. 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 involved and must be received on or before November 19, 2012.

ADDRESSES: You may send comments identified by docket number FAA-2007-
27903 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments digitally.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility 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.

    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review the
DOT's complete Privacy Act Statement in the Federal Register published
on April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility 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: Mark Forseth, ANM-113,<PHONE_NUMBER>,
Federal Aviation Administration, 1601 Lind Avenue SW., Renton, WA
98057-3356, or Ralen Gao,<PHONE_NUMBER>, Office of Rulemaking (ARM-1),
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 October 23, 2012.
Lirio Liu,
Director, Office of Rulemaking.

Petition for Exemption

    Docket No.: FAA-2007-27903.
    Petitioner: Embraer S.A.
    Section of 14 CFR Affected: Sec.  25.813(e) at Amendment 25-88.
    Description of Relief Sought: Amend Exemption No. 9458 to provide
relief from requirements to allow installation of motor-actuated doors
in passenger-

compartment partitions in Embraer Model ERJ 190-100 ECJ airplanes.

[FR Doc. 2012-26584 Filed 10-29-12; 8:45 am]
BILLING CODE 4910-13-P