[Federal Register: December 2, 2008 (Volume 73, Number 232)]
[Notices]
[Page 73320-73322]
[DOCID:fr02de08-62]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 Combined Notice of Filings 1

November 24, 2008.
    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC08-78-000.
    Applicants: Duke Energy Ohio, Inc., Cinergy Corp., Cinergy Power
Investments, Inc., Generating Facility LLCs.
    Description: Status Report and Amendment to Application of Cinergy
Corporation, et al.
    Filed Date: 11/17/2008.
    Accession Number: 20081117-5153.
    Comment Date: 5 p.m. Eastern Time on Monday, December 8, 2008.

    Docket Numbers: EC09-24-000.
    Applicants: Noble Altona Windpark, LLC, Noble Chateaugay Windpark,
LLC, Noble Wethersfield Windpark, LLC, Noble Environmental Power 2008
Hold Co., EFS Noble II, LLC, GE Capital Markets, Inc.
    Description: Application of Noble Altona Windpark, LLC, et al. for
Authorization of Transaction, Request for Waivers of Filing
Requirements, Confidential Treatment of Transaction Documents and
Request for Expedited Consideration.
    Filed Date: 11/21/2008.
    Accession Number: 20081121-5144.
    Comment Date: 5 p.m. Eastern Time on Friday, December 12, 2008.

    Docket Numbers: EC09-25-000.
    Applicants: MidAmerican Energy Company, Constellation Power Source
Generation LLC, Safe Harbor Water Power Corp.
    Description: Joint Application of MidAmerican Energy Holdings
Company, et al. for Authorization Under Section 203 of the FPA, Request
for Waiver of Certain Commission Requirements, and Requests for
Confidential Treatment and Expedited Treatment.
    Filed Date: 11/21/2008.
    Accession Number: 20081121-5146.
    Comment Date: 5 p.m. Eastern Time on Friday, December 12, 2008.

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

    Docket Numbers: ER98-4159-015; ER04-268-012; ER06-398-009; ER06-
399-009; ER07-157-005.
    Applicants: Duquesne Light Company; Duquesne Power, LLC; Duquesne
Keystone, LLC; Duquesne Conemaugh, LLC; Macquarie Cook Power, Inc.
    Description: Notice of Change in Status of Duquesne Light Company,
et al.
    Filed Date: 11/21/2008.
    Accession Number: 20081121-5081.
    Comment Date: 5 p.m. Eastern Time on Friday, December 12, 2008.

    Docket Numbers: ER01-1403-009; ER01-2968-010; ER01-845-008; ER04-
366-007; ER05-1122-006; ER06-1443-005; ER08-107-003.
    Applicants: FirstEnergy Operating Companies; FirstEnergy Solutions
Corp.; FirstEnergy Generation Corporation; Jersey Central Power & Light
Co.; FirstEnergy Nuclear Generation Corporation; Pennsylvania Power
Company; FirstEnergy Generation Mansfield Unit 1.
    Description: Report of FirstEnergy Service Company In Compliance
With Order Issued on October 17, 2008.
    Filed Date: 11/17/2008.
    Accession Number: 20081117-5189.
    Comment Date: 5 p.m. Eastern Time on Monday, December 8, 2008.

    Docket Numbers: ER01-1529-012; ER01-1527-012.
    Applicants: Nevada Power Company, Sierra Pacific Power Company.
    Description: Nevada Power Co. & Sierra Pacific Power Co. submit
notice of non-material change in status.
    Filed Date: 11/19/2008.
    Accession Number: 20081124-0314.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 10, 2008.

    Docket Numbers: ER06-635-004; ER06-634-004; ER95-1007-023.
    Applicants: Edgecombe Genco, LLC; Spruance Genco, LLC.

    Description: Edgecombe Genco, LLC et al. affirms that they have not
erected barriers to entry in the relevant market and will not erect
barriers to entry in the relevant market.
    Filed Date: 11/19/2008.
    Accession Number: 20081124-0206.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 10, 2008.

    Docket Numbers: ER06-758-005.
    Applicants: Chambers Cogeneration, Limited Partnership.
    Description: Chambers Cogeneration Limited Partnership affirms that
they have not erected barriers to entry in the relevant market and will
not erect barriers to entry in the relevant market.
    Filed Date: 11/19/2008.
    Accession Number: 20081124-0207.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 10, 2008.

    Docket Numbers: ER07-1372-013.
    Applicants: Midwest Independent Transmission System.
    Description: Readiness Recertification in compliance with the
Commission's February 25, 2008 Order.
    Filed Date: 11/21/2008.
    Accession Number: 20081121-5166.
    Comment Date: 5 p.m. Eastern Time on Monday, December 1, 2008.

    Docket Numbers: ER08-394-005.
    Applicants: Midwest Independent Transmission System.
    Description: Midwest Independent Transmission System Operator, Inc.
submits proposed revisions to its Open Access Transmission and Energy
Markets Tariff.
    Filed Date: 11/19/2008.
    Accession Number: 20081120-0130.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 10, 2008.

    Docket Numbers: ER08-394-006.
    Applicants: Midwest Independent Transmission System.
    Description: Midwest Independent Transmission System Operator, Inc.
submits proposed revisions to its Open Access Transmission and Energy
Markets Tariff to comply with FERC's 10/20/08 Order.
    Filed Date: 11/19/2008.
    Accession Number: 20081120-0131.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 10, 2008.

    Docket Numbers: ER08-394-007.
    Applicants: Midwest Independent Transmission System.
    Description: Midwest Independent Transmission System Operator, Inc.
submits proposed revisions to its Open Access Transmission and Energy
Markets Tariff to comply with FERC's 10/20/08 order under ER08-394.
    Filed Date: 11/19/2008.
    Accession Number: 20081120-0132.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 10, 2008.

    Docket Numbers: ER09-215-001.
    Applicants: Pittsfield Generating Company, L.P.
    Description: Pittsfield Generating Company, LP submits the
Commission proposed revisions to its FERC Electric Original Volume 1 to
reflect a change in Pittsfield's Agent under the tariff to become
effective 1/1/09.
    Filed Date: 11/18/2008.
    Accession Number: 20081121-0162.
    Comment Date: 5 p.m. Eastern Time on Monday, December 1, 2008.

    Docket Numbers: ER09-309-000.
    Applicants: New York Independent System Operator, Inc.
    Description: New York Independent System Operator, Inc. et al.
submits executed standard large generator interconnection agreement
among the NYISO, NYSEG, and the Developer, the Sheldon Energy LLC.
    Filed Date: 11/18/2008.
    Accession Number: 20081121-0160.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 9, 2008.

    Docket Numbers: ER09-310-000.
    Applicants: Midwest Independent Transmission System.
    Description: Midwest Independent Transmission System Operator, Inc.
et al. submits proposed revisions to Section 5.2 and Appendix B of the
Congestion Management Process of their Joint Operating Agreements.
    Filed Date: 11/18/2008.
    Accession Number: 20081121-0163.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 9, 2008.

    Docket Numbers: ER09-311-000.
    Applicants: LANXESS Energy LLC.
    Description: LANXESS Energy LLC submits Petition for Acceptance of
Initial Tariff, Waivers, and Blanket Authority, FERC Electric Tariff,
Original Volume 1.
    Filed Date: 11/21/2008.
    Accession Number: 20081124-0160.
    Comment Date: 5 p.m. Eastern Time on Friday, December 12, 2008.

    Docket Numbers: ER09-312-000.
    Applicants: LANXESS Corporation.
    Description: LANXESS Corporation submits a Petition for Acceptance
of Initial Tariff, Waivers, and Blanket Authority, FERC Electric
Tariff, Original Volume 1.
    Filed Date: 11/21/2008.
    Accession Number: 20081124-0161.
    Comment Date: 5 p.m. Eastern Time on Friday, December 12, 2008.

    Docket Numbers: ER09-313-000.
    Applicants: Niagara Mohawk Power Corporation.
    Description: Niagara Mohawk Power Corp submits executed cost
sharing agreement with Nine Mile Point Nuclear Station, LLC et al.
    Filed Date: 11/19/2008.
    Accession Number: 20081120-0128.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 10, 2008.

    Docket Numbers: ER09-314-000.
    Applicants: Direct Energy Business, LLC.
    Description: Direct Energy Business, LLC submits notice of
succession to notify FERC of a corporate name change.
    Filed Date: 11/19/2008.
    Accession Number: 20081120-0129.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 10, 2008.

    Docket Numbers: ER09-315-000.
    Applicants: Consolidated Edison Co. of New York, Inc.
    Description: Consolidated Edison Co. of New York, Inc. submits
notices of Cancellation for power sales service agreements.
    Filed Date: 11/19/2008.
    Accession Number: 20081120-0135.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 10, 2008.

    Docket Numbers: ER09-316-000.
    Applicants: Consolidated Edison Co. of New York, Inc.
    Description: Consolidated Edison Co. of New York, Inc. submits
Notices of Cancellation for service agreements for the Wholesale Sale
of Electricity etc.
    Filed Date: 11/19/2008.
    Accession Number: 20081120-0134.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 10, 2008.

    Docket Numbers: ER09-317-000.
    Applicants: MidAmerican Energy Company.
    Description: MidAmerican Energy Co. submits First Revised Sheet No.
2 to FERC Electric Tariff, Second Revised Volume No. 8, to be effective
12/29/08.
    Filed Date: 11/19/2008.
    Accession Number: 20081120-0133.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 10, 2008.

    Docket Numbers: ER09-320-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Interconnection, LLC submits an executed
interconnection service with WM Renewable Energy, LLC et al.
    Filed Date: 11/21/2008.
    Accession Number: 20081124-0159.
    Comment Date: 5 p.m. Eastern Time on Friday, December 12, 2008.

    Docket Numbers: ER09-321-000.
    Applicants: California Independent System Operator C.
    Description: California Independent System Operator Corporation
submits an executed Amended and Restated Metered Subsystem Agreement
with the City of Vernon, California.
    Filed Date: 11/20/2008.

    Accession Number: 20081124-0317.
    Comment Date: 5 p.m. Eastern Time on Thursday, December 11, 2008.

    Take notice that the Commission received the following electric
securities filings:
    Docket Numbers: ES09-11-000.
    Applicants: Southwestern Electric Power Company.
    Description: Application Under Section 204 of the Federal Power Act
to Issue Securities.
    Filed Date: 11/20/2008.
    Accession Number: 20081120-5111.
    Comment Date: 5 p.m. Eastern Time on Thursday, December 11, 2008.

    Take notice that the Commission received the following open access
transmission tariff filings:
    Docket Numbers: OA08-122-001.
    Applicants: Tampa Electric Company.
    Description: Tampa Electric Co submits Substitute Revised Sheet No.
23 to FERC Electric Tariff, Third Revised Volume No. 4 to be effective
7/23/08.
    Filed Date: 11/19/2008.
    Accession Number: 20081120-0142.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 10, 2008.

    Docket Numbers: OA08-127-000.
    Applicants: Avista Corporation.
    Description: Avista Corporation's Errata to the September 5, 2008
Compliance Filing.
    Filed Date: 11/20/2008.
    Accession Number: 20081120-5134.
    Comment Date: 5 p.m. Eastern Time on Thursday, December 11, 2008.

    Docket Numbers: OA08-93-002.
    Applicants: South Carolina Electric & Gas Company.
    Description: Order No. 890-A Compliance Filing.
    Filed Date: 11/20/2008.
    Accession Number: 20081120-5113.
    Comment Date: 5 p.m. Eastern Time on Thursday, December 11, 2008.

    Docket Numbers: OA08-95-002.
    Applicants: Alcoa Power Generating Inc.--Yadkin.
    Description: Yadkin Division of Alcoa Power Generating Inc submits
First Revised Sheet 286 et al. to FERC Electric Tariff, First Revised
Volume 3 for Schedules 4 and 9 of its Open Access Transmission Tariff
in compliance with Order 890 & 890-A.
    Filed Date: 11/20/2008.
    Accession Number: 20081124-0157.
    Comment Date: 5 p.m. Eastern Time on Thursday, December 11, 2008.

    Take notice that the Commission received the following public
utility holding company filings:
    Docket Numbers: PH09-4-000.
    Applicants: Texas Transmission Holdings Corporation, Texas
Transmission Investment LLC.
    Description: FERC 65 Waiver Notification of Texas Transmission
Holdings Corporation and Texas Transmission Investment LLC.
    Filed Date: 11/21/2008.
    Accession Number: 20081121-5112.
    Comment Date: 5 p.m. Eastern Time on Friday, December 12, 2008.

    Take notice that the Commission received the following electric
reliability filings:
    Docket Numbers: RR06-1-018; RR07-7-006.
    Applicants: North American Electric Reliability Corp.
    Description: Further Status Report of the North American Electric
Reliability Corporation and Western Electricity Coordinating Council in
Response to Paragraph 226 of March 21 2008 Commission Order under RR06-
1, et al.
    Filed Date: 11/21/2008.
    Accession Number: 20081121-5110.
    Comment Date: 5 p.m. Eastern Time on Thursday, December 11, 2008.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St. NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-28561 Filed 12-1-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 187 (Thursday, September 26, 2013)]
[Notices]
[Page 59347]
[FR Doc No: 2013-23502]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9901-46-OA; EPA-HQ-OA-2013-0125]

National and Governmental Advisory Committees to the U.S.
Representative to the Commission for Environmental Cooperation

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of advisory committee meeting teleconference call.

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SUMMARY: Under the Federal Advisory Committee Act, Public Law 92-463,
EPA gives notice of a meeting of the National Advisory Committee (NAC)
and Governmental Advisory Committee (GAC) to the U.S. Representative to
the North American Commission for Environmental Cooperation (CEC). The
National and Governmental Advisory Committees advise the EPA
Administrator in her capacity as the U.S. Representative to the CEC
Council. The Committees are authorized under Articles 17 and 18 of the
North American Agreement on Environmental Cooperation (NAAEC), North
American Free Trade Agreement Implementation Act, Public Law 103-182,
and as directed by Executive Order 12915, entitled ``Federal
Implementation of the North American Agreement on Environmental
Cooperation.'' The NAC is composed of 14 members representing academia,
environmental non-governmental organizations, and private industry. The
GAC consists of 15 members representing state, local, and Tribal
governments. The Committees are responsible for providing advice to the
U.S. Representative on a wide range of strategic, scientific,
technological, regulatory, and economic issues related to
implementation and further elaboration of the NAAEC.
    The purpose of this meeting is to provide advice on the 20th
anniversary of the NAAEC and to discuss other trade and environment
issues in North America. The meeting will also include a public comment
session. The agenda and meeting materials will be available at http://www.regulations.gov under Docket ID: EPA-HQ-OA-2013-0125. General
information about NAC and GAC can be found at http://www.epa.gov/ofacmo/nacgac-page.htm.

DATES: The NAC/GAC will hold a public teleconference on October 16,
2013, from 1:00 p.m. to 4:00 p.m. Eastern Standard Time.

ADDRESSES: The meeting will be held at the U.S. EPA East Building, 1201
Constitution Avenue NW., Room 1132, Washington, DC 20004.

FOR FURTHER INFORMATION CONTACT: Oscar Carrillo, Designated Federal
Officer<EMAIL_ADDRESS>202-564-0347, U.S. EPA, Office of
Diversity, Advisory Committee Management and Outreach (1601-M), 1200
Pennsylvania Avenue NW., Washington, DC 20004.

SUPPLEMENTARY INFORMATION: Requests to make oral comments or to provide
written comments to NAC/GAC should be sent to Oscar Carrillo at
<EMAIL_ADDRESS>by Wednesday, October 9, 2013. The meeting is
open to the public, with limited seating on a first-come, first-served
basis. Members of the public wishing to participate in the
teleconference should contact Oscar Carrillo at<EMAIL_ADDRESS>or<PHONE_NUMBER> by October 9, 2013.
    Meeting Access: For information on access or services for
individuals with disabilities, please contact Oscar Carrillo at 202-
564-0347 or<EMAIL_ADDRESS>To request accommodation of a
disability, please contact Oscar Carrillo, preferably at least 10 days
prior to the meeting, to give EPA as much time as possible to process
your request.

    Dated: September 17, 2013.
Oscar Carrillo,
Designated Federal Officer.
[FR Doc. 2013-23502 Filed 9-25-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 1 (Friday, January 2, 2015)]
[Notices]
[Pages 104-105]
[FR Doc No: 2014-30538]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Notice of Application for Special Permits

AGENCY: Office of Hazardous Materials Safety, Pipeline and Hazardous
Materials Safety Administration (PHMSA), DOT.

ACTION: List of applications for special permits.

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SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR part 107,
subpart B), notice is hereby given that the Office of Hazardous
Materials Safety has received the application described herein. Each
mode of transportation for which a particular special permit is
requested is indicated by a number in the ``Nature of Application''
portion of the table below as follows: 1--Motor vehicle, 2--Rail
freight, 3--Cargo vessel, 4--Cargo aircraft only, 5--Passenger-carrying
aircraft.

DATES: Comments must be received on or before February 2, 2015.
    Address Comments to: Record Center, Pipeline and Hazardous
Materials, Safety Administration, U.S. Department of Transportation,
Washington, DC 20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

For Further Information: Copies of the applications are available for
inspection in the Records Center, East Building, PHH-30, 1200 New
Jersey Avenue Southeast, Washington, DC or at http://regulations.gov.
    This notice of receipt of applications for special permit is
published in accordance with part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on December 8, 2014.
Donald Burger,
Chief, General Approvals and Permits.

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                                                                                Nature of special
   Application No.         Docket No.            Applicant       Regulation(s) affected      permits thereof
----------------------------------------------------------------------------------------------------------------
                                               NEW SPECIAL PERMITS
----------------------------------------------------------------------------------------------------------------
16316-N.............  ....................  Green Auto          49 CFR 171.2(k),         To authorize the
                                             Products            172.202(a)(5)(iii)(b),   transportation in
                                             International,      part 172, subpart H.     commerce of certain
                                             Inc., Orlando, FL.                           used DOT 3AL cylinders
                                                                                that contain oxygen,
                                                                                but not necessarily in
                                                                                an amount qualifying
                                                                                as hazardous material.
                                                                                (modes 1, 2, 3)
16318-N.............  ....................  Technical Chemical  49 CFR 173.304(d),       To authorize the
                                             Company,            173.306(a)(3).           manufacture, mark,
                                             Cleburne, TX.                                sale and use of a non-
                                                                                DOT specification
                                                                                packaging conforming
                                                                                in part with
                                                                                specification DOT 2Q.
                                                                                (modes 1, 2, 3, 4, 5)
16320-N.............  ....................  Digital Wave        49 CFR 180.205(g)......  To authorize the
                                             Corporation,                                 extension of the
                                             Centennial, CO.                              service life of
                                                                                certain DOT-CFFC
                                                                                cylinders which are
                                                                                subjected to certain
                                                                                requalification and
                                                                                operational controls.
                                                                                (modes 1, 2, 3, 4, 5)
16321-N.............  ....................  China Oilfield      49 CFR 173.201,          To authorize the
                                             Services Limited    173.301(f), 173.302,     manufacture, mark,
                                             Beijing.            173.304a.                sale, and use of
                                                                                certain non-DOT
                                                                                specification
                                                                                cylinders containing
                                                                                certain Division 2.1,
                                                                                2.2, and Class 3
                                                                                materials used for oil
                                                                                well sampling. (modes
                                                                                1, 2, 3, 4)
16323-N.............  ....................  Fibre Drum Sales,   49 CFR 172.203(a),       To authorize
                                             Inc., Blue          172.302(c), 180.352.     installation of a
                                             Island, IL.                                  tested inner
                                                                                receptacle of a
                                                                                composite IBC without
                                                                                subjecting the inner
                                                                                receptacle to a
                                                                                leakproofness test
                                                                                after installation.
                                                                                (modes 1, 2, 3)
16331-N.............  ....................  Airgas Specialty    49 CFR 173.301(f),       To authorize the
                                             Products, Inc.,     173.301(g).              transportation in
                                             Lawrenceville, GA.                           commerce of DOT
                                                                                specification
                                                                                cylinders, UN
                                                                                cylinders, tube
                                                                                trailers, and multi-
                                                                                element gas containers
                                                                                containing hydrogen
                                                                                chloride without
                                                                                pressure relief
                                                                                devices. (modes 1, 2,
                                                                                3)

16332-N.............  ....................  Nalco Company,      49 CFR 172.302(c),       To authorize the
                                             Naperville, IL.     178.705(c)(1).           transportation in
                                                                                commerce of certain
                                                                                existing UN 31A IBCs
                                                                                manufactured of
                                                                                stainless steel and
                                                                                modified with a lid
                                                                                manufactured of Linear
                                                                                Medium Density
                                                                                Polyethylene. (modes
                                                                                1, 2, 3)
16334-N.............  ....................  ICL Performance     49 CFR 178.255-11,       To authorize the
                                             Products LP, St.    178.274(h)(1).           transportation in
                                             Louis, MO.                                   commerce of an ISO
                                                                                tank with a damaged
                                                                                frame. (mode 1)
16337-N.............  ....................  Volkswagen Group    49 CFR 172.102(c)(2),    To authorize the
                                             of America          Special Provision A54,   transportation in
                                             (VWGoA), Herndon,   ICAO TI Special          commerce of certain
                                             VA.                 Provision A99.           lithium ion batteries
                                                                                each with a net weight
                                                                                greater than 35 kg by
                                                                                cargo aircraft only.
                                                                                (mode 4)
16338-N.............  ....................  Orion               49 CFR 173.306(a)(3)(v)  To authorize the
                                             Polyurethanes,                               transportation in
                                             sp. z.o.o. S.K.A.                            commerce of Division
                                             Dzierzoniow.                                 2.1 hazardous
                                                                                materials in certain
                                                                                DOT Specification 2Q
                                                                                non-refillable inside
                                                                                containers which have
                                                                                been tested by an
                                                                                alternative method in
                                                                                lieu of the hot water
                                                                                bath test. (modes 1,
                                                                                2, 3, 4, 5)
16346-N.............  ....................  FIBA Technologies,  49 CFR 173.301(a)(1),    To authorize the
                                             Inc., Littleton,    178.71.                  manufacture, mark,
                                             MA.                                          sale and use of Type
                                                                                2, hoop-wrapped,
                                                                                refillable, composite
                                                                                reinforced UN pressure
                                                                                receptacles. (modes 1,
                                                                                2, 3)
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2014-30538 Filed 12-31-14; 8:45 am]
BILLING CODE 4909-60-M


[Federal Register Volume 84, Number 72 (Monday, April 15, 2019)]
[Notices]
[Pages 15216-15217]
[FR Doc No: 2019-07440]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2019-0143; FRL-9992-28-OW]

Proposed Information Collection Request; Comment Request;
Treatment of Indian Tribes in a Similar Manner as States for Purposes
of Section 303(d) of the Clean Water Act (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Treatment of Indian
Tribes in a Similar Manner as States for Purposes of Section 303(d) of
the Clean Water Act (Renewal)'' (EPA ICR No. 2553.03 OMB Control No.
2040-0290), to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.). Before doing so, EPA is soliciting public comments on
specific aspects of the proposed information collection as described
below. This is a proposed extension of the ICR, which is currently
approved through December 31, 2019. An Agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number.

DATES: Comments must be submitted on or before June 14, 2019.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2019-0143; FRL-9992-28-OW, online using www.regulations.gov (our
preferred method) or by mail to: EPA Docket Center, Environmental
Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW,
Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information, or other information
whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Carol Peterson, Watershed Assessment,
Restoration, and Protection Division, Office of Wetlands, Oceans, and
Watersheds (4503T), Environmental Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents that explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket visit http://www.epa.gov/dockets.
    Pursuant to Section 3506(c)(2)(A) of the Paperwork Reduction Act,
EPA is soliciting comments and information to

enable it to: (i) Evaluate whether the proposed collection of
information is necessary for the proper performance of the functions of
the Agency, including whether the information will have practical
utility; (ii) 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; (iii) enhance the
quality, utility, and clarity of the information to be collected; and
(iv) 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. EPA will consider the comments received and
amend the ICR as appropriate. The final ICR package will then be
submitted to OMB for review and approval. At that time, EPA will issue
another Federal Register notice to announce the submission of the ICR
to OMB and the opportunity to submit additional comments to OMB.
    Abstract: In 2016, EPA issued regulations establishing a process
for federally recognized tribes to obtain treatment in a similar manner
as states (TAS) for purposes of administrating the water quality
restoration provisions of Clean Water Act (CWA) Section 303(d),
including establishing lists of impaired waters on their reservations
and developing total maximum daily loads (TMDLs). The CWA does not
require tribes to administer the CWA Section 303(d) program. However,
tribes seeking to be authorized must apply for and be found eligible
for TAS through the procedures described in the regulations.
    Section 303(d) of the CWA requires states, territories, and
authorized tribes to identify and establish a priority ranking for
waters that do not meet EPA-approved or promulgated water quality
standards (WQS) following the implementation of technology-based
controls. For waters so identified, Section 303(d) requires states,
territories, and authorized tribes to establish TMDLs in accordance
with their priority ranking for those pollutants the Administrator
identified as suitable for TMDL calculation. A TMDL is the calculation
and allocation to point and nonpoint sources of the maximum amount of a
pollutant that a water body can receive and still meet applicable WQS,
with a margin of safety.
    Form Numbers: None.
    Respondents/affected entities: Any federally recognized tribe with
a reservation.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: Five.
    Frequency of response: Once for initial TAS status, thereafter
biennially for lists of impaired waters, and from time to time for
TMDLs.
    Total estimated burden: 34,757 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $2,003,045 (per year). This action does not
include annualized capital or operation & maintenance costs.
    Changes in Estimates: There is a decrease of 55,147 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. Similarly, there is a decrease of $2,182,387 in the
total estimated cost compared with the ICR currently approved by OMB.
Estimates decreased 61% and 52% respectively. These decreases are due
to: (1) The estimated annual number of respondents decreasing from
twelve to five; (2) new and better data that parses out labor and costs
per activity; and (3) TAS application burden and cost estimates from
post-final rule, Revised Interpretation of Clean Water Act Tribal
Provision (Final Interpretive Rule) (the 2016 ICR for the CWA Section
303(d) Program (ICR No. 2553.02) used pre-final rule estimates).

    Dated: April 8, 2019.
John Goodin,
Director, Office of Wetlands, Oceans, and Watersheds.
[FR Doc. 2019-07440 Filed 4-12-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 88, Number 51 (Thursday, March 16, 2023)]
[Notices]
[Pages 16267-16268]
[FR Doc No: 2023-05333]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-1155]

The Use of Published Literature in Support of New Animal Drug
Approvals; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance for industry #106
entitled ``The Use of Published Literature in Support of New Animal
Drug Approvals.'' This guidance replaces existing guidance #106, ``The
Use of Published Literature in Support of New Animal Drug Approvals,''
which FDA published in August 2000. It addressed the use of a single
scientific article to support drug approval. This revision of the
guidance document considers multiple uses of the scientific literature,
including narrative reviews, systematic reviews, and meta-analyses to
support approval of a new animal drug.

DATES: The announcement of the guidance is published in the Federal
Register on March 16, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''

    Instructions: All submissions received must include the Docket No.
FDA-2021-D-1155 for ``The Use of Published Literature in Support of New
Animal Drug Approvals.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 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 guidance document.

FOR FURTHER INFORMATION CONTACT: Amey Adams, Center for Veterinary
Medicine (HFV-126), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of April 20, 2022 (87 FR 23523), FDA
published the notice of availability for a draft guidance entitled
``The Use of Published Literature in Support of New Animal Drug
Approvals'' giving interested persons until June 21, 2022, to comment
on the draft guidance. FDA received several comments on the draft
guidance, and those comments were considered as the guidance was
finalized. For example, one comment requested that we further clarify
and discuss the potential utility of published studies conducted
outside of the United States; we added such language to the final
guidance. In addition, other editorial changes were made to improve
clarity. The guidance announced in this notice finalizes the draft
guidance dated April 2022.
    This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidance represents
the current thinking of FDA on ``The Use of Published Literature in
Support of New Animal Drug Approvals.'' 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.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 514 have been approved under OMB control
number 0910-0032.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: March 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-05333 Filed 3-15-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 31 (Thursday, February 14, 2013)]
[Notices]
[Pages 10615-10616]
[FR Doc No: 2013-03366]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14483-000]

Westfield Water Resources Department; Notice of Application
Accepted for Filing and Soliciting Comments, Motions To Intervene,
Protests, Recommendations, and Terms and Conditions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Conduit Exemption.
    b. Project No.: 14483-000.
    c. Date filed: January 22, 2013.
    d. Applicant: Westfield Water Resources Department.
    e. Name of Project: Sackett Filtration Plant Hydroelectric Project.
    f. Location: The proposed Sackett Filtration Plant Hydroelectric
Project would be located on a water supply pipeline entering the
Sackett Filtration Plant in Hampden County, Massachusetts. The land on
which all the project structures are located is owned by the applicant.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791a-825r
    h. Applicant Contact: Mr. Charles Darling, Water Systems Engineer,
Westfield Water Resources Department, 28 Sackett Street, Westfield, MA
01085; phone<PHONE_NUMBER>.
    i. FERC Contact: Robert Bell,<PHONE_NUMBER><EMAIL_ADDRESS>    j. Status of Environmental Analysis: This application is ready for
environmental analysis at this time, and the Commission is requesting
comments, reply comments, recommendations, terms and conditions, and
prescriptions.
    k. Deadline for filing responsive documents: Due to the small size
of the proposed project, as well as the resource agency consultation
letters filed with the application, the 60-day timeframe specified in
18 CFR 4.34(b) for filing all comments, motions to intervene, protests,
recommendations, terms and conditions, and prescriptions is shortened
to 30 days from the issuance date of this notice. All reply comments
filed in response to comments submitted by any resource agency, Indian
tribe, or person, must be filed with the Commission within 45 days from
the issuance date of this notice.
    Comments, protests, and interventions may be filed electronically
via the Internet in lieu of paper; see 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov/docs-filing/efiling.asp. The Commission strongly encourages electronic
filings.
    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.
    l. Description of the project: The proposed Sackett Filtration
Plant Hydroelectric Project would consist of: (1) A proposed 16.19-
foot-long, 12-inch-diameter intake pipe; (2) a proposed powerhouse
containing one proposed generating unit with an installed capacity of
80 kilowatts; (3) a proposed 9.42-foot-long, 12-inch-diamter exit pipe;
and (4) appurtenant facilities. The applicant estimates the project
would have an average annual generation of 0.4745 gigawatt-hours.
    m. This filing is available for review and reproduction at the
Commission in the Public Reference Room, Room 2A, 888 First Street NE.,
Washington, DC 20426. The filing may also be viewed on the Web at
http://www.ferc.gov/docs-filing/elibrary.asp using the ``eLibrary''
link. Enter the docket number, P-14483, in the docket number field to
access the document. For assistance, call toll-free 1-866-208-3676 or
email<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy
is also available for review and reproduction at the address in item h
above.
    n. Development Application--Any qualified applicant desiring to
file a competing application must submit to the Commission, on or
before the specified deadline date for the particular application, a
competing development application, or a notice of intent to file such
an application. Submission of a timely notice of intent allows an
interested person to file the competing development application no
later than 120 days after the specified deadline date for the
particular application. Applications for preliminary permits will not
be accepted in response to this notice.
    o. Protests or Motions to Intervene--Anyone may submit a protest or
a motion to intervene in accordance with the requirements of Rules of
Practice and Procedure, 18 CFR 385.210, 385.211, and 385.214. In
determining the appropriate action to take, the Commission will
consider all protests 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 protests or motions to intervene must be
received on or before the specified deadline date for the particular
application.
    p. All filings must (1) Bear in all capital letters the title
``PROTEST,'' ``MOTION TO INTERVENE,'' ``COMMENTS,'' ``REPLY COMMENTS,''
``RECOMMENDATIONS,'' ``TERMS AND CONDITIONS,'' or ``PRESCRIPTIONS; ''
(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, recommendations, terms and
conditions or prescriptions 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. Any of
these documents must be filed by providing the original and seven
copies to: The Secretary, Federal Energy Regulatory Commission, 888
First Street NE., Washington, DC 20426. An additional copy must be sent
to Director, Division of Hydropower Administration and Compliance,
Office of Energy Projects, Federal Energy Regulatory Commission, at the
above address. A copy of any protest or motion to intervene must be
served upon each representative of the applicant specified in the
particular application. 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: February 7, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-03366 Filed 2-13-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 163 (Wednesday, August 22, 2018)]
[Notices]
[Page 42545]
[FR Doc No: 2018-18059]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-83865; File No. SR-NASDAQ-2018-008]

Self-Regulatory Organizations; The Nasdaq Stock Market LLC;
Notice of Designation of a Longer Period for Commission Action on
Proceedings To Determine Whether To Approve or Disapprove a Proposed
Rule Change To Modify the Listing Requirements Contained in Listing
Rule 5635(d) To Change the Definition of Market Value for Purposes of
the Shareholder Approval Rule and Eliminate the Requirement for
Shareholder Approval of Issuances at a Price Less Than Book Value but
Greater Than Market Value

August 16, 2018.
    On January 30, 2018, The Nasdaq Stock Market LLC (``Nasdaq'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to modify the listing requirements contained in
Nasdaq Rule 5635(d) to (1) change the definition of market value for
purposes of shareholder approval under Nasdaq Rule 5635(d); (2)
eliminate the requirement for shareholder approval of issuances at a
price less than book value but greater than market value; and (3) make
other conforming changes. The proposed rule change was published for
comment in the Federal Register on February 20, 2018.\3\ In response,
the Commission received three comments on the proposal.\4\ On April 4,
2018, the Commission extended the time period within which to approve
the proposed rule change, disapprove the proposed rule change, or
institute proceedings to determine whether to disapprove the proposed
rule change to May 21, 2018.\5\ The Commission issued an order
instituting proceedings under Section 19(b)(2)(B) of the Act \6\ to
determine whether to approve or disapprove the proposed rule change on
May 21, 2018 (``OIP'').\7\ The Commission received a letter from the
Exchange in response to the OIP.\8\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 82702 (February 13,
2018), 83 FR 7269 (February 20, 2018).
    \4\ See Letters to Brent J. Fields, Secretary, Commission, from
Michael A. Adelstein, Partner, Kelley Drye & Warren LLP, dated
February 28, 2018; Penny Somer-Greif, Chair, and Gregory T.
Lawrence, Vice-Chair, Committee on Securities Law of the Business
Law Section of the Maryland State Bar Association, dated March 13,
2018; and Greg Rodgers, Latham Watkins, dated March 14, 2018.
    \5\ See Securities Exchange Act Release No. 82994 (April 4,
2018), 83 FR 15441 (April 10, 2018).
    \6\ 15 U.S.C. 78s(b)(2)(B).
    \7\ See Securities Exchange Act Release No. 83294 (May 21,
2018), 83 FR 24379 (May 25, 2018).
    \8\ See Letter to Brent J. Fields, Secretary, Commission, from
Arnold Golub, Vice President, Listing Qualifications, Deputy General
Counsel, Nasdaq, dated July 18, 2018.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \9\ provides that, after initiating
disapproval proceedings, the Commission shall issue an order approving
or disapproving the proposed rule change not later than 180 days after
the date of publication of notice of filing of the proposed rule
change. The Commission may, however, extend the period for issuing an
order approving or disapproving the proposed rule change by not more
than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination. The
proposed rule change was published for notice and comment in the
Federal Register on February 20, 2018.\10\ August 19, 2018 is 180 days
from that date, and October 18, 2018 is 240 days from that date.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(2).
    \10\ See supra note 3.
---------------------------------------------------------------------------

    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed
rule change so that it has sufficient time to consider the proposed
rule change and the comment letters. Accordingly, the Commission,
pursuant to Section 19(b)(2) of the Act,\11\ designates October 18,
2018, as the date by which the Commission shall either approve or
disapprove the proposed rule change (File No. SR-Nasdaq-2018-008).
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(57).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-18059 Filed 8-21-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 7 (Friday, January 10, 2020)]
[Notices]
[Pages 1317-1320]
[FR Doc No: 2020-00259]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0025]

Testing Methods for Asbestos in Talc and Cosmetic Products
Containing Talc; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing a
public meeting entitled ``Testing Methods for Asbestos in Talc and
Cosmetic Products Containing Talc.'' The purpose of the public meeting
is to discuss and obtain scientific information on topics related to
testing methodologies, terminology, and criteria that can be applied to
characterize and measure asbestos and other potentially harmful
elongate mineral particles (EMPs) that may be present as contaminants
in talc and cosmetic products manufactured using talc as an ingredient.

DATES: The public meeting will be held on February 4, 2020, from 8:30
a.m. to 5 p.m. Eastern Time, or until after the last public commenter
has spoken, whichever occurs first. Submit requests to make oral
presentations and comments at the public meeting by January 17, 2020.
Electronic or written comments on this meeting will be accepted until
March 4, 2020. See the SUPPLEMENTARY INFORMATION section of this
document for information about early registration, requesting special
accommodations due to disability, and other information regarding
meeting participation.

ADDRESSES: The public meeting will be held at the Food and Drug
Administration, White Oak Campus, 10903 New Hampshire Ave., Building 31
Conference Center, The Great Room (Rm. 1503), Silver Spring, MD 20993.
Entrance for the public meeting participants (non-FDA employees) is
through Building 1, where routine security check procedures will be
performed. For parking and security information, please refer to
https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2020-N-0025. The docket will close on March 4,
2020. Submit either electronic or written comments on or before March
4, 2020. The electronic filing system will accept comments until 11:59
p.m. Eastern Time at the end of March 4, 2020. Comments received by
mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date. Please note that late,
untimely filed comments will not be considered.

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 below (see ``Written/Paper Submissions'' and
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-N-0025 for ``Testing Methods for Asbestos in Talc and Cosmetic
Products Containing Talc.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
     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.'' We will review
this copy, including the claimed confidential information, in our
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. If you do not wish your name
and contact information to be made publicly available, you can provide
this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Denise Hodge, Food and Drug
Administration, Center for Food Safety and Applied Nutrition, 5001
Campus Dr. (HFS-125), College Park, MD 20740,

301-796-7739, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Talc is used in a wide variety of consumer products, including
cosmetics. Talc is mined as a naturally occurring hydrous magnesium
silicate and may be contaminated with asbestos fibers due to the
proximity of asbestos to talc deposits. Asbestos is a known human
carcinogen, and its health risks are well documented. Inhalation of
asbestos is a safety concern because it can cause the formation of
scar-like tissue in the lung, resulting in asbestosis, or it may lead
to the development of lung cancers and malignant mesothelioma.
    In 1976, the cosmetics industry implemented voluntary asbestos
testing of talc raw materials using the Cosmetic, Toiletry, and
Fragrance Association (CTFA) J4-1 (Ref. 1) method in response to test
results indicating asbestos to be present. Talc suppliers to the
pharmaceutical industry use a similar method to certify that talc meets
the United States Pharmacopeia's (USP's) requirement for ``Absence of
Asbestos'' (Ref. 2). To date, both methods, which rely on the use of x
ray diffraction (XRD) or infrared (IR) spectroscopy followed by
polarized light microscopy (PLM) only if XRD or IR is positive for
amphibole or serpentine minerals in talc, remain standard test methods
despite long-recognized shortcomings in specificity and sensitivity
compared with electron microscopy-based methods. In 2010, FDA asked the
USP to consider revising the current tests for asbestos in talc to
ensure adequate specificity, and, in 2014, the Talc USP expert panel
recommended an update of the Talc USP monograph to require an electron
microscopy method for the measurement of asbestos in talc (Refs. 3 and
4). Recent testing of cosmetics by private laboratories \1\ using
transmission electron microscopy (TEM) has revealed the presence of
asbestos fibers in samples that had negative findings for the same
products using polarized light microscopy, thus highlighting the
shortcomings of optical microscopy methods.
---------------------------------------------------------------------------

    \1\ See AMA testing results at FDA's Investigation of Reports of
Asbestos Contamination in Cosmetics 2017-2019 tab at https://www.fda.gov/cosmetics/cosmetic-ingredients/talc.
---------------------------------------------------------------------------

    FDA monitors for asbestos in talc-containing cosmetic products,
including directing its sampling of products toward confirming reports
from various laboratories that have reported asbestos using electron
microscopy. For example, in 2010, shortly after reports of asbestos
contaminated talc-containing products in Asia, FDA surveyed 34 cosmetic
products,\2\ including body powders, face powders, foundation, eye
shadow, blush, and samples from four major talc suppliers and found no
asbestos contamination using the most sensitive techniques available.
FDA's survey was limited in scope but served to provide data from
testing using TEM, currently regarded by many experts as the most
reliable technique for detecting asbestos fibers (see Ref. 4). In July
2017, FDA began investigating reports of asbestos contamination of
cosmetic products that contained talc, presumably originating from talc
that was used as an ingredient in the cosmetic products. In 2019, FDA
surveyed 50 talc-containing cosmetic products. In March, June, August,
and October 2019, FDA confirmed the presence of chrysotile and/or
tremolite asbestos in several cosmetic products, which were voluntarily
recalled by the companies. The use of TEM was critical in detecting
asbestos in these cosmetic products.
---------------------------------------------------------------------------

    \2\ https://www.fda.gov/cosmetics/cosmetic-ingredients/talc.
---------------------------------------------------------------------------

    Even when using the most sensitive electron microscopy methods,
laboratories testing the same product may reach different conclusions
about the presence of asbestos. These differences may be attributed to
a lack of a uniform standard for testing which provides unambiguous
guidelines for identifying and counting asbestos fibers. Thus, at FDA's
request, on November 28, 2018, the Joint Institute for Food Safety and
Applied Nutrition (JIFSAN) convened an ``Asbestos in Talc'' symposium
to provide a forum for experts in asbestos mineral analysis,
academicians, and government officials to share knowledge and
experience.\3\ The discussions focused on the toolbox of available
testing methods for analysis of asbestos in talc and talc-containing
cosmetic products, criteria used for asbestos fiber identification and
counting in current published methods, and how analytical microscopy
data might be interpreted in making decisions about the suitability of
cosmetic products found to contain asbestos and other potentially
harmful mineral particles.
---------------------------------------------------------------------------

    \3\ https://jifsan.umd.edu/events/2018-asbestos-in-talc-symposium.
---------------------------------------------------------------------------

    During the fall of 2018, FDA formed an interagency working group on
asbestos in consumer products (IWGACP). The IWGACP consists of 38
subject matter experts from the following U.S. federal agencies: FDA,
National Institute for Occupational Safety and Health (NIOSH), National
Institutes of Health/National Institute of Environmental Health
Sciences, Occupational Safety and Health Administration, Environmental
Protection Agency, Consumer Product Safety Commission, National
Institute of Standards and Technology, and Department of Interior's
U.S. Geological Survey. The IWGACP was asked to support the development
of standardized testing methods for asbestos and other mineral
particles of concern that could potentially affect consumer product
safety. The IWGACP was tasked to address terminology and definitions of
asbestos and other EMPs of health concern in talc and talc-containing
consumer products, recommend methodological improvements for measuring
asbestos in talc and talc-containing consumer products, and recommend
laboratory reporting standards for testing talc and talc-containing
consumer products. The IWGACP is also addressing issues regarding
asbestos contamination in talc-containing cosmetic products, the
presumptive source of asbestos, as well as scientific and technical
information shared at the JIFSAN Symposium and how that information
could be used by different government agencies. The IWGACP is comprised
of three subgroups formed to address the following topics: (1)
Terminology and definitions of asbestos and other EMPs of health
concern in talc; (2) development of a robust analytical protocol for
detecting asbestos and other EMPs of health concern in talc and
consumer products containing talc; and (3) data reporting and analysis.

II. Purpose of the Public Meeting

    FDA is interested in obtaining information to further the
development of standardized testing methods to improve sensitivity,
consistency, and inter-laboratory concurrence of asbestos testing of
talc used in cosmetic products and of talc-containing cosmetic
products. Toward this end, at the public meeting, IWGACP members will
present preliminary recommendations (summarized in section IV.C) on
testing methods, including criteria to be used for asbestos fiber
identification and counting. We will also seek additional information
on these topics at the meeting. We do not intend for this meeting to
produce any decisions or new positions on specific regulatory
questions. However, we expect this meeting to be an important step in
our continued efforts to gather information, including data to improve
the consistency in terminology, analytical protocols, and data
reporting for

asbestos and other potentially harmful mineral particles that may be
present as contaminants in talc and cosmetic products containing talc
and provide information that can be used for future discussions on
health effects.

III. Participating in the Public Meeting

    Registration: To register to attend the public meeting on ``Testing
Methods for Asbestos in Talc and Cosmetic Products Containing Talc,''
either in person or by webcast, please register at https://www.fda.gov/cosmetics/cosmetics-news-events/meetings-conferences-workshops-cosmetics by January 28, 2020, at 11:59 p.m. Eastern Time. Please
provide complete contact information for each attendee, including name,
title, affiliation, and email and whether you want to attend in person
or by webcast. The FDA Conference Center at the White Oak location is a
Federal facility with security procedures and limited seating.
Attendance will be free and based on space and availability. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive confirmation when they have been accepted for
in-person attendance. If time and space permit, onsite registration on
the day of the public meeting will be provided beginning at 7:30 a.m.
We will inform registrants if registration closes before the day of the
public meeting. Persons attending this meeting are advised that FDA is
not responsible for providing access to electrical outlets. FDA will
make every effort to accommodate persons with physical disabilities or
special needs. If you need special accommodations due to a disability,
please contact Denise Hodge (see FOR FURTHER INFORMATION CONTACT) no
later than January 17, 2020.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to make a formal presentation (with up to five
slides) or present oral comments during the public comment session
(with no slides), and you may indicate which topic(s) you would like to
address. Oral presentations can only be made in person at the meeting.
FDA will do its best to accommodate requests to make public
presentations. We seek a broad representation of ideas and issues
presented at the meeting. We urge individuals and organizations with
common interests to consolidate or coordinate their presentations and
request time for a joint presentation. Following the close of
registration, we will determine the amount of time allotted to each
presenter and the approximate time each presentation is to begin and
will select and notify participants by January 21, 2020. All requests
to make oral presentations must be received by January 17, 2020, 11:59
p.m. Eastern time. Typically, presentations are between 3 and 5
minutes. If selected for a formal oral presentation (with slides), each
presenter must submit an electronic copy of their presentation
(PowerPoint or PDF) to<EMAIL_ADDRESS>on or before January 28,
2020. Those who are not giving electronic presentations are encouraged
to submit a single slide (PowerPoint or PDF) with their name,
affiliation, and topic. No commercial or promotional material will be
permitted to be presented or distributed at the public meeting. Persons
notified that they will be presenters are encouraged to arrive early
and check in at the onsite registration table to confirm their
designated presentation times. Actual presentation times may vary based
on how the meeting progresses in real time. An agenda for the public
meeting and any other background materials will be made available at
least 5 days before the meeting at https://www.fda.gov/cosmetics/cosmetics-news-events/meetings-conferences-workshops-cosmetics. Those
without internet or email access can register and/or request to
participate by contacting Denise Hodge (see FOR FURTHER INFORMATION
CONTACT) no later than January 17, 2020.
    Transcripts: A transcript of the public meeting will be made
available as soon as feasible. It will be accessible at
www.regulations.gov and https://www.fda.gov/cosmetics/cosmetics-news-events/meetings-conferences-workshops-cosmetics. It may be viewed at
the Dockets Management Staff (see ADDRESSES). A transcript will also be
made available in either hardcopy or on CD-ROM, in response to a
Freedom of Information Act request. A Freedom of Information Act
request may be submitted by visiting https://www.accessdata.fda.gov/scripts/foi/foirequest/requestform.cfm or by submitting an email
request to<EMAIL_ADDRESS>
IV. Issues for Consideration and Request for Information

    We encourage public comments and presentations at the public
meeting. In submitting information to the docket, please provide
available references for the information.

A. Testing Methodologies and Criteria

    As previously discussed, laboratories may reach different
conclusions as to whether asbestos and other potentially harmful EMPs
are present when testing consumer products. We are seeking scientific
information on the following topics related to testing methodologies
and criteria that can be applied to characterize and measure asbestos
and other potentially harmful EMPs present as contaminants in talc and
cosmetic products manufactured using talc as an ingredient. We invite
comments on the following:
    1. The sensitivity of PLM as a test method, including whether the
test method can lead to a false negative result for asbestos particles.
    2. The sensitivity of TEM as a test method, including the ability
of the test method to identify asbestos particles in comparison to PLM.
    3. Criteria for identification of the specified asbestos minerals,
noting that different minerals with the same chemical composition can
exist in samples.

B. Research Needs To Promote the Reliability of Analytical Methods

    The IWGACP identified the following as areas for directing efforts
to promote reliability of the analytical methods for asbestos and other
EMPs of health concern in talc and talc-containing consumer products.
We invite such information to be presented during the public comment
section of the meeting:
    1. Validation of analytical methods (XRD, PLM, TEM) specific to
talc and cosmetic products containing talc that minimize false positive
and false negative results.
    2. Research and validation of methods of sampling that maximize
sample representativeness and minimize error and false positives and
false negatives.
    3. Research on methods for sample preparation, in particular
treatment (e.g., ``concentration methods'') that improves sensitivity
while leaving covered minerals unchanged with respect to identity and
dimensions.
    4. Development of talc-specific reference standards with known
concentrations of specific EMPs that can be used to assess laboratory
and analyst proficiency, increase inter-laboratory concurrence in
method validation, minimize reporting errors, and potentially provide
for improved reliability of quantitative analysis.

C. IWGACP's Preliminary Recommendations

    We invite comments related to the following preliminary
recommendations from the IWGACP:
    1. Adoption of the term EMP as ``any mineral particle with a
minimum aspect ratio of 3:1'', consistent with how this term is defined
in NIOSH Bulletin 62 (Ref. 5).

    2. Testing laboratories should report all EMPs having length >=0.5
micrometers (500 nanometers (nm)).
    3. Test methods should specify reportable EMPs identified as
amphibole or chrysotile particles as covered minerals.
    4. Test methods should include the counting and reporting of
covered EMPs as a function of sample mass. In counting, guidelines such
as ISO 10312, ``Ambient air--Determination of asbestos fibres--Direct
transfer transmission electronic microscopy method'' (Ref. 6), classify
primary and secondary structures. Individual fibers in secondary
structures can be counted recording the dimensions of each fiber.
    5. Use of TEM at nominally 20,000 x magnification, in addition to
PLM, to resolve the issues of sensitivity that cause reporting of false
negatives for covered EMPs. Use of TEM with energy dispersive x ray
spectroscopy and selected area electron diffraction analyses may
reliably detect and identify chrysotile and asbestiform and non-
asbestiform amphibole minerals, including EMPs whose narrowest width is
<200 nm. Scanning electron microscopy might be useful as a
complementary method, but has significant shortcomings for
identification of chrysotile and visualization of the narrowest
particles in the population that can only be overcome by using TEM.
    6. ``Mass percent'', a unit that is frequently used to express
content of asbestos in commercial bulk materials, is not appropriate
for measurement of EMPs in talc and consumer products containing talc
because mass percent does not correlate with the number of fibers, and
one large fiber could dominate the mass percent value.

V. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

1. The Cosmetic, Toiletry and Fragrance Association, Inc. (CTFA)
1990. Method, J 4-1, ``Asbestiform Amphibole Minerals in Cosmetic
Talc'' in Compendium of Cosmetic Ingredient Composition:
Specifications Personal Care Products Council, Washington DC (1976)
(revised in 1990). See http://www.asbestosandtalc.com/EMP%20Detection%20Limits%20ASTM/PCPC000960.pdf.
2. USP, Revision Bulletin, ``Talc,'' dated August 1, 2011, at page
2. See https://www.usp.org/sites/default/files/usp/document/harmonization/excipients/m80360talc.pdf.
*3. Woodcock, J. (2010). Letter to Roger L. Williams, CEO of USP
(October 12, 2010). See https://www.usp.org/sites/default/files/usp/document/get-involved/monograph-modernization/2010-10-12-letter-from-dr-janet-woodcock.pdf.
4. Block L.H., D. Beckers, J. Ferret, G.P. Meeker, et al. (2014).
``Stimuli to the Revision Process, Modernization of Asbestos Testing
in USP Talc,'' USP-PF 40(4).
*5. NIOSH 2011. ``Asbestos Fibers and Other Elongate Mineral
Particles: State of the Science and Roadmap for Research,'' Current
Intelligence Bulletin 62. Department of Health and Human Services.
Centers for Disease Control and Prevention. National Institute for
Occupational Safety and Health. Publication No. 2011-159 (March
2011). https://www.cdc.gov/niosh/docs/2011-159/pdfs/2011-159.pdf.
6. International Organization for Standardization, ``ISO
10312:2019(en) Ambient air--Determination of asbestos fibres--Direct
transfer transmission electron microscopy method.'' See https://www.iso.org/obp/ui/#iso:std:iso:10312:ed-2:v1:en.

    Dated: January 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00259 Filed 1-9-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30598-30599]
[FR Doc No: 2014-12195]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC14-14-000]

Commission Information Collection Activities (FERC-519); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of information collection and request for comments.

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

SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, 44 USC 3506(c)(2)(A), the Federal Energy Regulatory
Commission (Commission or FERC) is soliciting public comment on the
currently approved information collection, Application under Federal
Power Act Section 203.

DATES: Comments on the collection of information are due July 28, 2014.

ADDRESSES: You may submit comments (identified by Docket No. IC14-14-
000) by either of the following methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-519, Application under Federal Power Act Section 203.
    OMB Control No.: 1902-0082.
    Type of Request: Three-year extension of the FERC-519 information
collection requirements with no changes to the current reporting
requirements.
    Abstract: The FERC-519, ``Application under Federal Power Act
Section 203,'' is necessary to enable the Commission to carry out its
responsibilities in implementing the statutory provisions of Section
203 of the Federal Power Act (FPA), 16 U.S.C. 824b. Section 203
authorizes the Commission to grant approval of transactions in which a
public utility disposes of jurisdictional facilities, merges such
facilities with the facilities owned by another person or acquires the
securities of another public utility. Under this statute, the
Commission must find that the proposed transaction will be consistent
with the public interest.
    Under section 203 of the FPA, FERC must review proposed mergers,
acquisitions and dispositions of jurisdictional facilities by public
utilities, if the value of the facilities exceeds $10 million, and must
approve these transactions if they are consistent with the public
interest. One of FERC's overarching goals is to promote competition in
wholesale power markets, having determined that effective competition,
as opposed to traditional forms of price regulation, can best protect
the interests of ratepayers. Market power, however, can be exercised to
the detriment of effective competition and customers, making it
necessary for FERC to review and approve or disapprove all
jurisdictional mergers, dispositions and acquisitions. The Commission
implements these filing requirements in the Code of Federal Regulations
(CFR) under 18 CFR part 33.

    Type of Respondents: Public utilities subject to the FPA.
    Estimate of Annual Burden: \1\ The Commission estimates the total
Public Reporting Burden for this information collection as:
---------------------------------------------------------------------------

    \1\ The Commission defines burden as 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. For further explanation of what is included in the
information collection burden, reference 5 Code of Federal
Regulations 1320.3.

                                                                        FERC-519
                                                    [Application under Federal Power Act Section 203]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Total annual
                                                          Number of      Annual number   Total number of  Average burden  burden hours &     Cost per
                                                         respondents      of responses      responses       & cost per     total annual     respondent
                                                                         per respondent                    response \2\        cost             ($)
                                                                  (1)              (2)      (1)*(2)=(3)              (4)     (3)*(4)=(5)         (5)/(1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
FERC-519.............................................             141                1              141              395          55,695       $27,847.5
                                                                                $27,847.5      $3,926,498  ..............
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.
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    \2\ The estimates for cost per response are derived using the
following formula: Average Burden Hours per Response * $70.50 per
Hour = Average Cost per Response. The hourly cost figure of $70.50
is the average FERC employee wage plus benefits. We assume that
respondents earn at a similar rate.

    Dated: May 19, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-12195 Filed 5-27-14; 8:45 am]
BILLING CODE 6717-01-P


Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the Exchange consents, the Commission shall: (a) by order approve
or disapprove such proposed rule change, or (b) institute proceedings
to determine whether the proposed rule change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to [email protected]. Please include
File Number SR-PEARL-2018-02 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-PEARL-2018-02. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549, on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the Exchange. All comments
received will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-PEARL-2018-02 and should be submitted on
or before March 20, 2018.
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    \60\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\60\
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-03894 Filed 2-26-18; 8:45 am]
 BILLING CODE 8011-01-P


MEMORANDUM TO: 304( m) Record ( EPA Docket Number OW 2004 0074)

FROM: Cortney Itle, ERG DATE: August 23, 2004 SUBJECT: Comparison of Methodologies for Estimation of Values Below the Detection Limit for the Steam Electric Industry Facilities that have NPDES permits submit discharge monitoring report data ( DMR) to their permitting authority. The DMR data is submitted to EPA's Permit Compliance System ( PCS) database. For parameters that are not detected during monitoring, permittees have the option of reporting the detection limit and that the measured concentration fell below detection limit ( BDL). BDL means that the actual concentration is between zero and the detection limit. Therefore, the following options have been used to estimate loadings from PCS data:

BDL is set equal to zero;

BDL is set to the detection limit; and

BDL is set equal to half the detection limit.

For the PCSLoads2000 database, ERG initially calculated loadings with BDL set equal to half the detection limit. This approach resulted in relatively high calculated mass loads for some parameters reported with a wide range in detection limits ( e. g., PCBs and dioxins). The high mass loads reflected high reported detection limits for discharges in which the parameters were never detected possibly as a result of relatively insensitive laboratory analyses. However, by setting the BDL to zero, ERG believes the pollutant discharges are likely to be underestimated because facilities generally monitor for only those pollutants likely to be generated by their industrial processes.

Therefore, ERG developed a hybrid approach where BDL was set equal to zero for parameters never detected by the facility in 2000. For parameters sometimes detected and sometimes not, BDL was set equal to half of the detection limit. ERG considered half the detection limit a reasonable estimate of the unknown concentration for an initial screening level review and prioritization of the toxic weighted pollutant loadings discharged by industrial categories.

ERG performed an analysis of pollutant loads associated with the steam electric industry to compare the resulting TWPE when: ° BDL values are set equal to zero ( abbreviated in the spreadsheet as KGY0);

° BDL is estimated to be equal to half the detection limit ( abbreviated in the spreadsheet as KGYE); and ° BDL is set equal to zero for parameters never detected by the facility in 2000, and for parameters sometimes detected and sometimes not, BDL is set equal to half of the detection limit ( this is the approach used to develop PCSLoads2000).

Toxic weighted pound equivalent ( TWPE) loads were estimated from PCS data for all of the circumstances listed above. Note that chlorine loads were excluded from this analysis ( see Section 5.4.4 of the TSD for a discussion of chlorine loads).

The total industry TWPE estimated with BDL set to zero represents 72 percent of the total industry TWPE estimated by ERG in PCSLoads2000. In other words, the total TWPE for the steam electric industry in PCSLoads2000 are 38 percent higher than loads estimated with BDL set equal to zero.

The total industry TWPE estimated with BDL set to half the detection limit represents 1,410 percent of the total industry TWPE estimated by ERG in PCSLoads2000. In other words, the total TWPE for the steam electric industry in PCSLoads2000 are 93 percent lower than loads estimated with BDL set equal to half the detection limit.

Please see the attached excel workbook for the data used to estimate the total industry TWPE for each BDL circumstance. The total load ( in pounds and TWPE) is shown by parameter for each BDL circumstance.