[Federal Register Volume 79, Number 150 (Tuesday, August 5, 2014)]
[Proposed Rules]
[Pages 45383-45385]
[FR Doc No: 2014-18449]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0532; Directorate Identifier 2014-CE-016-AD]
RIN 2120-AA64

Airworthiness Directives; Pacific Aerospace Limited Airplanes

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

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Pacific Aerospace Limited Models FU24-954 and FU24A-954 airplanes. This
proposed AD results from mandatory continuing airworthiness information
(MCAI) originated by an aviation authority of another country to
identify and correct an unsafe condition on an aviation product. The
MCAI describes the unsafe condition as cracking of control column at
the wiring access hole, which could lead to loss of control. We are
issuing this proposed AD to require actions to address the unsafe
condition on these products.

DATES: We must receive comments on this proposed AD by September 19,
2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Pacific Aerospace Limited, Airport Road, Hamilton Private Bag 3027
Hamilton 3240, New Zealand; telephone: +64 7 843 6144; fax: +64 7 843
6134; email<EMAIL_ADDRESS>Internet: http://www.aerospace.co.nz/. You may review this referenced service
information at the FAA, Small Airplane Directorate, 901 Locust, Kansas
City, Missouri 64106. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0532; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments
will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Karl Schletzbaum, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2014-0532;
Directorate Identifier 2014-CE-016-AD'' at the beginning of your
comments. We specifically invite

comments on the overall regulatory, economic, environmental, and energy
aspects of this proposed AD. We will consider all comments received by
the closing date and may amend this proposed AD because of those
comments.
    We will post all comments we receive, without change, to http://regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The Civil Aviation Authority (CAA), which is the airworthiness
authority for New Zealand, has issued AD DCA/FU24/183, dated May 29,
2014 (referred to after this as ``the MCAI''), to correct an unsafe
condition for Pacific Aerospace Limited Models FU24-954 and FU24A-954
airplanes and was based on mandatory continuing airworthiness
information originated by an aviation authority of another country. The
MCAI states:

    This AD requires an inspection of the control column for
mechanical damage, deformation and cracks per the instructions in
Pacific Aerospace Limited (PAL) Mandatory Service Bulletin (MSB) No.
PACSB/FU/095 issue 2 dated 28 May 2014. For control columns found
with mechanical damage or deformation the AD requires a 50 hour
repetitive NDT inspection until replacement. Control column
replacement is required at the next maintenance inspection, or
within the next 150 hours TIS, whichever is the later.

    You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0532.

Relevant Service Information

    Pacific Aerospace Limited has issued Mandatory Service Bulletin
PACSB/FU/095, Issue 2, dated May 28, 2014. The actions described in
this service information are intended to correct the unsafe condition
identified in the MCAI.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Costs of Compliance

    We estimate that this proposed AD will affect 1 product of U.S.
registry. We also estimate that it would take about .5 work-hour per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $85 per work-hour.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $42.50, or $42.50 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 8 work-hours and require parts costing $1,000, for a cost of
$1,680 per product. We have no way of determining the number of
products that may need these actions.
    According to the manufacturer, some of the costs of this AD may be
covered under warranty, thereby reducing the cost impact on affected
individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. Amend Sec.  39.13 by adding the following new AD:

Pacific Aerospace Limited: Docket No. FAA-2014-0532; Directorate
Identifier 2014-CE-016-AD.

(a) Comments Due Date

    We must receive comments by September 19, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Pacific Aerospace Limited Models FU24-954 and
FU24A-954 airplanes, all serial numbers, certificated in any
category.

(d) Subject

    Air Transport Association of America (ATA) Code 27: Flight
Controls.

(e) Reason

    This AD was prompted from mandatory continuing airworthiness
information (MCAI) issued by the aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as cracking of the
control column at the wiring access hole. We are issuing this AD to
detect and correct cracking of the control column at the wiring
access hole which could cause control column failure and subsequent
loss of control.

(f) Actions and Compliance

    Unless already done, do the following actions in paragraphs
(f)(1) through (f)(3) of

this AD, following the accomplishment instructions in Pacific
Aerospace Limited Mandatory Service Bulletin PACSB/FU/095, Issue 2,
dated May 28, 2014.
    (1) Within the next 50 hours time-in-service (TIS) after the
effective date of this AD, inspect the control column part number
(P/N) 08-45031/32 for cracks.
    (2) If any mechanical damage, deformation, or cracks are found,
before further flight, replace the control column with an airworthy
control column P/N 08-45031/32.
    (3) If no mechanical damage, deformation, or cracks are found
after the inspection required in paragraph (f)(1) of this AD, at the
next scheduled maintenance inspection or within the next 150 hours
TIS, whichever occurs later, replace the control column with an
airworthy P/N 08-45031/32.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Karl Schletzbaum, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER> ; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>Before using any approved AMOC on
any airplane to which the AMOC applies, notify your appropriate
principal inspector (PI) in the FAA Flight Standards District Office
(FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

 (h) Related Information

    Refer to MCAI Civil Aviation Authority (CAA) AD DCA/FU24/183,
dated May 29, 2014, and Pacific Aerospace Limited Mandatory Service
Bulletin PACSB/FU/095, Issue 2, dated May 28, 2014, for related
information. You may examine the MCAI on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-
2014-0532. For service information related to this AD, contact
Pacific Aerospace Limited, Airport Road, Hamilton Private Bag 3027
Hamilton 3240, New Zealand; telephone: +64 7 843 6144; fax: +64 7
843 6134; email<EMAIL_ADDRESS>Internet: http://www.aerospace.co.nz/. You may review this referenced service
information at the FAA, Small Airplane Directorate, 901 Locust,
Kansas City, Missouri 64106. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

    Issued in Kansas City, Missouri, on July 29, 2014.
James E. Jackson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-18449 Filed 8-4-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 82 (Monday, April 29, 2019)]
[Notices]
[Pages 18019-18020]
[FR Doc No: 2019-08571]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2014-0054; FRL-9992-98-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NESHAP for Pulp and Paper Production
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), NESHAP for Pulp and Paper
Production (EPA ICR No. 1657.09, OMB Control No. 2060-0387) to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a proposed
extension of the ICR, which is currently approved through April 30,
2019. Public comments were previously requested via the Federal
Register on October 15, 2018 during a 60-day comment period. This
notice allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. 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: Additional comments may be submitted on or before May 29, 2019.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2014-0054, to (1) EPA online using www.regulations.gov (our
preferred method), by email to [email protected], or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460, and (2) OMB via email to
[email protected]. Address comments to OMB Desk Officer for
EPA.
    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 (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Patrick Yellin, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which 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, EPA 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.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Pulp and Paper Production apply to existing and
new facilities that produce pulp, paper, or paperboard by employing
kraft, soda, sulfite, semi-chemical, or mechanical pulping processes
using wood, or any process using secondary or non-wood fiber and that
emits 10 tons per year or more of any hazardous air pollutant (HAP) or
25 tons per year or more of any combination of HAPs. Affected sources
are all the HAP emission points in the pulping and bleaching system for
mechanical pulping processes using wood and any process using secondary
or non-wood fiber. New facilities include those that commenced
construction or reconstruction after the date of proposal. This
information is being collected to assure compliance with 40 CFR part
63, subpart S.
    In general, all NESHAP standards require initial notifications,
performance tests, and periodic reports by the owners/operators of the
affected facilities. They are also required to maintain records of the
occurrence and duration of any startup, shutdown, or malfunction in the
operation of an affected facility, or any period during which the
monitoring system is inoperative. These notifications, reports, and
records are essential in determining compliance, and are required of
all affected facilities subject to NESHAP.
    Form Numbers: None.
    Respondents/affected entities: Owners and operators of pulp and
paper mills that are major sources of HAP emissions.
    Respondent's obligation to respond: Mandatory (40 CFR part 63,
subpart S).
    Estimated number of respondents: 114 (total).
    Frequency of response: Initially, occasionally, and semiannually.
    Total estimated burden: 44,438 hours (per year). Burden is defined
at 5 CFR 1320.3(b).
    Total estimated cost: $5,191,626 (per year), includes $841,000
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is an adjustment decrease in the
total estimated burden as currently identified in the OMB Inventory of
Approved Burdens. This decrease is not due to any program changes. The
currently approved burden estimates contain requirements from the
previous regulation as well as duplicate burden activities. In
preparing this ICR renewal, EPA has removed duplicate items and updated
the ICR so that it only reflects current requirements. This results in
an apparent decrease in burden.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2019-08571 Filed 4-26-19; 8:45 am]
 BILLING CODE 6560-50-P


AD Meets with the U. S. Silver Task Force On Wednesday, October 14,
2009, members from AD's silver registration review team and silver
registration team hosted a meeting with the U. S. Silver Task Force
(STF) to discuss the registration review process, their submitted public
comments, and the anticipated data needs that were identified in the
summary document for the silver registration review case.  The STF
requested this meeting to speak with the scientists involved in the
preparation of the summary document for silver and compounds.
Discussions also included bridging of silver salt/zeolite data, water
quality, additional safety factors, and, to a lesser extent,
nanotechnology to gain a better understanding of how the issues could
affect task force members and their current and future regulatory
approval.  The meeting summary and materials will be posted to the
public docket.  The Agency is scheduled to complete the final work plan
for registration review of silver and compounds in December 2009.


[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Page 55896]
[FR Doc No: 2011-23083]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 1

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

    Docket Numbers: ER11-4357-001.
    Applicants: Marathon Power LLC.
    Description: Amendment to Application of Marathon Power LLC.
    Filed Date: 08/31/2011.
    Accession Number: 20110831-5048.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 21, 2011.

    Docket Numbers: ER11-4393-000.
    Applicants: TAQA Gen X LLC.
    Description: TAQA Gen X LLC submits tariff filing per 35.12: TAQA
MBR Tariffs to be effective 8/31/2011.
    Filed Date: 08/30/2011.
    Accession Number: 20110830-5001.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 20, 2011.

    Docket Numbers: ER11-4395-000.
    Applicants: Duke Energy Carolinas, LLC.
    Description: Duke Energy Carolinas, LLC submits tariff filing per
35.13(a)(2)(iii: Amendment to PMPA NITSA to be effective 8/1/2011.
    Filed Date: 08/30/2011.
    Accession Number: 20110830-5080.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 20, 2011.

    Docket Numbers: ER11-4396-000.
    Applicants: Louisville Gas and Electric Company.
    Description: Louisville Gas and Electric Company submits tariff
filing per 35.13(a)(2)(iii: 08--30--11 TranServ Replacement ITO to be
effective 9/1/2012.
    Filed Date: 08/30/2011.
    Accession Number: 20110830-5090.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 20, 2011.

    Docket Numbers: ER11-4397-000.
    Applicants: Dynegy Midwest Generation, LLC.
    Description: Dynegy Midwest Generation, LLC submits tariff filing
per 35.13(a)(2)(iii: Notice of Succession to Black Start Service
Agreement to be effective 8/4/2011.
    Filed Date: 08/30/2011.
    Accession Number: 20110830-5112.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 20, 2011.

    Docket Numbers: ER11-4398-000.
    Applicants: Dynegy Midwest Generation, LLC.
    Description: Dynegy Midwest Generation, LLC submits tariff filing
per 35.13(a)(2)(iii: Notice of Succession to Market-Based Rate Tariff
to be effective 8/4/2011.
    Filed Date: 08/30/2011.
    Accession Number: 20110830-5117.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 20, 2011.

    Docket Numbers: ER11-4399-000.
    Applicants: Dynegy Midwest Generation, LLC.
    Description: Dynegy Midwest Generation, LLC submits tariff filing
per 35.13(a)(2)(iii: Notice of Succession to Reactive Service Rate
Schedule to be effective 8/4/2011.
    Filed Date: 08/30/2011.
    Accession Number: 20110830-5118.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 20, 2011.

    Docket Numbers: ER11-4400-000.
    Applicants: Dynegy Power Marketing, LLC.
    Description: Dynegy Power Marketing, LLC submits tariff filing per
35.13(a)(2)(iii: Notice of Succession to Market-Based Rate Tariff to be
effective 8/4/2011.
    Filed Date: 08/30/2011.
    Accession Number: 20110830-5119.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 20, 2011.

    Docket Numbers: ER11-4401-000.
    Applicants: Louisville Gas and Electric Company.
    Description: Louisville Gas and Electric Company submits tariff
filing per 35.13(a)(2)(iii: 08--30--11 BREC Amd NITSA to be effective
8/31/2011.
    Filed Date: 08/30/2011.
    Accession Number: 20110830-5135.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 20, 2011.

    Docket Numbers: ER11-4402-000.
    Applicants: PJM Interconnection, LLC.
    Description: PJM Interconnection, LLC submits tariff filing per
35.13(a)(2)(iii: Revisions to the Black Start Service--PJM Tariff
Schedule 6A to be effective 11/1/2011.
    Filed Date: 08/30/2011.
    Accession Number: 20110830-5148.
    Comment Date: 5 p.m. Eastern Time on Tuesday, September 20, 2011.

    Docket Numbers: ER11-4403-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits tariff filing
per 35.13(a)(2)(iii: Cantua Solar Station WDT SGIA to be effective 9/1/
2011.
    Filed Date: 08/31/2011.
    Accession Number: 20110831-5003.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 21, 2011.

    Docket Numbers: ER11-4404-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Pacific Gas and Electric Company submits tariff filing
per 35.13(a)(2)(iii: Giffen Solar Station WDT SGIA to be effective 9/1/
2011.
    Filed Date: 08/31/2011.
    Accession Number: 20110831-5004.
    Comment Date: 5 p.m. Eastern Time on Wednesday, September 21, 2011.

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

    Dated: August 31, 2011.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2011-23083 Filed 9-8-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 154 (Thursday, August 9, 2012)]
[Rules and Regulations]
[Pages 47511-47512]
[FR Doc No: 2012-19498]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 77, No. 154 / Thursday, August 9, 2012 /
Rules and Regulations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, and 524

[Docket No. FDA-2012-N-0002]

New Animal Drugs; Cephalexin; Fentanyl; Milbemycin Oxime and
Praziquantel

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval actions for new animal drug
applications (NADAs) and abbreviated new animal drug applications
(ANADAs) during June 2012. FDA is also informing the public of the
availability of summaries the basis of approval and of environmental
review documents, where applicable.

DATES: This rule is effective August 9, 2012.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA's Center for Veterinary Medicine is
adopting use of a monthly Federal Register document to codify approval
actions for new animal drug applications (NADAs) and abbreviated new
animal drug application (ANADAs). CVM will no longer publish a separate
rule for each action. This approach will allow a more efficient use of
available resources.
    In this document, FDA is amending the animal drug regulations to
reflect the original and supplemental approval actions during June
2012, as listed in table 1. In addition, FDA is informing the public of
the availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4
p.m., Monday through Friday. Persons with access to the Internet may
obtain these documents at the CVM FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm.

                                      Table 1--Original and Supplemental NADAs and ANADAs Approved During June 2012
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               New animal drug
     NADA/ANADA             Sponsor              product name                Action            21 CFR  section     FOIA  summary         NEPA  review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-326............  Virbac AH, Inc., 3200  RILEXINE (cephalexin)  Original approval for the              New   yes................  CE \1\
                      Meacham Blvd., Ft.     Chewable Tablets for   treatment of secondary            520.376
                      Worth, TX 76137.       Dogs.                  superficial bacterial
                                                                    pyoderma in dogs caused
                                                                    by susceptible strains of
                                                                    Staphylococcus
                                                                    pseudintermedius.
141-337............  Nexcyon                RECUVYRA (fentanyl)    Original approval for                  New   yes................  CE \1\
                      Pharmaceuticals,       Transdermal Solution.  control of postoperative          524.916
                      Inc., 644 W.                                  pain associated with
                      Washington Ave.,                              surgical procedures in
                      Madison, WI 53703.                            dogs.
141-338............  Novartis Animal        INTERCEPTOR SPECTRUM   Original approval for                  New   yes................  CE \1\
                      Health US, Inc.,       (milbemycin oxime/     prevention of heartworm          520.1445
                      3200 Northline Ave.,   praziquantel)          disease caused by
                      suite 300,             Chewable Tablets.      Dirofilaria immitis and
                      Greensboro, NC 27408.                         for the treatment and
                                                                    control of adult
                                                                    roundworm (Toxocara
                                                                    canis, Toxascaris
                                                                    leonina), adult hookworm
                                                                    (Ancylostoma caninum),
                                                                    adult whipworm (Trichuris
                                                                    vulpis), and adult
                                                                    tapeworm (Taenia
                                                                    pisiformis, Echinococcus
                                                                    multilocularis, and E.
                                                                    granulosus) infections in
                                                                    dogs and puppies two
                                                                    pounds of body weight or
                                                                    greater and six weeks of
                                                                    age and older.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The agency has determined under 21 CFR 25.33 that this action is categorically excluded (CE) from the requirement to submit an environmental
  assessment (EA) or an environmental impact statement (EIS) because it is of a type that does not individually or cumulatively have a significant
  effect on the human environment.

    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Parts 520 and 524

    Animal drugs.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, and 524 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), alphabetically
add an entry for ``Nexcyon Pharmaceuticals, Inc.''; and in the table in
paragraph (c)(2), numerically add an entry for ``050929'' to read as
follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                                 Drug
                   Firm name and address                       labeler
                                                                 code
------------------------------------------------------------------------

                                * * * * *
Nexcyon Pharmaceuticals, Inc., 644 W. Washington Ave.,            050929
 Madison, WI 53703.........................................

                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
           Drug labeler code                  Firm name and address
------------------------------------------------------------------------

                                * * * * *
050929.................................  Nexcyon Pharmaceuticals, Inc.,
                                          644 W. Washington Ave.,
                                          Madison, WI 53703

                                * * * * *
------------------------------------------------------------------------

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
4. Section 520.376 is added to read as follows:

Sec.  520.376  Cephalexin.

    (a) Specifications. Each chewable tablet contains 75, 150, 300, or
600 milligrams (mg) cephalexin.
    (b) Sponsor. See No. 051311 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer 22 mg per
kilogram of body weight twice daily for 28 days.
    (ii) Indications for use. For the treatment of secondary
superficial bacterial pyoderma in dogs caused by susceptible strains of
Staphylococcus pseudintermedius.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
    (2) [Reserved]

Sec.  520.1445  [Redesignated as Sec.  520.1441]

Sec.  520.1446  [Redesignated as Sec.  520.1443]

0
5. Redesignate Sec. Sec.  520.1445 and 520.1446 as Sec. Sec.  520.1441
and 520.1443, respectively.

0
6. Revise the section heading of newly redesignated Sec.  520.1445 to
read as follows:

Sec.  520.1441  Milbemycin oxime.

* * * * *

0
7. Revise the section heading of newly redesignated Sec.  520.1446 to
read as follows:

Sec.  520.1443  Milbemycin oxime and lufenuron.

* * * * *

0
8. Add new Sec.  520.1445 to read as follows:

Sec.  520.1445  Milbemycin oxime and praziquantel.

    (a) Specifications. Each chewable tablet contains:
    (1) 2.3 milligrams (mg) milbemycin oxime and 22.8 mg praziquantel;
    (2) 5.75 mg milbemycin oxime and 57 mg praziquantel;
    (3) 11.5 mg milbemycin oxime and 114 mg praziquantel; or
    (4) 23 mg milbemycin oxime and 228 mg praziquantel.
    (b) Sponsor. See No. 058198 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. Administer orally,
once a month, a minimum dosage of 0.23 mg per pound (mg/lb) of body
weight (0.5 mg per kilogram (mg/kg)) milbemycin oxime and 2.28 mg/lb of
body weight (5 mg/kg) praziquantel.
    (ii) Indications for use. For the prevention of heartworm disease
caused by Dirofilaria immitis and for the treatment and control of
adult roundworm (Toxocara canis, Toxascaris leonina), adult hookworm
(Ancylostoma caninum), adult whipworm (Trichuris vulpis), and adult
tapeworm (Taenia pisiformis, Echinococcus multilocularis, and E.
granulosus) infections in dogs and puppies 2 pounds of body weight or
greater and 6 weeks of age and older.
    (iii) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
    (2) [Reserved]

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
9. The authority citation for 21 CFR part 524 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
10. Add Sec.  524.916 to read as follows:

Sec.  524.916  Fentanyl.

    (a) Specifications. Each milliliter of solution contains 50
milligrams (mg) fentanyl.
    (b) Sponsor. See No. 050929 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Dogs--(i) Amount. 1.2 mg/lb (2.7 mg/kg)
applied topically to the dorsal scapular area 2 to 4 hours prior to
surgery.
    (ii) Indications for use. For the control of postoperative pain
associated with surgical procedures in dogs.
    (iii) Limitations. Fentanyl is a Class II controlled substance.
Observe all ``black-box warnings'' on product labeling. Federal law
restricts this drug to use by or on the order of a licensed
veterinarian.
    (2) [Reserved]

    Dated: August 3, 2012.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2012-19498 Filed 8-8-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: November 4, 2009 (Volume 74, Number 212)]
[Notices]
[Page 57161-57162]
[DOCID:fr04no09-56]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3671-084]

Allegheny Hydro Partners, Ltd.; Allegheny Energy Supply Company,
LLC; Notice of Application for Transfer of License and Soliciting
Comments and Motions To Intervene

October 28, 2009.
    On October 7, 2009, Allegheny Hydro Partners, Ltd. (transferor) and
Allegheny Energy Supply Company, LLC (transferee) filed an application
for transfer of license of the U.S. Army Corps of Engineers' Allegheny
Lock and

Dam No. 5 located in Armstrong County, Pennsylvania.
    Applicants seek Commission approval to transfer the license for the
Allegheny Lock and Dam No. 5 from the transferor to the transferee.
    Applicant Contact: Transferor: Allegheny Hydro Partners, Ltd.--Ms.
Michelle D. Grant, Dynegy Inc., 1000 Louisiana, Suite 5800, Houston, TX
77002,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>Transferee:
Allegheny Energy Supply Company, LLC--Mr. David T. Fisfis, Allegheny
Energy, Inc., 800 Cabin Hill Drive, Greensburg, PA 15601, phone (724)
838-6926, e-mail<EMAIL_ADDRESS>    FERC Contact: Patricia W. Gillis,<PHONE_NUMBER>.
    Deadline for filing comments and motions to intervene: 15 days from
the issuance of this notice. Comments and motions to intervene may be
filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii)(2008) and the instructions on the Commission's Web
site under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the eLibrary link of Commission's Web site at http://
www.ferc.gov/docs-filing/elibrary.asp.
    Enter the docket number (P-3671-084) in the docket number field to
access the document. For assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-26477 Filed 11-3-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: May 11, 2006 (Volume 71, Number 91)]
[Notices]
[Page 27492-27493]
[DOCID:fr11my06-68]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP05-360-000; CP05-357-000; CP05-358-000; CP05-359-000]

Creole Trail LNG, L.P.; Cheniere Creole Trail Pipeline Company;
Notice of Availability of the Final Environmental Impact Statement for
the Creole Trail LNG Terminal and Pipeline Project

May 5, 2006.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared this final Environmental Impact Statement
(EIS) for the construction and operation of the liquefied natural gas
(LNG) import terminal and natural gas pipeline facilities, referred to
as the Creole Trail LNG Terminal and Pipeline Project (Creole Trail
Project), as proposed by Creole Trail LNG, L.P. and Cheniere Creole
Trail Pipeline Company \1\ (collectively referred to as Creole Trail)
in the above-referenced dockets.
---------------------------------------------------------------------------

    \1\ On March 23, 2006, Cheniere Creole Trail Pipeline Company
filed a letter with the Commission stating that on or about March
31, 2006, Cheniere Creole Trail Pipeline Company will be merged
under Delaware law into Creole Trail Pipeline, L.P. Creole Trail
Pipeline L.P. will be formed solely for the purpose of acquiring
Cheniere Creole Trail Pipeline Company and will be the surviving
legal entity. Cheniere Creole Trail Pipeline Company requests in its
letter that the Commission issue a certificate of public convenience
and necessity to Creole Trail Pipeline, L.P.
---------------------------------------------------------------------------

    The final EIS was prepared to satisfy the requirements of the
National Environmental Policy Act. The staff concludes that approval of
the Creole Trail Project, with appropriate mitigating measures as
recommended, would have limited adverse environmental impact. The final
EIS evaluates alternatives to the proposal, including system
alternatives, alternative sites for the LNG import terminal, and
pipeline alternatives.
    The purpose of the Creole Trail Project is to provide the
facilities necessary to meet growing demand for natural gas in the
United States by providing access to a reliable and stable supply of
natural gas from diverse areas of the world and to allow natural gas
delivery to the Gulf of Mexico coast, midwest, northeast, and Atlantic
markets using existing interstate and intrastate natural gas pipeline
systems.
    The final EIS addresses the potential environmental effects of the
construction and operation of the following facilities in Cameron,
Calcasieu, Beauregard, Allen, Jefferson Davis, and Acadia Parishes,
Louisiana: \2\
---------------------------------------------------------------------------

    \2\ Since the draft EIS was issued in December 2005, Creole
Trail filed a project amendment to withdraw a 6.8-mile-long 20-inch-
diameter lateral pipeline, referred to in the draft EIS as the
Hackberry lateral.
---------------------------------------------------------------------------

     A ship unloading slip with two protected berths, each
equipped with three liquid unloading arms and one vapor return arm;
     Four LNG storage tanks, each with a usable volume of
1,006,400 barrels (160,000 cubic meters (m3));
     Twenty-one high pressure LNG sendout pumps, each with a
capacity of 1,686 gallons per minute (384 m3 per hour);
     Twenty-one high pressure submerged combustion vaporizers,
each with a capacity of 183 million cubic feet per day;
     Three boil-off gas compressors;
     Ancillary utilities, buildings, and service facilities at
the LNG terminal;
     116.8 miles of dual 42-inch-diameter natural gas pipeline;
     17 meter and regulation facilities; and
     Associated pipeline facilities including pig launcher and
receiver facilities, and eight MLVs along each of the individual
pipelines in the dual pipeline system.
    The final EIS has been placed in the public files of the FERC and
is available for distribution and public inspection at: Federal Energy
Regulatory Commission, Public Reference Room, 888 First Street, NE.,
Room 2A, Washington, DC 20426.<PHONE_NUMBER>.
    A limited number of copies of the final EIS are available from the
Public Reference Room identified above. In addition, copies of the
final EIS have been mailed to Federal, state, and local agencies;
elected officials; public interest groups; individuals and affected
landowners who requested a copy of the EIS; libraries; newspapers; and
parties to these proceedings.
    In accordance with the Council on Environmental Quality's (CEQ)
regulations implementing NEPA, no agency decision on a proposed action
may be made until 30 days after the U.S. Environmental Protection
Agency (EPA) publishes a notice of availability of a final EIS.
However, the CEQ regulations provide an exception to this rule when an
agency decision is subject to a formal internal process that allows
other agencies or the public to make their views known. In such cases,
the agency decision may be made at the same time the notice of the
final EIS is published, allowing both periods to run concurrently.
Should the FERC issue Creole Trail authorizations for the proposed
project, it would be subject to a 30-day rehearing period.
    Additional information about the project is available from the
Commission's Office of External Affairs, at 1-866-208-FERC or on the
FERC Internet Web site (http://www.ferc.gov) using the eLibrary link.

Click on the eLibrary link, click on ``General Search'' and enter the
docket number excluding the last three digits in the Docket Number
field. Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at:
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, or for TTY

at<PHONE_NUMBER>. The eLibrary link on the FERC Internet Web site also
provides access to the texts of formal documents issued by the
Commission, such as orders, notices, and rulemakings.
    In addition, the Commission now offers a free service called
eSubscription that allows you to keep track of all formal issuances and
submittals in specific dockets. This can reduce the amount of time you
spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links

to the documents. Go to http://www.ferc.gov/esubscribenow.htm.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-7199 Filed 5-10-06; 8:45 am]

BILLING CODE 6717-01-P