[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Proposed Rules]
[Pages 89878-89881]
[FR Doc No: 2016-28060]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-4220; Directorate Identifier 2015-NM-076-AD]
RIN 2120-AA64

Airworthiness Directives; BAE Systems (Operations) Limited
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (SNPRM); reopening
of comment period.

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

SUMMARY: We are revising an earlier proposal to supersede Airworthiness
Directive (AD) 2011-24-06. AD 2011-24-06 applies to all BAE Systems
(Operations) Limited Model Bae 146-100A, -200A, and -300A airplanes;
and Model Avro 146-RJ70A, 146-RJ85A, and 146-RJ100A airplanes. This
action revises the NPRM by adding airplanes to the applicability. We
are proposing this AD to address the unsafe condition on these
products. Since these actions impose an additional burden over those
proposed in the NPRM, we are reopening the comment period to allow the
public the chance to comment on these proposed changes.

DATES: We must receive comments on this SNPRM by January 27, 2017.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, 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, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this SNPRM, contact BAE
Systems (Operations) Limited, Customer Information Department,
Prestwick International Airport, Ayrshire, KA9 2RW, Scotland, United
Kingdom; telephone +44 1292 675207; fax +44 1292 675704; email
<EMAIL_ADDRESS>Internet http://www.baesystems.com/Businesses/RegionalAircraft/index.htm. You may view this referenced
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, WA. 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-2016-
4220; 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: Todd Thompson, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

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-2016-4220;
Directorate Identifier 2015-NM-076-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 based on those comments.
    We will post all comments we receive, without change, to http://www.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

    On November 8, 2011, we issued AD 2011-24-06, Amendment 39-16870
(76 FR 73477, November 29, 2011) (``AD 2011-24-06''). AD 2011-24-06
requires actions intended to address an unsafe condition on all BAE
Systems (Operations) Limited Model BAe 146 series airplanes; and Model
Avro 146-RJ series airplanes.
    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD to supersede AD 2011-24-06 that would apply to
all BAE Systems (Operations) Limited Model Avro 146-RJ series
airplanes. The NPRM published in the Federal Register on March 8, 2016
(81 FR 12044) (``the NPRM''). The NPRM was prompted by a determination
that new or revised structural inspection requirements are necessary.
The NPRM proposed to require revising the maintenance or inspection
program, as applicable, to incorporate new or revised structural
inspection requirements.

Actions Since Previous NPRM Was Issued

    Since we issued the NPRM, we have determined that the applicability
should include BAE Systems (Operations) Limited Model BAe 146 series
airplanes.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2014-0071, dated March 19, 2014 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for all BAE Systems
(Operations) Limited Model BAe 146 series and Avro 146-RJ series
airplanes. The MCAI states:

    The BAe 146/AVRO 146-RJ Aircraft Maintenance Manual (AMM)
includes the Chapters as listed in Appendix 1 of this [EASA] AD.
Compliance with these chapters has been identified as a mandatory
action for continued airworthiness and EASA AD 2012-0004 was issued
to require operators to comply with those instructions.
    Since that [EASA] AD was issued, BAE Systems (Operations) Ltd
revised the AMM (Revision 107), introducing a new defined life limit
for the Fire Bottle Cartridge Firing Unit into Chapter 05-10-15.
Subsequently, Revision 108 of the AMM introduced in Chapter 05-20-00
inspection tasks for repairs applied to fatigue critical structures
and also introduced a new Chapter 05-20-07 to provide Structural
Repair Manual (SRM) references for these tasks, applicable to
repairs accomplished after the publication of AMM Revision 108.
Finally, AMM Revision 111 introduced safe life limitations into
Chapter 05-10-15 for rollers of main landing gear and door up-locks.
    Furthermore, Section 6 of the Maintenance Review Board Report
(MRBR) Document MRB 146-01, Issue 2, Revision 18 was published (as
referenced in Chapter 05-20-01 of the AMM) to correct discrepancies
in inspection tasks for a number of Structurally Important Items
(SIIs). Grace periods for these revised inspection tasks are
included in BAE Systems (Operations) Ltd Inspection Service Bulletin
(ISB) ISB.53-237.
    Failure to comply with the new and more restrictive tasks and
limitations referenced above could result in an unsafe condition.
    For the reasons described above, this [EASA] AD retains the
requirements of EASA AD 2012-0004, which is superseded, and requires
implementation of the maintenance tasks and/or airworthiness
limitations as specified in the defined parts of Chapter 05 of the
AMM at Revision 112.

    The unsafe condition is fatigue cracking of certain structural
elements, which could adversely affect the structural integrity of the
airplane. You may examine the MCAI in the AD docket on the Internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2016-4220.

Comments

    We gave the public the opportunity to participate in developing
this proposed AD. We considered the comment received.

Request To Revise the Applicability

    Neptune Aviation Services requested that we revise the
applicability to include BAE Systems (Operations) Limited Model BAe
146-100A, -200A, and -300A airplanes. The commenter stated that these
airplanes are in the applicability of AD 2011-24-06.
    We agree that BAE Systems (Operations) Limited BAe 146-100A, -200A,
and -300A airplanes should be in the applicability in order to address
the identified unsafe condition for those airplanes. We have revised
paragraph (c) of this proposed AD accordingly.

FAA's Determination and Requirements of This SNPRM

    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 the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.
    Certain changes described above expand the scope of the NPRM. As a
result, we have determined that it is necessary to reopen the comment
period to provide additional opportunity for the public to comment on
this SNPRM.
    This proposed AD requires revisions to certain operator maintenance
documents to include new actions (e.g., inspections) and critical
design configuration control limitations (CDCCLs). Compliance with
these actions and CDCCLs is required by 14 CFR 91.403(c). For airplanes
that have been previously modified, altered, or repaired in the areas
addressed by this proposed AD, the operator may not be able to
accomplish the actions described in the revisions. In this situation,
to comply with 14 CFR 91.403(c), the operator must request approval for
an alternative method of compliance according to paragraph (k)(1) of
this proposed AD. The request should include a description of changes
to the required actions that will ensure the continued damage tolerance
of the affected structure.

Costs of Compliance

    We estimate that this SNPRM affects 2 airplanes of U.S. registry.
    The actions required by AD 2011-24-06 and retained in this proposed
AD take about 3 work-hours per product, at an average labor rate of $85
per work-hour. Based on these figures, the estimated cost of the
actions that are required by AD 2011-24-06 is $255 per product.
    We also estimate that it would take about 1 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 this proposed AD on U.S. operators to be $170, or $85 per
product.

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. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2011-24-06, Amendment 39-16870 (76 FR 73477, November 29, 2011), and
adding the following new AD:

BAE Systems (Operations) Limited: Docket No. FAA-2016-4220;
Directorate Identifier 2015-NM-076-AD.

(a) Comments Due Date

    We must receive comments by January 27, 2017.

(b) Affected ADs

    This AD replaces AD 2011-24-06, Amendment 39-16870 (76 FR 73477,
November 29, 2011) (``AD 2011-24-06'').

(c) Applicability

    This AD applies to BAE Systems (Operations) Limited Model BAe
146-100A, -200A, and -300A airplanes; and Model Avro 146-RJ70A, 146-
RJ85A, and 146-RJ100A airplanes; certificated in any category; all
serial numbers.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Periodic
Inspections.

(e) Reason

    This AD was prompted by a determination that new or revised
structural inspection requirements are necessary. We are issuing
this AD to detect and correct fatigue cracking of certain structural
elements, which could adversely affect the structural integrity of
the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Airworthiness Limitations Revisions of the Shock Absorber
Assemblies, With No Changes

    This paragraph restates the requirements of paragraph (j) of AD
2011-24-06, with no changes. Within 90 days after January 3, 2012
(the effective date of AD 2011-24-06), revise the maintenance
program, by incorporating Subject 05-10-15, ``Aircraft Equipment
Airworthiness Limitations'' of Chapter 05, ``Time Limits/Maintenance
Checks,'' of the BAE Systems (Operations) Limited BAe 146 Series/
Avro 146-RJ Series Aircraft Maintenance Manual (AMM), Revision 104,
dated April 15, 2011, to remove life limits on shock absorber
assemblies, but not the individual shock absorber components, amend
life limits on main landing gear (MLG) up-locks and door up-locks,
and to introduce and amend life limits on MLG components.
Accomplishing the actions required by paragraph (i) of this AD
terminates the actions required by this paragraph.

(h) Retained No Alternative Actions, Intervals, and/or Critical Design
Configuration Control Limitations (CDCCLs), With No Changes

    This paragraph restates the requirements of paragraph (k) of AD
2011-24-06, with no changes. Except as specified in paragraph (i) of
this AD: After accomplishing the revision required by paragraph (g)
of this AD, no

alternative actions (e.g., inspections), intervals, and/or CDCCLs
may be used, unless the actions, intervals, and/or CDCCLs are
approved as an alternative method of compliance (AMOC) in accordance
with the procedures specified in paragraph (k)(1) of this AD.

(i) New Revise Maintenance Program or Inspection Program

    Within 90 days after the effective date of this AD: Revise the
maintenance or inspection program, as applicable, to incorporate new
and revised limitations, tasks, thresholds, and intervals using a
method approved by the Manager, International Branch, ANM-116,
Transport Airplane Directorate, FAA. Accomplishing the actions
required by this paragraph terminates the actions required by
paragraph (g) of this AD.

    Note 1 to paragraph (i) of this AD: An additional source of
guidance for the actions specified in paragraph (i) of this AD can
be found in BAe 146/AVRO 146-RJ Airplane Maintenance Manual,
Revision 112, dated October 15, 2013.

    Note 2 to paragraph (i) of this AD:  An additional source of
guidance for the actions specified in paragraph (i) of this AD can
be found in Corrosion Prevention Control Program (CPCP) Document No.
CPCP-146-01, Revision 4, dated September 15, 2010.

    Note 3 to paragraph (i) of this AD:  An additional source of
guidance for the actions specified in paragraph (i) of this AD can
be found in Supplemental Structural Inspections Document (SSID)
Document No. SSID-146-01, Revision 2, dated August 15, 2012.

    Note 4 to paragraph (i) of this AD:  An additional source of
guidance for the actions specified in paragraph (i) of this AD can
be found in Maintenance Review Board Report Document No. MRB 146-01,
Issue 2, Revision 19, dated August 2012.

    Note 5 to paragraph (i) of this AD: An additional source of
guidance for the actions specified in paragraph (i) of this AD can
be found in BAE Systems (Operations) Limited Inspection Service
Bulletin ISB.53-237, Revision 1, dated April 2, 2013.

(j) New No Alternative Actions, Intervals, and/or CDCCLs

    After accomplishment of the revision required by paragraph (i)
of this AD, no alternative actions (e.g., inspections), intervals,
and/or CDCCLs may be used, unless the actions, intervals, and/or
CDCCLs are approved as an AMOC in accordance with the procedures
specified in paragraph (k)(1) of this AD.

(k) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Todd
Thompson, Aerospace Engineer, International Branch, ANM-116,
Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton,
WA 98057-3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information
may be emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the Manager, International Branch, ANM-116, Transport
Airplane Directorate, FAA; or the European Aviation Safety Agency
(EASA); or BAE Systems (Operations) Limited's EASA Design
Organization Approval (DOA). If approved by the DOA, the approval
must include the DOA-authorized signature.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2014-0071, dated March 19, 2014,
for related information. This MCAI may be found in the AD docket on
the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2016-4220.
    (2) For service information identified in this AD, contact BAE
Systems (Operations) Limited, Customer Information Department,
Prestwick International Airport, Ayrshire, KA9 2RW, Scotland, United
Kingdom; telephone +44 1292 675207; fax +44 1292 675704; email
<EMAIL_ADDRESS>Internet http://www.baesystems.com/Businesses/RegionalAircraft/index.htm. You may view this service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on November 10, 2016.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-28060 Filed 12-12-16; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: May 16, 2006 (Volume 71, Number 94)]
[Notices]
[Page 28317-28318]
[DOCID:fr16my06-70]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. AC06-96-000, et al.]

Electric Rate and Corporate Filings

May 9, 2006.
    The following filings have been made with the Commission. The
filings are listed in ascending order within each docket
classification.

1. Florida Power Corporation

[Docket No. AC06-96-000]

    On May 5, 2006, Florida Power Corporation filed a request for
authority to reduce the wholesale annual nuclear decommissioning
accrual for its Crystal River Unit 3 beginning January 2006
through December 2009, in the above referenced docket.
    Comment Date: 5 p.m. Eastern Time on May 23, 2006.

2. Rumford Falls Hydro LLC

[Docket No. EG06-46-000]

    Take notice that on April 17, 2006 Rumford Falls Hydro LLC filed
its notice of self-certification of exempt wholesale generator status
pursuant to sections 366.1 and 366.7 of the Commission's regulations
and section 1266 of the Public Utility Holding Company Act of 2005.
    Comment Date: 5 p.m. Eastern Time on May 15, 2006.

3. MMC Escondido LLC

[Docket No. EG06-48-000]

    Take notice that on April 19, 2006 MMC Escondido LLC filed its
notice of self-certification of exempt wholesale generator status
pursuant to sections 366.1 and 366.7 of the Commission's regulations
and section 1266 of the Public Utility Holding Company Act of 2005.
    Comment Date: 5 p.m. Eastern Time on May 15, 2006.

4. WGL Holdings, Inc.

[Docket No. PH06-47-000]

    Take notice that on May 3, 2006 WGL Holdings, Inc. filed a notice
for exemption from the requirements of the Public Utility Holding
Company Act of 2005 pursuant to 18 CFR 366.3(a) and 366.4(b)(1).
    Comment Date: 5 p.m. Eastern Time on May 24, 2006.

5. Legg Mason, Inc.

[Docket No. PH06-48-000]

    Take notice that on May 5, 2006 Legg Mason, Inc. filed a notice for
exemption from the requirements of the Public Utility Holding Company
Act of 2005 pursuant to 18 CFR 366.3(b)(1) and 366.4(b)(1).
    Comment Date: 5 p.m. Eastern Time on May 26, 2006.

6. ALLETE, Inc.

[Docket No. PH06-49-000]

    Take notice that on May 5, 2006 ALLETE, Inc. filed a notice of
petition for waiver of the Commission's regulations, pursuant to 18 CFR
366.3(c) and 366.4(c)(1), stating it is a single-state holding company
system.
    Comment Date: 5 p.m. Eastern Time on May 26, 2006.

Standard Paragraph

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the

``eFiling'' link at http://www.ferc.gov. Persons unable to file

electronically should submit an original and 14 copies of the protest
or intervention to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-7370 Filed 5-15-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 65 (Tuesday, April 5, 2011)]
[Notices]
[Page 18756]
[FR Doc No: 2011-8025]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14106-000]

Kahawai Power 5, LLC; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

    On March 1, 2011, Kahawai Power 5, LLC filed an application for a
preliminary permit, pursuant to section 4(f) of the Federal Power Act
(FPA), proposing to study the feasibility of the Wailua Reservoir Water
Power (Wailua Reservoir project) to be located on the Wailua reservoir
in the vicinity of Wailua Homesteads, in Kauai County, Hawaii. The sole
purpose of a preliminary permit, if issued, is to grant the permit
holder priority to file a license application during the permit term. A
preliminary permit does not authorize the permit holder to perform any
land-disturbing activities or otherwise enter upon lands or waters
owned by others without the owners' express permission.
    The proposed project will utilize flows from the existing 1,400-
foot-long earth-fill dam on the Wailua Reservoir, which is owned and
operated by State of Hawaii's Department of Land and Natural Resources.
New project features would consist of the following: (1) An intake
structure at the existing 36-inch low-level outlet structure with a
trash rack and control gate; (2) 14,600-foot-long, 42-inch-diameter
steel penstock from the intake structure to the powerhouse; (3) a 50-
foot by 40-foot reinforced concrete powerhouse containing one two-jet
Turgo turbine with a capacity of 2 megawatts; (4) a 45-foot-long, 15-
foot-wide tailrace channel; (5) an approximately 12,500-foot-long, 69-
kilovolt transmission line which will tie into the existing grid near
the Lyngate switchyard; and (6) appurtenant facilities. The estimated
annual generation of the Wailua Reservoir project would be 11.5
gigawatt-hours.
    Applicant Contact: Ramya Swaminthan, Kawahai Power 5, LLC, 239
Causeway St., Boston, MA 02114; phone:<PHONE_NUMBER>.
    FERC Contact: Ryan Hansen<PHONE_NUMBER> or through e-mail at
<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support. Although the Commission strongly encourages electronic filing,
documents may also be paper-filed. To paper-file, mail an original and
seven copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14106-000) in the docket number field to
access the document. For assistance, contact FERC Online Support.

    Dated: March 30, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011-8025 Filed 4-4-11; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 245 (Friday, December 22, 2017)]
[Notices]
[Pages 60747-60749]
[FR Doc No: 2017-27569]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0307]

Amendment to ``Revised Preventive Measures To Reduce the Possible
Risk of Transmission of Creutzfeldt-Jakob Disease and Variant
Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for
Industry;'' Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft document entitled ``Amendment to `Revised
Preventive Measures to Reduce the Possible Risk of Transmission of
Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by
Blood and Blood Products; Guidance for Industry;' Draft Guidance for
Industry.'' The draft guidance document provides blood collection
establishments with revised recommendations intended to reduce the
possible risk of transmission of variant Creutzfeldt-Jakob Disease
(vCJD) by blood and blood products by revising and removing certain
recommended deferrals for geographic risk of bovine spongiform
encephalopathy (BSE) exposure and recommending deferral for individuals
with a history of blood transfusion in Ireland from 1980 to the
present. The recommendations apply to the collection of Whole Blood and
blood components intended for transfusion or for use in further
manufacturing into injectable and non-injectable products, including
recovered plasma, Source Leukocytes and Source Plasma.
    The draft guidance, when finalized, will amend the document
entitled ``Revised Preventive Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob
Disease by Blood and Blood Products; Guidance for Industry'' updated
January 2016 (``2016 vCJD Guidance'') by incorporating into an updated
final guidance any new recommendations adopted. All other
recommendations in the 2016 vCJD Guidance will remain unchanged.

DATES: Submit either electronic or written comments on the draft
guidance by March 22, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2012-D-0307 for ``Amendment to `Revised Preventive Measures to
Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease
and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products;
Guidance for Industry;' Draft Guidance for Industry.'' 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.
     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.gpo.gov/fdsys/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.
    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 draft guidance to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Melissa Segal, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Amendment to `Revised Preventive Measures to Reduce the Possible Risk
of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-
Jakob Disease by Blood and Blood Products; Guidance for Industry;'
Draft Guidance for Industry.'' The draft guidance provides blood
collection establishments with revised recommendations intended to
reduce the possible risk of transmission of vCJD by blood and blood
products. The draft guidance, when finalized, will amend FDA's current
recommendations by revising and removing certain recommended deferrals
for geographic risk of BSE exposure; and recommending deferral for
individuals with a history of blood transfusion in Ireland from 1980 to
the present. The draft guidance also includes recommendations for blood
collection establishments to update their donor history questionnaires
(DHQ), including full-length and abbreviated DHQs and accompanying
materials, and processes to incorporate the recommendations provided in
the guidance, and recommendations for licensed establishments on how to
report such changes to FDA. The recommendations apply to the collection
of Whole Blood and blood components intended for transfusion or for use
in further manufacturing into injectable and non-injectable products,
including recovered plasma, Source Leukocytes and Source Plasma. While
this draft guidance specifically provides revised recommendations to
address vCJD risk, we may address Creutzfeldt-Jakob Disease (CJD) risk
in future guidance documents.
    The revised donor deferral recommendations are based on the results
of an FDA quantitative risk assessment model. The model was developed
to rank the risk of vCJD in different countries, to evaluate risk
reduction and donor loss resulting from the current donor deferral
policy compared with alternative policies, and to evaluate the
potential additional reduction in risk afforded by leukocyte reduction
of red blood cells. The model estimated that the United Kingdom,
Ireland, and France, the three countries with the highest vCJD risks,
contributed 95 percent of the total vCJD risk in the United States. The
model also predicted that a revised policy of deferring donors only for
time spent in these three countries would maintain a level of blood
safety similar to that resulting from current policy, assuming
approximately 71.3 to 95 percent of red blood cells currently
transfused in the United States are leukocyte reduced. Based on its
value in reducing the risk of transfusion-transmitted vCJD and its
other medical benefits, FDA continues to consider potential rulemaking
that would require leukocyte reduction of red blood cells and platelets
intended for transfusion. The draft guidance, when finalized, will
amend the 2016 vCJD Guidance.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Revised
Preventive Measures to Reduce the Possible Risk of Transmission of
Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by
Blood and Blood Products.'' 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. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 601.12 and Form FDA 356h have been
approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: December 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-27569 Filed 12-21-17; 8:45 am]
BILLING CODE 4164-01-P