[Federal Register Volume 79, Number 77 (Tuesday, April 22, 2014)]
[Notices]
[Pages 22517-22519]
[FR Doc No: 2014-09184]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2014-0002; Internal Agency Docket No. FEMA-B-1406]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Title
44, Part 65 of the Code of Federal Regulations (44 CFR Part 65). The
LOMR will be used by insurance agents and others to calculate
appropriate flood insurance premium rates for new buildings and the
contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will become effective on the
dates listed in the table below and revise the FIRM panels and FIS
report in effect prior to this determination for the listed
communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has ninety (90)
days in which to request through the community that the Deputy
Associate Administrator for Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at www.msc.fema.gov for comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
FEMA, 500 C Street SW., Washington, DC 20472,<PHONE_NUMBER>, or
(email<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR Part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures

that the community is required either to adopt or to show evidence of
having in effect in order to qualify or remain qualified for
participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at www.msc.fema.gov for comparison.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Chief executive                        Online location of
        State and county           Location and case        officer of         Community map       Letter of Map       Effective date of      Community
                                          No.               community           repository           Revision             modification           No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Arkansas:.......................
    White.......................  City of Searcy (13-  The Honorable David  City Hall, 401      http://             May 5, 2014............       050229
                                   06-2147P).           Morris, Mayor,       West Arch Avenue,   www.msc.fema.gov/
                                                        City of Searcy,      Searcy, AR 72143.   lomc.
                                                        401 West Arch
                                                        Avenue, Searcy, AR
                                                        72143.
    White.......................  Unincorporated       The Honorable        White County        http://             May 5, 2014............       050467
                                   areas of White       Michael Lincoln,     Office Building,    www.msc.fema.gov/
                                   County (13-06-       White County         Department of       lomc.
                                   2147P).              Judge, 300 North     Emergency
                                                        Spruce Street,       Management, 2301
                                                        Searcy, AR 72143.    Eastline Road,
                                                                             Searcy, AR 72143.
Pennsylvania: Crawford            Borough of           The Honorable Dave   Borough Hall, 603   http://             April 23, 2014.........       420352
                                   Saegertown (13-03-   Myers, Mayor,        Erie Street,        www.msc.fema.gov/
                                   2659P).              Borough of           Saegertown, PA      lomc.
                                                        Saegertown, 603      16433.
                                                        Erie Street,
                                                        Saegertown, PA
                                                        16433.
Oklahoma: Tulsa                   City of Tulsa (13-   The Honorable Dewey  Engineering         http://             May 14, 2014...........       405381
                                   06-3500P).           Bartlett, Jr.,       Services, 2317      www.msc.fema.gov/
                                                        Mayor, City of       South Jackson       lomc.
                                                        Tulsa, 175 East      Avenue, Room S-
                                                        2nd Street, Suite    312, Tulsa, OK
                                                        690, Tulsa, OK       74107.
                                                        74103.
Texas:..........................
    Brazos......................  City of Bryan (12-   The Honorable Jason  300 South Texas     http://             May 9, 2014............       480082
                                   06-1920P).           Bienski, Mayor,      Avenue, Bryan, TX   www.msc.fema.gov/
                                                        City of Bryan, 300   77803.              lomc.
                                                        South Texas
                                                        Avenue, Bryan, TX
                                                        77803.
    Brazos......................  Unincorporated       The Honorable Duane  Brazos County,      http://             May 9, 2014............       481195
                                   areas of Brazos      Peters, Brazos       2617 Highway 21     www.msc.fema.gov/
                                   County (12-06-       County Judge, 200    West, Bryan, TX     lomc.
                                   1920P).              South Texas          77803.
                                                        Avenue, Suite 332,
                                                        Bryan, TX 77803.
    Comal.......................  Unincorporated       The Honorable        Comal County        http://             May 5, 2014............       485463
                                   areas of Comal       Sherman Krause,      Engineer's          www.msc.fema.gov/
                                   County (13-06-       Comal County         Office, 195 David   lomc.
                                   2849P).              Judge, 150 North     Jonas Drive, New
                                                        Seguin Avenue, New   Braunfels, TX
                                                        Braunfels, TX        78132.
                                                        78130.
    Dallas......................  City of Irving (13-  The Honorable Beth   Capital             http://             April 28, 2014.........       480180
                                   06-1919P).           Van Duyne, Mayor,    Improvement         www.msc.fema.gov/
                                                        City of Irving,      Program             lomc.
                                                        825 West Irving      Department, 825
                                                        Boulevard, Irving,   West Irving
                                                        TX 75060.            Boulevard,
                                                                             Irving, TX 75060.
    Tarrant.....................  City of Fort Worth   The Honorable Betsy  Department of       http://             April 7, 2014..........       480596
                                   (12-06-1991P).       Price, Mayor, City   Transportation      www.msc.fema.gov/
                                                        of Fort Worth,       and Public Works,   lomc.
                                                        1000 Throckmorton    1000 Throckmorton
                                                        Street, Fort         Street, Fort
                                                        Worth, TX 76102.     Worth, TX 76102.
    Tarrant.....................  City of Fort Worth   The Honorable Betsy  Department of       http://             March 25, 2014.........       480596
                                   (12-06-3580P).       Price, Mayor, City   Transportation      www.msc.fema.gov/
                                                        of Fort Worth,       and Public Works,   lomc.
                                                        1000 Throckmorton    1000 Throckmorton
                                                        Street, Fort         Street, Fort
                                                        Worth, TX 76102.     Worth, TX 76102.
    Tarrant.....................  Unincorporated       The Honorable B.     Tarrant County      http://             March 25, 2014.........       480582
                                   areas of Tarrant     Glen Whitley,        Public Works        www.msc.fema.gov/
                                   County (12-06-       Tarrant County       Department,         lomc.
                                   3580P).              Judge, 100 East      Administration
                                                        Weatherford          Building, 100
                                                        Street, Suite 501,   East Weatherford
                                                        Fort Worth, TX       Street, Fort
                                                        76196.               Worth, TX 76196.
Virginia: Alleghany               Town of Clifton      The Honorable Carl   Town Hall, 547      http://             February 27, 2014......       510038
                                   Forge (12-03-        Brinkley, Mayor,     Main Street,        www.msc.fema.gov/
                                   1156P).              Town of Clifton      Clifton Forge, VA   lomc.
                                                        Forge, P.O. Box      24422.
                                                        631, Clifton
                                                        Forge, VA 24422.
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(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

    Dated: April 9, 2014.
Roy E. Wright,
Deputy Associate Administrator for Mitigation, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2014-09184 Filed 4-21-14; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 80, Number 107 (Thursday, June 4, 2015)]
[Notices]
[Page 31902]
[FR Doc No: 2015-13608]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

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

    Docket Numbers: RP15-841-000.
    Applicants: Trailblazer Pipeline Company LLC.
    Description: Compliance filing per 154.501: Fuel Refund Report in
Docket No. RP15-841 to be effective N/A.
    Filed Date: 5/12/15.
    Accession Number: 20150512-5096.
    Comments Due: 5 p.m. ET 6/10/15.

    Docket Numbers: RP15-1006-000.
    Applicants: Kern River Gas Transmission Company.
    Description: Sec.  4(d) rate filing per 154.204: 2015 South Midway
to be effective 7/1/2015.
    Filed Date: 5/28/15.
    Accession Number: 20150528-5103.
    Comments Due: 5 p.m. ET 6/9/15.

    Docket Numbers: RP15-1007-000.
    Applicants: El Paso Natural Gas Company, L.L.C.
    Description: Sec.  4(d) rate filing per 154.601: Negotiated Rate
Agreement Update (APS) to be effective 6/1/2015.
    Filed Date: 5/28/15.
    Accession Number: 20150528-5166.
    Comments Due: 5 p.m. ET 6/9/15.

    Docket Numbers: RP15-1008-000.
    Applicants: Destin Pipeline Company, L.L.C.
    Description: Sec.  4(d) rate filing per 154.204: Fuel Retention
Adjustment 2015 to be effective 6/1/2015.
    Filed Date: 5/28/15.
    Accession Number: 20150528-5251.
    Comments Due: 5 p.m. ET 6/9/15.

    Docket Numbers: RP15-1009-000.
    Applicants: Transcontinental Gas Pipe Line Company, LLC.
    Description: Sec.  4(d) rate filing per 154.204: Negotiated Rates--
Cherokee AGL--Replacement Shippers--Jun 2015 to be effective 6/1/2015.
    Filed Date: 5/28/15.
    Accession Number: 20150528-5277.
    Comments Due: 5 p.m. ET 6/9/15.

    Docket Numbers: RP15-1010-000.
    Applicants: Paiute Pipeline Company.
    Description: Sec.  4(d) rate filing per 154.204: Exhibit A Revision
to be effective 6/1/2015.
    Filed Date: 5/28/15.
    Accession Number: 20150528-5278.
    Comments Due: 5 p.m. ET 6/9/15.

    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: May 29, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-13608 Filed 6-3-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 180 (Wednesday, September 17, 2014)]
[Proposed Rules]
[Pages 55673-55675]
[FR Doc No: 2014-22151]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0625; Directorate Identifier 2014-NM-044-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Bombardier, Inc. Model CL-600-2A12 (CL-601), and CL-600-2B16
(CL-601-3A, CL-601-3R, and CL-604 Variants) airplanes. This proposed AD
was prompted by a report of an aft equipment bay fire due to chafing
and subsequent arcing of the integrated drive generator (IDG) power
cables. Additionally, we have received several reports of broken
support brackets of the hydraulic lines. This proposed AD would require
a one-time inspection of the IDG power cables for chafing, and for any
cracked or broken support bracket of the hydraulic line; and corrective
actions if necessary. We are proposing this AD to detect and correct
broken support brackets of the hydraulic lines, which could result in
inadequate clearance between the IDG power cables and hydraulic lines
and chafing of the IDG power cables, and consequent high energy arcing
and an uncontrolled fire in the aft equipment bay.

DATES: We must receive comments on this proposed AD by November 3,
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, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Bombardier, Inc., 400 C[ocirc]te Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>Internet http://www.bombardier.com. 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-2014-
0625; 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
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Assata Dessaline, Aerospace Engineer,

Avionics and Service Branch, ANE-172, FAA, New York Aircraft
Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New
York 11590; 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-2014-0625;
Directorate Identifier 2014-NM-044-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

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2014-05, dated January 20, 2014 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for the specified products. The MCAI
states:

    There has been one reported case on the CL-600-2B19 aeroplane of
an aft equipment bay fire occurring due to arcing of chafed
integrated drive generator (IDG) power cables. Additionally, the
hydraulic line support brackets located at the fuselage station (FS)
672 and FS 682 on a CL-600-2B19 aeroplane could result in inadequate
clearance between the IDG power cables and hydraulic lines,
potentially resulting in chafing of the IDG power cables. Chafed IDG
power cables can generate high energy arcing, which can result in an
uncontrolled fire in the aft equipment bay.
    It was found that a similar configuration exists on models CL-
600-2A12 and CL-600-2B16 aeroplanes. Therefore, a similar unsafe
condition exists.
    This [Canadian] AD mandates the detailed visual inspection and,
if required, rectification of the IDG power cables and hydraulic
line support bracket.

    Required corrective actions include repair or replacement of the
IDG power cable if any chafing is found, and replacement of any cracked
or broken support bracket. You may examine the MCAI in the AD docket on
the Internet at http://www.regulations.gov by searching for and
locating it in Docket No. FAA-2014-0625.

Relevant Service Information

    Bombardier has issued the following service information:
    (1) Bombardier Service Bulletin 605-24-007, Revision 01, dated
January 13, 2014 (for Model CL-600-2B16 airplanes);
    (2) Bombardier Service Bulletin 604-24-026, Revision 01, dated
January 13, 2014 (for Model CL-600-2B16 airplanes); and
    (3) Bombardier Service Bulletin 604-0625, Revision 01, dated
January 13, 2014 (for Model Cl-600-2A12 and CL-600-2B16 airplanes).
    The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This 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 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 the same
type design.

Costs of Compliance

    We estimate that this proposed AD affects 95 airplanes of U.S.
registry.
    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 $8,075, or $85 per
product.
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition repair of chafed power cables or
cracked or broken support brackets, as specified in this AD.

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 airworthiness
directive (AD):

Bombardier, Inc.: Docket No. FAA-2014-0625; Directorate Identifier
2014-NM-044-AD.

(a) Comments Due Date

    We must receive comments by November 3, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bombardier, Inc. airplanes identified in
paragraphs (c)(1), (c)(2), and (c)(3) of this AD, certificated in
any category.
    (1) Model CL-600-2A12 (CL-601) airplanes, serial numbers 3001
through 3066 inclusive.
    (2) Model CL-600-2B16 (CL-601-3A, CL-601-3R Variants) airplanes,
serial numbers 5001 through 5194 inclusive.
    (3) Model CL-600-2B16 (CL-604 Variant) airplanes, serial numbers
5301 through 5665 inclusive, and 5701 through 5934 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 24, Electrical
Power.

(e) Reason

    This AD was prompted by a report of an aft equipment bay fire
due to chafing and subsequent arcing of the integrated drive
generator (IDG) power cables. Additionally, we have received several
reports of broken support brackets of the hydraulic lines. We are
issuing this AD to detect and correct broken support brackets of the
hydraulic lines, which could result in inadequate clearance between
the IDG power cables and hydraulic lines and chafing of the IDG
power cables, and consequent high energy arcing and an uncontrolled
fire in the aft equipment bay.

(f) Compliance

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

(g) One-Time Inspection and Corrective Actions

    Within 400 flight hours or 18 months after the effective date of
this AD, whichever occurs first: Perform a one-time detailed
inspection of the IDG power cables for chafing between the cables
and the adjacent hydraulic and pneumatic lines, and for any cracked
or broken support bracket of the hydraulic lines, in accordance with
the Accomplishment Instructions of the applicable service
information identified in paragraphs (g)(1), (g)(2), and (g)(3) of
this AD. If any chafing of the power cables or any cracked or broken
support bracket is found, before further flight, repair or replace,
as applicable, in accordance with the Accomplishment Instructions of
the applicable service information identified in paragraphs (g)(1),
(g)(2), and (g)(3) of this AD.
    (1) Bombardier Service Bulletin 605-24-007, Revision 01, dated
January 13, 2014 (for Model CL-600-2B16 airplanes).
    (2) Bombardier Service Bulletin 604-24-026, Revision 01, dated
January 13, 2014 (for Model CL-600-2B16 airplanes).
    (3) Bombardier Service Bulletin 601-0625, Revision 01, dated
January 13, 2014 (for Model Cl-600-2A12 and CL-600-2B16 airplanes).

(h) Credit for Previous Actions

    This paragraph provides credit for action required by paragraph
(g) of this AD, if the action was performed before the effective
date of this AD using Bombardier Service Bulletin 605-24-007, 604-
24-026, or 601-0625, all dated September 18, 2012, provided that the
action specified in Service Request for Product Support Action
(SRPSA) 27512, SRPSA 30806, SRPSA 32727, SRPSA 32864, or SRPSA 33161
has not been done. Bombardier Service Bulletins 605-24-007, 604-24-
026, and 601-0625, all dated September 18, 2012, are not
incorporated by reference in this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, 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 ACO, send it to ATTN: Program Manager, Continuing
Operational Safety, FAA, New York ACO, 1600 Stewart Avenue, Suite
410, Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
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. The AMOC approval letter must specifically reference this
AD.
    (2) Contacting the Manufacturer: 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 Transport
Canada Civil Aviation (TCCA), or Bombardier, Inc.'s TCCA Design
Approval Organization (DAO). If approved by the DAO, the approval
must include the DAO-authorized signature.

(j) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian Airworthiness Directive CF-2014-05, dated January
20, 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 it in Docket No. FAA-2014-0625.
    (2) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax 514-855-
7401; email<EMAIL_ADDRESS>Internet http://www.bombardier.com. 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 September 9, 2014.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-22151 Filed 9-16-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 40 (Wednesday, March 3, 2021)]
[Notices]
[Pages 12471-12473]
[FR Doc No: 2021-04342]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0208]

Proposal To Refuse To Approve a New Drug Application for
Sotagliflozin Oral Tablets, 200 Milligrams and 400 Milligrams;
Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Director of the Center for Drug Evaluation and Research
(Center Director) of the Food and Drug Administration (FDA or Agency)
is proposing to refuse to approve a new drug application (NDA)
submitted by Lexicon Pharmaceuticals, Inc. (Lexicon) for sotagliflozin
oral tablets, 200 milligrams (mg) and 400 mg, in its present form. This
notice summarizes the grounds for the Center Director's proposal and
offers Lexicon an opportunity to request a hearing on the matter.

DATES: Submit either electronic or written requests for a hearing by
April 2, 2021; submit data, information, and analyses in support of the
hearing and any other comments by May 3, 2021.

ADDRESSES: You may submit hearing requests, documents in support of the
hearing, and any other comments as follows. Please note that late,
untimely filed requests and documents will not be considered.
Electronic requests for a hearing must be submitted on or before April
2, 2021; electronic documents in support of the hearing and any other
comments must be submitted on or before May 3, 2021. The https://www.regulations.gov electronic filing system will accept hearing
requests until 11:59 p.m. Eastern Time at the end of April 2, 2021, and
will accept documents in support of the hearing and any other comments
until 11:59 p.m. Eastern Time at the end of May 3, 2021. Documents
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 these dates.

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-N-0208 for ``Proposal to Refuse to Approve a New Drug
Application for Sotagliflozin Oral Tablets, 200 Milligrams and 400
Milligrams; Opportunity for a Hearing.'' 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,<PHONE_NUMBER>.
     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>.

FOR FURTHER INFORMATION CONTACT: Kevin Fain, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 6419, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Proposal To Refuse To Approve NDA 210934

    Sanofi-aventis U.S. LLC (Sanofi), Lexicon's predecessor-in-
interest, submitted NDA 210934 for sotagliflozin oral tablets in 200
and 400 mg strengths on March 22, 2018, pursuant to section 505(b)(1)
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
355(b)(1)). Sanofi proposed that sotagliflozin tablets be indicated as
an adjunct to insulin therapy to improve glycemic control in adults
with type 1 diabetes mellitus (T1DM).
    On March 22, 2019, the Office of Drug Evaluation II (ODE II) in the
Office of New Drugs (OND) in FDA's Center for Drug Evaluation and
Research (CDER) issued a complete response letter to Sanofi under Sec.
314.110(a) (21 CFR 314.110(a)) stating that NDA 210934 could not be
approved in its present form, describing the specific deficiencies,
and, where possible, recommending ways that Sanofi might remedy these
deficiencies. The application in its present form is not approvable
because the data submitted

do not show that the drug is safe under the proposed conditions of use.
The deficiencies, which are summarized below, include the following:
    (1) The data demonstrated that the addition of sotagliflozin to
insulin is associated with an increased risk of diabetic ketoacidosis
(DKA), a serious and often life-threatening consequence of insulin
insufficiency.
    a. In particular, the submitted clinical trial data showed a nearly
8-fold excess risk of DKA associated with sotagliflozin. Based on an
FDA analysis of all three trials, an overall estimated hazard ratio (95
percent confidence interval) for DKA associated with sotagliflozin was
7.9 (3.2, 19.9).
    b. The majority of these cases required hospitalization and
treatment in the intensive care unit, which underscores the seriousness
of this risk.
    c. Although DKA is an inherent risk in T1DM, the magnitude of
excess risk, severity of the cases, and characteristics of DKA (e.g.,
euglycemic DKA) associated with sotagliflozin treatment raised
significant safety concerns, particularly because they occurred in a
clinical trial setting, where patients are carefully selected for
enrollment and receive more intensive safety monitoring than in
clinical practice.
    d. Time-to-event analyses of the clinical trial data showed earlier
development of DKA in sotagliflozin-treated patients than in patients
assigned to placebo, without evidence that the risk stopped increasing
over time.
    e. The clinical trial data did not identify a patient group at
lower risk of DKA, but instead showed the DKA risk was associated with
sotagliflozin regardless of sex, age, duration of diabetes, method of
insulin delivery, or body mass index.
    f. Overall, risk mitigation strategies used in the clinical trials
were not sufficient to address the excess DKA risk observed in the
clinical trials, as evidenced by the nearly 8-fold excess risk.
    g. Data analyses assessing the impact of risk mitigation strategies
implemented during the course of the trials were inadequate to provide
reassurance that these strategies would be successful in reducing DKA
risk post-approval.
    (2) The data demonstrated the significant DKA risk resulting from
the addition of sotagliflozin to insulin was not justified by the
drug's modest clinical benefits.
    a. The data showed that sotagliflozin reduced HbA1c, a validated
surrogate endpoint for clinical benefits expected due to improved
glycemic control in the treatment of diabetes mellitus, including T1DM.
However, the effect on HbA1c in the sotagliflozin clinical trials was
modest.
    b. In the three pivotal trials, addition of sotagliflozin to
insulin resulted in statistically significant reductions in HbA1c at
Week 24. The treatment difference relative to placebo was approximately
-0.3 percent with sotagliflozin 200 mg and -0.4 percent with
sotagliflozin 400 mg.
    c. In the extension of two pivotal trials to 52 weeks, the effect
of sotagliflozin on HbA1c was smaller (-0.23 percent and -0.33 percent
HbA1c reductions with the 200 mg and 400 mg doses, respectively), and
there are no longer term data to evaluate persistence of effect. The
decrease in treatment effect from Week 24 to Week 52 is clinically
relevant, as the major benefits to consider with sotagliflozin
treatment are related to improved long-term glycemic control reducing
the risk of microvascular complications.
    d. The improved HbA1c associated with sotagliflozin was not
accompanied by an increased rate of hypoglycemia (defined as glucose <=
55 mg/dL) in the clinical trials, an adverse clinical effect that
occurs with insulin therapy; however, this observation does not
outweigh the increased rate of DKA. The data did not show sotagliflozin
was associated with an overall decrease in the rate of severe
hypoglycemia.
    e. In addition to improved glycemic control, other clinical
benefits associated with sotagliflozin, small reductions in body weight
and blood pressure, were not sufficient to outweigh the serious risk of
DKA.
    f. The data did not show that sotagliflozin was associated with an
effect on glycemic variability and time-in-range that provided benefits
distinct from reduced HbA1c.
    g. Patient reported outcome measures were not adequate in directly
reflecting important aspects of the patient's experience with T1DM and
how sotagliflozin treatment affected these important aspects.
    The complete response letter stated that Sanofi is required either
to resubmit the application, fully addressing all deficiencies listed
in the letter, or take other actions available under Sec.  314.110
(i.e., withdraw the application or request an opportunity for a
hearing). Applicable regulations, including 21 CFR 10.75, also provide
a mechanism for applicants to obtain formal review of one or more
decisions reflected in a complete response letter (see FDA's guidance
for industry and review staff ``Formal Dispute Resolution: Sponsor
Appeals Above the Division Level'' (May 2019)).\1\
---------------------------------------------------------------------------

    \1\ Available at https://www.fda.gov/media/126910/download. FDA
updates guidances periodically. To make sure you have the most
recent version of a guidance, check the FDA Drugs guidance web page
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.
---------------------------------------------------------------------------

    Sanofi submitted a formal dispute resolution request (FDRR) on
September 3, 2019, concerning the complete response letter issued by
ODE II. Peter Stein, Director of CDER's OND, denied the FDRR by
correspondence dated November 29, 2019, based on his determination that
the drug's immediate, sustained, and substantial increase in DKA risk
outweighed the modest benefit on glycemic control and any potential
additional benefits (e.g., reductions in body weight and blood
pressure). Sanofi submitted another FDRR on December 19, 2019, for
review of the OND denial. On January 30, 2020, FDA was notified that
NDA 210934 had been transferred from Sanofi to Lexicon. Robert Temple,
Deputy Director for Clinical Science, CDER, denied the second FDRR on
behalf of CDER by correspondence dated March 11, 2020, based on his
determination that the drug's DKA risk outweighed its benefits,
reaffirming the reasoning in OND's denial of the prior FDRR.
    On November 10, 2020, Lexicon submitted a request for an
opportunity for a hearing under Sec.  314.110(b)(3) on whether there
are grounds under section 505(d) of the FD&C Act for denying approval
of NDA 210934.

II. Notice of Opportunity for a Hearing

    For the reasons stated above and as explained in further detail in
the complete response letter and the November 29, 2019, and March 11,
2020, FDRR denials, notice is given to Lexicon and all other interested
persons that the Center Director proposes to issue an order refusing to
approve NDA 210934 on the grounds that the application fails to meet
the criteria for approval under section 505(d)(2) of the FD&C Act
because data submitted in the application do not show that the product
would be safe under the proposed conditions of use.\2\
---------------------------------------------------------------------------

    \2\ Section 505(d)(2) of the FD&C Act provides that FDA shall
refuse to approve an NDA if ``the results of . . . tests show that
such drug is unsafe for use under [the] conditions [prescribed,
recommended, or suggested in the proposed labeling] or do not show
that such drug is safe for use under such conditions[.]'' For the
reasons explained in this notice, CDER has concluded that the data
and information submitted in the NDA do not show that the drug is
safe for use under the proposed conditions of use.
---------------------------------------------------------------------------

    Lexicon may request a hearing before the Commissioner of Food and
Drugs

(the Commissioner) on the Center Director's proposal to refuse to
approve NDA 210934. If Lexicon decides to seek a hearing, it must file:
(1) A written notice of participation and request for a hearing (see
the DATES section) and (2) the studies, data, information, and analyses
relied upon to justify a hearing (see the DATES section), as specified
in Sec.  314.200 (21 CFR 314.200).
    As stated in Sec.  314.200(g), a request for a hearing may not rest
upon allegations or denials, but must present specific facts showing
that there is a genuine and substantial issue of fact that requires a
hearing to resolve. We note in this regard that because CDER proposes
to refuse to approve NDA 210934 based on the multiple deficiencies
summarized above, any hearing request from Lexicon must address all of
those deficiencies. Failure to request a hearing within the time
provided and in the manner required by Sec.  314.200 constitutes a
waiver of the opportunity to request a hearing. If a hearing request is
not properly submitted, FDA will issue a notice refusing to approve NDA
210934.
    The Commissioner will grant a hearing if there exists a genuine and
substantial issue of fact or if the Commissioner concludes that a
hearing would otherwise be in the public interest (Sec.
314.200(g)(6)). If a hearing is granted, it will be conducted according
to the procedures provided in 21 CFR parts 10 through 16 (21 CFR
314.201).
    Paper submissions under this notice of opportunity for a hearing
should be filed in one copy. Except for data and information prohibited
from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905,
submissions may be seen in the Dockets Management Staff Office between
9 a.m. and 4 p.m., Monday through Friday, and on the internet at
https://www.regulations.gov. This notice is issued under section
505(c)(1)(B) of the FD&C Act and Sec. Sec.  314.110(b)(3) and 314.200.

    Dated: February 25, 2021.
Patrizia Cavazzoni,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 2021-04342 Filed 3-2-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Rules and Regulations]
[Pages 38909-38912]
[FR Doc No: 2021-15480]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0188; Project Identifier MCAI-2020-00642-R;
Amendment 39-21572; AD 2021-11-10]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Airbus Helicopters Model SA-365N, SA-365N1, AS-365N2, and AS
365 N3 helicopters. This AD was prompted by a report that damage
(scorch marks) was found on an internal life raft installation that
contained a half rescue kit. This AD requires identifying the part
number and serial number of each half rescue kit located in the
internal life raft installation and, depending on the findings,
inspecting the life raft for damage, inspecting the condition of the
flashlight battery, testing the flashlight battery, and replacing the
life raft or flashlight battery (including the leak test) as
applicable, as specified in a European Aviation Safety Agency (now
European Union Aviation Safety Agency) (EASA) AD, which is incorporated
by reference. The FAA is issuing this AD to address the unsafe
condition on these products.

DATES: This AD is effective August 27, 2021.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of August 27,
2021.

ADDRESSES: For EASA material incorporated by reference (IBR) in this
AD, contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany;
telephone +49 221 8999 000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this material on the EASA website at
https://ad.easa.europa.eu. For Zodiac Aerospace service information
identified in this final rule, contact Safran Aerosystems--Plaisir, 61
rue Pierre Curie CS20001, 78373 Plaisir Cedex, France; telephone (33) 1
61 34 23 23; fax (33) 1 61 34 24 41; or at https://www.safran-aerosystems.com. You may view this material at the FAA, Office of the
Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321,
Fort Worth, TX 76177. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2021-0188.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0188; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Kathleen Arrigotti, Program Manager,
Large Aircraft Section, International Validation Branch, Compliance &
Airworthiness Division, FAA, 2200 South 216th St., Des Moines, WA
98198; telephone and fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2016-0028, dated February 15, 2016
(EASA AD 2016-0028) (also referred to as the Mandatory Continuing
Airworthiness Information, or the MCAI), to correct an unsafe condition
for certain Airbus Helicopters Model

SA-365N, SA-365N1, AS-365N2, and AS 365 N3 helicopters.
    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Model SA-365N,
SA-365N1, AS-365N2, and AS 365 N3 helicopters. The NPRM published in
the Federal Register on March 23, 2021 (86 FR 15431). The NPRM was
prompted by a report that damage (scorch marks) was found on an
internal life raft installation that contained a half rescue kit.
Investigation revealed that the damage was caused by an unsuitable
folding process for the life raft, which led to compression of the
flashlight battery in the half rescue kit. This compression caused an
electrolyte leakage, followed by a short-circuit that damaged the
internal life raft. The NPRM proposed to require identifying the part
number and serial number of each half rescue kit located in the
internal life raft installation and, depending on the findings,
inspecting the life raft for damage, inspecting the condition of the
flashlight battery, testing the flashlight battery, and replacing the
life raft or flashlight battery (including the leak test) as
applicable, as specified in an EASA AD.
    The FAA is issuing this AD to address leakage of the flashlight
battery in a half rescue kit, which could result in damage to the
internal life raft, and subsequent failure of the internal life raft to
deploy (for example after a ditching), which could impede or prevent
safe evacuation of the occupants from the helicopter. See the MCAI for
additional background information.

Discussion of Final Airworthiness Directive

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The FAA received no comments on the NPRM or
on the determination of the cost to the public.

Costs of Compliance Update

    The NPRM did not include the kit cost for the on-condition action
specified in paragraph (2) of EASA AD 2016-0028. The FAA has received
this cost data and has updated the costs of compliance accordingly.

Conclusion

    The FAA reviewed the relevant data and determined that air safety
and the public interest require adopting this final rule as proposed,
except for minor changes. In the NPRM, the FAA proposed to require
actions specified in EASA AD 2016-0028 through incorporation by
reference, except for certain differences. The FAA has obtained
approval to use this process from certain manufacturers, including
Airbus Helicopters; however, the FAA has not worked with Zodiac
Aerospace (which has been merged into Safran Aerosystems) for approval
of this process. EASA AD 2016-0028 specifies using Zodiac Aerospace
Service Bulletin SB 025-64-13, Revision 0, dated November 23, 2015 (SB
025-64-13 Rev 0) or Revision 1, dated January 19, 2016 (SB 025-64-13
Rev 1), to accomplish a certain action. In light of this, an exception
has been added into this final rule to directly use SB 025-64-13 Rev 0
or SB 025-64-13 Rev 1, instead of using SB 025-64-13 Rev 0 or SB 025-
64-13 Rev 1 through incorporation by reference of EASA AD 2016-0028.
    The FAA has determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    EASA AD 2016-0028 specifies identifying the part number and serial
number of each half rescue kit located in the internal life raft
installation, inspecting the life raft for damage (scorch marks),
inspecting the condition of the flashlight battery (including cracks,
impacts, swelling, damage, distorted case, and the connecting wire),
testing the flashlight battery (turning on the flashlight), and
replacing the life raft or flashlight battery (including the leak
test).
    The FAA reviewed SB 025-64-13 Rev 0, which specifies procedures to
visually inspect the condition of the life raft and battery, and test
the battery. The FAA also reviewed SB 025-64-13 Rev 1, which specifies
the same procedures as SB 025-64-13 Rev 0, except SB 025-64-13 Rev 1
corrects the serial numbers identified in the effectivity.
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Differences Between This AD and the MCAI

    Although the service information referenced in EASA AD 2016-0028
specifies to return damaged life rafts to the manufacturer, this AD
does not include that requirement.
    Where EASA AD 2016-0028 refers to its effective date or to January
7, 2016 (the effective date of EASA AD 2015-0242), this AD requires
compliance within 3 months after the effective date of this AD.
    Although the service information referenced in EASA AD 2016-0028
specifies that trained and authorized Zodiac Aerospace personnel must
do the inspection of the half rescue kit, this AD does not require that
Zodiac Aerospace personnel do the inspection.

Costs of Compliance

    The FAA estimates that this AD affects 30 helicopters of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
1 work-hour x $85 per hour = $85.............................          $3,000           $3,085          $92,550
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition actions that would be required based on the results of any
required actions. The FAA has no way of determining the number of
helicopters that might need these on-condition actions:

                                     Estimated Costs of On-Condition Actions
----------------------------------------------------------------------------------------------------------------
               Labor cost                             Parts cost                       Cost per product
----------------------------------------------------------------------------------------------------------------
7.5 work-hours x $85 per hour = $637.50  Up to $78,154......................  Up to $78,791.50.
----------------------------------------------------------------------------------------------------------------

    According to Zodiac Aerospace, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected operators. The FAA does not control warranty coverage for
affected operators. As a result, the FAA has included all known costs
in the 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.
    The FAA is 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

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) 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 Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 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 adding the following new airworthiness
directive:

2021-11-10 Airbus Helicopters: Amendment 39-21572; Docket No. FAA-
2021-0188; Project Identifier MCAI-2020-00642-R.

(a) Effective Date

    This airworthiness directive (AD) is effective August 27, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Helicopters Model SA-365N, SA-365N1,
AS-365N2, and AS 365 N3 helicopters, certificated in any category,
as identified in European Aviation Safety Agency (now European Union
Aviation Safety Agency) (EASA) AD 2016-0028, dated February 15, 2016
(EASA AD 2016-0028).

(d) Subject

    Joint Aircraft System Component (JASC) Code 2564, Life Raft.

(e) Reason

    This AD was prompted by a report that damage (scorch marks) was
found on an internal life raft installation that contained a half
rescue kit. Investigation revealed that the damage was caused by an
unsuitable folding process for the life raft, which led to
compression of the flashlight battery in the half rescue kit. The
FAA is issuing this AD to address leakage of the flashlight battery
in a half rescue kit, which could result in damage to the internal
life raft, and subsequent failure of the internal life raft to
deploy (for example after a ditching), which could impede or prevent
safe evacuation of the occupants from the helicopter.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2016-0028.

(h) Exceptions to EASA AD 2016-0028

    (1) Where EASA AD 2016-0028 refers to its effective date or to
January 7, 2016 (the effective date of EASA AD 2015-0242), this AD
requires compliance within 3 months after the effective date of this
AD.
    (2) The ``Remarks'' section of EASA AD 2016-0028 does not apply
to this AD.
    (3) Where paragraph (2) of EASA AD 2016-0028 specifies
accomplishing corrective actions in accordance with the instructions
of Zodiac Aerospace SB No. 025-64-13 referred to in paragraph 3.B of
Airbus Helicopters ASB AS365-25.01.63, this AD requires using Zodiac
Aerospace Service Bulletin SB 025-64-13, Revision 0, dated November
23, 2015 or Revision 1, dated January 19, 2016.
    (4) Although the service information referenced in EASA AD 2016-
0028 specifies to return certain parts, this AD does not include
that requirement.
    (5) Although the service information referenced in EASA AD 2016-
0028 specifies that trained and authorized Zodiac Aerospace
personnel must do the inspection of the half rescue kit, this AD
does not require that Zodiac Aerospace personnel do the inspection.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, 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 manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (j) of
this AD. Information may be emailed to<EMAIL_ADDRESS>    (2) 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.

(j) Related Information

    For more information about this AD, contact Kathleen Arrigotti,
Program Manager, Large Aircraft Section, International Validation
Branch, Compliance & Airworthiness Division, FAA, 2200 South 216th
St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
(k) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference

(IBR) of the service information listed in this paragraph under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Aviation Safety Agency (EASA) AD 2016-0028, dated
February 15, 2016.
    (ii) Zodiac Aerospace Service Bulletin SB 025-64-13, Revision 0,
dated November 23, 2015.
    (iii) Zodiac Aerospace Service Bulletin SB 025-64-13, Revision
1, dated January 19, 2016.
    (3) For EASA AD 2016-0028, contact the EASA, Konrad-Adenauer-
Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu. For Zodiac
Aerospace service information, contact Safran Aerosystems--Plaisir,
61 rue Pierre Curie CS20001, 78373 Plaisir Cedex, France; telephone
(33) 1 61 34 23 23; fax (33) 1 61 34 24 41; or at https://www.safran-aerosystems.com.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2021-0188.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on June 10, 2021.
Ross Landes,
Deputy Director for Regulatory Operations, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-15480 Filed 7-22-21; 8:45 am]
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[Federal Register: October 8, 2008 (Volume 73, Number 196)]
[Notices]
[Page 58983-58985]
[DOCID:fr08oc08-93]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2008-0038]

1,2-Dibromo-3-Chloropropane (DBCP) Standard; Extension of the
Office of Management and Budget's (OMB) Approval of Information
Collection (Paperwork) Requirements

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

ACTION: Request for public comment.

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

SUMMARY: OSHA solicits public comment concerning its proposal to extend
OMB approval of the information collection requirements specified by
the 1,2-Dibromo-3-

Chloropropane (DBCP) Standard (29 CFR 1910.1044).

DATES: Comments must be submitted (postmarked, sent, or received) by
December 8, 2008.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
erulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages, you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit three copies of your comments
and attachments to the OSHA Docket Office, Docket No. OSHA-2008-0038,
U.S. Department of Labor, Occupational Safety and Health
Administration, Room N-2625, 200 Constitution Avenue, NW., Washington,
DC 20210. Deliveries (hand, express mail, messenger, and courier
service) are accepted during the Department of Labor's and Docket
Office's normal business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the Information Collection Request (ICR) (OSHA-2008-
0038). All comments, including any personal information you provide,
are placed in the public docket without change, and may be made
available online at http://www.regulations.gov. For further information
on submitting comments see the ``Public Participation'' heading in the
section of this notice titled ``SUPPLEMENTARY INFORMATION.''
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Todd Owen at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Todd Owen, Directorate of Standards
and Guidance, OSHA, U.S. Department of Labor, Room N-3609, 200
Constitution Avenue, NW., Washington, DC 20210; telephone (202) 693-
2222.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accordance with the Paperwork Reduction Act
of 1995 (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection instruments are clearly understood, and OSHA's
estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651
et seq. ) authorizes information collection by employers as necessary
or appropriate for enforcement of the OSH Act or for developing
information regarding the causes and prevention of occupational
injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also
requires that OSHA obtain such information with minimum burden upon
employers, especially those operating small businesses, and to reduce
to the maximum extent feasible unnecessary duplication of efforts in
obtaining information (29 U.S.C. 657).
    The information collection requirements in the DBCP Standard
provide protection for employees from the adverse health effects
associated with exposure to DBCP. In this regard, the DBCP Standard
requires employers to: monitor employees' exposure to DBCP; monitor
employee health, and provide employees with information about their
exposures and the health effects of exposure to DBCP.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    OSHA is proposing to extend the information collection requirements
contained in the DBCP Standard (29 CFR 1910.1044). No employers
currently use DBCP. The Agency requests one hour for OMB to approve the
information requests requirements should the Environmental Protection
Agency lift the registration suspension for this substance or
technology develops new applications for DBCP. The Agency will
summarize the comments submitted in response to this notice and will
include this summary in the request to OMB.
    Type of Review: Extension of a currently approved collection.
    Title: 1,2-Dibromo-3-Chloropropane (DBCP) Standard (29 CFR
1910.1044).
    OMB Number: 1218-0101.
    Affected Public: Business or other for-profits; Federal Government;
State, Local or Tribal Government.
    Frequency: On occasion.
    Average Time per Response: No U.S. employers currently produce DBCP
or DBCP-based end-use products.
    Estimated Total Burden Hours: 1.
    Estimated Cost Operation and Maintenance):$ 0.

IV. Public Participation--Submission of Comments on this Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:(1)
Electronically at http://www.regulations.gov, which is the Federal
erulemaking Portal; (2) by facsimile (FAX); or (3) by hard copy. All
comments, attachments, and other material must identify the Agency name
and the OSHA docket number for the ICR (Docket No. OSHA-2008-0038). You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ``ADDRESSES
''). The additional materials must clearly identify your electronic
comments by your name, date, and the docket number so the Agency can
attach them to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER> (TTY<PHONE_NUMBER>).

    Comments and submissions are posted without change at http://
www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
date of birth. Although all submissions are listed in the http://
www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through this
Web site. All submissions, including copyrighted material, are
available for inspection and copying at the OSHA Docket Office.
    Information on using the http://www.regulations.gov Web site to
submit comments and access the docket is available at the Web site's
``User Tips'' link. Contact the OSHA Docket Office for information
about materials not available through the website, and for assistance
in using the Internet to locate docket submissions.

V. Authority and Signature

    Edwin G. Foulke, Jr., Assistant Secretary of Labor for Occupational
Safety and Health, directed the preparation of this notice. The
authority for this notice is the Paperwork Reduction Act of 1995 (44
U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 5-2007 (72 FR
31159).

    Signed at Washington, DC, this 3rd day of October, 2008.
Edwin G. Foulke, Jr.,
Assistant Secretary of Labor for Occupational Safety and Health.
 [FR Doc. E8-23808 Filed 10-7-08; 8:45 am]

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