[Federal Register: November 29, 2010 (Volume 75, Number 228)]
[Notices]
[Page 73109-73110]
[DOCID:fr29no10-107]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0150; Formerly Docket No. 2007D-0367]

Guidance for Industry on Antibacterial Drug Products: Use of
Noninferiority Trials to Support Approval; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Antibacterial Drug
Products: Use of Noninferiority Trials to Support Approval.'' The
purpose of this guidance is to provide information on FDA's current
thinking regarding appropriate use of noninferiority (NI) clinical
trial designs to evaluate antibacterial drug products. The Agency's
thinking in this area has evolved in recent years in response to a
number of public discussions on the use of active-controlled trials
designed to show NI as the basis for approval of antibacterial drug
products. This guidance finalizes the draft guidance published in the
Federal Register of October 15, 2007.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

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

FOR FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6244, Silver Spring, MD 20993-0002, 301-
796-1300.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Antibacterial Drug Products: Use of Noninferiority Trials to
Support Approval.'' The purpose of this guidance is to inform industry,
sponsors, applicants, researchers, and the public on the appropriate
uses of NI clinical trial designs to evaluate antibacterial drug
products and to amend ongoing or completed trials accordingly. In the
Federal Register of October 15, 2007 (72 FR 58312), FDA announced a
notice of availability of the draft guidance for industry entitled
``Antibacterial Drug Products: Use of Noninferiority Studies to Support
Approval'' in response to numerous public discussions that focused
primarily on the following indications: Acute bacterial sinusitis,
acute bacterial exacerbation of chronic bronchitis, and acute bacterial
otitis media. Since FDA issued the draft guidance, there have been
public discussions on consistent and reliable estimates of the efficacy
of active treatment to placebo for other infectious disease indications
for the NI trial design. The public comments received on the draft
guidance have been considered and the guidance has been revised as
appropriate. The guidance emphasizes that adequate scientific evidence
should be provided to support the proposed NI margin for any indication
being studied in any proposed, ongoing, or completed active-controlled
trial designed to show NI.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115).

The guidance represents the Agency's current thinking on this topic. It
does not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statutes
and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively, and the collection of information under the guidance for
industry ``Special Protocol Assessment'' has been approved under OMB
control number 0910-0470.

III. Comments

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

IV. Electronic Access

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

    Dated: November 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29796 Filed 11-26-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 166 (Friday, August 26, 2011)]
[Proposed Rules]
[Pages 53346-53348]
[FR Doc No: 2011-21853]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0909; Directorate Identifier 2011-NM-027-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Model DC-9-81 (MD-
81), DC-9-82 (MD-82), DC-9-83 (MD-83), DC-9-87 (MD-87), and MD-88
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 the
products listed above. This proposed AD would require repetitive high
frequency eddy current (HFEC) inspections for cracking of the left and
right rib hinge bearing lugs of the aft face of the center section of
the horizontal stabilizer; measuring crack length and blending out
cracks; and replacing the horizontal stabilizer center section rib, if
necessary. This proposed AD was prompted by reports of cracks of the
hinge bearing lugs of the center section ribs of the horizontal
stabilizer. We are proposing this AD to detect and correct cracking in
the hinge bearing lugs of the horizontal stabilizer center section
ribs, which would result in failure of the lugs, and consequent
inability of the horizontal stabilizer to sustain the required limit
loads and loss of control of the airplane.

DATES: We must receive comments on this proposed AD by October 11,
2011.

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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, California 90846-
0001; telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com. You may
review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. 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; 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 (phone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Roger Durbin, Aerospace Engineer,
Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification
Office, 3960 Paramount Boulevard, Lakewood, California 90712-4137;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2011-0909;
Directorate Identifier 2011-NM-027-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://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

    We received reports of cracks on Model MD-80 series airplanes and
on Model MD-90-30 airplanes. The cracks were found on the aft face of
the center section left and right hinge bearing lugs on either the left
or right, or in two cases, on both sides of the center section ribs of
the horizontal stabilizer. Cracks were reported on Model MD-80
airplanes that had accumulated 23,700 to 41,963 total flight hours, and
23,300 to 35,294 total flight cycles. The cause of the cracking has not
been determined. Undetected cracking in the hinge bearing lugs of the
center section of the left and right ribs, if not corrected, could
result in failure of the hinge bearing lugs and consequent inability of
the horizontal stabilizer to sustain required limit loads and loss of
control of the airplane.

Related Rulemaking

    The proposed AD affects Model MD-80 series airplanes. We issued AD
2011-01-11, Amendment 39-16565 (76 FR 430, January 5, 2011) to address
the identified unsafe condition on Model MD-90-30 airplanes, on
December 22, 2010. AD 2011-01-11 requires similar actions as proposed
in this NPRM.

Relevant Service Information

    We reviewed Boeing Alert Service Bulletin MD80-55A069, dated
January 19, 2011. That service bulletin describes procedures for
repetitive high frequency eddy current (HFEC) inspections for cracking
of the left and right rib hinge bearing lugs of the aft face of the
center

section of the horizontal stabilizer; measuring crack length and
blending out cracks; and replacement of the horizontal stabilizer
center section rib, if necessary.

FAA's Determination and Proposed AD Requirements

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of these same type
designs. This proposed AD would require accomplishing the actions
specified in the service information described previously, except as
discussed under ``Differences Between the Proposed AD and the Service
Information.''

Differences Between the Proposed AD and the Service Information

    Although Boeing Alert Service Bulletin MD80-55A069, dated January
19, 2011, specifies to send the inspection results to the manufacturer,
this proposed AD would not require any report.

Interim Action

    We consider this proposed AD interim action since investigation is
ongoing and no terminating action has been developed yet. The
manufacturer is currently developing a modification that will address
the unsafe condition identified in this AD. Once this modification is
developed, approved, and available, we may consider additional
rulemaking.

Costs of Compliance

    We estimate that this proposed AD affects 668 airplanes of U.S.
registry. We estimate the following costs to comply with this proposed
AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Inspection..........................  6 work-hours x $85 per               $0             $510         $340,680
                                       hour = $510 per
                                       inspection cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
labor cost estimates for the on-condition actions (blend-out repair(s)
or replacement of center section rib(s)) specified in this proposed AD.
However, we have been advised that replacement parts would be $14,500
per horizontal stabilizer rib crack repair kit.

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

    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]

    2. The FAA amends Sec.  39.13 by adding the following new
airworthiness directive (AD):

The Boeing Company: Docket No. FAA-2011-0909; Directorate Identifier
2011-NM-027-AD.

Comments Due Date

    (a) We must receive comments by October 11, 2011.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to The Boeing Company Model DC-9-81 (MD-81),
DC-9-82 (MD-82), DC-9-83 (MD-83), DC-9-87 (MD-87), and MD-88
airplanes, certificated in any category, as identified in Boeing
Alert Service Bulletin MD80-55A069, dated January 19, 2011.

Subject

    (d) Air Transport Association (ATA) of America Code 55:
Stabilizers.

Unsafe Condition

    (e) This AD was prompted by reports of cracks of the hinge
bearing lugs of the center section ribs of the horizontal
stabilizer. We are proposing this AD to detect and correct cracking
in the hinge bearing lugs of the horizontal stabilizer center
section ribs, which would result in failure of the lugs, and
consequent inability of the horizontal stabilizer to sustain the
required limit loads and loss of control of the airplane.

Compliance

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

Actions on Horizontal Stabilizer Ribs Made From 7075-T7351 Material

    (g) For Group 1 airplanes, as identified in Boeing Alert Service
Bulletin MD80-55A069, dated January 19, 2011: Before the
accumulation of 23,000 total flight cycles, or within 4,383 flight
cycles after the effective

date of this AD, whichever occurs later, do a high frequency eddy
current (HFEC) inspection for cracking of the left and right rib
hinge bearing lugs of the aft face of the center section of the
horizontal stabilizer, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin MD80-55A069, dated
January 19, 2011. For any crack-free lug, repeat the inspection on
that lug thereafter at intervals not to exceed 8,200 flight cycles.
    (h) If, during any inspection required by paragraph (g) of this
AD, any crack is found, before further flight, measure the length of
the crack between the points specified in Boeing Alert Service
Bulletin MD80-55A069, dated January 19, 2011. Do the action in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin MD80-55A069, dated January 19, 2011.
    (1) If the crack length between points `A' and `B' is less than
or equal to 0.15 inch and the crack length between points `C' and
`D' is less than or equal to 0.05 inch: Before further flight, blend
out the crack, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin MD80-55A069, dated January 19, 2011.
Within 15,600 flight cycles after doing the blend out, do an HFEC
inspection of the blend out on the center section rib hinge bearing
lug for cracking, in accordance with the Accomplishment Instructions
of Boeing Alert Service Bulletin MD80-55A069, dated January 19,
2011, and repeat that inspection thereafter at intervals not to
exceed 3,900 flight cycles.
    (2) If the crack length between points `A' and `B' is greater
than 0.15 inch or the crack length between points `C' and `D' is
greater than 0.05 inch: Before further flight, replace the
horizontal stabilizer center section rib with a new horizontal
stabilizer center section rib, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin MD80-55A069, dated
January 19, 2011. Repeat the inspection required by paragraph (g) of
this AD one time before the accumulation of 23,000 total flight
cycles on the new horizontal stabilizer center section rib, and
thereafter at intervals not to exceed 11,300 flight cycles.

Actions on Horizontal Stabilizer Ribs Made From 7050-T7451 Material

    (i) For Group 2 airplanes, as identified in Boeing Alert Service
Bulletin MD80-55A069, dated January 19, 2011: Before the
accumulation of 23,000 total flight cycles, or within 4,383 flight
cycles after the effective date of this AD, whichever occurs later,
do an HFEC inspection for cracking of the left and right rib hinge
bearing lugs of the aft face of the center section of the horizontal
stabilizer, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin MD80-55A069, dated January 19, 2011.
For any crack-free lug, repeat the inspection on that lug thereafter
at intervals not to exceed 11,300 flight cycles.
    (j) If, during any inspection required by paragraph (i) of this
AD, any crack is found, before further flight, measure the length of
the crack between the points specified in and in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin MD80-
55A069, dated January 19, 2011.
    (1) If the crack length between points `A' and `B' is less than
or equal to 0.15 inch and the crack length between points `C' and
`D' is less than or equal to 0.05 inch: Before further flight, blend
out the crack, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin MD80-55A069, dated January 19, 2011.
Within 15,600 flight cycles after doing the blend out, do an HFEC
inspection of the blend out on the center section rib hinge bearing
lug for cracking, in accordance with the Accomplishment Instructions
of Boeing Alert Service Bulletin MD80-55A069, dated January 19,
2011, and repeat that inspection thereafter at intervals not to
exceed 5,800 flight cycles.
    (2) If the crack length between points `A' and `B' is greater
than 0.15 inch or the crack length between points `C' and `D' is
greater than 0.05 inch: Before further flight, replace the
horizontal stabilizer center section rib with a new horizontal
stabilizer center section rib, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin MD80-55A069, dated
January 19, 2011. Repeat the inspection required by paragraph (i) of
this AD one time before the accumulation of 23,000 total flight
cycles on the new horizontal stabilizer center section rib, and
thereafter at intervals not to exceed 11,300 flight cycles.

No Reporting Requirement

    (k) Although Boeing Alert Service Bulletin MD80-55A069, dated
January 19, 2011, specifies to submit certain information to the
manufacturer, this AD does not include that requirement.

Alternative Methods of Compliance (AMOCs)

    (l)(1) The Manager, Los Angeles Aircraft Certification Office
(ACO), 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 ACO, send it to the
attention of the person identified in the Related Information
section of this AD.
    (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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Los Angeles ACO to
make those findings. For a repair method to be approved, the repair
must meet the certification basis of the airplane and 14 CFR 25.571,
Amendment 45, and the approval must specifically refer to this AD.

Related Information

    (m) For more information about this AD, contact Roger Durbin,
Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles
Aircraft Certification Office, 3960 Paramount Boulevard, Lakewood,
California 90712-4137; phone:<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-
mail<EMAIL_ADDRESS>    (n) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, California 90846-
0001; telephone<PHONE_NUMBER>, extension 2; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on August 19, 2011.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-21853 Filed 8-25-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 98 (Wednesday, May 20, 2020)]
[Rules and Regulations]
[Pages 30597-30601]
[FR Doc No: 2020-10744]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0977; Product Identifier 2018-CE-041-AD; Amendment
39-21123; AD 2020-10-05]
RIN 2120-AA64

Airworthiness Directives; Rockwell Collins, Inc. Flight
Management Systems

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Rockwell Collins, Inc. (Rockwell Collins) flight management
systems (FMS) installed on airplanes. This AD was prompted by reports
of the flight management computer (FMC) software issuing incorrect turn
commands when the altitude climb field is edited or the temperature
compensation is activated on the FMS control display unit. This AD
requires disabling the automatic temperature compensation feature of
the FMS through the configuration strapping units (CSU) and revising
the airplane flight manual (AFM) Limitations section. The FAA is
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective June 24, 2020.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of June 24,
2020.

ADDRESSES: For service information identified in this final rule,
contact

Rockwell Collins, Inc., Collins Aviation Services, 400 Collins Road NE,
M/S 164-100, Cedar Rapids, IA 52498-0001; telephone:<PHONE_NUMBER>
(U.S.) or<PHONE_NUMBER>; fax:<PHONE_NUMBER> (outside U.S.); email:
<EMAIL_ADDRESS>internet: https://portal.rockwellcollins.com/web/publications-and-training. You may view
this service information at the FAA, Airworthiness Products Section,
Operational Safety Branch, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call (816)
329-4148. It is also available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0977.

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-2018-
0977; 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, the regulatory evaluation, any comments received, and
other information. The address 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: Avi Acharya, Aerospace Engineer,
Wichita Aircraft Certification Office, FAA, 1801 Airport Road, Room
100, Wichita, Kansas 67209; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain part-numbered
Rockwell Collins Pro Line 4 and Pro Line 21 FMSs. The NPRM published in
the Federal Register on December 6, 2018 (83 FR 62736).
    The NPRM was prompted by a flight inspection on a Bombardier Model
CRJ-200 airplane, during which Nav Canada, which is Canada's civil air
navigation service provider, observed the FMS map displaying an
incorrect turn for the Fort St. John airport instrument landing system
runway 29 missed approach while using temperature compensation. Nav
Canada assumed this was only an issue with the map display and reported
the incident to Rockwell Collins. Rockwell Collins subsequently
determined that an error in the design of the Pro Line 4 and Pro Line
21 FMC software causes changes to the procedure-defined turn direction
when the procedure has been significantly modified. The FMS removes the
planned database turn direction when the flight crew edits the altitude
climb field, and the flight crew may not notice the change during
climb. The FMS also removes the planned database turn direction if the
flight crew uses the temperature compensation to edit the altitude
climb field, which may go unnoticed by the flight crew with the
increased workload involved with a missed approach procedure. Editing
the altitude or using temperature compensation does not change the
flight segment. However, due to the design error, the software thinks
the flight segment has changed. The change of the planned turn
direction can occur for either left or right turns.
    The FMS commanding incorrect turn direction may result in a
collision or controlled flight into terrain.
    The NPRM proposed to require disabling the automatic temperature
compensation feature of the FMS through the CSU and revising the AFM
Limitations section. The FAA is issuing this AD to address the unsafe
condition on these products.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The following presents the comments
received on the NPRM and the FAA's response to each comment.

Request To Remove Requirement To Disable Temperature Compensation

    Bombardier Commercial Aircraft (Bombardier) and Endeavor Air
(Endeavor) requested the FAA remove paragraph (g), which proposed to
require disabling the automatic temperature compensation feature on the
CSU. These commenters stated that disabling this feature would also
disable the temperature compensation calculator, which would increase
crew workload and introduce error by necessitating that pilots manually
calculate this information.
    While the FAA agrees that performing manual temperature
compensation calculations or using standard cold temperature altitude
correction charts increases flight crew workload, the FAA finds that
these are acceptable piloting tasks. The FMS and its built-in
temperature compensation feature are not required under the FAA's
airworthiness standards; rather, the temperature compensation feature
of the FMS is an aid to the flight crew. Additionally, disabling the
temperature compensation feature is necessary to address the unsafe
condition. The FAA did not change the AD based on this comment.

Request To Revise the Language of the AFM Limitation Requirement

    Bombardier, Endeavor, and Collins Aerospace (Collins) requested the
FAA revise the AFM Limitations for altitude edits. The NPRM proposed to
require the limitation in Rockwell Collins Service Information Letter
(SIL) FMC-XX00-18-1, dated June 27, 2018, which prohibits editing
altitudes on departure, approach, and missed approach procedures. The
commenters requested the FAA change the limitation to only prohibit
editing altitudes on departure and missed approach procedures, and
eliminate the limitation for approach procedures. Collins stated that
following this limitation during approach prior to the missed approach
could adversely impact Vertical Navigation (VNAV) safety and crew
workload because it results in misleading VNAV alerts and displays
prior to the missed approach point.
    The FAA agrees. Rockwell Collins has revised the SIL and issued SIL
FMC-XX00-18-1, Revision 1, dated February 5, 2019, which contains the
limitation language requested by the commenters. This final rule
requires revising the AFM to add the information in SIL FMC-XX00-18-1,
Revision 1, dated February 5, 2019.

Request To Reduce the Compliance Time for the AFM Revision

    Endeavor requested the FAA reduce the time to revise the AFM from
12 months to 30 days.
    The FAA does not agree. The FAA considered the variety of aircraft
types and operations that would be affected by this AD and determined a
12-month compliance time is appropriate for both the AFM revisions and
the requirement to disable the temperature compensation feature. The
FAA did not change this AD based on this comment because 12 months
after the effective date of this AD is necessary to allow the owner/
operator a reasonable amount of time to perform the hardware
modification. The AFM limitations cannot be implemented without the
hardware change.

Request To Withdraw the NPRM

    WR Ryan stated that this matter is not serious enough to warrant an
AD. The commenter also stated that this issue is being exaggerated, as
Collins will eventually fix the problem. The FAA

infers the commenter wants the FAA to withdraw the NPRM.
    The FAA does not agree. The FAA issues an airworthiness directive
when it finds an unsafe condition exists in a product and the condition
is likely to exist or develop in other products of the same type
design. The FAA has determined the FMS design error is an unsafe
condition. While an operator may choose to comply with the service
information released by Rockwell Collins, not all operators are
required to do so. In order for the corrective actions in a service
document to become mandatory, and to correct the unsafe condition
identified in the NPRM, the FAA must issue an AD. The FAA did not
change this AD based on this comment.

Revise the Costs of Compliance

    WR Ryan stated the FAA estimated labor costs of $85 per work hour
in the NPRM, while the majority of maintenance shops charge labor rates
of $120 or more an hour. The FAA infers the commenter wants the FAA to
revise the labor rate in its estimated cost of complying with the AD.
    The FAA does not agree with this comment. The labor rate of $85 per
work-hour is provided by the FAA Office of Aviation Policy and Plans
for the FAA to use when estimating the labor costs of complying with AD
requirements. The FAA did not change this AD based on this comment.

Authority To Issue the AD/Extension of Comment Period

    Bombardier stated the FAA's Wichita ACO Branch lacks the legal
authority under 49 U.S.C. 44701 to issue an AD addressing a component
and requiring changes to an AFM. Bombardier requested the FAA's Wichita
ACO Branch coordinate the proposed AD with the FAA's New York ACO
Branch and consider whether the AD should instead address the aircraft.
Bombardier disagreed with the FAA's proposed AD because Transport
Canada, the responsible authority for the state of design for its
airplanes, has already issued an AD covering this same unsafe
condition. Alternatively, Bombardier requested an extension to the NPRM
commenting period to allow Bombardier and the New York ACO Branch to
provide input to the Wichita ACO Branch.
    The FAA does not agree. Although Canada is the state of design for
Bombardier products, the United States is the state of design for
Rockwell Collins products. Under the authority of 49 U.S.C. 44701 and
the FAA's regulations regarding ADs (14 CFR part 39), the FAA issues an
AD addressing a product (aircraft, engine, propeller, or appliance)
that has an unsafe condition if the condition is likely to exist or
develop in other products of the same type design. The FMS is an
appliance, as that term is defined in 14 CFR 1.1, that may be installed
in multiple aircraft types. Contrary to Bombardier's suggestion, 49
U.S.C. 44701 does not require the FAA to adopt the Transport Canada AD.
Rather, 49 U.S.C. 44701(e)(5) permits the FAA to either accept a
foreign AD (under certain conditions) or issue an FAA AD if determined
necessary for safety. The Transport Canada AD for this issue applies
only to Bombardier airplanes. The FAA determined corrective action is
necessary for U.S. operators of all aircraft with an FMS installed.
    The FAA also notes that its Wichita ACO Branch did not issue the
NPRM. The NPRM was coordinated with all appropriate FAA offices and
subsequently issued by the Deputy Director of the Policy and Innovation
Division (AIR-601) of the FAA's Aircraft Certification Service. The FAA
has not changed the AD based on this comment.

Request To Revise Preamble Information

    Collins requested the FAA replace some of the information in the
preamble with text from Rockwell Collins Operational Service Bulletin
0166-l7R5. Collins stated the description in the NPRM does not
accurately describe the issue. According to Collins, the design error
is that the FMS removes the planned turn direction if the crew manually
edits or uses temperature compensation to edit the altitude climb
field. In addition, Collins stated the FMS does not always turn in an
incorrect direction, but rather only when the shortest turn differs
from the planned turn.
    The FAA partially agrees. For clarification purposes, the FAA has
revised the referenced text in accordance with Collins' comment.
However, the FAA disagrees with replacing the referenced text with the
description from Rockwell Collins Operational Service Bulletin 0166-
17R5. The specific language requested by the commenter is a detailed
engineering description of the FMS design error that is appropriate for
a service bulletin.

Support of AD Action

    The Air Line Pilots Association and an anonymous commenter
supported the NPRM.

Conclusion

    The FAA reviewed the relevant data, considered the comments
received, and determined that air safety and the public interest
require adopting this final rule with the changes described previously.
The FAA determined that these changes will not increase the economic
burden on any operator or increase the scope of this final rule.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Rockwell Collins Service Information Letter, CSU-
XX00-18-1, dated June 27, 2018. The service letter contains procedures
for disabling the automatic temperature compensation option in Pro Line
4 and Pro Line 21 FMC systems. The FAA also reviewed Rockwell Collins
Service Information Letter FMC-XX00-18-1, Revision 1, dated February 5,
2019. The service letter provides instructions for revising the
Limitations section of the AFM by adding prohibitions on editing
altitudes for specific Pro Line 4 and Pro Line 21 Flight Management
Systems. This service information 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.

Costs of Compliance

    The FAA estimates that this AD affects 2,855 products installed on
airplanes of U.S. registry.
    The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
              Action                      Labor cost              Parts cost          product        operators
----------------------------------------------------------------------------------------------------------------
CSU strapping change.............  2 work-hours x $85 per    Not applicable.....            $170        $485,350
                                    hour = $170.
Revision to the AFM Limitations    .5 work-hour x $85 per    Not applicable.....           42.50      121,337.50
 section.                           hour = $42.50.
----------------------------------------------------------------------------------------------------------------

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.

Adoption of 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 (AD):

2020-10-05 Rockwell Collins, Inc.: Amendment 39-21123; Docket No.
FAA-2018-0977; Product Identifier 2018-CE-041-AD.

(a) Effective Date

    This AD is effective June 24, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Rockwell Collins, Inc. (Rockwell Collins) Pro
Line 4 and Pro Line 21 Flight Management Systems installed on
airplanes, certificated in any category, that has a flight
management computer (FMC) with a Rockwell Collins part number (RCPN)
listed in paragraph (c)(1) of this AD and with a configuration
strapping unit (CSU) listed in paragraph (c)(2) of this AD.
    (1) FMC-3000 RCPN 822-0883-031, -036, -038, -040, -041, -053, -
054, -056, -057, -058, -059, -060, -081, -082, -083, -084; FMC-4200
RCPN 822-0783-022, -025, -028, -032, -036, -039, -040; FMC-5000 RCPN
822-0891-021, -027, -028, -034, -040; or FMC-6000 RCPN 822-0868-074,
-075, -082, -083, -084, -085, -087, -089, -090, -109, -110, -111, -
112, -113, -114, -116, -117, -122, -123, -127, -130, -132, -133, -
134, -139.
    (2) CSU-3100 RCPN 822-1363-002, CSU-4000 RCPN 822-0049-002, or
CSU-4100 RCPN 822-1364-002.

    Note 1 to paragraph (c) of this AD: To determine the CSU and FMC
unit RCPN, refer to the aircraft manufacturer or applicable STC
holder maintenance instructions for accessing them.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 3460, Flight Management Computing Hardware
System.

(e) Unsafe Condition

    This AD was prompted by reports of the FMC software issuing
incorrect turn commands when the altitude climb field is edited or
when the temperature compensation is activated. The FAA is issuing
this AD to prevent the FMC from issuing an incorrect turn direction
command. The unsafe condition, if not addressed, could result in a
collision or controlled flight into terrain.

(f) Compliance

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

(g) Disable Temperature Compensation

    Within the next 12 months after June 24, 2020 (the effective
date of this AD), disable the automatic temperature compensation
feature on the CSU by following steps (2) through (6) of the
Instructions in Rockwell Collins Service Information Letter CSU-
XX00-18-1, dated June 27, 2018.

(h) Revise the Airplane Flight Manual Limitations

    Within the next 12 months after June 24, 2020 (the effective
date of this AD), revise the airplane flight manual by adding the
information from step 2 of the Aircraft Flight Manual Recommendation
in Rockwell Collins Service Information Letter FMC-XX00-18-1,
Revision 1, dated February 5, 2019, into the Limitations section of
the AFM.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Wichita ACO 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 ACO, send it to the attention of the person
identified in paragraph (j) of this AD.
    (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 Avi Acharya,
Aerospace Engineer, Wichita ACO Branch, FAA, 1801 Airport Road, Room
100, Wichita, Kansas 67209; phone:<PHONE_NUMBER>; 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 the AD specifies otherwise.
    (i) Rockwell Collins Service Information Letter CSU-XX00-18-1,
dated June 27, 2018.
    (ii) Rockwell Collins Service Information Letter FMC-XX00-18-1,
Revision 1, dated February 5, 2019.
    (3) For service information identified in this AD, contact
Rockwell Collins, Inc., Collins Aviation Services, 400 Collins Road
NE, M/S 164-100, Cedar Rapids, IA 52498-0001; telephone: 888-265-
5467 (U.S.) or<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>internet: https://portal.rockwellcollins.com/web/publications-and-training.
    (4) You may view this service information at the FAA,
Airworthiness Products Section, Operational Safety Branch, 901
Locust, Kansas City, Missouri 64106. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. In
addition, you can access this service information on the internet at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2018-0977.
    (5) You may view this service information 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 May 14, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-10744 Filed 5-19-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 186 (Wednesday, September 25, 2013)]
[Notices]
[Pages 59092-59093]
[FR Doc No: 2013-23358]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2013-0064; Notice 1]

Notice of Receipt of Petition for Decision that Nonconforming
1988-1996 Alpina B10 Passenger Cars Are Eligible for Importation

AGENCY: National Highway Traffic Safety Administration, DOT.

ACTION: Receipt of petition.

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

SUMMARY: This document announces receipt by the National Highway
Traffic Safety Administration (NHTSA) of a petition for a decision that
nonconforming 1988-1996 Alpina B10 passenger cars that were not
originally manufactured to comply with all applicable Federal Motor
Vehicle Safety Standards (FMVSS), are eligible for importation into the
United States because they have safety features that comply with, or
are capable of being altered to comply with, all such standards.

DATES: October 25, 2013.

ADDRESSES: Comments should refer to the docket and notice numbers above
and be submitted by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Send comments by mail addressed to: U.S. Department
of Transportation, 1200 New Jersey Avenue SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001
     Hand Delivery: Deliver comments by hand to: West Building
Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., between 9 a.m.
and 5 p.m. ET, Monday through Friday, except Federal holidays.
     Electronically: Submit comments electronically by: logging
onto the Federal Docket Management System (FDMS) Web site at http://www.regulations.gov/. Follow the online instructions for submitting
comments. Comments may also be faxed to<PHONE_NUMBER>
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that your comments were received, please
enclose a stamped, self-addressed postcard with the comments. Note that
all comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
    Documents submitted to a docket may be viewed by anyone at the
address and times given above. The documents may also be viewed on the
Internet at http://www.regulations.gov by following the online
instructions for accessing the dockets. DOT's complete Privacy Act
Statement is available for review in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated below will
be filed and will be considered. All comments and supporting materials
received after the closing date will also be filed and will be
considered to the extent possible. When the petition is granted or
denied, notice of the decision will be published in the Federal
Register pursuant to the authority indicated below.

FOR FURTHER INFORMATION CONTACT: George Stevens, Office of Vehicle
Safety Compliance, NHTSA<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 30141(a)(1)(B), a motor vehicle that was not
originally manufactured to conform to all applicable FMVSS, and has no
substantially similar U.S.-certified counterpart, shall be refused
admission into the United States unless NHTSA has decided that the
motor vehicle has safety features that comply with, or are capable of
being altered to comply with, all applicable FMVSS based on destructive
test data or such other evidence as NHTSA decides to be adequate.
    Petitions for eligibility decisions may be submitted by either
manufacturers or importers who have registered with NHTSA pursuant to
49 CFR Part 592. As specified in 49 CFR 593.7, NHTSA publishes notice
in the Federal Register of each petition that it receives, and affords
interested persons an opportunity to comment on the petition. At the
close of the comment period, NHTSA decides, on the basis of the
petition and any comments that it has received, whether the vehicle is
eligible for importation. The agency then publishes this decision in
the Federal Register.
    101 Innovations, LLC. of Lummi Island, WA (Registered Importer 07-
350) has petitioned NHTSA to decide whether nonconforming 1988-1996
Alpina B10 passenger cars are eligible for importation into the United
States. 101 Innovations believes these vehicles are capable of being
modified to meet all applicable FMVSS.
    In the past, NHTSA has granted import eligibility to a number of
Alpina vehicles that were derived from BMW vehicles. These include the
2005-2007 (manufactured before September 1, 2006) Alpina B5 series,
1987-1994 Alpina B11 sedan, the 1989-1996 Alpina B12 2-door coupe, and
the 1988-1994 Alpina B12 5.0 sedan (assigned vehicle eligibility
numbers VCP-53, VCP-48, VCP-43, and VCP-41, respectively). These
eligibility decisions were based on petitions submitted by Registered
Importers (RIs) who claimed that the vehicles were capable of being
altered to comply with all applicable FMVSS.
    Because those vehicles were not manufactured for importation into
and sale in the United States, and were not

certified by their original manufacturer (Alpina), as conforming to all
applicable FMVSS, they cannot be categorized as ``substantially
similar'' to the vehicle that is the subject of the petition at issue
for the purpose of establishing import eligibility for that vehicle
under 49 U.S.C. 30141(a)(1)(A). Therefore, the agency will consider 101
Innovation's petition as a petition pursuant to 49 U.S.C.
30141(a)(1)(B).
    101 Innovations submitted information with its petition intended to
demonstrate that non-U.S. certified 1988-1996 Alpina B10 passenger
cars, as originally manufactured, conform to many FMVSS. Specifically,
the petitioner claims that non-U.S. certified 1988-1996 Alpina B10
passenger cars, as originally manufactured, conform to: Standard Nos.
102 Transmission Shift Lever Sequence, Starter Interlock, and
Transmission Braking Effect, 103 Windshield Defrosting and Defogging
Systems, 104 Windshield Wiping and Washing Systems, 105 Hydraulic and
Electric Brake Systems, 106 Brake Hoses, 107 Reflective Surfaces, 109
New Pneumatic Tires, 113 Hood Latch System, 116 Motor Vehicle Brake
Fluids, 124 Accelerator Control Systems, 201 Occupant Protection in
Interior Impact, 202 Head Restraints, 204 Steering Control Rearward
Displacement, 205 Glazing Materials, 206 Door Locks and Door Retention
Components, 207 Seating Systems, 210 Seat Belt Assembly Anchorages, 211
Wheel Nuts, Wheel Disks, and Hub Caps, 212 Windshield Mounting, 214
Side Impact Protection, 216 Roof Crush Resistance, 219 Windshield Zone
Intrusion, 301 Fuel System Integrity, and 302 Flammability of Interior
Materials.
    The petitioner also contends that the vehicles are capable of being
readily altered to meet the following standards, in the manner
indicated:
    Standard No. 101 Controls and Displays: replacement of the
instrument cluster with components from the U.S.-model BMW E34 5-series
and reprogramming the vehicle computer to operate the necessary safety
systems.
    Standard No. 108 Lamps, Reflective Devices, and Associated
Equipment: replacement of the headlamps and front and rear marker
lights with components from the U.S.-model BMW E34 5-series, and
installation of the high-mounted stop light assembly from the U.S.-
model BMW E34 5-series.
    Standard No. 110 Tire Selection and Rims for Motor Vehicles with a
GVWR of 4,536 kilograms (10,000 pounds) or Less: installation of a tire
information placard.
    Standard No. 111 Rearview Mirrors: replacement of the passenger
side rearview mirror with a component from the U.S.-model BMW E34 5-
series or inscription of the required warning statement on the face of
that mirror.
    Standard No. 114 Theft Protection and Rollaway Prevention:
activation of occupant warning chime by reprogramming vehicle modules
and inspection and replacement of ignition switch with component from
the U.S.-model BMW E34 5-series if necessary to incorporate key
detection micro switch.
    Standard No. 115 Vehicle Identification Number: installation of a
VIN plate near the left windshield pillar.
    Standard No. 118 Power-operated Window, Partition, and Roof Panel
Systems: inspection of early models of these vehicles for remote
activation devices that exceed the distance limitations of this
standard. Systems not conforming to this standard will be disabled to
achieve conformity.
    Standard No. 208 Occupant Crash Protection: installation of airbag
system components from the U.S.-model BMW E34 5-series as necessary.
Installation of driver and/or passenger knee bolsters that conform to
the requirements of this standard.
    Standard No. 209 Seat Belt Assemblies: inspection of seat belt
assemblies and replacement of any non-conforming components with U.S.-
model BMW E34 5-series components.

    Authority:  49 U.S.C. 30141(a)(1)(A), (a)(1)(B), and (b)(1); 49
CFR 593.7; delegation of authority at 49 CFR 1.95 and 501.8.

Claude H. Harris,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2013-23358 Filed 9-24-13; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 78, Number 238 (Wednesday, December 11, 2013)]
[Notices]
[Pages 75398-75400]
[FR Doc No: 2013-29488]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-70990; File No. SR-MSRB-2013-08]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Order Granting Approval of a Proposed Rule Change Consisting of
Amendments to MSRB Rule G-11, on Primary Offering Practices, Relating
to Changes in a Bond Authorizing Document

December 5, 2013.

I. Introduction

    On September 19, 2013, the Municipal Securities Rulemaking Board
(``MSRB'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change consisting of amendments to MSRB Rule G-11,
Primary Offering Practices, relating to consents to changes in a bond
authorizing document. The proposed rule change was published for
comment in the Federal Register on October 22, 2013.\3\ The Commission
received no comments on the proposal. This order approves the proposed
rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 70607 (October 3, 2013),
78 FR 62736 (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    The MSRB states in the Notice that municipal entity issuers
(``issuers'') or bond owners often request amendments to bond
authorizing documents in order to modernize outdated provisions or
address other concerns that have arisen after the initial issuance of
bonds. These amendments are typically achieved by the consent of owners
of a specified

percentage of the aggregate principal amount of bonds, as determined by
the authorizing document. The MSRB asserts that the process of
obtaining consents from bond owners and related costs can be
significant because the identity of beneficial owners of bonds is
frequently unknown to issuers and trustees.\4\ To address some of these
burdens, issuers frequently have requested underwriters, as temporary
owners of bonds during the initial distribution period and representing
the aggregate principal amount of bonds underwritten, to provide
consents to amendments to authorizing documents. According to the MSRB,
this allows issuers to avoid the potential cost and delay of obtaining,
by direct solicitation, consents from beneficial owners. However,
according to the MSRB, this approach may result in a dealer consenting
to changes to authorizing documents that adversely affect the interests
of existing bond owners.\5\
---------------------------------------------------------------------------

    \4\ The MSRB states that many municipal securities are issued in
book-entry form and registered as a single ``global'' certificate in
the name of a depository. Thus, the identity of beneficial owners of
the bonds is frequently unknown to issuers and trustees.
Additionally, the MSRB states that identifying such owners and
obtaining consents often results in cost and delay in achieving the
requisite number of consents.
    \5\ The MSRB represents, that while existing bond owners may be
considered as having agreed to provisions relating to amendments to
the authorizing documents at the time of purchase, such bond owners
are not likely to have anticipated that a dealer, acting as an
underwriter or remarketing agent with no prior or future long-term
economic interest in the bonds, could provide such consent unless
such ability had been specifically authorized in the authorizing
documents and disclosed to bond owners.
---------------------------------------------------------------------------

    The MSRB proposes to amend MSRB Rule G-11, Primary Offering
Practices, to prohibit brokers, dealers and municipal securities
dealers (``dealers'') from providing consents to any amendment to
authorizing documents for municipal securities, either as an
underwriter, a remarketing agent, or as agent for or in lieu of bond
owners, except in certain limited circumstances set forth in proposed
section (l) of Rule G-11.\6\
---------------------------------------------------------------------------

    \6\ The MSRB notes that consents from dealers solely in their
capacity as an underwriter or a remarketing agent and required or
permitted in connection with their administrative duties under
authorizing documents are not subject to the proposed rule change.
Further, the MSRB notes that the proposed rule change does not
affect other methods used by issuers to obtain consents from owners
of newly issued bonds, such as consents received from bond owners
upon initial purchase of the bonds.
---------------------------------------------------------------------------

    Subparagraph (l)(i)(A) will except from the prohibition an
underwriter that provides bond owner consents to changes in authorizing
documents if such documents expressly allowed an underwriter to provide
such consents and the offering documents for the issuer's existing
securities expressly disclosed that consents could be provided by
underwriters of other securities issued under the same authorizing
documents.
    Subparagraph (l)(i)(B) will except from the prohibition a dealer
that owns the relevant securities other than in the capacity of an
underwriter or a remarketing agent. The MSRB states that the
determination of whether a dealer owns the securities for purposes of
this exception will depend on whether it purchased such securities
without a view to distribution.
    Subparagraph (l)(i)(C) will except a dealer acting as a remarketing
agent to whom the relevant securities had been tendered as a result of
a mandatory tender, provided that all securities affected by the
amendment (other than securities retained by an owner in lieu of a
tender and for which such bond owner had delivered consent) had been
tendered. If a bond owner elects to exercise its right to ``hold''
bonds subject to a mandatory tender in lieu of tendering, the
remarketing agent will be prohibited from providing consents to any
amendment to an authorizing document unless it also receives the
specific written consent of such bond owner to such change.
    Subparagraph (l)(i)(D) will except a dealer that provides consent
to changes to authorizing documents solely as agent for and on behalf
of bond owners that delivered separate written consents to such
amendments. An underwriter providing an ``omnibus'' consent under this
subparagraph will not be viewed as substituting its judgment for that
of bond owners but rather as an agent facilitating the collection and
delivery of consents.
    Subparagraph (l)(i)(E) will except a dealer, in its capacity as an
underwriter, that provides consent on behalf of prospective purchasers
to amendments to authorizing documents if the amendments would not
become effective until all existing bond owners affected by the
proposed amendments (other than the prospective purchasers for whom the
underwriter had provided consent) had also consented.\7\
---------------------------------------------------------------------------

    \7\ The MSRB states that this exception recognizes a limited
circumstance in which an underwriter's consent to amendments to
authorizing documents, provided in lieu and on behalf of new
purchasers of bonds, will be permitted. In this case, the
underwriter's consent will not become effective until existing
owners of all bonds (other than the prospective purchasers for whom
the underwriter had provided consent) affected by such amendment and
outstanding at the time such consent became effective had also
provided consent. The MSRB states that this alternative might be
considered when an issuer was in the process of accumulating
consents from all owners of outstanding bonds and had not completed
acquiring the consents prior to issuing a new series of bonds. In
that case, an underwriter's consent on behalf of new purchasers
would not become effective until all other bond owners affected by
the amendment had also provided their consent and such other
consents were currently effective. The MSRB represents that this
exception would not affect an underwriter's ability to provide
consents as permitted in subparagraph (l)(i)(D) of the proposed rule
change.
---------------------------------------------------------------------------

    Lastly, paragraph (l)(ii) will define certain terms for purposes of
proposed section (l), specifically the terms ``authorizing document,''
\8\ ``bond owner,'' \9\ and ``bond owner consent.'' \10\
---------------------------------------------------------------------------

    \8\ The MSRB defines the term ``authorizing document'' to mean
the trust indenture, resolution, ordinance, or other document under
which the securities are issued.
    \9\ The MSRB defines the term ``bond owner'' as the owner of
municipal securities issued under the applicable authorizing
document.
    \10\ The MSRB defines the term ``bond owner consent'' to mean
any consent specified in an authorizing document that may be or is
required to be given by a bond owner pursuant to such authorizing
document.
---------------------------------------------------------------------------

III. Discussion and Commission Findings

    The Commission has carefully considered the proposed rule change
and finds that the proposal is consistent with the requirements of the
Act and the rules and regulations thereunder.\11\ In particular, the
proposed rule change is consistent with Section 15B(b)(2)(C) of the
Act, which provides that the MSRB's rules shall be designed to prevent
fraudulent and manipulative acts and practices, to promote just and
equitable principles of trade, to foster cooperation and coordination
with persons engaged in regulating, clearing, settling, processing
information with respect to, and facilitating transactions in municipal
securities and municipal financial products, to remove impediments to
and perfect the mechanism of a free and open market in municipal
securities and municipal financial products, and, in general, to
protect investors, municipal entities, obligated persons, and the
public interest.\12\
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    \11\ In approving the proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. 15 U.S.C. 78c(f).
    \12\ 15 U.S.C. 78o-4(b)(2)(C).
---------------------------------------------------------------------------

    The Commission believes that the proposed rule change is consistent
with Section 15B(b)(2)(C) of the Act, because it should protect
investors by prohibiting consents to amendments to authorizing
documents from a dealer who may be only the temporary owner of the
bonds and thus may not share a bond owner's prior or long-term economic
interest in the bonds, except under limited circumstances set forth in
the rule. The Commission notes that the

exceptions in the rule to allow dealer consent to changes in
authorizing documents are limited in nature so as to protect existing
bond holders, while addressing concerns of issuers about obtaining
consents to amendments of their authorizing documents in certain
situations. In addition, the Commission believes that the proposed rule
change will enhance transparency regarding the practice of obtaining
bond owner consents from dealers.
    At the same time, the Commission notes that the MSRB has
represented that the proposed rule change does not grant an affirmative
right to dealers to provide consents to changes to authorizing
documents and does not alter the dealer's obligations applicable under
other MSRB rules, including its fair dealing obligations under Rule G-
17. Accordingly, dealers may not simply rely on the exceptions
prescribed in the rule but rather are obligated to consider and comply
with their Rule G-17 obligations in seeking to provide consents to
amendments in authorizing documents at the request of an issuer in
accordance with the exceptions provided.
    For these reasons, the Commission believes that the proposed rule
change is consistent with the Act.

IV. Conclusion

    For the foregoing reasons, the Commission finds that the proposed
rule change is consistent with the requirements of the Act and the
rules and regulations thereunder applicable to the MSRB, and in
particular, Section 15B(b)(2)(C) of the Act.
    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\13\ that the proposed rule change (SR-MSRB-2013-08) be, and hereby
is, approved.
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    \13\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-29488 Filed 12-10-13; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 53 (Monday, March 22, 2021)]
[Notices]
[Pages 15213-15214]
[FR Doc No: 2021-05861]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2997-031]

South Sutter Water District; Notice of Application Ready for
Environmental Analysis and Soliciting Comments, Recommendations, Terms
and Conditions, and Prescriptions

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Major, new license.
    b. Project No.: P-2997-031.
    c. Date filed: July 1, 2019.
    d. Applicant: South Sutter Water District.
    e. Name of Project: Camp Far West Hydroelectric Project.
    f. Location: The existing project is located on the Bear River in
Yuba, Nevada, and Placer Counties, California. The project, with the
proposed project boundary modifications, would occupy a total of 2,674
acres. No federal or tribal lands occur within or adjacent to the
project boundary or along the Bear River downstream of the project.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791a-825r.
    h. Applicant Contact: Mr. Brad Arnold, General Manager, South
Sutter Water District, 2464 Pacific Avenue, Trowbridge, California
95659.
    i. FERC Contact: Quinn Emmering,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, recommendations, terms and
conditions, and prescriptions: 60 days from the issuance date of this
notice; reply comments are due 105 days from the issuance date of this
notice.
    The Commission strongly encourages electronic filing. Please file
comments, recommendations, terms and conditions, and prescriptions
using the Commission's eFiling system at https://ferconline.ferc.gov/FERCOnline.aspx. Commenters can submit brief comments up to 6,000
characters, without prior registration, using the eComment system at
http://www.ferc.gov/docs-filing/ecomment.asp. You must include your
name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, you may submit a paper copy.
Submissions sent via the U.S. Postal Service must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE, Room 1A, Washington, DC 20426. Submissions sent via
any other carrier must be addressed to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 12225 Wilkins Avenue, Rockville,
Maryland 20852. The first page of any filing should include docket
number P-2997-031.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    k. This application has been accepted and is ready for
environmental analysis at this time.
    l. The existing Camp Far West Hydroelectric Project operates to
provide water during the irrigation season, generate power, and meet
streamflow requirements for the Bear River. The project includes: (1) A
185-foot-high, 40-foot-wide, 2,070-foot-long, earth-filled main dam;
(2) a 45-foot-high, 20-foot-wide, 1,060-foot-long, earth-filled south
wing dam; (3) a 25-foot-high, 20-foot-wide, 1,460-foot-long, earth-
filled north wing dam; (4) a 15-foot-high, 20-foot-wide, 1,450-foot-
long, earth-filled north dike; (5) a 2,020-acre reservoir with a gross
storage capacity of about 104,000 acre-feet at the normal maximum water
surface elevation (NMWSE) of 300 feet; (6) an overflow spillway with a
maximum design capacity of 106,500 cubic feet per second (cfs) at a
reservoir elevation of 320 feet with a 15-foot-wide concrete approach
apron, 300-foot-long ungated, ogee-type concrete structure, and a 77-
foot-long downstream concrete chute with concrete sidewalls and a
302.5-foot single span steel-truss bridge across the spillway crest;
(7) a 1,200-foot-long, unlined, rock channel that carries spill
downstream to the Bear River; (8) a 22-foot-high, concrete, power
intake tower with openings on three sides protected by steel
trashracks; (9) a 25-foot-4-inch-high, concrete, intake tower with
openings on three sides, each of which is protected by steel trashracks
that receives water for the outlet works; (10) a 760-foot-long, 8-foot-
diameter concrete tunnel through the left abutment of the main dam that
conveys water from the power intake to the powerhouse; (11) a steel-
reinforced, concrete powerhouse with a 6.8-megawatt, vertical-shaft,
Francis-type turbine, which discharges to the Bear River at the base of
the main dam; (12) a 350-foot-long, 48-inch-diameter steel pipe that
conveys water from the intake structure to a valve chamber for the
outlet works; (13) a 400-foot-long, 7.5-foot-diameter concrete-lined
horseshoe tunnel that connects to the valve chamber to a 48-inch-
diameter, Howell Bunger outlet valve with a capacity of 500 cfs that
discharges directly into the Bear River; (14) a fenced switchyard
adjacent to the powerhouse; (15) two recreation areas with campgrounds,
day-use areas, boat ramps, restrooms, and sewage holding ponds; and
(16) a recreational water system that includes two pumps in the
reservoir that deliver water to a treatment facility that is piped to a
60,000-gallon storage tank to supply water to recreation facilities.
The project has no transmission facilities. The estimated average
annual generation (2010 to 2017) is 22,637 megawatt-hours.
    South Sutter Water District proposes to: (1) Raise the NMWSE of the
project reservoir by 5 feet from an elevation of 300 feet to an
elevation of 305 feet; (2) raise the crest of the existing spillway
from an elevation of 300 feet to an

elevation of 305 feet to accommodate the proposed pool raise; (3)
replace and restore several recreation facilities; (4) add an existing
0.25-mile road as a primary project road to access the powerhouse and
switchyard; and (5) modify the project boundary to account for the
removal of the 1.9-mile-long transmission line from the license in
1991, corrections based on current project operation and maintenance,
and changes under the category of a contour 20 feet above the 300-feet
NMWSE or proximity of 200-horizontal-feet from the 300-foot NMWSE.
    m. In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's website at http://www.ferc.gov using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document (i.e., P-
2997). At this time, the Commission has suspended access to the
Commission's Public Reference Room, due to the proclamation declaring a
National Emergency concerning the Novel Coronavirus Disease (COVID-19),
issued by the President on March 13, 2020. For assistance, contact FERC
Online Support.
    All filings must (1) bear in all capital letters the title
``COMMENTS'', ``REPLY COMMENTS'', ``RECOMMENDATIONS,'' ``TERMS AND
CONDITIONS,'' or ``PRESCRIPTIONS;'' (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person submitting the filing; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. Each filing must be
accompanied by proof of service on all persons listed on the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b) and 385.2010.
    You may also register online at https://ferconline.ferc.gov/FERCOnline.aspx to be notified via email of new filings and issuances
related to this or other pending projects. For assistance, contact FERC
Online Support.
    n. A license applicant must file no later than 60 days following
the date of issuance of this notice: (1) A copy of the water quality
certification; (2) a copy of the request for certification, including
proof of the date on which the certifying agency received the request;
or (3) evidence of waiver of water quality certification.
    o. Procedural schedule: The application will be processed according
to the following schedule. Revisions to the schedule will be made as
appropriate.

Deadline for Filing Comments, Recommendations, and Agency Terms and
Conditions/Prescriptions--May 17, 2021
Licensee's Reply to REA Comments--June 29, 2021
Commission issues Draft EA--January 2022
Comments on EA--February 2022
Commission issues Final EA--May 2022
Commission issues license order--August 2022

    Dated: March 16, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-05861 Filed 3-19-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 205 (Tuesday, October 23, 2018)]
[Rules and Regulations]
[Pages 53376-53377]
[FR Doc No: 2018-23073]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2018-0950]

Drawbridge Operation Regulation; Hood Canal, Port Gamble, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Washington State pontoon highway
bridge (Hood Canal Bridge) across Hood Canal, mile 5.0, near Port
Gamble, WA. The deviation is necessary to accommodate replacement newly
discovered draw span operating equipment while installing upgrades.
This deviation allows the bridge to open the half the draw, 300 feet,
after receiving at least a four hour notice.

DATES: This deviation is effective without actual notice from October
23, 2018 to 11:59 p.m. on November 16, 2019. For purposes of
enforcement, actual notice will be used from 6 p.m. on October 13,
2018, to October 23, 2018.

ADDRESSES: The docket for this deviation, USCG-2018- 0950 is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Steven Fischer, Bridge
Administrator, Thirteenth Coast Guard District; telephone<PHONE_NUMBER>,
email [email protected].

SUPPLEMENTARY INFORMATION: The Washington Department of Transportation
(WSDOT), the bridge owner, has requested a temporary deviation from the
operating schedule of the Hood Canal Bridge. This deviation will allow
the subject bridge to open

half of the draw span, east half only, to facilitate replacement of
worn equipment discovered after installation of upgrades. The Hood
Canal Bridge crosses Hood Canal, mile 5.0, near Port Gamble, WA. The
bridge has two fixed spans (east and west), and one draw span (center).
The east span provides 50 feet of vertical clearance, the west span
provides 35 feet of vertical clearance, and the center span provides
zero feet of vertical clearance in the closed-to-navigation position.
The center span provides unlimited vertical clearance in the open-to-
navigation position. Vertical clearances are referenced to mean high-
water elevation.
    This deviation allows the center span of the Hood Canal Bridge to
open half-way (300 feet vice 600 feet) on signal after receiving at
least a four hour notice from 6 a.m. on October 13, 2018 to 11:59 p.m.
on November 16, 2019. During the period of this deviation, the
drawbridge will not be able to operate according to the normal
operating schedule. The normal operating schedule for the Hood Canal
Bridge is in accordance with 33 CFR 117.1045. The bridge shall operate
in accordance to 33 CFR 117.1045 at all other times. Waterway usage on
this part of Hood Canal (Admiralty Inlet) includes commercial tugs and
barges, U.S. Navy and U.S. Coast Guard vessels, and small pleasure
craft. Coordination has been completed with known waterway users, and a
no objections to the deviation have been received.
    Vessels able to pass through the east and west spans may do so at
any time. The center span does not provide passage in the closed-to-
navigation position. The subject bridge will be able to open half the
center span for Navy and Coast Guard vessels during emergencies, when
at least a one hour notice has been given by the Navy or Coast Guard.
The Coast Guard will also inform the users of the waterways through our
Local and Broadcast Notices to Mariners of the change in operating
schedule for the bridge so that vessels can arrange their transits to
minimize any impact caused by this temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: October 17, 2018.
Steven Fischer,
Chief, Bridge Program, Thirteenth Coast Guard District.
[FR Doc. 2018-23073 Filed 10-22-18; 8:45 am]
 BILLING CODE 9110-04-P