[Federal Register Volume 83, Number 101 (Thursday, May 24, 2018)]
[Rules and Regulations]
[Pages 24012-24016]
[FR Doc No: 2018-09863]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0530; Product Identifier 2017-NM-012-AD; Amendment
39-19271; AD 2018-09-14]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc., Airplanes

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

ACTION: Final rule.

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SUMMARY: We are superseding Airworthiness Directive (AD) 2016-11-02,
which applied to all Bombardier, Inc., Model CL-600-2C10 (Regional Jet
Series 700, 701, & 702) airplanes; Model CL-600-2D15 (Regional Jet
Series 705) airplanes; Model CL-600-2D24 (Regional Jet Series 900)
airplanes; and Model CL-600-2E25 (Regional Jet Series 1000) airplanes.
AD 2016-11-02 required repetitive inspections of the upper and lower
engine pylons for protruding, loose, or missing fasteners; and repair
if necessary. This AD continues to require the repetitive inspections
of the upper and lower engine pylons for protruding, loose, or missing
fasteners; and repair if necessary. This AD also requires replacement
of affected fasteners, which terminates the inspections. This AD was
prompted by reports of loose or missing fasteners and collars on the
upper and lower engine pylon structure common to the upper and lower
pylon skin panels and engine thrust fitting. We are issuing this AD to
address the unsafe condition on these products.

DATES: This AD is effective June 28, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of June 28,
2018.
    The Director of the Federal Register approved the incorporation by
reference of certain other publications listed in this AD as of June
10, 2016 (81 FR 33371, May 26, 2016).

ADDRESSES: For service information identified in this final rule,
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 protected]; internet http://www.bombardier.com. You may view this referenced service information at
the FAA, Transport Standards Branch, 2200 South 216th Street, Des
Moines, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0530.

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-2017-
0530; 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 AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (telephone 800-
647-5527) is Docket Management Facility, 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: Aziz Ahmed, Aerospace Engineer,
Airframe and Mechanical Systems Section, FAA, New York ACO Branch, 1600
Stewart Avenue, Suite 410, Westbury, NY 11590; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2016-11-02, Amendment 39-18529 (81 FR 33371,
May 26, 2016) (``AD 2016-11-02''). AD 2016-11-02 applied to all
Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series 700, 701, &
702) airplanes; Model CL-600-2D15 (Regional Jet Series 705) airplanes;
Model CL-600-2D24 (Regional Jet Series 900) airplanes; and Model CL-
600-2E25 (Regional Jet Series 1000) airplanes. The NPRM published in
the Federal Register on June 12, 2017 (82 FR 26864). The NPRM was
prompted by reports of loose or missing fasteners and collars on the
upper and lower engine pylon structure common to the upper and lower
pylon skin panels and engine thrust fitting. The NPRM proposed to
continue to require the repetitive inspections of the upper and lower
engine pylons for protruding, loose, or missing fasteners; and repair
if necessary. The NPRM also proposed to require replacement of affected
fasteners, which terminates the inspections. We are issuing this AD to
prevent protruding, loose, or missing fasteners, which could result in
structural failure of the engine pylons.
    Transport Canada Civil Aviation (TCCA), which is the aviation
authority

for Canada, has issued Canadian Airworthiness Directive CF-2016-10R1,
dated July 8, 2016 (referred to after this as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for all Bombardier, Inc., Model CL-600-2C10 (Regional Jet
Series 700, 701, & 702) airplanes; Model CL-600-2D15 (Regional Jet
Series 705) airplanes; Model CL-600-2D24 (Regional Jet Series 900)
airplanes; and Model CL-600-2E25 (Regional Jet Series 1000) airplanes.
The MCAI states:

    There have been several reported findings of loose or missing
Hi-Lite fasteners and collars on the left hand (L/H) and right hand
(R/H) upper and lower engine pylon structure common to the upper and
lower pylon skin panels and engine thrust fitting. Missing fasteners
in these areas are shown to significantly reduce the safety margins
and could result in a structural failure of the engine pylon.
    Bombardier, as an interim corrective action issued a new
Aircraft Maintenance Manual (AMM) task for detailed inspection of
the engine pylon rib and skin fasteners to inspect for protruding,
loose or missing fasteners and rectify any discrepancies noted in
accordance with a Repair Engineering Order (REO). The original
version of this [Canadian] AD, CF-2016-10, mandated the subject
inspection and necessary rectification.
    Bombardier has since issued Service Bulletin (SB) 670BA-54-007
to replace all affected fasteners with interference fit fasteners
[including applicable related investigative and corrective actions],
as terminating action for the mandated inspection requirement.
[Canadian] AD CF-2016-10 is now being revised to mandate compliance
with SB 670BA-54-007.

    Related investigative actions include measurements of the attach
holes in the engine pylon upper structure and special detailed visual
inspections for cracks in the engine pylon structure. Corrective
actions include repair. You may examine the MCAI in the AD docket on
the internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2017-0530.
    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0530.

Comments

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

Request To Include Additional Service Information in Credit Paragraph

    Mesa Airlines suggested that Bombardier Service Bulletin 670BA-54-
007, dated May 13, 2016, be included in paragraph (l), ``Credit for
Previous Actions,'' of the proposed AD. The commenter did not provide
justification for its request. We infer that the commenter made this
request to provide credit for operators that completed the actions in
Bombardier Service Bulletin 670BA-54-007, dated May 13, 2016, prior to
the effective date of the proposed AD.
    We do not agree that the commenter's requested change is needed.
Paragraph (f) of this AD states that the actions specified in this AD
must be accomplished ``unless already done.'' The phrase ``unless
already done'' provides credit for accomplishment of the actions
required by paragraph (j) of this AD, if done in accordance with the
Accomplishment Instructions of Bombardier Service Bulletin 670BA-54-
007, dated May 13, 2016, prior to the effective date of this AD.
Therefore, we have not changed this AD in this regard.

Request To Revise Paragraph (g) of the Proposed AD To Require Airplane
Maintenance Manual Task

    Bombardier requested that Task 54-51-01-220-801, ``Detailed
Inspection of the Engine Pylon Rib and Skin Fasteners,'' to Chapter 54,
``Nacelle/Pylons,'' to Part 2 of the Bombardier CRJ700/900/1000
Aircraft Maintenance Manual (AMM), be required by paragraph (g) of the
proposed AD in lieu of Bombardier Temporary Revision (TR) 54-0007,
dated March 8, 2016, to the CRJ700/900/1000 AMM. The commenter stated
that Bombardier TR 54-0007 was incorporated into Revision 52 of the
Bombardier CRJ700/900/1000 AMM, and that the AMM is currently at
Revision 56.
    We partially agree with the commenter's request. We agree to
include Task 54-51-01-220-801, ``Detailed Inspection of the Engine
Pylon Rib and Skin Fasteners,'' to Chapter 54, ``Nacelle/Pylons,'' to
Part 2 of the Bombardier CRJ700/900/1000 AMM as a method of compliance
in paragraph (g) of this AD, but we do not agree to remove Bombardier
TR 54-0007, dated March 8, 2016, to the Bombardier CRJ700/900/1000 AMM.
We have revised paragraph (g) of this AD to include both Task 54-51-01-
220-801, ``Detailed Inspection of the Engine Pylon Rib and Skin
Fasteners,'' to Chapter 54, ``Nacelle/Pylons,'' to Part 2 of the
Bombardier CRJ700/900/1000 AMM, CSP B-001, Revision 56, dated September
25, 2017; and Bombardier TR 54-0007, dated March 8, 2016. This revision
provides operators with an option to use either service document to
accomplish the required action.

Conclusion

    We reviewed the available data, including the comments received,
and determined that air safety and the public interest require adopting
this AD with the changes described previously and minor editorial
changes. We have determined that these changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    We also determined that these changes will not increase the
economic burden on any operator or increase the scope of this AD.

Related Service Information Under 1 CFR Part 51

    Bombardier, Inc., issued Service Bulletin 670BA-54-007, dated May
13, 2016. This service information describes procedures for replacing
fasteners and collars, including applicable related investigative and
corrective actions.
    Bombardier, Inc., also issued Repair Engineering Order 670-54-51-
034, ``Repair for Missing or Loose/Protruding Fasteners in Upper and
Lower Pylon Skins FS 1088--FS 1098, PBL 69.3 L & RHS,'' Revision A,
dated April 20, 2016. This service information describes procedures for
repair, including applicable related investigative and corrective
actions.
    In addition, Bombardier, Inc., issued TR 54-0007, dated March 8,
2016, to the CRJ700/900/1000 AMM; and Task 54-51-01-220-801, ``Detailed
Inspection of the Engine Pylon Rib and Skin Fasteners,'' to Chapter 54,
``Nacelle/Pylons,'' to Part 2 of the Bombardier CRJ700/900/1000 AMM,
CSP B-001, Revision 56, dated September 25, 2017. This service
information describes procedures for a detailed visual inspection for
protruding, loose, or missing fasteners of the left-hand and right-hand
upper and lower engine pylons. The content of these documents is nearly
identical, except for labels on the figures; we have chosen to
incorporate both documents by reference so that either may be used to
comply with certain requirements of this AD.
    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

    We estimate that this AD affects 273 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
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                                                                                Cost on U.S.
             Action                     Labor cost          Parts cost     Cost per product        operators
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Inspection (retained from AD     1 work-hour x $85 per                $0  $85 per inspection  $23,205 per
 2016-11-02).                     hour = $85 per                           cycle.              inspection cycle.
                                  inspection cycle.
Replacement (new action).......  43 work-hours x $85 per           1,808  $5,463 per          $1,491,399 per
                                  hour = $3,655 per                        inspection cycle.   inspection cycle.
                                  inspection cycle.
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    We estimate the following costs to do any necessary repairs that
will be required based on the results of the inspection. We have no way
of determining the number of aircraft that might need these repairs:

                                               On-Condition Costs
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               Action                          Labor cost             Parts cost          Cost per product
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Repair (retained from AD 2016-11-02)  Up to 32 work-hours x $85              (\1\)  Up to $2,720.
                                       per hour = $2,720.
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\1\ We have received no definitive data that will enable us to provide cost estimates for the parts cost
  specified in this AD for the on-condition repairs.

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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes to
the Director of the System Oversight Division.

Regulatory Findings

    We determined that 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. 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.

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 removing Airworthiness Directive (AD)
2016-11-02, Amendment 39-18529 (81 FR 33371, May 26, 2016), and adding
the following new AD:

2018-09-14 Bombardier, Inc.: Amendment 39-19271; Docket No. FAA-
2017-0530; Product Identifier 2017-NM-012-AD.

(a) Effective Date

    This AD is effective June 28, 2018.

(b) Affected ADs

    This AD replaces AD 2016-11-02, Amendment 39-18529 (81 FR 33371,
May 26, 2016) (``AD 2016-11-02'').

(c) Applicability

    This AD applies to the airplanes identified in paragraphs (c)(1)
through (c)(4) of this AD, certificated in any category.
    (1) Bombardier, Inc., Model CL-600-2C10 (Regional Jet Series
700, 701, & 702) airplanes, serial numbers (S/Ns) 10002 through
10344 inclusive.
    (2) Bombardier, Inc., Model CL-600-2D15 (Regional Jet Series
705) airplanes, S/Ns 15001 through 15388 inclusive, 15391, 15392,
and 15395.
    (3) Bombardier, Inc., Model CL-600-2D24 (Regional Jet Series
900) airplanes, S/Ns 15001 through 15388 inclusive, 15391, 15392,
and 15395.
    (4) Bombardier, Inc., Model CL-600-2E25 (Regional Jet Series
1000) airplanes, S/Ns 19001 through 19044 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 54, Nacelles/
Pylons.

(e) Reason

    This AD was prompted by reports of loose or missing fasteners
and collars on the upper and lower engine pylon structure common to
the upper and lower pylon skin panels and engine thrust fitting. We
are issuing this AD to prevent protruding, loose, or missing
fasteners, which could result in structural failure of the engine
pylons.

(f) Compliance

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

(g) Retained Inspection, With a Reference To Terminating Action and
Additional Service Information

    This paragraph restates the requirements of paragraph (g) of AD
2016-11-02, with a reference to new terminating action and
additional service information. At the applicable time specified in
paragraph (g)(1) or (g)(2) of this AD: Do a detailed visual
inspection for protruding, loose, or missing fasteners of the upper
and lower engine pylons, in accordance with Bombardier Temporary
Revision 54-0007, dated March 8, 2016, to the CRJ700/900/1000
Aircraft Maintenance Manual; or Task 54-51-01-220-801, ``Detailed
Inspection of the Engine Pylon Rib and Skin Fasteners,'' to Chapter
54, ``Nacelle/Pylons,'' to Part 2 of the Bombardier CRJ700/900/1000
Aircraft Maintenance Manual, CSP B-001, Revision 56, dated September
25, 2017. Repeat the inspection thereafter at intervals not to
exceed 1,500 flight hours. Accomplishment of the replacement
required by paragraph (j) of this AD is terminating action for the
inspections required by this paragraph.
    (1) For airplanes that have accumulated more than 840 total
flight hours as of June 10, 2016 (the effective date of AD 2016-11-
02): Inspect within 660 flight hours or 3 months, whichever occurs
first, after June 10, 2016.
    (2) For airplanes that have accumulated 840 total flight hours
or less as of June 10, 2016 (the effective date of AD 2016-11-02):
Inspect before the accumulation of 1,500 total flight hours.

(h) Retained Repair, With New Service Information and Contact
Information

    This paragraph restates the requirements of paragraph (h) of AD
2016-11-02, with new service information and contact information. If
any protruding, loose, or missing fastener is found during any
inspection required by paragraph (g) of this AD, before further
flight, repair, including applicable related investigative and
corrective actions, in accordance with Bombardier Repair Engineering
Order (REO) 670-54-51-034, ``Repair for Missing or Loose/Protruding
Fasteners in Upper and Lower Pylon Skins FS 1088-FS 1098, PBL 69.3 L
& RHS,'' dated March 7, 2016, or Revision A, dated April 20, 2016;
except where Bombardier REO 670-54-51-034, ``Repair for Missing or
Loose/Protruding Fasteners in Upper and Lower Pylon Skins FS 1088-FS
1098, PBL 69.3 L & RHS,'' dated March 7, 2016, or Revision A, dated
April 20, 2016; specifies to contact Bombardier for further
instruction, before further flight, repair using a method approved
by the Manager, FAA, New York ACO Branch; or Transport Canada Civil
Aviation (TCCA); or Bombardier, Inc.'s TCCA Design Approval
Organization (DAO). As of the effective date of this AD, use
Bombardier REO 670-54-51-034, ``Repair for Missing or Loose/
Protruding Fasteners in Upper and Lower Pylon Skins FS 1088-FS 1098,
PBL 69.3 L & RHS,'' Revision A, dated April 20, 2016, for the
actions required by this paragraph.

(i) Retained Credit for Previous Actions, With No Changes

    This paragraph restates paragraph (i) of AD 2016-11-02, with no
changes. This paragraph provides credit only for the initial
inspection specified in paragraph (g) of this AD, if that action was
performed before June 10, 2016 (the effective date of AD 2016-11-02)
using Bombardier Reference Instruction Letter 4212, dated December
23, 2015; or Bombardier Reference Instruction Letter 4212A, Revision
A, dated January 28, 2016. These documents are not incorporated by
reference in this AD.

(j) New Requirements of This AD: Fastener and Collar Replacement

    Within 12,600 flight hours or 72 months after the effective date
of this AD, whichever occurs first: Replace affected fasteners and
collars, including doing all applicable related investigative and
corrective actions, in accordance with the Accomplishment
Instructions of Bombardier Service Bulletin 670BA-54-007, dated May
13, 2016. Where Bombardier Service Bulletin 670BA-54-007, dated May
13, 2016, specifies to contact Bombardier for appropriate action:
Before further flight, accomplish the applicable corrective action
in accordance with the procedures specified in paragraph (m)(2) of
this AD.

(k) Terminating Action for the Introductory Text of Paragraph (g) of
This AD

    Accomplishing the replacement required by paragraph (j) of this
AD constitutes terminating action for the inspections required by
the introductory text of paragraph (g) of this AD.

(l) Credit for Previous Actions

    (1) This paragraph provides credit for the actions specified in
paragraph (h) of this AD, if those actions were performed before the
effective date of this AD using Bombardier REO 670-54-51-034,
``Repair for Missing or Loose/Protruding Fasteners in Upper and
Lower Pylon Skins FS 1088-FS 1098, PBL 69.3 L & RHS,'' dated March
7, 2016. This document was incorporated by reference in AD 2016-11-
02.
    (2) This paragraph provides credit for the actions specified in
paragraph (j) of this AD, if those actions were performed before the
effective date of this AD using Bombardier REO 670-54-51-035,
``Permanent Repair for Clearance Fit Installed (-8) Size Fasteners
in Upper and Lower Pylon Skins FS 1088--FS 1098, PBL 69.3 L & RHS &
Terminating Action for GREO 670-54-51-034,'' dated April 20, 2016.
This document is not incorporated by reference in this AD.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, FAA,
New York ACO Branch, 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 certification
office, send it to ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
    (i) 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.
    (ii) AMOCs approved previously for AD 2016-11-02 are acceptable
for the corresponding provisions of 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, FAA, New York
ACO Branch; or TCCA; or Bombardier, Inc.'s TCCA DAO. If approved by
the DAO, the approval must include the DAO-authorized signature.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian AD CF-2016-10R1, dated July 8, 2016, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2017-0530.
    (2) For more information about this AD, contact Aziz Ahmed,
Aerospace Engineer, Airframe and Mechanical Systems Section, FAA,
New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY
11590; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>.
    (3) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (o)(5) and (o)(6) of this AD.

(o) 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.
    (3) The following service information was approved for IBR on
June 28, 2018.
    (i) Bombardier Repair Engineering Order 670-54-51-034, ``Repair
for Missing or Loose/Protruding Fasteners in Upper and Lower Pylon
Skins FS 1088--FS 1098, PBL 69.3 L & RHS,'' Revision A, dated April
20, 2016.
    (ii) Bombardier Service Bulletin 670BA-54-007, dated May 13,
2016.
    (iii) Task 54-51-01-220-801, ``Detailed Inspection of the Engine
Pylon Rib and Skin Fasteners,'' to Chapter 54, ``Nacelle/Pylons,''
to Part 2 of the Bombardier CRJ700/900/1000 Aircraft Maintenance
Manual, CSP B-001, Revision 56, dated September 25, 2017.
    (4) The following service information was approved for IBR on
June 10, 2016 (81 FR 33371, May 26, 2016).
    (i) Bombardier Temporary Revision 54-0007, dated March 8, 2016,
to the CRJ700/900/1000 Aircraft Maintenance Manual.
    (ii) Reserved.
    (5) 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
514-855-5000; fax<PHONE_NUMBER>; email [email protected];
internet http://www.bombardier.com.
    (6) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th Street, Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (7) 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, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on April 27, 2018.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-09863 Filed 5-23-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Rules and Regulations]
[Pages 35093-35094]
[FR Doc No: 2017-15924]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2017-0508]

Special Local Regulations; EQT Pittsburgh Three Rivers Regatta,
Pittsburgh, PA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce a special local regulation for
navigable waters of the Allegheny, Ohio, and Monongahela Rivers during
the EQT Pittsburgh Three Rivers Regatta. This regulation is needed to
provide for the safety of life during the marine event. During the
enforcement period, entry into this regulated area is prohibited to all
vessels not registered with the sponsor as participants or official
patrol vessels, unless specifically authorized by the Captain of the
Port Marine Safety Unit Pittsburgh (COTP) or a designated
representative.

DATES: The regulations in 33 CFR 100.801, Table 1, Sector Ohio Valley,
line 20, will be enforced each day from August 4, 2017 through August
6, 2017.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email MST1 Jennifer Haggins, Marine
Safety Unit

Pittsburgh, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce a special local
regulation for the annual EQT Pittsburgh Three Rivers Regatta listed in
33 CFR 100.801, Table 1, line 20, from August 4, 2017 through August 6,
2017. Entry into the regulated area is prohibited unless authorized by
the Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a
designated representative. Persons or vessels desiring to enter into or
pass through the area must request permission from the COTP or a
designated representative. If permission is granted, all persons and
vessels shall comply with the instructions of the COTP or designated
representative.
    This notice of enforcement is issued under authority of 33 CFR
100.801 and 5 U.S.C. 552(a). In addition to this notice in the Federal
Register, the Coast Guard will provide the maritime community with
advance notification of this enforcement period via Local Notice to
Mariners and updates via Marine Information Broadcasts.

    Dated: July 20, 2017.
L. McClain, Jr.,
Commander, U.S. Coast Guard, Captain of the Port Marine Safety Unit
Pittsburgh.
[FR Doc. 2017-15924 Filed 7-27-17; 8:45 am]
 BILLING CODE 9110-04-P


need for information on possible interactions. Some interactions that could
be envisaged are intoxication due to amplification of toxic effects, loss of
therapeutic effect due to antagonism between the two drugs, or other side
effects. Intoxication by ionophores induced by simultaneously administered
tiamulin is well known (see chapter 7). No reports have been found on
interactions between other AFA and therapeutic substances. As AFA are a
constant part of the feed, it is likely that their use would not be connected
with disturbances during therapy. Interactions between AFA and other
substances might therefore easily be overlooked.
Little information is available on possible interactions.
5.6 Summary comments
For humans, the use of AFA is an occupational hazard. The risks involved
are allergy and, for quinoxalines, genotoxicity. The population at risk
includes farmers, farm workers, feed mill workers and other persons
handling products containing the substances.
In target animals, the use of quinoxalines results in adrenal damage
(Addisons disease). This is deleterious for animal well being.

SOU 1997:132
5. Toxicological aspects
149
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"AARS¹!*¹*AGER¹,0¹3PIERENBERG¹4*¹DE¹'RAAF¹'*¹AND¹3EINHORST¹*7
, 1991.
Residues of carbadox metabolites in edible pork products.
!RCHIVES½OF½4OXICOLOGY
3UPPL¹
288-292.
"AARS¹!*¹VAN¹'INKEL¹,!¹!ERTS¹--,¹DE¹'RAAF¹'*¹3EINHORST¹*7
+EUKENS¹(*¹3CHWILLENS¹0,7*¹3PIERENBURG¹4*¹AND¹*AGER¹,0
,  1990.
Kinetics of carbadox residues in pigs.
)N½PROCEEDINGS½OF½2ESIDUES½OF½VETERINARY
DRUGS½IN½FOOD½½%URO2ESIDUE½CONFERENCE
May 21-23, Noordwijkerhout. pp. 110-112.
"INNENDIJK¹'-¹!ERTS¹--,¹AND¹+EUKENS¹(*
, 1991. Optimization and
ruggedness testing of the determination of residues of carbadox and metabolites in
products of animal origin. Stability studies in animal tissues.
*OURNAL½OF
#HROMATOGRAPHY

401-410.
#ARAFFINI¹3¹!SSALVE¹$¹3TINGENI¹,¹AND¹,ISI¹0
, 1994. Tylosin, an airborne contact
allergen in veterinarians.
#ONTACT½$ERMATITIS

327-328.
#IH¡K¹2¹AND¹3RB¹6
, 1983. Cytogenetic effects of quinoxaline-1,4-dioxide-type growth-
promoting agents.
-UTATION½2ESEARCH

129-135.
#ROSSMAN¹0*¹AND¹0OYSER¹-2
, 1981. Effect of inadvertently feeding tylosin and
tylosin with dimetridazole to dairy cows.
6ETERINARY½2ECORD

285.
$ANESE¹0¹:ANCA¹!¹AND¹"ERTAZZONI¹-'
, 1994. Occupational contact dermatitis from
tylosin.
#ONTACT½$ERMATITIS

122-123.
DE¹6RIES¹(¹"EYERSBERGEN¹VAN¹(ENEGOUWEN¹'-¹+ALLOE¹&¹AND¹"ERKHUYSEN
-(
, 1990. Phototoxicity of olaquindox in the rat.
2ESEARCH½IN½6ETERINARY½3CIENCE

240-244.
&!/7(/
, 1990. 36th report of the Joint Expert Committee on Food Additives:
Evaluation of Certain Veterinary Drugs.
4ECHNICAL½REPORT½SERIES½.O½
50-56.
WHO, Geneva.
&!/7(/
, 1991. Monographs prepared by the 38th meeting of the Joint FAO/WHO
Expert Committee on Food Additives. Residues of some veterinary drugs in animals
and foods.
&!/½&OOD½AND½.UTRITION½0APER
41/4 pp.136. WHO, Rome.
&!/7(/
, 1994. Forty-second Meeting of the Joint FAO/WHO Expert Committee on
Food Additives. Toxicological evaluation of certain veterinary drug residues in
food.
7(/½&OOD½!DDITIVES½3ERIES½
pp. 55-57. WHO, Rome.
&!/7(/
, 1995. Forty-second report of the joint FAO/WHO Expert Committee on
Food Additives. Evaluation of certain veterinary drug residues in food.
7(/
4ECHNICAL½2EPORT½3ERIES½.O½
pp. 19-21. WHO, Geneva.
'OLLINS¹7*
, 1989. Occupational asthma due to tylosin tartrate.
"RITISH½*OURNAL½OF
)NDUSTRIAL½-EDICINE

894.

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150
'OTTSCHALL¹$7¹&ILTER¹-,¹AND¹7ANG¹2
, 1995. Analysis of tissue residues and
comparative metabolism of ardacin in cattle, broilers, and rats.
*OURNAL½OF
!GRICULTURAL½AND½&OOD½#HEMISTRY

2956-2963.
'RANDINETTI¹0*¹AND¹&OWLER¹*&¹*R
, 1990. Simultaneous contact allergy to neomycin,
bacitracin, and polymyxin.
*OURNAL½OF½!MERICAN½!CADEMY½OF½½$ERMATOLOGY

646-
647.
(UBER¹'
,  1979. Moenomycin and related phosphorus-containing antibiotics.
)N
F.E.
Hahn (ed.),
!NTIBIOTICS½
Vol. 5, pt 1. Springer Verlag, New York. pp. 135-153.
+ATZ¹"%¹AND¹&ISHER¹!!
, 1987. Bacitracin: a unique topical antibiotic sensitizer.
*OURNAL½OF½!MERICAN½!CADEMY½OF½$ERMATOLOGY

1016-1024.
+EUKENS¹(*¹INNENDIJK¹'-¹AND¹!ERTS¹--,
,  1990. Determination of residues of
carbadox and metabolites in edible tissues -
IN½VITRO
stability studies.
)N½PROCEEDINGS
OF½4HE½%URO2ESIDUE½CONFERENCE½2ESIDUES½OF½6ETERINARY½$RUGS½IN½&OOD
May 21-
23, Noordwijkerhout. pp. 235-239.
+¶FER¹*¹(¶CHER¹(¹AND¹(INTERDORFER¹&
, 1990. Olaquindoxvergiftung bei Ferkeln.
7IENER½4IER¤RZTLICHE½-ONATSSCHRIFT

135-137.
,EE¹(3¹7ANG¹94¹9EO¹#4¹4AN¹+4¹AND¹2ATNAM¹+6
, 1989. Occupational
asthma due to tylosin tartrate.
"RITISH½*OURNAL½OF½)NDUSTRIAL½-EDICINE

498-499.
-AGNUSSEN¹*$¹$ALIDOWICZ¹*%¹4HOMSON¹4$¹AND¹$ONOHO¹!,
, 1991. Tissue
residues and metabolism of avilamycin in swine and rats.
*OURNAL½OF½!GRICULTURAL
AND½&OOD½#HEMISTRY

306-310.
.ABUURS¹-*!¹VAN¹DER¹-OLEN¹%*¹DE¹'RAAF¹'*¹AND¹*AGER¹,0
, 1990. Clinical
signs and performance of pigs treated with different doses of carbadox, cyadox and
olaquindox.
*OURNAL½OF½6ETERINARY½-EDICINE½3ERIES½!

68-76.
.UNOSHIBA¹4¹AND¹.ISHIOKA¹(
, 1989. Genotoxicity of quinoxaline 1,4-dioxide
derivatives in
%SCHERICHIA½COLI
and
3ALMONELLA TYPHIMURIUM
.
-UTATION½RESEARCH

203-209.
0ILLETTE¹-¹#LAUDEL¹*0¹-ULLER¹#¹AND¹,ORETTE¹'
, 1990. Toxidermie à la
Pristinamycine après sensibilisation à la virginiamycine topique.
!LLERGIE½ET
)MMUNOLGIE

197.
0OWER¹3"¹$ONNELLY¹7*#¹-C,AUGHLIN¹*'¹7ALSH¹-#¹AND¹$ROMEY¹-&
,
1989. Accidental carbadox overdosage in pigs in an Irish weaner-producing herd.
6ETERINARY½2ECORD

367-370.
0RESCOTT¹*&¹AND¹"AGGOT¹*$¹EDS
, 1993.
!NTIMICROBIAL½THERAPY½IN½VETERINARY
MEDICINE
2nd ed. Iowa State University Press, Ames. pp. 612.
2EETZ¹*¹"USCH¹!¹AND¹7ITTHUHN¹5
, 1991. Bisergon©-induzierte
Nebennierenveränderungen bei Puten- und Broilerküken.
-ONATSHEFTE½F¼R
6ETERIN¤RMEDIZIN

220-225.

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2ICO¹!'
,  1985. Toxicological assessment of residues of feed additives and veterinary
medicinal products in foodstuffs of animal origin.
)N½PROCEEDINGS½OF½TH½%UROPEAN
6ETERINARY½#ONGRESS
September 12-15, Exeter. pp. 1-22.
2UTALJ¹-¹"AZULIC¹$¹3APUNAR
0OSTRUZNIK¹*¹:IVKOVIC¹*¹AND¹,JUBICIC¹)
, 1996.
Quinoxaline-2-carboxylic acid (QCA) in swine liver and muscle.
&OOD½!DDITIVES
AND½#ONTAMINANTS

879-882.
3AMBETH¹7¹"AUER¹&¹$OST¹'¹AND¹.ESEMANN¹'
,  1974. Evaluation of the saferty of
flavomycin in poultry.
)N½PROCEEDINGS½OF½86½7ORLDS½0OULTRY½#ONGRESS
August 11-
16, New Orleans. pp. 78-80.
3CHAUDER¹3¹3CHR¶DER¹7¹AND¹'EIER¹*
, 1996. Olaquindox-induced airborne
photoallergic contact dermatitis followed by transient or persistent light reactions in
15 pig breeders.
#ONTACT½$ERMATITIS

344-354.
3PIERENBURG¹4*¹"AARS¹!*¹DE¹'RAAF¹'*¹AND¹*AGER¹,0
,  1988a. Carbadox
induced inhibition of aldosterone production in porcine adrenals
½IN½VITRO
.
)N
PROCEEDINGS½OF½TH½#ONGRESS½OF½%UROPEAN½!SSOCIATION½FOR½6ETERINARY
0HARMACOLOGY½AND½4OXICOLOGY
August 28-September 2, Budapest. p. 95.
3PIERENBURG¹4*¹"AARS¹!*¹DE¹'RAAF¹'*¹AND¹*AGER¹,0
, 1988b. Carbadox-
induced inhibition of aldosterone production in porcine adrenals
IN½VITRO
.
4OXICOLOGY½IN½6ITRO

141-143.
3TOCKHOFE
:URWIEDEN¹.¹"RUNCKHORST¹$¹7ALDMANN¹+(¹AND¹0OHLENZ¹*
, 1991.
Pathomorphologische Verlaufsuntersuchungen nach Olaquindoxintoxikation bei
Mastschweinen.
4IER¤RZTLICHE½0RAXIS

58-63.
VAN¹DER¹-OLEN¹%*
, 1988. Pathological effects of carbadox in pigs with special emphasis
on the adrenal.
*OURNAL½OF½#OMPARATIVE½0ATHOLOGY

55-67.
6EIEN¹.+¹(ATTEL¹4¹*USTESEN¹/¹AND¹.ORHOLM¹!
, 1980. Occupational contact
dermatitis due to spiramycin and/or tylosin among farmers.
#ONTACT½$ERMATITIS

410-413.
7OODGER¹'*!
, 1979. Antibiotic contamination of compound cattle feed.
6ETERINARY
2ECORD

173.

5. Toxicological aspects
SOU 1997:132
152

SOU 1997:132
6
Environmental aspects on antibacterial feed
additives
6.1
Introduction
Several factors are of interest for the assessment of environmental effects of
AFA. The environmental burden, i.e. the amount of the substance that enters
and is deposited in the environment, as well as the distribution and transport
between different environmental compartments, defines the exposure. Effects
to be considered include: effects on soil microbes, earthworms, algae and
aquatic organisms. Furthermore, safety for wildlife and other unintended
recipients must also be considered.
The environmental deposition of AFA is related to the number of animals
fed these substances, duration of use, dosage, metabolism, excretion pattern
and method of waste disposal. As most of these substances are poorly, or not
at all, absorbed in the gut, the amount excreted in faeces is almost as large as
the total amount fed to various animal species. The impact on the
environment from the use of AFA is therefore through excretion in faeces.
Some AFA may also be excreted in urine. Although the concentrations in
urine would be expected to be far lower than in faeces, evaporation and
precipitation during storage could lead to higher concentrations, especially at
the bottom of the storage tank.
According to directive 70/525/EEC and the guidelines in 94/40/EC, studies
on excreted residues and an environmental assessment should be performed
on all feed additives.
An overall assessment of environmental effects must include thorough
estimations of secondary effects and evaluations of different production
systems as a whole. For example, waste from the manufacture of AFA has a
high nitrogen content and may also include other potentially harmful
components, excess AFA among others. The disposal of this waste must be
taken into account. The need for long-term assessments when it comes to
environmental effects cannot be overemphasised.
In the following, some information available on environmental aspects of
AFA will be discussed. Corresponding information on coccidiostats (and
ionophore AFA) is found in chapter 7.

6. Environmental aspects
SOU 1997:132
154
6.2
Exposure of the environment to AFA
Many of the AFA are derived from soil microorganisms and are therefore
likely to be, eventually, degraded in soil. Nonetheless, degradability and
degradation rates must be determined for each substance. This testing must
be standardised as far as possible. Many variables need to be considered in
this standardisation (Bouwman and Reus, 1994). As the compounds will be
excreted in faeces, degradation studies should be conducted in soil mixed
with manure. The type of manure used is important in this regard. Animal
species from which the manure originates and dry matter content is of prime
importance, but feed composition, management factors and geographic area
may also influence the composition of the manure.
Other factors that may affect the outcome of degradation studies are
temperature, light, oxygen concentration, microbial composition in soil and
manure, and sampling procedures. The methods for analysing the substance
in question, as well as its major metabolites, must also be standardised. When
all these requirements are fulfilled, it will still be very difficult to apply the
results of experimental studies to the environment as a whole. Antimicrobial
substances that are released into the environment via faeces will disperse
through a number of transport mechanisms. A model for this was presented
by Addison (1984), in which volatilisation, degradation, diffusion, adsorption
to sediment, losses to ground water and streams etc. is calculated. This model
clearly illustrates the complexity of the matter and how difficult it is to
predict the exact fate of antimicrobials that are released into the environment.
Various studies have been reported on aerobic degradation in soil of
substances used as AFA including bacitracin, tylosin spiramycin and
flavomycin (Bewick, 1978; Jagnow, 1978; Bewick and Tribe, 1980;
Gavalchin and Katz, 1994). Most study designs are fairly simple; the
substance under investigation is mixed with soil or soil/manure mixes and the
decline in concentration under different conditions is measured over time.
Most substances appear to have a half life in soil of about 2-3 weeks at 20°C,
while lower temperatures generally cause a slower degradation. In sterile
soil, no degradation occurs, indicating that microbes are essential for the
process (Gavalchin and Katz, 1994). Two studies have been found that
demonstrate no uptake of tylosin (Bewick, 1979b) or bacitracin (Vogtmann
ET½AL
, 1978) by vegetables from soil fertilised with AFA-containing manure.
For the quinoxalines, no information has been found. Being synthetic
substances, they are of special interest as they might not be as easily
degradable by existing soil microflora.
Some losses to surface or ground water are to be expected. Bewick (1979a)
demonstrated a notable difference in adsorptive capacity of different clays.
When release from soils was studied, the concentration in leakage was
related to the amount of tylosin applied. Under practical conditions, the

SOU 1997:132
6. Environmental aspects
155
degree of leaching will depend, among other things, on fertilising practices,
weather conditions and type of soil. In view of the large variation of such
factors within the European Union, experimental data are especially difficult
to interpret. No data on degradation in water has been found.
Larger standardised studies would be necessary to draw firm conclusions
on the environmental burden (Bouwman and Reus, 1994). As light and
temperature are important variables regarding degradation times, it may be
necessary to conduct separate studies for application to different geographic
areas.
Most antibiotic AFA appear to have a half life in soil of about 2-3 weeks at
20°C. Information is lacking on the synthetic substances (quinoxalines).
Due to the complexity of the matter, it is difficult to predict the exact fate of
antimicrobials that are released into the environment.
6.3
Effects of AFA on the environment
6.3.1
Disruption of microecology
Many ecosystems depend on complex microbial interactions. Soil is a
heterogeneous system with a mixed biota and fluctuating local conditions.
The microbiota is essential for supplying nutrients to crops, stimulating plant
growth, control or inhibition of the activity of plant pathogens and
improvement of soil structure. Microbes are also important in the degradation
of pollutants. Disruption of these microbial populations is detrimental for
agriculture as well as for the society as a whole.
Antibacterial substances such as AFA, if present in animal wastes in
inhibitory concentrations, are expected to affect the environmental
microflora. Bewick (1978), in one of a series of experiments on waste from
tylosin production, investigated the effects of added tylosin on various
parameters for soil activity. At concentrations corresponding to 37 ppm or
more, nitrogen mineralisation was reduced. A decrease in microbial
respiration could be noted for 5 to 7 weeks after the addition of the antibiotic.
Degradation of most AFA would be expected during composting (Vogtmann
ET½AL
, 1978).
Other microbial systems could be affected. Treatment of wastewater from
animal production facilities and slaughterhouses, as well as sewage, often
includes a microbial process. This may be impaired by low concentrations of
antimicrobial substances in the wastewater. No information has been found
on this subject.

6. Environmental aspects
SOU 1997:132
156
Source separated municipal solid waste and agricultural waste can be
utilised for biogas production. Substances with an antimicrobial effect
against anaerobic bacteria could disturb this process. Thaveesri (1994) found
that monensin negatively affected the performance of UASB (upflow
anaerobic sludge blanket) reactors. Contrary to this, in studies on manure
from pigs and poultry fed avilamycin, Sutton (1989) reported efficient
operation of experimental and large mesophilic digesters. The presence of
avilamycin appeared to alter the metabolism of the microflora, increasing the
efficiency to degrade volatile solids.
Considerable research and investments are currently spent on optimising
biogas plants in order to meet with the requirements for more sustainable
systems. In such highly efficient, modern anaerobic digestion plants, the
processes are strictly controlled. The effects of AFA on such sensitive
systems must therefore be carefully evaluated.
Albeit transient, the deleterious effects of antibiotics on environmental
microflora cannot be ignored.
6.3.2
Decreased nutrient losses
The beneficial effect of AFA on nitrogen excretion and total amount of
animal manure has been widely discussed (Roth and Kirchgessner, 1993;
Lindermayer and Propstmeier, 1994; Roth
½ET½AL
, 1994; Verbeke and Viaene,
1996). This effect is a consequence of the improved feed efficiency
associated with AFA use. The amounts of nutrients excreted in faeces and
urine are lowered in proportion to the decreased amount of feed consumed by
the animals, i.e. by approximately 3-4 % (Thomke and Elwinger, 1997).
In combination with AFA, high protein diets are often used. Dietary
manipulations can also reduce nitrogen excretion while maximum growth is
maintained (Williams, 1995; Cromwell
½ET½AL
, 1996; Henry, 1996).
Multiphase feeding, where the daily supply of nutrients is adjusted as closely
as possible to the requirements of the animals, will substantially reduce
nitrogen excretion while supporting maximum growth (Henry, 1996).
Appropriate feeding strategies will not only affect nitrogen excretion, but
also reduce pollution by other substances, such as phosphorus and trace
elements. Investments in feed storage, feed preparation and feed distribution
with computerised automated systems may be costly but adjustment to the
physiological requirements of the animals may still be a beneficial alternative
to costly waste treatments and the risk of future environmental damage.
It appears logical that the amount of nitrogen in the feed will affect the
amount of nitrogen excreted in faeces and urine. A pig feed with a protein
content of 14% with added amino acids will result in similar or smaller
nitrogen excretion per animal than feed with 18% protein content
supplemented with AFA (Roth and Kirchgessner, 1993; Williams, 1995;

SOU 1997:132
6. Environmental aspects
157
Verbeke and Viaene, 1996). Supplementations of feed with enzymes and
probiotics also aim at a situation in which a greater share of the nutrients
supplied in the feed is made available for absorption by the animal. The
higher rate of nutrient absorption leads to a lowered output with animal
voiding.
The protein content of both pig and broiler feed in Sweden was reduced as
a consequence of the ban of AFA enforced in 1986 (Wierup, 1996). This has
been possible since several crystalline amino acids are available at
competitive price levels. Although the alteration in feed composition was
primarily aimed at avoiding intestinal disturbances, there were also benefits
in terms of lowered nitrogen excretion.
When discussing nitrogen load it is also important to remember that
inorganic fertilisers added to agricultural soil contain a substantial amount of
nitrogen. As an example, the amount of nitrogen fertilisers used in France,
Germany and Sweden expressed in kg/hectare cultured land in 1995 was 120,
140 and 70 respectively (SCB, 1997). Finding ways of a better utilisation of


                         UNITED STATES OF AMERICA

                 DEPARTMENT OF TRANSPORTATION

                         OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on August 16, 2002

   NOTICE OF ACTION TAKEN -- DOCKET OST-2000-7940

________________________________________________________________________
_________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of AMERICAN AIRLINES, INC AND TWA AIRLINES LLC  filed
8/01/02 to:

XX  Renew for two years exemption under 49 U.S.C. 40109 to provide the
following service:

Scheduled foreign air transportation of persons, property, and mail
between a point or points in the United States and a point or points in
Jamaica.

Applicant rep: Carl B. Nelson,<PHONE_NUMBER>    DOT Analyst:  Keith
Glatz,<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted

The above action was effective when taken:  August 16, 2002 through
August 16, 2004

Action taken by:   Paul L. Gretch, Director

		    Office of International Aviation

XX  The authority granted to serve Montego Bay and Kingston is
consistent with the aviation agreement by and between the United States
and Jamaica.  Authority to serve other points is consistent with the
overall state of aviation relations between the United States and
Jamaica.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:  XX Holder’s
certificates of public convenience and necessity

	   XX  Standard exemption conditions (attached)

________________________________________________________________________
______________

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicant qualified to provide
the services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our

action was consistent with Department policy; (2) grant of the exemption
authority was consistent with the public interest; and (3) grant of the
authority would not constitute a major regulatory action under the
Energy Policy and Conservation Act of 1975.  To the extent not granted,
we denied all requests in the referenced Docket.  We may amend, modify,
or revoke the authority granted in this Notice at any time without
hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

http://dms.dot.gov//reports/reports_aviation.asp

APPENDIX

U.S. CARRIER

Standard Exemption Conditions

In the conduct of operations authorized by the attached notice, the
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with the applicable requirements of the Federal Aviation
Administration Regulations and with all U.S. Government requirements
concerning security; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.


[Federal Register Volume 86, Number 3 (Wednesday, January 6, 2021)]
[Notices]
[Pages 697-701]
[FR Doc No: 2020-29245]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2000-7006; FMCSA-2000-7165; FMCSA-2001-11426; FMCSA-
2002-12294; FMCSA-2004-18885; FMCSA-2004-19477; FMCSA-2005-21711;
FMCSA-2006-24783; FMCSA-2006-26066; FMCSA-2007-0071; FMCSA-2008-0021;
FMCSA-2008-0106; FMCSA-2008-0174; FMCSA-2008-0266; FMCSA-2008-0292;
FMCSA-2008-0340; FMCSA-2010-0161; FMCSA-2010-0187; FMCSA-2010-0201;
FMCSA-2010-0287; FMCSA-2010-0354; FMCSA-2010-0385; FMCSA-2012-0039;
FMCSA-2012-0161; FMCSA-2012-0215; FMCSA-2012-0216; FMCSA-2012-0279;
FMCSA-2013-0168; FMCSA-2013-0170; FMCSA-2014-0002; FMCSA-2014-0006;
FMCSA-2014-0007; FMCSA-2014-0010; FMCSA-2014-0011; FMCSA-2014-0296;
FMCSA-2014-0299; FMCSA-2014-0300; FMCSA-2016-0028; FMCSA-2016-0030;
FMCSA-2016-0207; FMCSA-2016-0208; FMCSA-2016-0209; FMCSA-2016-0210;
FMCSA-2018-0010; FMCSA-2018-0207]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of renewal of exemptions; request for comments.

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

SUMMARY: FMCSA announces its decision to renew exemptions for 66
individuals from the vision requirement in the Federal Motor Carrier
Safety Regulations (FMCSRs) for interstate commercial motor vehicle
(CMV) drivers. The exemptions enable these individuals to continue to
operate CMVs in interstate commerce without meeting the vision
requirements in one eye.

DATES: Each group of renewed exemptions are applicable on the dates
stated in the discussions below and will expire on the dates stated in
the discussions below. Comments must be received on or before February
5, 2021.

ADDRESSES: You may submit comments identified by the Federal Docket
Management System (FDMS) Docket No. FMCSA-2000-7006, Docket No. FMCSA-
2000-7165, Docket No. FMCSA-2001-11426, Docket No. FMCSA-2002-12294,
Docket No. FMCSA-2004-18885, Docket No. FMCSA-2004-19477, Docket No.
FMCSA-2005-21711, Docket No. FMCSA-2006-24783, Docket No. FMCSA-2006-
26066, Docket No. FMCSA-2007-0071, Docket No. FMCSA-2008-0021, Docket
No. FMCSA-2008-0106, Docket No. FMCSA-2008-0174, Docket No. FMCSA-2008-
0266, Docket No. FMCSA-2008-0292, Docket No. FMCSA-2008-0340, Docket
No.

FMCSA-2010-0161, Docket No. FMCSA-2010-0187, Docket No. FMCSA-2010-
0201, Docket No. FMCSA-2010-0287, Docket No. FMCSA-2010-0354, Docket
No. FMCSA-2010-0385, Docket No. FMCSA-2012-0039, Docket No. FMCSA-2012-
0161, Docket No. FMCSA-2012-0215, Docket No. FMCSA-2012-0216, Docket
No. FMCSA-2012-0279, Docket No. FMCSA-2013-0168, Docket No. FMCSA-2013-
0170, Docket No. FMCSA-2014-0002, Docket No. FMCSA-2014-0006, Docket
No. FMCSA-2014-0007, Docket No. FMCSA-2014-0010, Docket No. FMCSA-2014-
0011, Docket No. FMCSA-2014-0296, Docket No. FMCSA-2014-0299, Docket
No. FMCSA-2014-0300, Docket No. FMCSA-2016-0028, Docket No. FMCSA-2016-
0030, Docket No. FMCSA-2016-0207, Docket No. FMCSA-2016-0208, Docket
No. FMCSA-2016-0209, Docket No. FMCSA-2016-0210, Docket No. FMCSA-2018-
0010, or Docket No. FMCSA-2018-0207 using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Dockets Operations; U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m.,
ET, Monday through Friday, except Federal Holidays.
     Fax:<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation'' portion of the SUPPLEMENTARY
INFORMATION section for instructions on submitting comments

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE, Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
ET, Monday through Friday, except Federal holidays. If you have
questions regarding viewing or submitting material to the docket,
contact Dockets Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Submitting Comments

    If you submit a comment, please include the docket number for this
notice (Docket No. FMCSA-2000-7006; FMCSA-2000-7165; FMCSA-2001-11426;
FMCSA-2002-12294; FMCSA-2004-18885; FMCSA-2004-19477; FMCSA-2005-21711;
FMCSA-2006-24783; FMCSA-2006-26066; FMCSA-2007-0071; FMCSA-2008-0021;
FMCSA-2008-0106; FMCSA-2008-0174; FMCSA-2008-0266; FMCSA-2008-0292;
FMCSA-2008-0340; FMCSA-2010-0161; FMCSA-2010-0187; FMCSA-2010-0201;
FMCSA-2010-0287; FMCSA-2010-0354; FMCSA-2010-0385; FMCSA-2012-0039;
FMCSA-2012-0161; FMCSA-2012-0215; FMCSA-2012-0216; FMCSA-2012-0279;
FMCSA-2013-0168; FMCSA-2013-0170; FMCSA-2014-0002; FMCSA-2014-0006;
FMCSA-2014-0007; FMCSA-2014-0010; FMCSA-2014-0011; FMCSA-2014-0296;
FMCSA-2014-0299; FMCSA-2014-0300; FMCSA-2016-0028; FMCSA-2016-0030;
FMCSA-2016-0207; FMCSA-2016-0208; FMCSA-2016-0209; FMCSA-2016-0210;
FMCSA-2018-0010; FMCSA-2018-0207), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. FMCSA recommends that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so that FMCSA can contact you if there are questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
put the docket number, FMCSA-2000-7006; FMCSA-2000-7165; FMCSA-2001-
11426; FMCSA-2002-12294; FMCSA-2004-18885; FMCSA-2004-19477; FMCSA-
2005-21711; FMCSA-2006-24783; FMCSA-2006-26066; FMCSA-2007-0071; FMCSA-
2008-0021; FMCSA-2008-0106; FMCSA-2008-0174; FMCSA-2008-0266; FMCSA-
2008-0292; FMCSA-2008-0340; FMCSA-2010-0161; FMCSA-2010-0187; FMCSA-
2010-0201; FMCSA-2010-0287; FMCSA-2010-0354; FMCSA-2010-0385; FMCSA-
2012-0039; FMCSA-2012-0161; FMCSA-2012-0215; FMCSA-2012-0216; FMCSA-
2012-0279; FMCSA-2013-0168; FMCSA-2013-0170; FMCSA-2014-0002; FMCSA-
2014-0006; FMCSA-2014-0007; FMCSA-2014-0010; FMCSA-2014-0011; FMCSA-
2014-0296; FMCSA-2014-0299; FMCSA-2014-0300; FMCSA-2016-0028; FMCSA-
2016-0030; FMCSA-2016-0207; FMCSA-2016-0208; FMCSA-2016-0209; FMCSA-
2016-0210; FMCSA-2018-0010; FMCSA-2018-0207, in the keyword box, and
click ``Search.'' When the new screen appears, click on the ``Comment
Now!'' button and type your comment into the text box on the following
screen. Choose whether you are submitting your comment as an individual
or on behalf of a third party and then submit.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
    FMCSA will consider all comments and material received during the
comment period.

B. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov.
Insert the docket number, FMCSA-2000-7006; FMCSA-2000-7165; FMCSA-2001-
11426; FMCSA-2002-12294; FMCSA-2004-18885; FMCSA-2004-19477; FMCSA-
2005-21711; FMCSA-2006-24783; FMCSA-2006-26066; FMCSA-2007-0071; FMCSA-
2008-0021; FMCSA-2008-0106; FMCSA-2008-0174; FMCSA-2008-0266; FMCSA-
2008-0292; FMCSA-2008-0340; FMCSA-2010-0161; FMCSA-2010-0187; FMCSA-
2010-0201; FMCSA-2010-0287; FMCSA-2010-0354; FMCSA-2010-0385; FMCSA-
2012-0039; FMCSA-2012-0161; FMCSA-2012-0215; FMCSA-2012-0216; FMCSA-
2012-0279; FMCSA-2013-0168; FMCSA-2013-0170; FMCSA-2014-0002; FMCSA-
2014-0006; FMCSA-2014-0007; FMCSA-2014-0010; FMCSA-2014-0011; FMCSA-
2014-0296; FMCSA-2014-0299; FMCSA-2014-0300; FMCSA-2016-0028; FMCSA-
2016-0030; FMCSA-2016-0207; FMCSA-2016-0208; FMCSA-2016-0209; FMCSA-
2016-0210; FMCSA-2018-0010; FMCSA-2018-0207, in the keyword box, and
click ``Search.'' Next, click the ``Open Docket Folder'' button and
choose the document to review. If you do not have access to the
internet, you may view the docket online by visiting Dockets Operations
in Room W12-140 on the ground floor of the DOT West Building, 1200 New
Jersey Avenue SE, Washington, DC 20590-0001, between 9

a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays. To
be sure someone is there to help you, please call<PHONE_NUMBER> or
(202) 366-9826 before visiting Dockets Operations.

C. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.transportation.gov/privacy.

II. Background

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The physical qualification standard for drivers regarding vision
found in 49 CFR 391.41(b)(10) states that a person is physically
qualified to drive a CMV if that person has distant visual acuity of at
least 20/40 (Snellen) in each eye without corrective lenses or visual
acuity separately corrected to 20/40 (Snellen) or better with
corrective lenses, distant binocular acuity of a least 20/40 (Snellen)
in both eyes with or without corrective lenses, field of vision of at
least 70[deg] in the horizontal meridian in each eye, and the ability
to recognize the colors of traffic signals and devices showing red,
green, and amber.
    The 66 individuals listed in this notice have requested renewal of
their exemptions from the vision standard in Sec.  391.41(b)(10), in
accordance with FMCSA procedures. Accordingly, FMCSA has evaluated
these applications for renewal on their merits and decided to extend
each exemption for a renewable 2-year period.

III. Request for Comments

    Interested parties or organizations possessing information that
would otherwise show that any, or all, of these drivers are not
currently achieving the statutory level of safety should immediately
notify FMCSA. The Agency will evaluate any adverse evidence submitted
and, if safety is being compromised or if continuation of the exemption
would not be consistent with the goals and objectives of 49 U.S.C.
31136(e) and 31315(b), FMCSA will take immediate steps to revoke the
exemption of a driver.

IV. Basis for Renewing Exemptions

    In accordance with 49 U.S.C. 31136(e) and 31315(b), each of the 66
applicants has satisfied the renewal conditions for obtaining an
exemption from the vision standard (see 65 FR 20245; 65 FR 33406; 65 FR
57230; 65 FR 57234; 67 FR 10471; 67 FR 19798; 67 FR 46016; 67 FR 57266;
67 FR 57627; 69 FR 19611; 69 FR 51346; 69 FR 52741; 69 FR 53493; 69 FR
62742; 69 FR 64806; 70 FR 2705; 70 FR 48797; 70 FR 61493; 71 FR 26602;
71 FR 32183; 71 FR 41310; 71 FR 50970; 71 FR 53489; 71 FR 62147; 71 FR
62148; 71 FR 63379; 72 FR 1050; 72 FR 1051; 72 FR 1056; 72 FR 64273; 73
FR 6242; 73 FR 6244; 73 FR 15567; 73 FR 16950; 73 FR 16952; 73 FR
27015; 73 FR 27018; 73 FR 35197; 73 FR 35198; 73 FR 36955; 73 FR 38498;
73 FR 38499; 73 FR 48273; 73 FR 48275; 73 FR 51336; 73 FR 51689; 73 FR
61922; 73 FR 61925; 73 FR 61925; 73 FR 63047; 73 FR 74565; 73 FR 75803;
73 FR 75807; 73 FR 76439; 73 FR 78421; 73 FR 78423; 74 FR 6209; 74 FR
62632; 75 FR 9477; 75 FR 19674; 75 FR 22179; 75 FR 36778; 75 FR 36779;
75 FR 39725; 75 FR 44051; 75 FR 47883; 75 FR 50799; 75 FR 52062; 75 FR
54958; 75 FR 59327; 75 FR 59327; 75 FR 61833; 75 FR 63257; 75 FR 64396;
75 FR 69737; 75 FR 70078; 75 FR 72863; 75 FR 77591; 75 FR 77942; 75 FR
77949; 75 FR 79079; 75 FR 79083; 75 FR 79084; 76 FR 1499; 76 FR 2190;
76 FR 4413; 76 FR 5425; 76 FR 70215; 77 FR 13689; 77 FR 20879; 77 FR
23797; 77 FR 31427; 77 FR 36338; 77 FR 38384; 77 FR 41879; 77 FR 46153;
77 FR 48590; 77 FR 52381; 77 FR 52389; 77 FR 52391; 77 FR 56261; 77 FR
60008; 77 FR 60010; 77 FR 64582; 77 FR 64583; 77 FR 64583; 77 FR 64841;
77 FR 65933; 77 FR 68200; 77 FR 68202; 77 FR 71671; 77 FR 74273; 77 FR
74730; 77 FR 74733; 77 FR 74734; 77 FR 75496; 77 FR 76166; 78 FR 797;
78 FR 63302; 78 FR 64280; 78 FR 67454; 78 FR 77780; 79 FR 4803; 79 FR
10606; 79 FR 10609; 79 FR 14331; 79 FR 22003; 79 FR 23797; 79 FR 35212;
79 FR 35218; 79 FR 35220; 79 FR 37843; 79 FR 38659; 79 FR 38661; 79 FR
41735; 79 FR 45868; 79 FR 46153; 79 FR 47175; 79 FR 51643; 79 FR 53514;
79 FR 56097; 79 FR 56099; 79 FR 56104; 79 FR 56117; 79 FR 58856; 79 FR
59348; 79 FR 59357; 79 FR 64001; 79 FR 65759; 79 FR 65760; 79 FR 70928;
79 FR 72754; 79 FR 72756; 79 FR 73397; 79 FR 73686; 79 FR 73687; 79 FR
73689; 79 FR 74169; 80 FR 2473; 80 FR 3305; 80 FR 3723; 80 FR 9304; 80
FR 18693; 80 FR 63869; 80 FR 80443; 81 FR 20435; 81 FR 28138; 81 FR
39320; 81 FR 45214; 81 FR 66720; 81 FR 66726; 81 FR 70248; 81 FR 70251;
81 FR 70253; 81 FR 71173; 81 FR 72664; 81 FR 80161; 81 FR 81230; 81 FR
90046; 81 FR 90050; 81 FR 91239; 81 FR 94013; 81 FR 96165; 81 FR 96178;
81 FR 96180; 81 FR 96191; 81 FR 96196; 82 FR 13048; 83 FR 3861; 83 FR
6925; 83 FR 18633; 83 FR 28325; 83 FR 28342; 83 FR 34661; 83 FR 53724;
83 FR 56140; 83 FR 56902; 84 FR 2309; 84 FR 2311; 84 FR 2314). They
have submitted evidence showing that the vision in the better eye
continues to meet the requirement specified at Sec.  391.41(b)(10) and
that the vision impairment is stable. In addition, a review of each
record of safety while driving with the respective vision deficiencies
over the past 2 years indicates each applicant continues to meet the
vision exemption requirements. These factors provide an adequate basis
for predicting each driver's ability to continue to drive safely in
interstate commerce. Therefore, FMCSA concludes that extending the
exemption for each renewal applicant for a period of 2 years is likely
to achieve a level of safety equal to that existing without the
exemption.
    In accordance with 49 U.S.C. 31136(e) and 31315(b), the following
groups of drivers received renewed exemptions in the month of February
and are discussed below. As of February 5, 2021, and in accordance with
49 U.S.C. 31136(e) and 31315, the following 63 individuals have
satisfied the renewal conditions for obtaining an exemption from the
vision requirement in the FMCSRs for interstate CMV drivers (65 FR
20245; 65 FR 33406; 65 FR 57230; 65 FR 57234; 67 FR 10471; 67 FR 19798;
67 FR 46016; 67 FR 57266; 67 FR 57627; 69 FR 19611; 69 FR 51346; 69 FR
52741; 69 FR 53493; 69 FR 62742; 69 FR 64806; 70 FR 2705; 70 FR 48797;
70 FR 61493; 71 FR 26602; 71 FR 32183; 71 FR 41310; 71 FR 50970; 71 FR
53489; 71 FR 62147; 71 FR 62148; 71 FR 63379; 72 FR 1050; 72 FR 1051;
72 FR 1056; 72 FR 64273; 73 FR 6242; 73 FR 6244; 73 FR 15567; 73 FR
16950; 73 FR 16952; 73 FR 27015; 73 FR 27018; 73 FR 35197; 73 FR 35198;
73 FR 36955; 73 FR 38498; 73 FR 38499; 73 FR 48273; 73 FR 48275; 73 FR
51336; 73 FR 51689; 73 FR 61922; 73 FR 61925; 73 FR 61925; 73 FR 63047;
73 FR 74565; 73 FR 75803; 73 FR 75807; 73 FR 76439; 73 FR 78421; 73 FR
78423; 74 FR 6209; 74 FR 62632; 75 FR 9477; 75 FR 19674; 75 FR 22179;
75 FR 36778; 75 FR 36779; 75 FR 39725; 75 FR 44051; 75 FR 47883; 75 FR
50799; 75 FR 52062; 75 FR 54958; 75 FR 59327; 75 FR 59327; 75 FR 61833;
75 FR 63257; 75 FR 64396; 75 FR 69737; 75 FR 70078; 75 FR 72863; 75 FR
77591; 75 FR 77942; 75 FR 77949; 75 FR 79079;

75 FR 79083; 75 FR 79084; 76 FR 1499; 76 FR 2190; 76 FR 4413; 76 FR
5425; 76 FR 70215; 77 FR 13689; 77 FR 20879; 77 FR 23797; 77 FR 31427;
77 FR 36338; 77 FR 38384; 77 FR 41879; 77 FR 46153; 77 FR 48590; 77 FR
52381; 77 FR 52389; 77 FR 52391; 77 FR 56261; 77 FR 60008; 77 FR 60010;
77 FR 64582; 77 FR 64583; 77 FR 64583; 77 FR 64841; 77 FR 65933; 77 FR
68200; 77 FR 68202; 77 FR 71671; 77 FR 74273; 77 FR 74730; 77 FR 74733;
77 FR 74734; 77 FR 75496; 77 FR 76166; 78 FR 797; 78 FR 63302; 78 FR
64280; 78 FR 67454; 78 FR 77780; 79 FR 4803; 79 FR 10606; 79 FR 10609;
79 FR 14331; 79 FR 22003; 79 FR 23797; 79 FR 35212; 79 FR 35218; 79 FR
35220; 79 FR 37843; 79 FR 38659; 79 FR 38661; 79 FR 41735; 79 FR 45868;
79 FR 46153; 79 FR 47175; 79 FR 51643; 79 FR 53514; 79 FR 56097; 79 FR
56099; 79 FR 56104; 79 FR 56117; 79 FR 58856; 79 FR 59348; 79 FR 59357;
79 FR 64001; 79 FR 65759; 79 FR 65760; 79 FR 70928; 79 FR 72754; 79 FR
72756; 79 FR 73397; 79 FR 73686; 79 FR 73687; 79 FR 73689; 79 FR 74169;
80 FR 3305; 80 FR 9304; 80 FR 63869; 80 FR 80443; 81 FR 20435; 81 FR
28138; 81 FR 39320; 81 FR 45214; 81 FR 66720; 81 FR 66726; 81 FR 70248;
81 FR 70251; 81 FR 70253; 81 FR 71173; 81 FR 72664; 81 FR 80161; 81 FR
81230; 81 FR 90046; 81 FR 90050; 81 FR 91239; 81 FR 94013; 81 FR 96165;
81 FR 96178; 81 FR 96180; 81 FR 96191; 81 FR 96196; 82 FR 13048; 83 FR
3861; 83 FR 6925; 83 FR 18633; 83 FR 28325; 83 FR 28342; 83 FR 34661;
83 FR 53724; 83 FR 56140; 83 FR 56902; 84 FR 2309; 84 FR 2311; 84 FR
2314):

Lennie D. Baker, Jr. (NC)
Donald L. Blakeley II (NV)
Timothy Bradford (TN)
Scott Brady (FL)
Marty R. Brewster (KS)
David S. Brumfield (KY)
Todd A. Carlson (MN)
Dionicio Carrera (TX)
Juan Castanon (NM)
Scott F. Chalfant (DE)
Derrick L. Cowan (NC)
Dorothy J. Crum (OH)
Louis J. Cullen (NJ)
Larry G. Davis (TN)
Christopher L. Depuy (OH)
Craig E. Dorrance (MT)
Lucious J. Erwin (TX)
James H. Facemyre (WV)
Hector O. Flores (MD)
Larry J. Folkerts (IA)
Christopher K. Foot (NV)
Kelvin Frandin Bombu (KY)
Stanley W. Goble (IA)
John P. Grum (PA)
William R. Guida (PA)
Walter D. Hague, Jr. (VA)
Eric C. Hammer (MO)
Billy R. Hampton (NC)
Clifford J. Harris (VA)
Nylo K. Helberg (ND)
Robert K. Ipock (NC)
Jesse P. Jamison (TN)
Perry D. Jensen (WI)
Robert E. Kelley (WA)
Lewis A. Kielhack (IL)
Gregory L. Kockelman (MN)
Matthew B. Lairamore (OK)
Bradley W. Lovelace (NC)
Duane R. Martin (PA)
John C. McLaughlin (SD)
Rodney M. Pegg (PA)
Chad M. Quarles (AL)
Joseph L. Rigsby (AL)
Joe A. Root (MN)
Preston S. Salisbury (MT)
Benny L. Sanchez (CA)
Randal C. Schmude (WI)
James C. Sharp (PA)
Joseph B. Shaw, Jr. (VA)
Sylvester Silver (VA)
Kenneth D. Sisk (NC)
Loren Smith (SD)
Paul W. Sorenson (UT)
David C. Stitt (KS)
Gary R. Thomas (OH)
Richard T. Traigle (LA)
David J. Triplett (KY)
Melvin V. Van Meter (PA)
Nicholas J. Vance (OH)
Michael J. Welle (MN)
Carl V. Wheeler (NC)
Earl L. White, Jr. (NH)
Joseph F. Wood (MS)

    The drivers were included in docket numbers FMCSA-2000-7006; FMCSA-
2000-7165; FMCSA-2001-11426; FMCSA-2002-12294; FMCSA-2004-18885; FMCSA-
2004-18885; FMCSA-2004-19477; FMCSA-2005-21711; FMCSA-2006-24783;
FMCSA-2006-26066; FMCSA-2007-0071; FMCSA-2008-0021; FMCSA-2008-0106;
FMCSA-2008-0174; FMCSA-2008-0266; FMCSA-2008-0292; FMCSA-2008-0340;
FMCSA-2010-0161; FMCSA-2010-0187; FMCSA-2010-0201; FMCSA-2010-0287;
FMCSA-2010-0354; FMCSA-2010-0385; FMCSA-2012-0039; FMCSA-2012-0161;
FMCSA-2012-0215; FMCSA-2012-0216; FMCSA-2012-0279; FMCSA-2013-0168;
FMCSA-2013-0170; FMCSA-2014-0002; FMCSA-2014-0006; FMCSA-2014-0007;
FMCSA-2014-0010; FMCSA-2014-0011; FMCSA-2014-0296; FMCSA-2014-0299;
FMCSA-2016-0028; FMCSA-2016-0030; FMCSA-2016-0207; FMCSA-2016-0208;
FMCSA-2016-0209; FMCSA-2016-0210; FMCSA-2018-0010; FMCSA-2018-0207.
Their exemptions are applicable as of February 5, 2021, and will expire
on February 5, 2023.
    As of February 18, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following two individuals have satisfied the renewal
conditions for obtaining an exemption from the vision requirement in
the FMCSRs for interstate CMV drivers (80 FR 2473; 80 FR 18693; 82 FR
13048; 84 FR 2314):

Keith A. Looney (AR) and Van C. Mac (IL)

    The drivers were included in docket number FMCSA-2014-0030. Their
exemptions are applicable as of February 18, 2021, and will expire on
February 18, 2023.
    As of February 25, 2021, and in accordance with 49 U.S.C. 31136(e)
and 31315, the following individual has satisfied the renewal
conditions for obtaining an exemption from the vision requirement in
the FMCSRs for interstate CMV drivers (69 FR 64806; 70 FR 2705; 72 FR
1056; 73 FR 76439; 75 FR 79084; 77 FR 75496; 80 FR 3723; 82 FR 13048;
84 FR 2314):

Lester W. Carter (CA)

    The driver was included in docket number FMCSA-2004-19477. The
exemption is applicable as of February 25, 2021, and will expire on
February 25, 2023.

V. Conditions and Requirements

    The exemptions are extended subject to the following conditions:
(1) Each driver must undergo an annual physical examination (a) by an
ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the requirements in 49 CFR 391.41(b)(10),
and (b) by a certified medical examiner (ME), as defined by Sec.
390.5, who attests that the driver is otherwise physically qualified
under Sec.  391.41; (2) each driver must provide a copy of the
ophthalmologist's or optometrist's report to the ME at the time of the
annual medical examination; and (3) each driver must provide a copy of
the annual medical certification to the employer for retention in the
driver's qualification file or keep a copy of his/her driver's
qualification if he/she is self-employed. The driver must also have a
copy of the exemption when driving, for presentation to a duly
authorized Federal, State, or local enforcement official. The exemption
will be rescinded if: (1) The person fails to comply with the terms and
conditions of the exemption; (2) the exemption has resulted in a lower
level of safety than was maintained before it was granted; or (3)
continuation of the exemption would not be consistent with the goals
and objectives of 49 U.S.C. 31136(e) and 31315(b).

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or

regulation that conflicts with this exemption with respect to a person
operating under the exemption.

VI. Conclusion

    Based upon its evaluation of the 66 exemption applications, FMCSA
renews the exemptions of the aforementioned drivers from the vision
requirement in Sec.  391.41(b)(10), subject to the requirements cited
above. In accordance with 49 U.S.C. 31136(e) and 31315(b), each
exemption will be valid for 2 years unless revoked earlier by FMCSA.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2020-29245 Filed 1-5-21; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Notices]
[Pages 12760-12761]
[FR Doc No: 2013-04195]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-D-0153; formerly 2005D-0011]

Guidance for Industry on Labeling for Human Prescription Drug and
Biological Products--Implementing the Physician Labeling Rule Content
and Format Requirements; 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 ``Labeling for Human
Prescription Drug and Biological Products--Implementing the PLR Content
and Format Requirements.'' This guidance is intended to assist
applicants in complying with the content and format requirements of
labeling for human prescription drug and biological products. The
recommendations in this guidance will help ensure that the labeling is
clear; useful; informative; and to the extent possible, consistent in
content and format. It will assist applicants in developing labeling
for new products, revising existing labeling, and implementing the
requirements on content and format of labeling for human prescription
drug and biological products (71 FR 3922), which appeared in the
Federal Register of January 24, 2006. The rule is commonly referred to
as the ``Physician Labeling Rule'' (PLR) because it addresses
prescription drug labeling that is used by prescribers and other health
care practitioners.

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 or Office of Communication,
Outreach and Development (HFM-40), Center for Biologics Evaluation and
Research (CBER), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448. 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: Lori Bickel, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6353, Silver Spring, MD 20993-0002, 301-
796-0210; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Labeling for Human Prescription Drug and Biological
Products--Implementing the PLR Content and Format Requirements.'' The
guidance provides recommendations on how to create professional
labeling consistent with the requirements on content and format of
labeling for human prescription drug and biological products under
Sec. Sec.  201.56 and 201.57 (21 CFR 201.56 and 201.57) (71 FR 3922).
The guidance also provides recommendations on how to organize labeling
sections and what information should be included in each.
    This guidance is one of a series of guidances FDA is developing, or
has

developed, to assist applicants with the content and format of the
labeling for human prescription drug and biological products. In the
Federal Register of January 24, 2006 (71 FR 3998), FDA announced the
availability of final guidances on the content and format of the
``Adverse Reactions'' (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075057.pdf) and
``Clinical Studies'' (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075059.pdf)
sections of labeling. In the Federal Register of October 19, 2009 (74
FR 53507), FDA announced the availability of final guidance on
determining established pharmacologic class for use in the Highlights
of Prescribing Information (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM186607.pdf). In
the Federal Register of March 23, 2010 (75 FR 13766), FDA announced the
availability of final guidance on the content and format of the
``Dosage and Administration'' section of labeling (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075066.pdf). In the Federal Register of October 12, 2011 (76 FR
63303), FDA announced the availability of final guidance on the content
and format of the ``Warnings and Precautions,'' ``Contraindications,''
and ``Boxed Warning'' sections of labeling (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075096.pdf) and in the Federal Register of March 3, 2009 (74 FR
9250), FDA announced the availability of draft guidance on the content
and format of the ``Clinical Pharmacology'' section of labeling (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM109739.pdf). The labeling requirements and these guidances
are intended to make information in prescription drug labeling easier
for health care practitioners to access, read, and use.
    On January 24, 2006, FDA announced the availability of draft
guidance entitled ``Labeling for Human Prescription Drug and Biological
Products--Implementing the New Content and Format Requirements'' to
obtain public comment (71 FR 3998). FDA received a number of comments,
most of which sought clarifications and illustrations of the issues
discussed in individual sections of the guidance. FDA reviewed all
received comments carefully during the finalization of the guidance and
made clarifying changes based on input from these comments and comments
from FDA reviewers with labeling expertise.
    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 implementing the PLR content and format
requirements for labeling for human prescription drug and biological
products. 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. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in Sec. Sec.  201.56 and 201.57 have been
approved under OMB control number 0910-0572.

IV. Electronic Access

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

    Dated: February 19, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04195 Filed 2-22-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: October 6, 2006 (Volume 71, Number 194)]
[Notices]
[Page 59169-59170]
[DOCID:fr06oc06-104]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54533; File No. SR-CBOE-2006-79]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change to Include DXL Options on the Hybrid 2.0 Platform

September 28, 2006.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 22, 2006, the Chicago Board Options Exchange, Incorporated
(``CBOE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the CBOE. The
Exchange filed the proposal as a ``non-controversial'' proposed rule
change pursuant to section 19(b)(3)(A)(iii) of the Act \3\ and Rule
19b-4(f)(6) thereunder.\4\ The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The CBOE proposes to amend CBOE Rule 8.3 relating to Market-Maker
appointments to include DXL options on the Hybrid 2.0 Platform. The
text of the proposed rule change is available on the Exchange's Web
site http://www.cboe.com, at the Exchange's Office of the Secretary and

at the Commission.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of this rule change is to amend CBOE Rule 8.3 in
connection with CBOE's determination to trade options based on \1/10\
the Value of The Dow Jones Industrial Average (DXL) on the Hybrid 2.0
Platform.\5\ Specifically, CBOE proposes to amend Rule 8.3(c)(iv) to
delete the reference to DXL options in the table listing the non-Hybrid
option classes and their related appointment costs. As a Hybrid 2.0
Class, DXL would fall within the appointment cost structure set forth
in CBOE Rule 8.3(c)(i), and based on its trading volume, initially be
included in Tier E with an appointment cost of .01.\6\ As a result, it
would have an appointment cost that is identical to its current
appointment cost.
---------------------------------------------------------------------------

    \5\ CBOE Rule 1.1(aaa) defines Hybrid Trading System and Hybrid
2.0 Platform.
    \6\ CBOE Rules 8.3 and 8.4 provide that Market-Makers and RMMs,
respectively, can create a Virtual Trading Crowd (``VTC'')
Appointment, which confers the right to quote electronically in a
certain number of products selected from various ``Tiers.''
Currently, there are five Tiers (Tiers A, B, C, D, and E) that are
structured according to trading volume statistics, an ``A++'' Tier
which consists of options on the CBOE Volatility Index (VIX), and an
``A+'' Tier which consists of two option classes--options on
Standard & Poor's Depositary Receipts (SPY) and options on the
Nasdaq-100 Index Tracking Stock (QQQQ). These Tiers are also
utilized for purposes of determining DPM and e-DPM membership
ownership requirements as provided in CBOE Rules 8.85 and 8.92,
respectively.
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2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act and the rules and regulations under the Act applicable to a
national securities exchange and, in particular, the requirements of
section 6(b) of the Act.\7\ Specifically, the Exchange believes the
proposed rule change is consistent with the requirements of section
6(b)(5) \8\ that the rules of an exchange be designed to promote just
and equitable principles of trade, to prevent fraudulent and
manipulative acts and, in general, to protect investors and the public
interest.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange neither received nor solicited written comments on the
proposal.

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

    Because the foregoing rule does not (i) significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest, provided that the Exchange has given the
Commission written notice of its intent to file the proposed rule
change prior to the date

of filing of the proposed rule change or such shorter time as
designated by the Commission, the proposed rule change has become
effective pursuant to section 19(b)(3)(A) of the Act \9\ and Rule 19b-
4(f)(6) thereunder.\10\
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.
    Under Rule 19b-4(f)(6)(iii) of the Act,\11\ the proposal does not
become operative for 30 days after the date of its filing, or such
shorter time as the Commission may designate if consistent with the
protection of investors and the public interest. The Exchange has
requested that the Commission waive the five-day pre-filing requirement
and accelerate the 30-day operative date. The Commission, consistent
with the protection of investors and the public interest, has
determined to waive the five-day pre-filing requirement and to
accelerate the 30-day operative date to allow DXL options to be traded
on Hybrid 2.0 without delay.\12\
---------------------------------------------------------------------------

    \11\ 17 CFR 240.19b-4(f)(6)(iii).
    \12\ For purposes only of waiving the five-day pre-filing
requirement and accelerating the 30-day operative period for this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CBOE-2006-79 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-CBOE-2006-79. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the CBOE. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-CBOE-2006-79 and should be submitted on or before
October 27, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\13\
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    \13\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
 [FR Doc. E6-16579 Filed 10-5-06; 8:45 am]

BILLING CODE 8011-01-P