[Federal Register Volume 76, Number 222 (Thursday, November 17, 2011)]
[Rules and Regulations]
[Pages 71241-71246]
[FR Doc No: 2011-29680]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2011-0648; Directorate Identifier 2010-NM-276-AD;
Amendment 39-16859; AD 2011-23-08]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Model CL-600-2B19
(Regional Jet Series 100 & 440) Airplanes

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

ACTION: Final rule.

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SUMMARY: We are superseding an existing airworthiness directive (AD)
that applies to certain Bombardier, Inc. Model CL-600-2B19 (Regional
Jet Series 100 & 440) airplanes. This AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    Seven cases of on-ground hydraulic accumulator screw cap/end cap
failure have been experienced on CL-600-2B19 aeroplanes, resulting
in the loss of the associated hydraulic system and high-energy
impact damage to adjacent systems and structure. * * *
* * * * *
    A detailed analysis of the calculated line of trajectory of a
failed screw cap/end cap for each of the accumulators has been
conducted, resulting in the identification of several areas where
systems and/or structural components could potentially be damaged.
Although all of the failures to date have occurred on the ground, an
in-flight failure affecting such components could potentially have
an adverse effect on the controllability of the aeroplane.
* * * * *

We are issuing this AD to require actions to correct the unsafe
condition on these products.

DATES: This AD becomes effective December 22, 2011.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of December 22,
2011.
    The Director of the Federal Register approved the incorporation by
reference of certain other publications listed in this AD as of
November 4, 2010 (75 FR 64636, October 20, 2010).

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Christopher Alfano, Aerospace
Engineer, Airframe and Mechanical Systems Branch, ANE-171, FAA, New
York Aircraft Certification Office (ACO), 1600 Stewart Avenue, Suite
410, Westbury, New York 11590; telephone<PHONE_NUMBER>; fax (516) 794-
5531.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an AD that would apply to the specified products.
That NPRM was published in the Federal Register on June 29, 2011 (76 FR
38065), and proposed to supersede AD 2010-22-02, Amendment 39-16481 (75
FR 64636, October 20, 2010). That NPRM proposed to correct an unsafe
condition for the specified products.
    Since we issued AD 2010-22-02, Amendment 39-16481 (75 FR 64636,
October 20, 2010), we have determined

that further rulemaking is necessary. While AD 2010-22-02 did not
require the removal of the hydraulic system No. 3 accumulator, or
replacement of the hydraulic system No. 1, inboard brake and outboard
brake accumulators, as specified in Part IV and Part VII of Canadian
Airworthiness Directive CF-2010-24, dated August 3, 2010, this AD
requires those actions. Also, for airplanes on which Bombardier Service
Bulletin 601R-29-035, dated May 11, 2010, is done, and a reducer having
part number MS21916D8-6 installed, this AD requires replacing the
reducer with a new reducer. We have coordinated with Transport Canada
Civil Aviation (TCCA) on this issue.

Comments

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

Request for Restatement of All Compliance Requirements of AD 2010-22-
02, Amendment 39-16481 (75 FR 64636, October 20, 2010)

    Comair, Inc. (the commenter) requested that we revise the NPRM (76
FR 38065, June 29, 2011) to restate all the compliance requirements of
AD 2010-22-02, Amendment 39-16481 (75 FR 64636, October 20, 2010), and
reasoned that it is less confusing and more accurate to completely
restate all the compliance requirements of AD 2010-22-02. The commenter
expressed that the way the NPRM was written, a copy of AD 2010-22-02
must be on-hand to fully cross reference between AD 2010-22-02 and the
NPRM. The commenter stated that as an example, paragraph (h) of the
NPRM, in part, states: ``Doing the removal of the hydraulic system No.
3 accumulator in paragraph (o) of this AD is an alternative method of
compliance with the requirements of this paragraph,'' but that AD 2010-
22-02 actually references paragraph (j) instead of paragraph (o) of the
NPRM. The commenter explained that the content of paragraphs (j) and
(m) of AD 2010-22-02 is not included in the NPRM.
    We agree to clarify. We have restated the requirements of AD 2010-
22-02, Amendment 39-16481 (75 FR 64636, October 20, 2010), in this
final rule. We provided a table in the Change to Existing AD paragraph
in the NPRM (76 FR 38065, June 29, 2011) to identify and cross-
reference paragraph requirements in AD 2010-22-02 with the
corresponding paragraph requirements in this AD. That table did not
identify the paragraphs that did not change from AD 2010-22-02 to the
NPRM. The actions specified in paragraph (j) of AD 2010-22-02 are
specified in paragraph (o) of this AD. The actions specified in
paragraph (m) of AD 2010-22-02 are specified in paragraph (p) of this
AD. No changes have been made to this AD in this regard.

Request for Clarification of Intent of Paragraph (o) of the NPRM (76 FR
38065, June 29, 2011)

    The commenter requested that action specified in paragraph (o) of
the NPRM (76 FR 38065, June 29, 2011) be considered a superseding
requirement, instead of an ``alternate method of compliance'' for the
actions specified in paragraph (h) of the NPRM. The commenter did not
provide a reason for this request.
    We agree that the wording in paragraph (h) of this final rule
should be revised to clarify the intent of paragraph (o) of this AD. We
have revised paragraph (h) of this final rule to specify that paragraph
(o) of this final rule is terminating action instead of an alternative
method of compliance (AMOC) for the requirements of paragraph (h) of
this final rule, by replacing ``is an alternate method of compliance''
with ``terminates.''

Request for Consideration of Other AMOCs

    The commenter requested that we revise the NPRM (76 FR 38065, June
29, 2011) to allow for previous AMOCs, which would, among other
actions, allow for the relocation of the No. 3 Accumulator using ``SB
601R-29-0 Rev B.'' The commenter proposed that we do this as a separate
paragraph or optional paragraph, or to include this in paragraph (t)(1)
of the NPRM.
    For the reasons stated by the commenter, we agree to allow for
previous approved AMOCs in accordance with AD 2010-22-02, Amendment 39-
16481 (75 FR 64636, October 20, 2010) in this final rule. We have
revised paragraph (t)(1) of this final rule accordingly.

Conclusion

    We reviewed the available data, including the comments received,
and determined that air safety and the public interest require adopting
the AD with the changes described previously. We determined that these
changes will not increase the economic burden on any operator or
increase the scope of the AD.

Differences Between This AD and the MCAI or Service Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have required different actions in this AD from those
in the MCAI in order to follow our FAA policies. Any such differences
are highlighted in a NOTE within the AD.

Costs of Compliance

    We estimate that this AD will affect about 605 products of U.S.
registry.
    The actions that are required by AD 2010-22-02, Amendment 39-16481
(75 FR 64636, October 20, 2010), and retained in this AD take about 19
work-hours per product, at an average labor rate of $85 per work-hour.
Based on these figures, the estimated cost of the currently required
actions is $1,615 per product.
    We estimate that it will take about 14 work-hours per product to
comply with the new basic requirements of this AD. The average labor
rate is $85 per work-hour. Required parts will cost about $3,054 per
product. Where the service information lists required parts costs that
are covered under warranty, we have assumed that there will be no
charge for these parts. As we do not control warranty coverage for
affected parties, some parties may incur costs higher than estimated
here. Based on these figures, we estimate the cost of this AD to the
U.S. operators to be $2,567,620, or $4,244 per product.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this 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 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); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains the NPRM (76 FR 38065, June 29, 2011),
the regulatory evaluation, any comments received, and other
information. The street address for the Docket Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

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 Amendment 39-16481 (75 FR
64636, October 20, 2010) and adding the following new AD:

2011-23-08 Bombardier, Inc.: Amendment 39-16859. Docket No. FAA-
2011-0648; Directorate Identifier 2010-NM-276-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective December
22, 2011.

Affected ADs

    (b) This AD supersedes AD 2010-22-02, Amendment 39-16481 (75 FR
64636, October 20, 2010).

Applicability

    (c) This AD applies to Bombardier, Inc. Model CL-600-2B19
(Regional Jet Series 100 & 440) airplanes, certificated in any
category, serial numbers 7003 and subsequent.

Subject

    (d) Air Transport Association (ATA) of America Code 29 and 32:
Hydraulic Power and Landing Gear, respectively.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Seven cases of on-ground hydraulic accumulator screw cap/end cap
failure have been experienced on CL-600-2B19 aeroplanes, resulting
in the loss of the associated hydraulic system and high-energy
impact damage to adjacent systems and structure. * * *
* * * * *
    A detailed analysis of the calculated line of trajectory of a
failed screw cap/end cap for each of the accumulators has been
conducted, resulting in the identification of several areas where
systems and/or structural components could potentially be damaged.
Although all of the failures to date have occurred on the ground, an
in-flight failure affecting such components could potentially have
an adverse effect on the controllability of the aeroplane.
* * * * *

Compliance

    (f) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Restatement of Requirements of AD 2010-22-02, Amendment 39-16481 (75 FR
64636, OCTOBER 20, 2010), With Revised Service Information:

Airplane Flight Manual (AFM) Revision

    (g) Within 30 days after November 4, 2010 (the effective date of
AD 2010-22-02, Amendment 39-16481 (75 FR 64636, October 20, 2010)),
revise the Limitations section, Normal Procedures section, and
Abnormal Procedures section of the Canadair Regional Jet AFM, CSP A-
012, by incorporating Canadair Regional Jet Temporary Revision (TR)
RJ/186-1, dated August 24, 2010, into the applicable section of
Canadair Regional Jet AFM, CSP A-012. Thereafter, except as provided
by paragraph (t) of this AD, no alternative actions specified in
Canadair Regional Jet TR RJ/186-1, dated August 24, 2010, may be
approved.

    Note 1: The actions required by paragraph (g) of this AD may be
done by inserting a copy of Canadair Regional Jet TR RJ/186-1, dated
August 24, 2010, into the applicable section of the Canadair
Regional Jet AFM, CSP A-012. When this TR has been included in the
general revisions of this AFM, the general revisions may be inserted
into this AFM, and this TR removed, provided that the relevant
information in the general revision is identical to that in Canadair
Regional Jet TR RJ/186-1, dated August 24, 2010.

Deactivation of the Hydraulic System No. 3 Accumulator

    (h) Within 250 flight cycles after November 4, 2010, deactivate
the hydraulic system No. 3 accumulator, in accordance with Part A of
the Accomplishment Instructions of Bombardier Alert Service Bulletin
A601R-29-031, Revision A, dated March 26, 2009. Doing the removal of
the hydraulic system No. 3 accumulator in paragraph (o) of this AD
terminates the requirements of this paragraph. The actions in this
paragraph apply to all accumulators in hydraulic system No. 3.

Removal of the Hydraulic System No. 2 Accumulator

    (i) Within 500 flight cycles after November 4, 2010, remove the
hydraulic system No. 2 accumulator, in accordance with the
Accomplishment Instructions of Bombardier Service Bulletin 601R-29-
032, Revision A, dated January 26, 2010. The actions in this
paragraph apply to all accumulators in hydraulic system No. 2.

Initial and Repetitive Ultrasonic Inspections of Hydraulic System No.
1, Inboard Brake and Outboard Brake Accumulators

    (j) For hydraulic system No. 1, inboard brake and outboard brake
accumulators having P/N 601R75138-1 (08-60163-001 or 08-60163-002):
At the applicable compliance times specified in paragraph (l) of
this AD, do the inspections required by paragraphs (j)(1) and (j)(2)
of this AD. Repeat the inspections for each accumulator having P/N
601R75138-1 (08-60163-001 or 08-60163-002) thereafter at intervals
not to exceed 500 flight cycles until the replacement specified in
this paragraph is done or the replacement specified in paragraph (p)
of this AD is done. If any crack is found, before further flight,
replace the accumulator with a new accumulator having P/N 601R75138-
1 (08-60163-001 or 08-60163-002) and having the letter ``T'' after
the serial number on the identification plate, in accordance with
the Accomplishment Instructions of the applicable service bulletin
identified in table 1 or table 2 of this AD.
    (1) Do an ultrasonic inspection for cracks on each accumulator,
in accordance with Part B of the Accomplishment Instructions of the
applicable service bulletin identified in table 1 of this AD.

                       Table 1--Bombardier Service Information for Accumulator Inspection
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          Accumulator                       Document                  Revision                  Date
----------------------------------------------------------------------------------------------------------------
Hydraulic System No. 1........  Bombardier Alert Service          B..............  May 11, 2010.
                                 Bulletin A601R-29-029,
                                 including Appendix A, dated
                                 October 18, 2007.
Inboard and Outboard Brake....  Bombardier Alert Service          D..............  May 11, 2010.
                                 Bulletin A601R-32-103,
                                 including Appendix A, Revision
                                 A, dated October 18, 2007.
----------------------------------------------------------------------------------------------------------------

    (2) Do an ultrasonic inspection for cracks on the screw cap, in
accordance with the Accomplishment Instructions of the applicable
service bulletin identified in table 2 of this AD.

                        Table 2--Bombardier Service Information for Screw Cap Inspection
----------------------------------------------------------------------------------------------------------------
          Accumulator                       Document                  Revision                  Date
----------------------------------------------------------------------------------------------------------------
Hydraulic System No. 1........  Bombardier Service Bulletin 601R- A..............  May 11, 2010.
                                 29-033, including Appendix A,
                                 dated May 5, 2009.
Inboard and Outboard Brake....  Bombardier Service Bulletin 601R- A..............  May 11, 2010.
                                 32-106, including Appendix A.
----------------------------------------------------------------------------------------------------------------

    (k) For hydraulic system No. 1 inboard brake, and outboard brake
accumulators having P/N 601R75138-1 (08-60163-001 or 08-60163-002):
Do the inspections specified in paragraph (j) of this AD at the
applicable time in paragraph (k)(1), (k)(2), and (k)(3) of this AD.
    (1) For any accumulator not having the letter ``T'' after the
serial number on the identification plate and with more than 4,500
flight cycles on the accumulator as of November 4, 2010: Inspect
within 500 flight cycles after November 4, 2010.
    (2) For any accumulator not having the letter ``T'' after the
serial number on the identification plate and with 4,500 flight
cycles or less on the accumulator as of November 4, 2010: Inspect
prior to the accumulation of 5,000 flight cycles on the accumulator.
    (3) If it is not possible to determine the flight cycles
accumulated for any accumulator not having the letter ``T'' after
the serial number on the identification plate: Inspect within 500
flight cycles after November 4, 2010.

    Note 2: For any accumulator having P/N 601R75138-1 (08-60163-001
or 08-60163-002) and the letter ``T'' after the serial number on the
identification plate, or if the accumulator P/N is not listed in
paragraph (j) of this AD, the inspection specified in paragraph (j)
of this AD is not required.

Credit for Actions Accomplished in Accordance With Previous Service
Information

    (l) Deactivating the hydraulic system No. 3 accumulator before
November 4, 2010, in accordance with Part A of the Accomplishment
Instructions of Bombardier Alert Service Bulletin A601R-29-031,
dated December 23, 2008, is acceptable for compliance with the
requirements of paragraph (h) of this AD.
    (m) Removing the hydraulic system No. 2 accumulator in
accordance with the Accomplishment Instructions of Bombardier
Service Bulletin 601R-29-032, dated November 12, 2009, before
November 4, 2010, is acceptable for compliance with the requirements
of paragraph (i) of this AD.
    (n) An ultrasonic inspection for cracks done before November 4,
2010, in accordance with Part B of the Accomplishment Instructions
of the applicable service bulletin identified in table 3 of this AD,
or the Accomplishment Instructions of the applicable service
bulletin identified in table 4 of this AD, is acceptable for
compliance with the corresponding ultrasonic inspection required by
paragraph (j) of this AD.

                    Table 3--Bombardier Credit Service Information for Accumulator Inspection
----------------------------------------------------------------------------------------------------------------
                 Document                           Revision                              Date
----------------------------------------------------------------------------------------------------------------
Bombardier Alert Service Bulletin A601R-   ..........................  October 18, 2007.
 29-029.
Bombardier Alert Service Bulletin A601R-   A.........................  November 12, 2009.
 29-029.
Bombardier Alert Service Bulletin A601R-   ..........................  November 21, 2006.
 32-103.
Bombardier Alert Service Bulletin A601R-   A.........................  March 7, 2007.
 32-103.
Bombardier Alert Service Bulletin A601R-   B.........................  October 18, 2007.
 32-103.
Bombardier Alert Service Bulletin A601R-   C.........................  February 26, 2009.
 32-103.
----------------------------------------------------------------------------------------------------------------

 Table 4--Bombardier Credit Service Information For Screw Cap Inspection
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              Document                               Date
------------------------------------------------------------------------
Bombardier Service Bulletin 601R-29-  May 5, 2009.
 033.
Bombardier Service Bulletin 601R-32-  May 5, 2009.
 106.
------------------------------------------------------------------------

New Requirements of This AD

Removal of the Hydraulic System No. 3 Accumulator

    (o) Within 1,000 flight cycles after the effective date of this
AD, remove the hydraulic system No. 3 accumulator, in accordance
with Part B of the Accomplishment Instructions of Bombardier Alert
Service Bulletin A601R-29-031, Revision A, dated March 26, 2009.
Doing the action in this paragraph terminates the requirements of
paragraph (h) of this AD.

Replacement of the Hydraulic System No. 1, Inboard Brake and Outboard
Brake Accumulators

    (p) Within 4,000 flight cycles or 24 months after the effective
date of this AD, whichever occurs first, replace any hydraulic
system No. 1, inboard brake or outboard brake

accumulator having P/N 601R75138-1 (08-60163-001 or 08-60163-002),
with a new accumulator having P/N 601R75139-1 (11093-4), in
accordance with the Accomplishment Instructions of the applicable
service bulletin identified in table 5 of this AD. Doing the action
in this paragraph terminates the requirement for the inspections in
paragraph (j) of this AD for that accumulator. As of the effective
date of this AD, use only Bombardier Service Bulletin 601R-29-035,
Revision A, dated December 8, 2010; or Bombardier Service Bulletin
601R-32-107, Revision B, dated December 8, 2010; as applicable.

                       Table 5--Bombardier Service Information for Accumulator Replacement
----------------------------------------------------------------------------------------------------------------
          Accumulator                       Document                  Revision                  Date
----------------------------------------------------------------------------------------------------------------
Hydraulic System No. 1........  Bombardier Service Bulletin 601R- ...............  May 11, 2010.
                                 29-035.
Hydraulic System No. 1........  Bombardier Service Bulletin 601R- A..............  December 8, 2010.
                                 29-035.
Inboard and Outboard Brake....  Bombardier Service Bulletin 601R- A..............  June 17, 2010.
                                 32-107.
Inboard and Outboard Brake....  Bombardier Service Bulletin 601R- B..............  December 8, 2010.
                                 32-107.
----------------------------------------------------------------------------------------------------------------

Action for Airplanes on Which Bombardier Service Bulletin 601R-29-035,
Dated May 11, 2010, Is Done and Reducer Having P/N MS21916D8-6 Is
Installed

    (q) For airplanes on which Bombardier Service Bulletin 601R-29-
035, dated
    May 11, 2010, is done, and reducer having P/N MS21916D8-6 is
installed: Within 1,200 flight cycles or 8 months after the
effective date of this AD, replace the reducer of the hydraulic
system No. 1 with a new reducer in accordance with Part B of
Bombardier Service Bulletin 601R-29-035, Revision A, dated December
8, 2010.

Credit for Actions Accomplished in Accordance With Previous Service
Information

    (r) Removing the hydraulic system No. 3 accumulator in
accordance with Part B of the Accomplishment Instructions of
Bombardier Alert Service Bulletin
    A601R-29-031, dated December 23, 2008, before November 4, 2010,
is acceptable for compliance with the requirements of paragraph (o)
of this AD.
    (s) Replacing any hydraulic system No. 1, inboard brake, or
outboard brake accumulator before November 4, 2010, in accordance
with the Accomplishment Instructions of Bombardier Service Bulletin
601R-32-107, dated May 11, 2010; or Bombardier Service Bulletin
601R-32-107, Revision A, dated June 17, 2010; is acceptable for
compliance with the corresponding requirements of paragraph (p) of
this AD.

FAA AD Differences

    Note 3: This AD differs from the MCAI and/or service information
as follows: (1) The actions specified in Canadian Airworthiness
Directive CF-2010-24, dated August 3, 2010, apply only to Tactair
accumulators. The actions required by paragraphs (h), (i), and (o)
of this AD apply to all accumulators in the positions specified in
paragraphs (h), (i), and (o) of this AD.
    (2) While Canadian Airworthiness Directive CF-2010-24, dated
August 3, 2010, does not require replacement of the reducer of the
hydraulic system No. 1 with a new reducer, paragraph (q) of this AD
does.

Other FAA AD Provisions

    (t) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to ATTN: Program
Manager, Continuing Operational Safety, FAA, New York ACO, 1600
Stewart Avenue, Suite 410, Westbury, New York 11590; telephone (516)
228-7300; fax<PHONE_NUMBER>. Before using any approved AMOC, notify
your appropriate principal inspector, or lacking a principal
inspector, the manager of the local flight standards district
office/certificate holding district office. The AMOC approval letter
must specifically reference this AD. AMOCs approved previously in
accordance with AD 2010-22-02, Amendment 39-16481 (75 FR 64636,
October 20, 2010), are approved as AMOCs for the corresponding
provisions of this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

Related Information

    (u) Refer to MCAI Canadian Airworthiness Directive CF-2010-24,
dated August 3, 2010; Canadair Regional Jet Temporary Revision RJ/
186-1, dated August 24, 2010, to the Canadair Regional Jet Airplane
Flight Manual, CSP A-012; Bombardier Alert Service Bulletin A601R-
29-029, Revision B, dated May 11, 2010, including Appendix A, dated
October 18, 2007; Bombardier Alert Service Bulletin A601R-29-031,
Revision A, dated March 26, 2009; Bombardier Alert Service Bulletin
A601R-32-103, Revision D, dated May 11, 2010, including Appendix A,
Revision A, dated October 18, 2007; Bombardier Service Bulletin
601R-29-032, Revision A, dated January 26, 2010; Bombardier Service
Bulletin 601R-29-033, Revision A, dated May 11, 2010, including
Appendix A, dated May 5, 2009; Bombardier Service Bulletin 601R-29-
035, Revision A, dated December 8, 2010; Bombardier Service Bulletin
601R-32-106, Revision A, including Appendix A, dated May 11, 2010;
and Bombardier Service Bulletin 601R-32-107, Revision B, dated
December 8, 2010; for related information.

Material Incorporated by Reference

    (v) You must use the following service information, as
applicable, to do the actions required by this AD, unless the AD
specifies otherwise. The Director of the Federal Register approved
the incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (1) Canadair Regional Jet Temporary Revision RJ/186-1, dated
August 24, 2010, to the Canadair Regional Jet Airplane Flight
Manual, CSP A-012 (previously approved for incorporation by
reference on November 4, 2010 (75 FR 64636, October 20, 2010));
    (2) Bombardier Alert Service Bulletin A601R-29-029, Revision B,
dated May 11, 2010, including Appendix A, dated October 18, 2007
(previously approved for incorporation by reference on November 4,
2010 (75 FR 64636, October 20, 2010))*;
    (3) Bombardier Alert Service Bulletin A601R-29-031, Revision A,
dated March 26, 2009 (previously approved for incorporation by
reference on November 4, 2010 (75 FR 64636, October 20, 2010));
    (4) Bombardier Alert Service Bulletin A601R-32-103, Revision D,
dated May 11, 2010, including Appendix A, Revision A, dated October
18, 2007 (previously approved for incorporation by reference on
November 4, 2010 (75 FR 64636, October 20, 2010))*;
    (5) Bombardier Service Bulletin 601R-29-032, Revision A, dated
January 26, 2010 (previously approved for incorporation by reference
on November 4, 2010 (75 FR 64636, October 20, 2010));
    (6) Bombardier Service Bulletin 601R-29-033, Revision A, dated
May 11, 2010, including Appendix A, dated May 5, 2009 (previously
approved for incorporation by reference on November 4, 2010 (75 FR
64636, October 20, 2010))*;
    (7) Bombardier Service Bulletin 601R-29-035, Revision A, dated
December 8, 2010 (approved for incorporation by reference on
December 22, 2011);
    (8) Bombardier Service Bulletin 601R-32-106, Revision A,
including Appendix A, dated May 11, 2010 (previously approved for
incorporation by reference on November 4, 2010 (75 FR 64636, October
20, 2010))*; and
    (9) Bombardier Service Bulletin 601R-32-107, Revision B, dated
December 8, 2010 (approved for incorporation by reference on
December 22, 2011).

    Note 4: * In Appendix A to these documents, the document number
is shown only on page A1 of these appendices.

    (10) For service information identified in this AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval,
Qu[eacute]bec H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax (514)
855-7401; email

<EMAIL_ADDRESS>Internet http://www.bombardier.com.
    (11) You may review copies of the service information at the
FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.
    (12) You may also review copies of the 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/code_of_federal_regulations/ibr_locations.html.

    Issued in Renton, Washington, on October 20, 2011.
Kalene C. Yanamura,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2011-29680 Filed 11-16-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: August 18, 2010 (Volume 75, Number 159)]
[Notices]
[Page 51128-51132]
[DOCID:fr18au10-164]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-62715, File No. SR-MSRB-2009-17]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Notice of Filing of Amendment No. 1 and Order Granting
Accelerated Approval of Proposed Rule Change, as Modified by Amendment
No. 1 Thereto, Consisting of (i) Amendments to Rule G-8 (Books and
Records To Be Made by Brokers, Dealers and Municipal Securities
Dealers), Rule G-9 (Preservation of Records), and Rule G-11 (New Issue
Syndicate Practices); (ii) a Proposed Interpretation of Rule G-17
(Conduct of Municipal Securities Activities); and (iii) the Deletion of
a Previous Rule G-17 Interpretive Notice

August 13, 2010.

I. Introduction

    On November 18, 2009, the Municipal Securities Rulemaking Board
(``MSRB'' or ``Board''), filed with the Securities and Exchange
Commission (``Commission'' or ``SEC''), pursuant to Section 19(b)(1) of
the Securities Exchange Act of 1934 (``Exchange Act''),\1\ and Rule
19b-4 thereunder,\2\ a proposed rule change consisting of (i) proposed
amendments to Rule G-8 (books and records to be made by brokers,
dealers and municipal securities dealers), Rule G-9 (preservation of
records), and Rule G-11 (new issue syndicate practices); (ii) a
proposed interpretation (the ``proposed interpretive notice'') of Rule
G-17 (conduct of municipal securities activities); and (iii) the
deletion of a previous Rule G-17 interpretive notice on priority of
orders dated December 22, 1987 (the ``1987 interpretive notice''). The
proposed rule change was published for comment in the Federal Register
on December 10, 2009.\3\ The Commission received four comment letters
about the proposed rule change.\4\ On August 4, 2010, the MSRB filed
with the Commission, pursuant to Section 19(b)(1) of the Exchange Act
\5\ and Rule 19b-4 thereunder,\6\ Amendment No. 1 to the proposed rule
change, which made technical changes to the proposed rule change and
responded to the comment letters received by the Commission in response
to the Commission's Notice. The text of Amendment No. 1 is available on
the MSRB's Web site (http://www.msrb.org), at the MSRB's principal
office, and for Web site viewing and printing in the Commission's
Public Reference Room. This order provides notice of Amendment No. 1
and approves the proposed rule change as modified by Amendment No. 1 on
an accelerated basis.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 61110 (December 3,
2009), 74 FR 65573 (December 10, 2009) (``Commission's Notice'')
(the ``original proposed rule change'').
    \4\ See letters from: John C. Melton, Sr., Houston, Texas, dated
December 15, 2009; Karrie McMillan, General Counsel, Investment
Company Institute (``ICI''), dated December 23, 2009 (``ICI
Letter''); Mike Nicholas, CEO, Regional Bond Dealers Association
(``RBDA''), dated December 30, 2009 (``RBDA Letter''); Leon J.
Bijou, Managing Director and Associate General Counsel, Securities
Industry and Financial Markets Association (``SIFMA''), dated
December 31, 2009 (``SIFMA Letter'').
    \5\ 15 U.S.C. 78s(b)(1).
    \6\ 17 CFR 240.19b-4.
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II. Description of the Proposed Rule Change, As Modified by Amendment
No. 1 to the Proposed Rule Change

    The proposed amendments to Rule G-11 would: (1) Apply the rule to
all primary offerings, not just those for which a syndicate is formed;
(2) require that all dealers (not just syndicate members) disclose
whether their orders are for their own account or a related account;
and (3) require that priority be given to orders from customers over
orders from syndicate members for their own accounts or orders from
their respective related accounts, to the extent feasible and
consistent with the orderly distribution of securities in the offering,
unless the issuer otherwise agrees or it is in the best interests of
the syndicate not to follow that order of priority.
    The proposed amendments to Rules G-8 and G-9 would require that
records be retained for all primary offerings of: (1) All orders,
whether or not filled; (2) whether there was a retail order period and,
if so, the issuer's definition of ``retail;'' and (3) those instances
when the syndicate manager allocated bonds other than in accordance
with the priority provisions of Rule G-11 and the specific reasons why
it was in the best interests of the syndicate to do so.
    The proposed interpretive notice would provide that violation of
these priority provisions would be a violation

of Rule G-17, subject to the same exceptions as provided in proposed
amended Rule G-11. It also would provide that Rule G-17 does not
require that customer orders be accorded greater priority than orders
from dealers that are not syndicate members or their respective related
accounts. The proposed interpretive notice also would provide that it
would be a violation of Rule G-17 for a dealer to allocate securities
in a manner that is inconsistent with an issuer's requirements for a
retail order period without the issuer's consent. Issuance of the
notice, in addition to the amendments to Rule G-11, is consistent with
previous guidance issued by the Board that all activities of dealers
must be viewed in light of the basic fair dealing principles of Rule G-
17, regardless of whether other MSRB rules establish additional
requirements on dealers.\7\
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    \7\ MSRB Notice 2009-42 (July 14, 2009)--Guidance on Disclosure
and Other Sales Practice Obligations to Individual and Other Retail
Investors in Municipal Securities.
---------------------------------------------------------------------------

    The original proposed rule change arose out of the Board's ongoing
review of its General Rules as well as concerns expressed by
institutional investors that their orders were sometimes not filled in
whole or in part during a primary offering, yet the bonds became
available shortly thereafter in the secondary market. They attributed
that problem to two causes: First, some retail dealers were allowed to
place orders in retail order periods without going away orders and
second, syndicate members, their affiliates, and their respective
related accounts were allowed to buy bonds in the primary offering for
their own account even though other orders remained unfilled. There was
also concern that these two factors could contribute to restrictions on
access to new issues by retail investors, in a manner inconsistent with
the issuer's intent. A full description of the original proposed rule
change is contained in the Commission's Notice.
    Amendment No. 1 amends the text of the original proposed rule
change to clarify that (i) amended MSRB Rule G-8(a)(viii) requires that
records must be kept of whether there was a retail order period,
regardless of whether the issuer required that there be one; (ii) the
term ``priority provisions'' as used in amended Rule G-8(a)(viii)(A)
includes both the customer priority provisions set forth in amended
Rule G-11(e) and any other priority provisions of the syndicate (e.g.,
those included in an agreement among underwriters); (iii) the
recordkeeping requirements of amended Rule G-8(a)(viii) concerning
deviations from the customer priority provisions and the specific
reasons for doing so are the same for both sole underwriters and
syndicate managers; and (iv) the customer priority requirements of the
interpretive notice are the same as those of amended Rule G-11(e).\8\
Amendment No. 1 also corrects a typographical error in amended G-
11(e)(ii).
---------------------------------------------------------------------------

    \8\ Amendment No. 1 would make no changes to revised Rule G-9 as
set forth in the original proposed rule change.
---------------------------------------------------------------------------

    The MSRB is proposing the revision to the original proposed rule
change set forth in clause (i) of the description of Amendment No. 1
above, because in many cases a retail order period is conducted based
on the recommendation of the underwriter, not because the issuer has
required that there be a retail order period. The MSRB considers it
important to know whether there was a retail order period, regardless
of whether the issuer required that there be one. There is no revision
to the requirement of amended Rule G-8(a)(viii) that requires a record
of the issuer's definition of ``retail,'' if applicable.
    As more fully described below, the MSRB is proposing the revision
to the original proposed rule change set forth in clause (ii) of the
description of Amendment No. 1 above in response to a comment filed by
the Regional Bond Dealers Association, which suggested that it was
unclear what the term ``priority provisions'' meant in amended Rule G-
8(a)(viii)(A).
    The MSRB is proposing the revision to the original proposed rule
change set forth in clause (iii) of the description of Amendment No. 1
above to conform the recordkeeping rules for syndicates and sole
managers, finding no reason for distinguishing between the two.
Furthermore, the revision to amended Rule G-8(a)(viii)(A) is intended
to remove what might have been perceived as a difference between
amended Rule G-11(e) and the proposed interpretive notice.
    As more fully described below, the MSRB is proposing the revision
to the original proposed rule change set forth in clause (iv) of the
description of Amendment No. 1 above in response to a comment received
from the Securities Industry and Financial Markets Association, which
interpreted the use of the word ``generally'' to mean that there could
be exceptions to the priority of orders provisions other than those set
forth in the proposed interpretive notice. The revision makes it clear
that the exceptions set forth in the proposed interpretive notice are
the only exceptions. The Board considers those exceptions sufficient to
cover the circumstances under which an underwriter might find it
necessary to deviate from the priority provisions.

Effective Date of Proposed Rule Change

    The MSRB requested that the proposed rule change become effective
for new issues of municipal securities for which the Time of Formal
Award (as defined in Rule G-34(a)(ii)(C)(1)(a)) occurs more than 60
days after approval of the proposed rule change by the SEC.

III. Discussion and Commission Findings

    The Commission has carefully considered the proposed rule change,
the comment letters received, and the MSRB's responses to the comment
letters and finds that the proposed rule change is consistent with the
requirements of the Exchange Act and the rules and regulations
thereunder applicable to the MSRB \9\ and, in particular, the
requirements of Section 15B(b)(2)(C) of the Exchange Act \10\ and the
rules and regulations thereunder. Section 15B(b)(2)(C) of the Exchange
Act requires, among other things, that the MSRB's rules be designed to
prevent fraudulent and manipulative acts and practices, to promote just
and equitable principles of trade, to foster cooperation and
coordination with persons engaged in regulating, clearing, settling,
processing information with respect to, and facilitating transactions
in municipal securities, to remove impediments to and perfect the
mechanism of a free and open market in municipal securities, and, in
general, to protect investors and the public interest.\11\ In
particular, the Commission finds that the proposed rule change is
consistent with the Exchange Act because it will prevent fraudulent and
manipulative acts and practices and protect investors and the public
interest. The Commission believes the proposal will help achieve a
broader distribution of municipal securities while still providing
sufficient flexibility to syndicate managers and sole underwriters, and
further believes that investors would benefit from a broader
distribution of securities that is fair and reasonable and consistent
with principles of fair dealing.
---------------------------------------------------------------------------

    \9\ In approving this proposed rule change, the Commission notes
that it has considered the proposed rule's impact on efficiency,
competition and capital formation. 15 U.S.C. 78c(f).
    \10\ 15 U.S.C. 78o-4(b)(2)(C).
    \11\ Id.

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

Discussion of Comment Letters

    The Commission received four comment letters in response to the
Commission's Notice. ICI supported the proposal. RBDA, SIFMA and Mr.
Melton expressed concerns about various aspects of the proposal.
    ICI stated that they believe the proposal would improve access to
new issues by investors and would help address uncertainty surrounding
Rule G-17. They also stated that the experience of their members has
demonstrated that industry practice over the previous year has allowed
for the regular disregard of previous MSRB guidance on priority of
orders. In addition, they stated that there is no reason to
disadvantage, or allow for the appearance of disadvantaging, retail
customers in primary offerings because the offering does not use a
syndicate.
    ICI urged the MSRB to consider defining ``retail'' for purposes of
``retail order periods'' in a way that recognizes that retail investors
access the municipal market through a variety of ways, including mutual
funds. ICI noted that retail investors are excluded from the retail
order periods if they choose to make their municipal bond investments
through mutual funds, and that these retail investors often are the
smaller or less sophisticated investors who do not have the necessary
assets to purchase bonds on their own.
    The MSRB stated that it appreciated the concerns expressed by ICI
regarding the pricing of bonds purchased by retail investors. The MSRB
indicated that it is aware of the substantial retail participation in
the municipal securities market that is accomplished through mutual
fund investments. Nevertheless, the MSRB stated that MSRB rules do not
require that primary offerings of municipal securities include retail
order periods, and that the MSRB considers it appropriate to leave that
decision and the decision of how ``retail'' is defined to issuers of
municipal securities. The Commission believes that leaving decisions
about retail order periods to the discretion of municipal issuers is
not inconsistent with the Exchange Act.
    RBDA supports the intent of the proposed amendments to the priority
provisions which generally would give express priority to customer
orders over orders by members of a syndicate or a sole underwriter for
their own or related accounts. Nonetheless, RBDA urges the MSRB to
permit syndicate managers and sole underwriters to refuse to prioritize
as a customer order any order that the syndicate manager or sole
underwriter reasonably believes to have been placed by an opportunistic
investor purchasing bonds with the expectation of reselling them at
higher prices shortly after the initial offering.
    The MSRB stated in response that the proposed rule change would
permit deviation from the priority provisions of amended Rule G-11 if
following the priority provisions was not consistent with the orderly
distribution of securities in the offering or, in the case of
syndicates, the syndicate manager determined that it was in the best
interests of the syndicate to deviate from the priority provisions. The
MSRB believes that, depending on the specific facts and circumstances,
a sole underwriter or syndicate manager could reasonably determine that
according priority to an order from a customer whom the sole
underwriter or syndicate manager reasonably believes would purchase
municipal securities with the expectation of selling them at higher
prices shortly thereafter might be an appropriate basis for departing
from the priority provisions consistent with the proposed rule change.
    RBDA was also concerned that the proposed amendment would require
records to be made of each instance in which the syndicate manager
accorded equal or greater priority over other orders to orders by
syndicate members for their own or related accounts, even if such
prioritization were in compliance with the priority provisions of Rule
G-11. The MSRB responded that in order for the proposed recordkeeping
rule to track the proposed amendment to Rule G-11 more closely,
Amendment No. 1 would amend the syndicate recordkeeping rule (Rule G-
8(a)(viii)(A)) to require records of: ``those instances in which the
syndicate manager allocated securities in a manner other than in
accordance with the priority provisions, including those instances in
which the syndicate manager accorded equal or greater priority over
other orders to orders by syndicate members for their own accounts or
their respective related accounts. * * *''
    In addition, RBDA was concerned that the proposal's requirement to
record the specific reasons why it was in the best interests of the
syndicate to make any such alternate allocations would be unnecessarily
perilous for syndicate managers. RBDA believes the amendment is unclear
about the amount of detail regarding these reasons that would be
necessary to record in order to satisfy the new requirements. RBDA also
states that the requirement for such qualitative analysis will create
an opportunity to second guess in hindsight the recorded judgment of
the syndicate manager.
    The MSRB responded that existing Rule G-11 already provides that,
in the event the syndicate manager allocates bonds other than in
accordance with the priority provisions of the syndicate, ``the
syndicate manager or managers shall have the burden of justifying that
such allocation was in the best interests of the syndicate.'' The MSRB
also stated that the proposed rule change does not change this
requirement; it merely requires the syndicate manager to keep a
contemporaneous record of such justification.
    The Commission believes the MSRB has adequately addressed RBDA's
concerns. The proposed rule change would permit deviation from the
priority provisions of amended Rule G-11 if following the priority
provisions was not consistent with the orderly distribution of
securities in the offering or, in the case of syndicates, the syndicate
manager determined that it was in the best interests of the syndicate
to deviate from the priority provisions. Amendment No. 1 should address
RBDA's duplicative recordkeeping concerns. And the Commission agrees
that the proposed rule change does not change the syndicate manager's
existing burden of justifying that such allocation was in the best
interests of the syndicate; rather, it merely requires the syndicate
manager to keep a contemporaneous record of such justification.
    SIFMA expressed concern that the intent of the proposed rule is
ambiguous. SIFMA infers that the MSRB's intent is, at least in part, to
prevent flipping. SIFMA stated that there are many reasons why orders
are not filled and that there are many ways securities can be sold at
higher prices in the secondary market that do not require regulatory
response. The MSRB stated in its response that its goal behind the
proposed rule change was to achieve a broader distribution of municipal
securities, and the proposed rule change was not directed at flipping.
    SIFMA suggested that helping to ensure that institutional
investors' orders are filled would be the antithesis of ``a broader
distribution of municipal securities.'' In addition, SIFMA stated that
the exceptions to the priority provisions contradict the claim that the
purpose of the proposal is to encourage a broader distribution of
municipal securities.
    The MSRB noted in its response that many institutional investors
serve as vehicles for individual investors to invest in municipal
securities, as explained in ICI's comment letter. The MSRB stated that,
as of September 2009, 20 percent of municipal securities were

held by mutual funds on behalf of retail investors. The MSRB stated
that these investors frequently are able to negotiate lower prices for
their customers and provide a means for individual investors to achieve
diversification without making large investments. The MSRB further
stated that the proposed rule change does not require that underwriters
accord non-underwriter dealers the same priority as customers; it
simply permits them to do so.
    The MSRB believes the allowance of some exceptions to the priority
provisions provides needed flexibility. The MSRB noted that the
proposed interpretation provides that it ``understands that syndicate
managers must balance a number of competing interests in allocating
securities in a primary offering and must be able quickly to determine
when it is appropriate to allocate away from the priority provisions,
to the extent consistent with the issuer's requirements.'' The
interpretation applies equally to sole underwriters. The need for such
flexibility does not contradict the purpose of achieving broader
distribution of municipal securities. The Commission agrees that the
proposal would help achieve a broader distribution of municipal
securities, while still allowing flexibility depending on various
market conditions.
    SIFMA also questioned whether the MSRB is authorized to determine
the preferred order of distributing securities. The MSRB stated in its
response that the MSRB is directed by Congress in section 15B of the
Exchange Act to write rules designed, among other things, ``to remove
impediments to and perfect the mechanism of a free and open market in
municipal securities, and, in general, to protect investors and the
public interest.'' The MSRB believes that broadening the distribution
of municipal securities to investors in the primary market, at what are
generally attendant lower prices than those available in the secondary
market, is clearly within that statutory purpose. The MSRB further
noted that Congressional concerns led to the provision of section 15B
of the Exchange Act, and support its view that broadening the
distribution of municipal securities falls within its statutory
purpose. The Commission agrees that the proposed rule falls within the
MSRB's statutory authority.
    SIFMA expressed concern that the proposed amendments contain
several different and possibly conflicting standards, and that newly
revised Rule G-11(e)(i) is confusing and contradictory. SIFMA suggested
that the proposed interpretive notice does not define what would
constitute ``the orderly distribution of securities,'' and that dealers
could have difficulty determining what ``is in the best interests of
the syndicate.'' The MSRB responded that the phrase ``orderly
distribution of new issue securities'' was used in the 1987
Interpretive Notice, which the proposed rule change would replace. The
MSRB recognizes that, while broad distribution of securities was a
concern of Congress when it enacted section 15B of the Exchange Act,
the underwriter must be free to exert some control over that process if
necessary to achieve a favorable result for the issuer. The MSRB
further stated that it was the MSRB's intent that the priority
provisions may be deviated from if it is in the best interests of the
syndicate to do so, and noted that the proposed interpretation contains
the same exception as is found in the proposed amendment to Rule G-11.
    SIFMA believes the proposed rule change would have a detrimental
effect on competition and borrowing costs and would not apply equally
to all dealers. SIFMA believes that the proposal would result in higher
borrowing costs for issuers and subordinate a very large group of
active municipal market investors to other investors because they are
affiliated with or related to the syndicate manager.
    The MSRB responded that the proposal would apply equally to all
dealers when they serve as underwriters. All underwriters would
continue to be able to place going-away orders (i.e., orders for which
customers are already conditionally committed) during the primary
offering that would be accorded priority under the proposal.\12\ The
MSRB stated that the proposed rule change incorporates the same
exceptions to the priority provisions that exist under current law. The
MSRB further stated that what the proposed rule change would do is to
require accountability of underwriters who deviated from the priority
provisions, because they would be required to keep records of their
reasons for doing so.\13\
---------------------------------------------------------------------------

    \12\ The MSRB stated that the fact that Rule G-14 requires that
such orders be reported to the MSRB's Real-Time Trade Reporting
System as interdealer orders will not cause such orders to be
treated as interdealer orders for purposes of the priority of orders
provisions of Rule G-11(e) and Rule G-17, as long as an equivalent
amount of customer orders for the same securities is reported under
Rule G-14 on the same day as the interdealer order is executed.
    \13\ The MSRB also notes that a ``municipal securities
investment trust'' is only a related account if sponsored by a
syndicate member, sole underwriter, or an affiliate of either. To be
a sponsor of such a trust a dealer or its affiliate must share in
the benefits and burdens of ownership of the municipal securities in
the trust. The provision of structuring, remarketing, or liquidity
services with respect to such a trust will not alone cause the trust
to be a related account of the dealer or affiliate providing such
services.
---------------------------------------------------------------------------

    SIFMA stated that the proposed interpretive notice is less
restrictive than the proposed rule amendments. SIFMA said that the
greater flexibility of the proposed interpretive notice is the result
of the word ``generally,'' which was included to indicate that the
principles of fair dealing contained in Rule G-17 provide guidance that
must take into account all of the circumstances surrounding an
allocation of securities in a primary offering and do not compel giving
priority to customers' orders. SIFMA stated that the interpretive
notice is also more flexible than the proposed rule for sole
underwriters who are not part of a syndicate. The MSRB responded that
there was no intent to make the proposed interpretation less rigorous
than the proposed amendment to Rule G-11. For the avoidance of doubt,
Amendment No. 1 would slightly revise the proposed interpretation.
    The Commission believes the MSRB has adequately addressed SIFMA's
concerns about the purpose of the proposal, the application of the
proposal's requirements, its impact on competition and borrowing costs
and the MSRB's statutory authority. Amendment No. 1 should clarify that
the interpretive notice is not inconsistent with the rule.
    Mr. Melton states that the intent of the MSRB is to restrict
activity that many see as free riding in new issue municipal offerings.
He suggests that the proposal should be re-drafted to allow
underwriters the flexibility to identify flippers and treat those
orders as dealer orders rather than affording flippers customer status.
He is also of the view that the ``best interests of the syndicate''
exception would require unnecessary effort and not provide assurance
that an underwriter could protect itself against allegations of rule
violations in new issue allocations. Mr. Melton suggested that clear
language should be drafted that allows an underwriter to identify
flippers and prioritize flipper orders accordingly.
    The MSRB responded that the MSRB considers it consistent with the
permitted exceptions from the priority provisions for a sole
underwriter or syndicate manager to refuse to accord priority to an
order from a customer whom the sole underwriter or syndicate manager
reasonably believes would purchase municipal securities with the

expectation of selling them at higher prices shortly thereafter.
Furthermore, the MSRB stated that the proposed rule change incorporates
the same exceptions to the priority provisions that exist under current
law, and that what the proposed rule change would do is to require
accountability of underwriters who deviated from the priority
provisions, because they would be required to keep records of why they
did so. The Commission believes the MSRB's explanation of the
application of the proposal adequately addresses Mr. Melton's concerns.
With regard to all other issues raised by the commenters, the
Commission believes that the MSRB has adequately addressed the
commenters' concerns.

IV. Order Granting Accelerated Approval of Proposed Rule Change

    Pursuant to Section 19(b)(2) of the Exchange Act,\14\ the
Commission may not approve any proposed rule change, or amendment
thereto, prior to the 30th day after the date of publication of notice
of the filing thereof, unless the Commission finds good cause for so
doing and publishes its reasons for so finding. The MSRB requests that
the Commission find good cause, pursuant to Section 19(b)(2) of the
Exchange Act, for approving Amendment No. 1 prior to the thirtieth day
after publication of notice of filing of Amendment No. 1 in the Federal
Register. The MSRB believes that the Commission has good cause for
granting accelerated approval of the proposed rule change because the
revisions made by Amendment No. 1 are technical amendments that do not
significantly alter the substance of the original proposed rule change,
are consistent with the purpose of the original proposed rule change,
and do not raise significant new issues. The Commission hereby finds
good cause for approving the proposed rule change, as modified by
Amendment No. 1, before the 30th day after the date of publication of
notice of filing thereof in the Federal Register. The Commission notes
that the original proposed rule change was published in the Federal
Register on December 10, 2009. The Commission does not believe that
Amendment No. 1 significantly alters the proposal. In Amendment No. 1,
the MSRB made technical revisions in response to comments. The
Commission believes that Amendment No. 1 is consistent with the
proposal's purpose and raises no new significant issues. Accordingly,
pursuant to Section 19(b)(2) of the Exchange Act,\15\ the Commission
finds good cause to approve the proposed rule change, as amended, on an
accelerated basis.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(2).
    \15\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

V. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change, as amended, is consistent with the Exchange 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-MSRB-2009-17 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MSRB-2009-17. 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 Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the MSRB. 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-MSRB-2009-17 and should be
submitted on or before September 8, 2010.

VI. Conclusion

    For the foregoing reasons, the Commission finds that the proposed
rule change, as amended, is consistent with the Exchange Act and the
rules and regulations thereunder applicable to the MSRB\16\ and, in
particular, the requirements of Section 15B(b)(2)(C) of the Exchange
Act\17\ and the rules and regulations thereunder. The proposal will
become effective for new issues of municipal securities for which the
Time of Formal Award (as defined in Rule G-34(a)(ii)(C)(1)(a)) occurs
more than 60 days after approval of the proposed rule change by the
SEC, as requested by the MSRB.
---------------------------------------------------------------------------

    \16\ In approving this proposed rule change, the Commission
notes that it has considered the proposed rule's impact on
efficiency, competition and capital formation. 15 U.S.C. 78c(f).
    \17\ 15 U.S.C. 78o-4(b)(2)(C).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Exchange Act,\18\ that the proposed rule change (SR-MSRB-2010-17), as
amended, be, and it hereby is, approved on an accelerated basis.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-20467 Filed 8-17-10; 8:45 am]
BILLING CODE 8010-01-P


[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Notices]
[Pages 41993-41995]
[FR Doc No: 2020-14996]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-0359]

Cancer Clinical Trial Eligibility Criteria: Patients With Organ
Dysfunction or Prior or Concurrent Malignancies; Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Cancer
Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or
Prior or Concurrent Malignancies.'' This guidance is one in a series of
guidances that provide recommendations regarding eligibility criteria
for clinical trials of drugs or biological products regulated by the
Center for Drug Evaluation and Research (CDER) and the Center for
Biologics Evaluation and Research (CBER) for the treatment of cancer.
Specifically, this guidance includes recommendations on the inclusion
of patients with organ dysfunction or with prior or concurrent
malignancies. This guidance finalizes the draft guidance of the same
title that published on March 13, 2019.

DATES: The announcement of the guidance is published in the Federal
Register on July 13, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-0359 for ``Cancer Clinical Trial Eligibility Criteria:
Patients with Organ Dysfunction or Prior or Concurrent Malignancies.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    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, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Julia Beaver, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2100, Silver Spring, MD 20993-0002, 240-
402-0489; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Cancer Clinical Trial Eligibility Criteria: Patients with
Organ Dysfunction or Prior or Concurrent Malignancies.'' This guidance
provides recommendations on the inclusion of patients with organ
dysfunction or prior or concurrent malignancies in clinical trials of
drugs or biological products regulated by CDER and CBER for the
treatment of cancer.
    A clinical trial's eligibility criteria (for inclusion and
exclusion) are essential components of the trial, defining the
characteristics of the study population. Because there is variability
in investigational drugs and trial objectives, eligibility criteria
should be developed taking into consideration the mechanism of action
of the drug, the targeted disease or patient population, the
anticipated safety of the investigational drug, the availability of
adequate safety data, and the ability to recruit trial participants
from the patient population to meet the objectives of the clinical
trial. However, some eligibility criteria have become commonly accepted
over time or used as a template across trials without clear scientific
or clinical rationale. Unnecessarily restrictive eligibility criteria
may slow patient accrual, limit patients' access to clinical trials,
and lead to trial results that do not fully represent treatment effects
in the patient population that will ultimately use the drug. Broadening
cancer trial eligibility criteria can maximize the generalizability of
trial results and the ability to understand the therapy's benefit-risk
profile across the patient population likely to use the drug in
clinical practice and should be considered to avoid jeopardizing
patient safety.
    The recommendations in this guidance for clinical trial eligibility
criteria for patients with organ dysfunction focus on renal function,
cardiac function, and hepatic function. This guidance also includes
recommendations for eligibility criteria for patients with cancer who
have prior or concurrent malignancies.
    In the Federal Register of March 13, 2019 (84 FR 9129), FDA
announced the

availability of the draft guidance of the same title. FDA received
comments and considered those comments as the guidance was finalized.
The final guidance clarifies the recommendations regarding eligibility
criteria related to renal function, cardiac function, and hepatic
function. For example, recommendations regarding the equation used to
assess renal function for eligibility were clarified and
recommendations regarding population pharmacokinetic analyses of
patients with renal impairment were added. In addition, recommendations
regarding QTc prolongation were clarified and the recommendation on
patients with asymptomatic elevations in unconjugated bilirubin was
removed because it is out of the scope of organ dysfunction.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Cancer Clinical Trial Eligibility
Criteria: Patients with Organ Dysfunction or Prior or Concurrent
Malignancies.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved FDA collections of
information. 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. 3501-3521). The collections of information in 21
CFR part 312 have been approved under OMB control number 0910-0014; the
collections of information in 21 CFR 201.56 and 201.57 have been
approved under OMB control number 0910-0572.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: July 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-14996 Filed 7-10-20; 8:45 am]
BILLING CODE 4164-01-P


            UNITED STATES OF AMERICA

    DEPARTMENT OF TRANSPORTATION

            OFFICE OF THE SECRETARY

                     WASHINGTON, DC

U.S.-BRAZIL COMBINATION FREQUENCIES

(Atlanta-Rio de Janeiro)

Docket OST-2004-19161

									          Served:  January 10, 2005

NOTICE SHORTENING ANSWER PERIOD

On January 7, 2005, Delta Air Lines, Inc. (Delta) filed a motion in the
above captioned docket requesting that the Department (1) act
immediately on its application filed September 1, 2004, for allocation
of seven U.S.-Brazil frequencies for Atlanta-Rio de Janeiro service and

(2) shorten the answer period to the motion and require answers to be
filed no later than noon, January 11, 2005, to permit final action by
January 14, 2005.

On January 10, Delta advised the Department that there were no
objections to a shortened answer date of 5:00 p.m. January 11.

Under these circumstances we will shorten the answer period to 5:00 p.m.
January 11.  Acting under authority assigned in 14 CFR 385.13, answers
to Delta’s January 7 motion will now be due no later than 5:00 p.m.
January 11.

We will serve this notice by email or facsimile on all parties served
with the motion.  We authorize answers to be served by facsimile or
email.

By:

						PAUL L. GRETCH

						Director, Office of International Aviation

(SEAL)

Dated: January 10, 2005

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

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

 Under the Department’s regulations (14 CFR 302.11), answers to the
motion would be due January 19, 2005.