[Federal Register: March 1, 2006 (Volume 71, Number 40)]
[Notices]
[Page 10557-10565]
[DOCID:fr01mr06-115]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[V-04-1]

Commonwealth Dynamics, Inc., Mid-Atlantic Boiler & Chimney,
Inc.,\1\ and R and P Industrial Chimney Co., Inc.; Grant of a Permanent
Variance
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    \1\ Designated as Alberici Mid-Atlantic, LLC (``Alberici'') on
the notice of an application for a permanent variance and interim
order published at 69 FR 48754. Mid-Atlantic Boiler & Chimney, Inc.
(``MAB&C'') has acquired Alberici's chimney-construction assets,
including equipment, contracts, and employees. Prior to this
acquisition, Alberici notified employees who were being transferred
to MAB&C that it has requested OSHA to transfer its interest in the
variance application and interim order to MAB&C. In addition, an
authorized representative for MAB&C certified that MAB&C agrees to
comply with the grant of an interim order published at 69 FR 48754,
and to comply with the conditions of the variance grant resulting
from the variance application. (See Ex. 5-19.)
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AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.

ACTION: Notice of a grant of a permanent variance.

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SUMMARY: This notice announces the grant of a permanent variance to
Commonwealth Dynamics, Inc., Mid-Atlantic Boiler & Chimney, Inc., and R
and P Industrial Chimney Co., Inc. (``the employers''). The permanent
variance addresses the provision that regulates the tackle used for
boatswains' chairs (29 CFR 1926.452 (o)(3)), as well as the provisions
specified for personnel hoists by paragraphs (c)(1) through (c)(4),
(c)(8), (c)(13), (c)(14)(i), and (c)(16) of 29 CFR 1926.552. Instead of
complying with these provisions, the employers must comply with a
number of alternative conditions listed in this grant; these
alternative conditions regulate rope-guided personnel-hoisting systems
used during inside or outside chimney construction to raise or lower
employees in personnel cages, personnel platforms, and boatswains'
chairs between the bottom landing of a chimney and an elevated work
location. Accordingly, OSHA finds that these alternative conditions
protect employees at least as well as the requirements specified by 29
CFR 1926.452(o)(3) and 1926.552(c)(1) through (c)(4), (c)(8), (c)(13),
(c)(14)(i), and (c)(16).

DATES: The effective date of the permanent variance is March 1, 2006.

FOR FURTHER INFORMATION: For information about this notice contact Ms.
MaryAnn S. Garrahan, Director, Office of Technical Programs and
Coordination Activities, Room N-3655, OSHA, U.S. Department of Labor,
200 Constitution Avenue, NW., Washington, DC 20210; telephone (202)
693-2110; fax<PHONE_NUMBER>. You may obtain additional copies of this
notice from the Office of Publications, Room N-3101, OSHA, U.S.
Department of Labor, 200 Constitution Avenue, NW., Washington, DC
20210; telephone<PHONE_NUMBER>. For electronic copies of this notice,
contact the Agency on its Web page at http://ww.osha.gov, and select

``Federal Register,'' ``Date of Publication,'' and then ``2005.''
    Additional information also is available from the following OSHA
Regional Offices:

U.S. Department of Labor, OSHA, JFK Federal Building, Room E340,
Boston, MA 02203, telephone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>.
U.S. Department of Labor, OSHA, 201 Varick St., Room 670, New York, NY
10014, telephone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>.
U.S. Department of Labor, OSHA, the Curtis Center, Suite 740 West, 170
South Independence Mall West, Philadelphia, PA 19106-3309, telephone:
(215) 861-4900, fax:<PHONE_NUMBER>.
U.S. Department of Labor, OSHA, Atlanta Federal Center, 61 Forsyth St.,
SW., Room 6T50, Atlanta, GA 30303, telephone:<PHONE_NUMBER>, fax:
(404) 562-2295.
U.S. Department of Labor, OSHA, 230 South Dearborn St., Room 3244,
Chicago, IL 60604, telephone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>.
U.S. Department of Labor, OSHA, City Center Square, 1100 Main St.,
Suite 800, Kansas City, MO 64105, telephone:<PHONE_NUMBER>, fax: (816)
426-2750.
U.S. Department of Labor, OSHA, 525 Griffin St., Room 602, Dallas, TX
75202, telephone:<PHONE_NUMBER>/-4736 (ext. 224), fax:<PHONE_NUMBER>/
-4188.
U.S. Department of Labor, OSHA, 1999 Broadway, Suite 1690, P.O. Box
46550, Denver, CO 80201-6550, telephone:<PHONE_NUMBER>, fax: (720)
264-6585.
U.S. Department of Labor, OSHA, 71 Stevenson St., Room 420, San
Francisco, CA 94105, telephone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>.
U.S. Department of Labor, OSHA, 1111 Third Ave., Suite 715, Seattle, WA
98101-3212, telephone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the past 30 years, a number of chimney-construction companies
have demonstrated to OSHA that several personnel-hoist requirements
(i.e., paragraphs (c)(1), (c)(2), (c)(3), (c)(4), (c)(8), (c)(13),
(c)(14)(i), and (c)(16) of 29 CFR 1926.552), as well as the tackle
requirements for boatswains' chairs (i.e., paragraph (o)(3) of 29 CFR
1926.452), result in access problems that pose a serious danger to
their employees. These companies requested permanent variances from
these requirements, and proposed alternative equipment and procedures
to protect employees while being transported to and from their elevated
worksites during chimney construction and repair. The Agency
subsequently granted these companies permanent variances based on the
proposed alternatives (see 38 FR 8545 (April 3, 1973), 44 FR 51352
(August 31, 1979), 50 FR 40627 (October 4, 1985), 52 FR 22552 (June 12,
1987), and 68 FR 52961 (September 8, 2003)).\2\
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    \2\ Zurn Industries, Inc. received two permanent variances from
OSHA. The first variance, granted on May 14, 1985 (50 FR 20145),
addressed the boatswains'-chair provision (then in paragaph (l)(5)
of 29 CFR 1926.451), as well as the hoist-platform requirements of
paragraphs (c)(1), (c)(2), (c)(3), and (c)(14)(i) of 29 CFR
1926.552. The second variance, granted on June 12, 1987 (52 FR
22552), includes these same paragraphs, as well as paragraphs
(c)(4), (c)(8), (c)(13), and (c)(16) of 29 CFR 1926.552.
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    On October 27, 2003, January 20, 2004, and March 16, 2004,
Commonwealth Dynamics, Inc., R and P Industrial Chimney Co., Inc., and
Mid-Atlantic Boiler & Chimney, Inc., respectively, applied for a
permanent variance from the same personnel-hoist and boatswains'-chair
requirements as the previous companies, and proposed as an alternative
to these requirements the same equipment and procedures approved by
OSHA in the earlier variances. The Agency published their variance
application in the Federal Register on August 10, 2004 (69 FR 48754).
OSHA received no hearing requests in response to these Federal Register
notices. However, a private individual and a number of States and
Territories having OSHA-approved safety and health programs (``State-
Plan States and Territories'') submitted comments on the proposed
alternative. In addition, several other State-Plan States and
Territories have commented on an earlier variance application involving
the same standards submitted by other employers engaged in chimney
construction and repair;\3\ OSHA is relying on these previous comments
to determine the position of these State-Plan States and Territories on
the variance application submitted by the present employers. (See
sections IV (``Comments on the Proposed Variance'') and V (``Multi-
State Variance'') below for a discussion of these comments.)
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    \3\ The previous variance application was from American Boiler
and Chimney Co. and Oak Park Chimney Corp. (68 FR 52961, September
8, 2003).
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    Commonwealth Dynamics, Inc., Mid-Atlantic Boiler & Chimney, Inc.,
and R and P Industrial Chimney Co., Inc. (``the employers'') construct,
remodel, repair, maintain, inspect, and demolish tall chimneys made of
reinforced concrete, brick, and steel. This work, which occurs
throughout the United States, requires the employers to transport
employees and construction material to and from elevated work platforms
and scaffolds located, respectively, inside and outside tapered
chimneys. While tapering contributes to the stability of a chimney, it
necessitates frequent relocation of, and adjustments to, the

work platforms and scaffolds so that they will fit the decreasing
circumference of the chimney as construction progresses upwards.
    To transport employees to various heights inside and outside a
chimney, the employers proposed in their variance application to use a
hoist system that lifts and lowers personnel-transport devices that
include personnel cages, personnel platforms, or boatswains' chairs. In
this regard, the employers proposed to use personnel cages, personnel
platforms, or boatswains' chairs solely to transport employees with the
tools and materials necessary to do their work, and not to transport
only materials or tools on these devices in the absence of employees.
In addition, the employers proposed to attach a hopper or concrete
bucket to the hoist system to raise or lower material inside or outside
a chimney.
    The employers also proposed to use a hoist engine, located and
controlled outside the chimney, to power the hoist system. The proposed
system consisted of a wire rope that: spools off the winding drum (also
known as the hoist drum or rope drum) into the interior of the chimney;
passes to a footblock that redirects the rope from the horizontal to
the vertical planes; goes from the footblock through the overhead
sheaves above the elevated platform; and finally drops to the bottom
landing of the chimney where it connects to a personnel- or material-
transport device. The cathead, which is a superstructure at the top of
a derrick, supports the overhead sheaves. The overhead sheaves (and the
vertical span of the hoist system) move upward with the derrick as
chimney construction progresses. Two guide cables, suspended from the
cathead, eliminate swaying and rotation of the load. If the hoist rope
breaks, safety clamps activate and grip the guide cables to prevent the
load from falling. The employers proposed to use a headache ball,
located on the hoist rope directly above the load, to counterbalance
the rope's weight between the cathead sheaves and the footblock.
    Additional conditions that the employers proposed to follow to
improve employee safety included:
     Attaching the wire rope to the personnel cage using a
keyed-screwpin shackle or positive-locking link;
     Adding limit switches to the hoist system to prevent
overtravel by the personnel-or material-transport devices;
     Providing the safety factors and other precautions
required for personnel hoists specified by the pertinent provisions of
29 CFR 1926.552(c), including canopies and shields to protect employees
located in a personnel cage from material that may fall during hoisting
and other overhead activities;
     Providing falling-object protection for scaffold platforms
as specified by 29 CFR 1926.451(h)(1);
     Conducting tests and inspections of the hoist system as
required by 29 CFR 1926.20(b)(2) and 1926.552(c)(15);
     Establishing an accident-prevention program that conforms
to 29 CFR 1926.20(b)(3);
     Ensuring that employees who use a personnel platform or
boatswains' chair wear full-body harnesses and lanyards, and that the
lanyards are attached to the lifelines during the entire period of
vertical transit; and
     Securing the lifelines (used with a personnel platform or
boatswains' chair) to the rigging at the top of the chimney and to a
weight at the bottom of the chimney to provide maximum stability to the
lifelines.

II. Proposed Variance From 29 CFR 1926.452(o)(3)

    The employers noted in their variance request that it is necessary,
on occasion, to use a boatswains' chair to transport employees to and
from a bracket scaffold on the outside of an existing chimney during
flue installation or repair work, or to transport them to and from an
elevated scaffold located inside a chimney that has a small or tapering
diameter. Paragraph (o)(3) of 29 CFR 1926.452, which regulates the
tackle used to rig a boatswains' chair, states that this tackle must
``consist of correct size ball bearings or bushed blocks containing
safety hooks and properly 'eye-spliced' minimum five-eighth (5/8) inch
diameter first-grade manila rope [or equivalent rope].''
    The primary purpose of this paragraph is to allow an employee to
safely control the ascent, descent, and stopping locations of the
boatswains' chair. However, the employers stated in their variance
request that, because of space limitations, the required tackle is
difficult or impossible to operate on some chimneys that are over 200
feet tall. Therefore, as an alternative to complying with the tackle
requirements specified by 29 CFR 1926.452(o)(3), the employers proposed
to use the hoisting system described above in section I
(``Background'') of this notice to raise or lower employees in a
personnel cage to work locations both inside and outside a chimney. In
addition, the employers proposed to use a personnel cage for this
purpose to the extent that adequate space is available, and to use a
personnel platform when using a personnel cage was infeasible because
of limited space. When available space makes using a personnel platform
infeasible, the employers proposed to use a boatswains' chair to lift
employees to work locations. The proposed variance limited use of the
boatswains' chair to elevations above the last work location that the
personnel platform can reach; under these conditions, the employers
proposed to attach the boatswains' chair directly to the hoisting cable
only when the structural arrangement precludes the safe use of the
block and tackle required by 29 CFR 1926.452(o)(3).

III. Proposed Variance from 29 CFR 1926.552(c)

    Paragraph (c) of 29 CFR 1926.552 specifies the requirements for
enclosed hoisting systems used to transport employees from one
elevation to another. This paragraph ensures that employers transport
employees safely to and from elevated work platforms by mechanical
means during the construction, alteration, repair, maintenance, or
demolition of structures such as chimneys. However, this standard does
not provide specific safety requirements for hoisting employees to and
from elevated work platforms and scaffolds in tapered chimneys; the
tapered design requires frequent relocation of, and adjustment to, the
work platforms and scaffolds. The space in a small-diameter or tapered
chimney is not large enough or configured so that it can accommodate an
enclosed hoist tower. Moreover, using an enclosed hoist tower for
outside operations exposes employees to additional fall hazards because
they need to install extra bridging and bracing to support a walkway
between the hoist tower and the tapered chimney.
    Paragraph (c)(1) of 29 CFR 1926.552 requires the employers to
enclose hoist towers located outside a chimney on the side or sides
used for entrance to, and exit from, the chimney; these enclosures must
extend the full height of the hoist tower. The employers asserted in
their proposed variance that it is impractical and hazardous to locate
a hoist tower outside tapered chimneys because it becomes increasingly
difficult, as a chimney rises, to erect, guy, and brace a hoist tower;
under these conditions, access from the hoist tower to the chimney or
to the movable scaffolds used in constructing the chimney exposes
employees to a serious fall hazard. Additionally, they noted that the
requirement to extend the enclosures 10 feet above the outside
scaffolds often exposes the employees

involved in building these extensions to dangerous wind conditions.
    Paragraph (c)(2) of 29 CFR 1926.552 requires that employers enclose
all four sides of a hoist tower even when the tower is located inside a
chimney; the enclosure must extend the full height of the tower. In the
proposed variance, the employers contended that it is hazardous for
employees to erect and brace a hoist tower inside a chimney, especially
small-diameter or tapered chimneys or chimneys with sublevels, because
these structures have limited space and cannot accommodate hoist
towers; space limitations result from chimney design (e.g., tapering),
as well as reinforced steel projecting into the chimney from formwork
that is near the work location.
    As an alternative to complying with the hoist-tower requirements of
29 CFR 1926.552(c)(1) and (c)(2), the employers proposed to use the
rope-guided hoist system discussed in section I (``Background'') of
this notice to transport employees to and from work locations inside
and outside chimneys. They claimed that this hoist system would make it
unnecessary for them to comply with other provisions of 29 CFR
1926.552(c) that specify requirements for hoist towers, including:
     (c)(3)--Anchoring the hoist tower to a structure;
     (c)(4)--Hoistway doors or gates;
     (c)(8)--Electrically interlocking entrance doors or gates
that prevent hoist movement when the doors or gates are open;
     (c)(13)--Emergency stop switch located in the car;
     (c)(14)(i)--Using a minimum of two wire ropes for drum-
type hoisting; and
     (c)(16)--Construction specifications for personnel hoists,
including materials, assembly, structural integrity, and safety
devices.
    The employers asserted that the proposed hoisting system protected
employees at least as effectively as the personnel-hoist requirements
of 29 CFR 1926.552(c). The following section of this preamble reviews
the comments received on the employers' proposed variance.

IV. Comments on the Proposed Variance

    The only comment from the private sector regarding the proposed
variance was submitted by Mr. Bradley Glosson of MACB Technical
Services (Ex. 4-1). Mr. Glosson recommended adopting American National
Safety Standard ASME B30.23 (``Personnel Lifting Systems''), stating:

    Any variance approved should be based upon a uniform, nationally
endorsed and professionally established set of criteria for the safe
design and operational issues. Review and consideration of the B30.3
Standard, and the President[i]al Order to use existing National
Standards wherever feasible, should be undertaken prior to issuance
of this variance.

    In response to this comment, the Agency notes that the employer
seeking a permanent variance proposes the alternative conditions in the
variance request. The Agency's responsibility under section (6)(d) of
the Occupational Safety and Health Act of 1970 is to determine ``by a
preponderance of the evidence that the conditions, practices, means,
methods, operations, or processes used or proposed to be used * * *
will provide employment and places of employment to [their] employees
which are as safe and healthful as those which would prevail if [they]
complied with the standard.'' (See 29 U.S.C. 655.) Therefore,
employers, not the Agency, determine what will be proposed as an
alternative to an OSHA standard.
    The ``Presidential Order'' to which Mr. Glosson refers is most
likely Office of Management and Budget (OMB) Circular A-119 (``Federal
Participation in the Development and Use of Voluntary Consensus
Standards and in Conformity Assessment Activities''), the most recent
edition of which was published by OMB on August 19, 2002. The Circular
does not refer to variances. Variances are applied narrowly (only to
the employers that request them) and typically involve only a few
provisions of a standard. As explained above, OSHA's obligation to
issue variances is set forth in Section 6(d) of the OSH Act; the
granting of these permanent variances is in accord with OSHA's
statutory responsibilities.
    OSHA also received comments from 17 of the 26 States and
Territories that operate occupational safety and health State plans
approved under section 18 of the Occupational Safety and Health Act of
1970 (i.e., ``State-Plan States''; 29 U.S.C. 667). The Agency received
these 17 comments after it sent each of these 26 States and Territories
a copy of the application and requested that they provide information
on whether their standards (the ones that would be affected by the
proposed variance) were identical to the corresponding Federal OSHA
standards, and, if so, did they agree to accept the alternative
conditions proposed by the employers.
    None of the 17 State-Plan States and Territories that submitted
comments provided substantive remarks regarding the conditions proposed
in the variance application. Ten of these 17 State-Plan States and
Territories reported that they have standards that are identical to the
Federal OSHA standards, and that they agreed to accept the proposed
alternative. These 10 State-Plan States and one Territory are: Arizona,
Indiana, Maryland, Minnesota, North Carolina, Oregon, Puerto Rico,
Tennessee, Virginia, and Wyoming (Exs. 5-1, 5-3-1, 5-16, 5-14, , 5-11,
5-10, 5-9, 5-7, 5-6, and 5-5, respectively). Three of the State-Plan
States (Kentucky, Michigan, and South Carolina) agreed with the
proposed alternative, but did so conditionally. Kentucky (Ex. 5-4)
noted that, while it agreed with the terms of the variance, Kentucky
statutory law requires affected employers to apply to the State for a
State variance. Michigan (Ex. 5-15) agreed to the alternative
conditions, but noted that its standards are not identical to the OSHA
standards covered by the variance application. Therefore, Michigan
cautioned that employers electing to use the variance in that State
must comply with several provisions in the Michigan standards that are
not addressed in the OSHA standard. South Carolina (Ex. 5-8) indicated
that it would accept the alternative conditions, but noted that, for
the grant of such a variance to be accepted by the South Carolina
Commissioner of Labor, the employers must file the grant at the
Commissioner's office in Columbia, South Carolina.
    Three State-Plan States (Connecticut (Ex. 5-2), New Jersey (Ex. 5-
13), and New York (Ex. 5-12)) have OSHA-approved safety and health
programs that cover only public-sector (i.e., State and local
government) employment. While OSHA received no comment from the Virgin
Islands, its State-Plan program also covers only public-sector
employment. Therefore, in these State-Plan States and one Territory,
the authority to cover private-sector employers under the variance
continues to reside with Federal OSHA.
    Washington State (Ex. 5-17) could not agree to the alternative
conditions because its applicable standards were not identical to the
OSHA standards. Therefore, the employers must apply separately for a
permanent variance from Washington State.
    In response to a previous application by chimney-construction
companies for an identical variance (see footnote 3), four State-Plan
States (Alaska, Nevada, New Mexico, and Vermont) indicated that their
standards were the same as the Federal OSHA standards, and agreed to
the terms of the variance. Utah agreed to accept the Federal variance,
but requires the employers to contact the Occupational Safety and
Health Division, Labor Commission of Utah,

regarding a procedural formality that must be completed before
implementing the variance in that State. California, Iowa, and Hawaii
have standards that either differ from the Federal standards or did not
agree to the alternative conditions proposed in the variance
application, and would not permit the employers to implement in their
States any variance resulting from the application without further
application to the State.

V. Multi-State Variance

    The variance application stated that the employers perform chimney
work in a number of geographic locations in the United States, some of
which could include locations in one or more of the States and
Territories that operate OSHA-approved safety and health programs under
section 18 of the Occupational Safety and Health Act of 1970 (``State-
Plan States and Territories''; see 29 U.S.C. 651 et seq.). State-Plan
States and Territories have primary enforcement responsibility over the
work performed in those States and Territories. Under the provisions of
29 CFR 1952.9 (``Variances affecting multi-state employers'') and 29
CFR 1905.14(b)(3) (``Actions on applications''), a permanent variance
granted by the Agency becomes effective in State-Plan States and
Territories as an authoritative interpretation of the applicants'
compliance obligation when: (1) The relevant standards are the same as
the Federal OSHA standards from which the applicants are seeking the
permanent variance; and (2) the State-Plan State or Territory does not
object to the terms of variance application.
    OSHA requested comments on this application from each of the State-
Plan States and Territories. The Agency noted in its request that,
absent any comment, it would assume that the State or Territory's
position regarding this variance application was the same as the
position it took on a previous variance application (see footnote 3).
As noted under the previous section, several State-Plan States and
Territories did not submit comments on this variance application,
indicating that they continue to maintain their previous positions
regarding the alternative conditions proposed under this variance
application. The following paragraph provides a summary of the
positions taken by the State-Plan States and Territories on the
proposed alternative conditions.
    The following thirteen State-Plan States and one Territory have
identical standards and agreed to accept the alternative conditions:
Alaska, Arizona, Indiana, Maryland, Minnesota, Nevada, New Mexico,
North Carolina, Oregon, Puerto Rico, Tennessee, Vermont, Virginia, and
Wyoming. Of the remaining 12 States and Territories with OSHA-approved
State plans, three of the States and one Territory (Connecticut, New
Jersey, New York, and the Virgin Islands) cover only public-sector
employees and have no authority over the private-sector employees
addressed in the variance application (i.e., that authority continues
to reside with Federal OSHA). Additionally, four States (Kentucky,
Michigan, South Carolina, and Utah) accepted the proposed alternative
when specific additional requirements are fulfilled, while three States
and one Territory (California, Hawaii, Iowa, and Washington) either had
different requirements in their standards or declined to accept the
terms of the variance.
    Based on the responses received from State-Plan States and
Territories, the permanent Federal OSHA variance will be effective in
the following State-Plan States and one Territory: Alaska, Arizona,
Indiana, Maryland, Minnesota, Nevada, New Mexico, North Carolina,
Oregon, Puerto Rico, Tennessee, Virginia, Vermont, and Wyoming; and in
Kentucky, Michigan, South Carolina, and Utah when the employers meet
specific additional requirements. However, this permanent variance does
not apply in Washington, California, Hawaii, or Iowa. As stated
earlier, in the three States and one Territory (Connecticut, New
Jersey, New York, and the Virgin Islands) that have State-Plan programs
that cover only public-sector employees, authority over the employers
under the permanent variance continues to reside with Federal OSHA.

VI. Decision

    Commonwealth Dynamics, Inc., Mid-Atlantic Boiler & Chimney, Inc.,
and R and P Industrial Chimney Co., Inc. seek a permanent variance from
the provision that regulates the tackle used for boatswains' chairs (29
CFR 1926.452 (o)(3)), as well as the provisions specified for personnel
hoists by paragraphs (c)(1) through (c)(4), (c)(8), (c)(13),
(c)(14)(i), and (c)(16) of 29 CFR 1926.552. Paragraph (o)(3) of 29 CFR
1926.452 states that the tackle used for boatswains' chairs must
``consist of correct size ball bearings or bushed blocks containing
safety hooks and properly `eye-spliced' minimum five-eighth (\5/8\)
inch diameter first-grade manila rope [or equivalent rope].'' The
primary purpose of this provision is to allow an employee to safely
control the ascent, descent, and stopping locations of the boatswains'
chair. The proposed alternative to these requirements allows the
employer to use a boatswains' chair to lift employees to work locations
inside and outside a chimney when both a personnel cage and a personnel
platform are infeasible. The employers proposed to attach the
boatswains' chair to the hoisting system described as an alternative
for paragraph (c) of 29 CFR 1926.552.
    Paragraph (c) of 29 CFR 1926.552 specifies the requirements for
enclosed hoisting systems used to transport personnel from one
elevation to another. This paragraph ensures that employers transport
employees safely to and from elevated work platforms by mechanical
means during construction work involving structures such as chimneys.
In this regard, paragraph (c)(1) of 29 CFR 1926.552 requires employers
to enclose hoist towers located outside a chimney on the side or sides
used for entrance to, and exit from, the structure; these enclosures
must extend the full height of the hoist tower. Under the requirements
of paragraph (c)(2) of 29 CFR 1926.552, employers must enclose all four
sides of a hoist tower located inside a chimney; these enclosures also
must extend the full height of the tower.
    As an alternative to complying with the hoist-tower requirements of
29 CFR 1926.552(c)(1) and (c)(2), the employers proposed to use a rope-
guided hoist system to transport employees to and from elevated work
locations inside and outside chimneys. The proposed hoist system
includes a hoist machine, cage, safety cables, and safety measures such
as limit switches to prevent overrun of the cage at the top and bottom
landings, and safety clamps that grip the safety cables if the main
hoist line fails. To transport employees to and from elevated work
locations, the employers proposed to attach a personnel cage to the
hoist system. However, when they can demonstrate that adequate space is
not available for the cage, they may use a personnel platform above the
last worksite that the cage can reach. Further, when the employers show
that space limitations make it infeasible to use a work platform for
transporting employees, they have proposed to use a boatswains' chair
above the last worksite serviced by the personnel platform. Using the
proposed hoist system as an alternative to the hoist-tower requirements
of 29 CFR 1926.552(c)(1) and (c)(2) eliminates the need to comply with
the other provisions of 29 CFR 1926.552(c) that specify requirements
for hoist towers.
    Accordingly, the employers have requested a permanent variance from
these and related provisions (i.e.,

paragraphs (c)(3), (c)(4), (c)(8), (c)(13), (c)(14)(i), and (c)(16)).
    After reviewing the variance application, as well as the comments
made to the record regarding the application, OSHA has made only minor
editorial amendments and technical corrections to the proposed
variance.\4\ Therefore, under section 6(d) of the Occupational Safety
and Health Act of 1970 (29 U.S.C. 655), and based on the record
discussed above, the Agency finds that when the employers comply with
the conditions of the following order, their employees will be exposed
to working conditions that are at least as safe and healthful as they
would be if the employers complied with paragraph (o)(3) of 29 CFR
1926.452, and paragraphs (c)(1) through (c)(4), (c)(8), (c)(13),
(c)(14)(i), and (c)(16) of 29 CFR 1926.552.
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    \4\ Among the technical corrections, OSHA added two conditions
to the permanent variance. The first condition is a new paragraph
1(b) that requires the employers to use personnel cages, personnel
platforms, or boatswains' chairs only to transport employees with
the tools and materials necessary to do their work, and to attach a
hopper or concrete bucket to the hoist system for transporting other
materials and tools inside or outside a chimney. The second
condition revises paragraph 2(b) in the variance application by
adding a requirement that employers attach a boatswains' chair to
the hoisting cable only when they can demonstrate that the
structural arrangement of the chimney precludes the safe use of the
block and tackle required by 29 CFR 1926.452(o)(3). Both of these
technical corrections are consistent with language proposed by the
employers and described in section III (SUPPLEMENTARY INFORMATION)
of their variance application (see 69 FR 48755 and 48756).
---------------------------------------------------------------------------

VII. Order

    OSHA issues this order authorizing Commonwealth Dynamics, Inc.,
Mid-Atlantic Boiler & Chimney, Inc., and R and P Industrial Chimney
Co., Inc. (``the employers'') to comply with the following conditions
instead of complying with paragraph (o)(3) of 29 CFR 1926.452 and
paragraphs (c)(1) through (c)(4), (c)(8), (c)(13), (c)(14)(i), and
(c)(16) of 29 CFR 1926.552:

1. Scope of the Permanent Variance

    (a) This permanent variance applies only when the employers use a
rope-guided hoist system during inside or outside chimney construction
to raise or lower their employees between the bottom landing of a
chimney and an elevated work location on the inside or outside surface
of the chimney.
    (b) When using a rope-guided hoist system as specified in this
permanent variance, the employers must:
    (i) Use the personnel cages, personnel platforms, or boatswains'
chairs raised and lowered by the rope-guided hoist system solely to
transport employees with the tools and materials necessary to do their
work; and
    (ii) Attach a hopper or concrete bucket to the rope-guided hoist
system to raise and lower all other materials and tools inside or
outside a chimney.
    (c) Except for the requirements specified by 29 CFR 1926.452(o)(3)
and 1926.552(c)(1) through (c)(4), (c)(8), (c)(13), (c)(14)(i), and
(c)(16), the employers must comply fully with all other applicable
provisions of 29 CFR parts 1910 and 1926.

2. Replacing a Personnel Cage With a Personnel Platform or a
Boatswains' Chair

    (a) Personnel platform. When the employers demonstrate that
available space makes a personnel cage for transporting employees
infeasible, they may replace the personnel cage with a personnel
platform when they limit use of the personnel platform to elevations
above the last work location that the personnel cage can reach.
    (b) Boatswains' chair. Employers must:
    (i) Before using a boatswains' chair, demonstrate that available
space makes it infeasible to use a personnel platform for transporting
employees;
    (ii) Limit use of a boatswains' chair to elevations above the last
work location that the personnel platform can reach; and
    (iii) Use a boatswains' chair in accordance with block-and-tackle
requirements specified by 29 CFR 1926.452(o)(3), unless they can
demonstrate that the structural arrangement of the chimney precludes
such use.

3. Qualified Competent Person

    (a) The employers must:
    (i) Provide a qualified competent person, as specified in
paragraphs (f) and (m) of 29 CFR 1926.32, who is responsible for
ensuring that the design, maintenance, and inspection of the hoist
system comply with the conditions of this grant and with the
appropriate requirements of 29 CFR part 1926 (``Safety and Health
Regulations for Construction''); and
    (ii) Ensure that the qualified competent person is present at
ground level to assist in an emergency whenever the hoist system is
raising or lowering employees.
    (b) The employers must use a qualified competent person to design
and maintain the cathead described under Condition 8 (``Cathead and
Sheave'') below.

4. Hoist Machine

    (a) Type of hoist. The employers must designate the hoist machine
as a portable personnel hoist.
    (b) Raising or lowering a transport. The employers must ensure
that:
    (i) The hoist machine includes a base-mounted drum hoist designed
to control line speed; and
    (ii) Whenever they raise or lower a personnel or material hoist
(e.g., a personnel cage, personnel platform, boatswains' chair, hopper,
concrete bucket) using the hoist system:
    (A) The drive components are engaged continuously when an empty or
occupied transport is being lowered (i.e., no ``freewheeling'');
    (B) The drive system is interconnected, on a continuous basis,
through a torque converter, mechanical coupling, or an equivalent
coupling (e.g., electronic controller, fluid clutches, hydraulic
drives).
    (C) The braking mechanism is applied automatically when the
transmission is in the neutral position and a forward-reverse coupling
or shifting transmission is being used; and
    (D) No belts are used between the power source and the winding
drum.
    (c) Power source. The employers must power the hoist machine by an
air, electric, hydraulic, or internal-combustion drive mechanism.
    (d) Constant-pressure control switch. The employers must:
    (i) Equip the hoist machine with a hand- or foot-operated constant-
pressure control switch (i.e., a ``deadman control switch'') that stops
the hoist immediately upon release; and
    (ii) Protect the control switch to prevent it from activating if
the hoist machine is struck by a falling or moving object.
    (e) Line-speed indicator. The employers must:
    (i) Equip the hoist machine with an operating line-speed indicator
maintained in good working order; and
    (ii) Ensure that the line-speed indicator is in clear view of the
hoist operator during hoisting operations.
    (f) Braking systems. The employers must equip the hoist machine
with two (2) independent braking systems (i.e., one automatic and one
manual) located on the winding side of the clutch or couplings, with
each braking system being capable of stopping and holding 150 percent
of the maximum rated load.
    (g) Slack-rope switch. The employers must equip the hoist machine
with a slack-rope switch to prevent rotation of the winding drum under
slack-rope conditions.
    (h) Frame. The employers must ensure that the frame of the hoist

machine is a self-supporting, rigid, welded-steel structure, and that
holding brackets for anchor lines and legs for anchor bolts are
integral components of the frame.
    (i) Stability. The employers must secure hoist machines in position
to prevent movement, shifting, or dislodgement.
    (j) Location. The employers must:
    (i) Locate the hoist machine far enough from the footblock to
obtain the correct fleet angle for proper spooling of the cable on the
drum; and
    (ii) Ensure that the fleet angle remains between one-half degree
(\1/2\[deg]) and one and one-half degrees (1\1/2\[deg]) for smooth
drums, and between one-half degree (\1/2\[deg]) and two degrees
(2[deg]) for grooved drums, with the lead sheave centered on the
drum.\1\
---------------------------------------------------------------------------

    \1\ This variance adopts the definition of, and specifications
for, fleet angle from Cranes and Derricks, H. I. Shapiro, et al.
(eds.); New York: McGraw-Hill; 3rd ed., 1999, page 592. Accordingly,
the fleet angle is ``[t]he angle the rope leading onto a [winding]
drum makes with the line perpendicular to the drum rotating axis
when the lead rope is making a wrap against the flange.''
---------------------------------------------------------------------------

    (k) Drum and flange diameter. The employers must:
    (i) Provide a winding drum for the hoist that is at least 30 times
the diameter of the rope used for hoisting; and
    (ii) Ensure that the winding drum has a flange diameter that is at
least one and one-half (1\1/2\) times the winding-drum diameter.
    (l) Spooling of the rope. The employers must never spool the rope
closer than two (2) inches (5.1 cm) from the outer edge of the winding-
drum flange.
    (m) Electrical system. The employers must ensure that all
electrical equipment is weatherproof.
    (n) Limit switches. The employers must equip the hoist system with
limit switches and related equipment that automatically prevent
overtravel of a personnel cage, personnel platform, boatswains' chair,
or material-transport device at the top of the supporting structure and
at the bottom of the hoistway or lowest landing level.

5. Methods of Operation

    (a) Employee qualifications and training. The employers must:
    (i) Ensure that only trained and experienced employees, who are
knowledgeable of hoist-system operations, control the hoist machine;
and
    (ii) Provide instruction, periodically and as necessary, on how to
operate the hoist system, to each employee who uses a personnel cage
for transportation.
    (b) Speed limitations. The employers must not operate the hoist at
a speed in excess of:
    (i) Two hundred and fifty (250) feet (76.9 m) per minute when a
personnel cage is being used to transport employees;
    (ii) One hundred (100) feet (30.5 m) per minute when a personnel
platform or boatswains' chair is being used to transport employees; or
    (iii) A line speed that is consistent with the design limitations
of the system when only material is being hoisted.
    (c) Communication. The employers must:
    (i) Use a voice-mediated intercommunication system to maintain
communication between the hoist operator and the employees located in
or on a moving personnel cage, personnel platform, or boatswains'
chair;
    (ii) Stop hoisting if, for any reason, the communication system
fails to operate effectively; and
    (iii) Resume hoisting only when the site superintendent determines
that it is safe to do so.

6. Hoist Rope

    (a) Grade. The employers must use a wire rope for the hoist system
(i.e., ``hoist rope'') that consists of extra-improved plow steel, an
equivalent grade of non-rotating rope, or a regular lay rope with a
suitable swivel mechanism.
    (b) Safety factor. The employers must maintain a safety factor of
at least eight (8) times the safe workload throughout the entire length
of hoist rope.
    (c) Size. The employers must use a hoist rope that is at least one-
half (1/2) inch (1.3 cm) in diameter.
    (d) Inspection, removal, and replacement. The employers must:
    (i) Thoroughly inspect the hoist rope before the start of each job
and on completing a new setup;
    (ii) Maintain the proper diameter-to-diameter ratios between the
hoist rope and the footblock and the sheave by inspecting the wire rope
regularly (see Conditions 7(c) and 8(d) below); and
    (iii) Remove and replace the wire rope with new wire rope when any
of the conditions specified by 29 CFR 1926.552(a)(3) occurs.
    (e) Attachments. The employers must attach the rope to a personnel
cage, personnel platform, or boatswains' chair with a keyed-screwpin
shackle or positive-locking link.
    (f) Wire-rope fastenings. When the employers use clip fastenings
(e.g., U-bolt wire-rope clips) with wire ropes, they must:
    (i) Use Table H-20 of 29 CFR 1926.251 to determine the number and
spacing of clips;
    (ii) Use at least three (3) drop-forged clips at each fastening;
    (iii) Install the clips with the ``U'' of the clips on the dead end
of the rope; and
    (iv) Space the clips so that the distance between them is six (6)
times the diameter of the rope.

7. Footblock

    (a) Type of block. The employers must use a footblock:
    (i) Consisting of construction-type blocks of solid single-piece
bail with a safety factor that is at least four (4) times the safe
workload, or an equivalent block with roller bearings;
    (ii) Designed for the applied loading, size, and type of wire rope
used for hoisting;
    (iii) Designed with a guard that contains the wire rope within the
sheave groove;
    (iv) Bolted rigidly to the base; and
    (v) Designed and installed so that it turns the moving wire rope to
and from the horizontal or vertical direction as required by the
direction of rope travel.
    (b) Directional change. The employers must ensure that the angle of
change in the hoist rope from the horizontal to the vertical direction
at the footblock is approximately 90[deg].
    (c) Diameter. The employers must ensure that the line diameter of
the footblock is at least 24 times the diameter of the hoist rope.

8. Cathead and Sheave

    (a) Support. The employers must use a cathead (i.e., ``overhead
support'') that consists of a wide-flange beam, or two (2) steel-
channel sections securely bolted back-to-back to prevent spreading.
    (b) Installation. The employers must ensure that:
    (i) All sheaves revolve on shafts that rotate on bearings; and
    (ii) The bearings are mounted securely to maintain the proper
bearing position at all times.
    (c) Rope guides. The employers must provide each sheave with
appropriate rope guides to prevent the hoist rope from leaving the
sheave grooves when the rope vibrates or swings abnormally.
    (d) Diameter. The employers must use a sheave with a diameter that
is at least 24 times the diameter of the hoist rope.

9. Guide Ropes

    (a) Number and construction. The employers must affix two (2) guide
ropes by swivels to the cathead. The guide ropes must:

    (i) Consist of steel safety cables not less than one-half (1/2)
inch (1.3 cm) in diameter; and
    (ii) Be free of damage or defect at all times.
    (b) Guide rope fastening and alignment tension. The employers must
fasten one end of each guide rope securely to the overhead support,
with appropriate tension applied at the foundation.
    (c) Height. The employers must rig the guide ropes along the entire
height of the hoist-machine structure.

10. Personnel Cage

    (a) Construction. A personnel cage must be of steel-frame
construction and capable of supporting a load that is four (4) times
its maximum rated load capacity. The employers also must ensure that
the personnel cage has:
    (i) A top and sides that are permanently enclosed (except for the
entrance and exit);
    (ii) A floor securely fastened in place;
    (iii) Walls that consist of 14-gauge, one-half (\1/2\) inch (1.3
cm) expanded metal mesh, or an equivalent material;
    (iv) Walls that cover the full height of the personnel cage between
the floor and the overhead covering;
    (v) A sloped roof constructed of one-eighth (\1/8\) inch (0.3 cm)
aluminum, or an equivalent material; and
    (vi) Safe handholds (e.g., rope grips--but not rails or hard
protrusions \2\) that accommodate each occupant.
---------------------------------------------------------------------------

    \2\ To reduce impact hazards should employees lose their balance
because of cage movement.
---------------------------------------------------------------------------

    (b) Overhead weight. A personnel cage must have an overhead weight
(e.g., a headache ball of appropriate weight) to compensate for the
weight of the hoist rope between the cathead and footblock. In
addition, the employers must:
    (i) Ensure that the overhead weight is capable of preventing line
run; and
    (ii) Use a means to restrain the movement of the overhead weight so
that the weight does not interfere with safe personnel hoisting.
    (c) Gate. The personnel cage must have a gate that:
    (i) Guards the full height of the entrance opening; and
    (ii) Has a functioning mechanical lock that prevents accidental
opening.
    (d) Operating procedures. The employers must post the procedures
for operating the personnel cage conspicuously at the hoist operator's
station.
    (e) Capacity. The employers must:
    (i) Hoist no more than four (4) occupants in the cage at any one
time; and
    (ii) Ensure that the rated load capacity of the cage is at least
250 pounds (113.4 kg) for each occupant so hoisted.
    (f) Employee notification. The employers must post a sign in each
personnel cage notifying employees of the following conditions:
    (i) The standard rated load, as determined by the initial static
drop test specified by Condition 10(g) (``Static drop tests'') below;
and
    (ii) The reduced rated load for the specific job.
    (g) Static drop tests. The employers must:
    (i) Conduct static drop tests of each personnel cage that comply
with the definition of ``static drop test'' specified by section 3
(``Definitions'') and the static drop-test procedures provided in
section 13 (``Inspections and Tests'') of American National Standards
Institute (ANSI) standard A10.22-1990 (R1998) (``American National
Standard for Rope-Guided and Nonguided Worker's Hoists--Safety
Requirements'');
    (ii) Perform the initial static drop test at 125 percent of the
maximum rated load of the personnel cage, and subsequent drop tests at
no less than 100 percent of its maximum rated load; and
    (iii) Use a personnel cage for raising or lowering employees only
when no damage occurred to the components of the cage as a result of
the static drop tests.

11. Safety Clamps

    (a) Fit to the guide ropes. The employers must:
    (i) Fit appropriately designed and constructed safety clamps to the
guide ropes; and
    (ii) Ensure that the safety clamps do not damage the guide ropes
when in use.
    (b) Attach to the personnel cage. The employers must attach safety
clamps to each personnel cage for gripping the guide ropes.
    (c) Operation. The safety clamps attached to the personnel cage
must:
    (i) Operate on the ``broken rope principle'' defined in section 3
(``Definitions'') of ANSI standard A10.22-1990 (R1998);
    (ii) Be capable of stopping and holding a personnel cage that is
carrying 100 percent of its maximum rated load and traveling at its
maximum allowable speed if the hoist rope breaks at the footblock; and
    (iii) Use a pre-determined and pre-set clamping force (i.e., the
``spring compression force'') for each hoist system.
    (d) Maintenance. The employers must keep the safety-clamp
assemblies clean and functional at all times.

12. Overhead Protection

    (a) The employers must install a canopy or shield over the top of
the personnel cage that is made of steel plate at least three-sixteenth
(3/16) of an inch (4.763 mm) thick, or material of equivalent strength
and impact resistance, to protect employees (i.e., both inside and
outside the chimney) from material and debris that may fall from above.
    (b) The employers must ensure that the canopy or shield slopes to
the outside of the personnel cage.\3\
---------------------------------------------------------------------------

    \3\ Paragraphs (a) and (b) were adapted from OSHA's Underground
Construction Standard (29 CFR 1926.800(t)(4)(iv)).
---------------------------------------------------------------------------

13. Emergency-Escape Device

    (a) Location. The employers must provide an emergency-escape device
in at least one of the following locations:
    (i) In the personnel cage, provided that the device is long enough
to reach the bottom landing from the highest possible escape point; or
    (ii) At the bottom landing, provided that a means is available in
the personnel cage for the occupants to raise the device to the highest
possible escape point.
    (b) Operating instructions. The employers must ensure that written
instructions for operating the emergency-escape device are attached to
the device.
    (c) Training. The employers must instruct each employee who uses a
personnel cage for transportation on how to operate the emergency-
escape device:
    (i) Before the employee uses a personnel cage for transportation;
and
    (ii) Periodically, and as necessary, thereafter.

14. Personnel Platforms and Fall-Protection Equipment

    (a) Personnel platforms. When the employers elect to replace the
personnel cage with a personnel platform in accordance with Condition
2(a) of this variance, they must:
    (i) Ensure that an enclosure surrounds the platform, and that this
enclosure is at least 42 inches (106.7 cm) above the platform's floor;
    (ii) Provide overhead protection when an overhead hazard is, or
could be, present; and
    (iii) Comply with the applicable scaffolding strength requirements
specified by 29 CFR 1926.451(a)(1).
    (b) Fall-protection equipment. Before employees use work platforms
or boatswains' chairs, the employers must equip the employees with, and
ensure that they use, full body harnesses,

lanyards and lifelines as specified by 29 CFR 1926.104 and the
applicable requirements of 29 CFR 1926.502(d). This requirement
includes securing the lifelines to the top of the chimney and to a
weight at the bottom of the chimney, and ensuring the employees'
lanyards are attached to the lifeline during the entire period of
vertical transit.

15. Inspections, Tests, and Accident Prevention

    (a) The employers must:
    (i) Conduct inspections of the hoist system as required by 29 CFR
1926.20(b)(2);
    (ii) Ensure that a competent person conducts daily visual
inspections of the hoist system; and
    (iii) Inspect and test the hoist system as specified by 29 CFR
1926.552(c)(15).
    (b) The employers must comply with the accident-prevention
requirements of 29 CFR 1926.20(b)(3).

16. Welding

    (a) The employers must use only qualified welders to weld
components of the hoisting system.
    (b) The employers must ensure that the qualified welders:
    (i) Are familiar with the weld grades, types, and materials
specified in the design of the system; and
    (ii) Perform the welding tasks in accordance with 29 CFR part 1926,
subpart J (``Welding and Cutting'').

VII. Authority and Signature

    Jonathan L. Snare, Acting Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, 200
Constitution Ave., NW., Washington, DC directed the preparation of this
notice. This notice is issued under the authority specified by section
6(d) of the Occupational Safety and Health Act of 1970 (29 U.S.C. 655),
Secretary of Labor's Order No. 5-2002 (67 FR 65008), and 29 CFR part
1905.

    Signed at Washington, DC on January 30, 2005.
Jonathan L. Snare,
Acting Assistant Secretary of Labor.
[FR Doc. E6-2959 Filed 2-28-06; 8:45 am]

BILLING CODE 4510-26-P


[Federal Register: July 27, 2010 (Volume 75, Number 143)]
[Rules and Regulations]
[Page 43803-43807]
[DOCID:fr27jy10-3]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0173; Directorate Identifier 2009-NM-076-AD;
Amendment 39-16374; AD 2010-15-08]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Model 737-100, -200,
-200C, -300, -400, and -500 Series Airplanes

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

ACTION: Final rule.

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

SUMMARY: The FAA is superseding an existing airworthiness directive
(AD), which applies to all Model 737-100, -200, -200C, -300, -400, and
-500 series airplanes. That AD currently requires repetitive
inspections to find cracks, fractures, or corrosion of each carriage
spindle of the left and right outboard mid-flaps, and corrective action
if necessary. That AD also currently requires repetitive gap checks of
the inboard and outboard carriage of the outboard mid-flaps to detect
fractured carriage spindles, and corrective actions if necessary. This
new AD requires any new or serviceable carriage spindle installed per
the requirements of the existing AD to meet minimum allowable diameter
measurements taken at three locations. This AD also requires new
repetitive inspections, measurements, and overhaul of the carriage
spindles, and applicable corrective actions. In addition, this AD
requires replacing any carriage spindle when it has reached its maximum
life limit. This AD results from reports of fractures that resulted
from stress corrosion and pitting along the length of the spindle and
spindle diameter, and additional reports of corrosion on the outboard
flap carriage spindles. We are issuing this AD to detect and correct
cracked, corroded, or fractured carriage spindles, and to prevent
severe flap asymmetry, which could result in reduced control or loss of
controllability of the airplane.

DATES: This AD becomes effective August 31, 2010.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of August 31,
2010.
    On December 4, 2003 (68 FR 67027, December 1, 2003), the Director
of the Federal Register approved the incorporation by reference of a
certain other publication listed in the AD.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management, P.
O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone 206-
544-5000, extension 1; fax<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
Internet https://www.myboeingfleet.com.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document 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: Nancy Marsh, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone (425)
917-6440; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 to include an AD that supersedes AD 2003-24-08, Amendment
39-13377 (68 FR 67027, December 1, 2003). The existing AD applies to
all Model 737-100, -200, -200C, -300, -400, and -500 series airplanes.
That NPRM was published in the Federal Register on March 1, 2010 (75 FR
9137). That NPRM proposed to continue to require repetitive gap checks
of the inboard and outboard carriage of the outboard mid-flaps to
detect fractured carriage spindles, and corrective actions if
necessary, and continue to require repetitive inspections to find
cracks, factures, or corrosion of each carriage spindle of the left and
right outboard mid-flaps. That NPRM also proposed to require any new or
serviceable carriage spindle installed per the requirements of the
existing AD to meet minimum allowable diameter measurements taken at
three locations. That NPRM proposed to require new repetitive
inspections, measurements, and overhaul of the carriage spindles, and
applicable corrective actions. In addition, that NPRM also proposed to
require replacing any carriage spindle

when it has reached its maximum life limit.

Actions Since Original NPRM Was Issued

    Since we issued the original NPRM, there has been an in-service
event of a dual fracture of the outboard flap carriages. This event is
currently under investigation. As a result, we consider this AD to be
interim action. If final action is later identified, we might consider
further rulemaking then.

Explanation of Changes to AD

    We have added paragraph (t)(4) to this final rule to provide credit
for actions done in accordance with previously issued AMOCs for
individual repairs. In paragraph (m) of this AD, we have also
referenced the most current issue of the Boeing (737) Standard Overhaul
Practices Manual for actions done as of the effective date of this AD.

Comments

    We provided the public the opportunity to participate in the
development of this AD. We have considered the comments that have been
received on the NPRM.

Support for the NPRM

    Boeing supports the intent of the NPRM.

Request for Stricter Inspection and Overhaul Limits in Lieu of Life
Limits

    Safair states that it has experienced only one flap carriage
spindle failure before AD 2003-24-08 was issued. Safair states that its
main concern is scrapping serviceable carriages in order to enforce the
life limits on the flap carriages. Safair states that stricter
inspections and overhaul requirements would ensure that stress and
pitting corrosion are detected and corrected, which would avoid
failures and would extend the life of the flap carriages.
    We do not agree that substituting stricter inspection and overhaul
limits for life limits would address the unsafe condition. Since AD
2003-24-08 was issued, we have received many additional reports of
carriage spindle fractures, including fractures caused by fatigue.
Because of the difficulty in detecting small cracks and the rapid crack
growth in these parts, in combination with the concerns with reduced
fatigue life of reworked and overhauled parts, the most effective way
to maintain the continued operational safety of the fleet is to mandate
life limits. We have not changed the AD in regard to this issue.

Request for Clarification of Requirements to Remove Flap Carriage

    KLM requests clarification concerning the requirements to remove
the carriage spindle in order to perform a detailed inspection for
corrosion, pitting, cracking, and measurement of some minimal allowable
spindle diameters. KLM points out that the times specified for this
action are the same as for the initial gap check and the nondestructive
test for new carriage spindles. KLM asks whether the removal of the
carriage spindle is required at 12,000 flight cycles, if the initial or
repetitive gap check and the non-destructive test (NDT) at the same
time are still useful. KLM further states that carriage spindles that
receive a thorough detailed inspection and have been found to be
serviceable do not require a gap check or an NDT inspection at the
times specified in the 12,000- to 20,000-flight-cycle range as
specified in Table 1 and Table 2 of Boeing Alert Service Bulletin 737-
57A1277, Revision 1, dated November 25, 2003. KLM states that the gap
checks and NDTs are still required, although at a different time
interval after completing the requirements of paragraph (o) of the
NPRM.
    We agree that clarification might be necessary. Paragraph (o) of
this final rule requires the overhaul to be performed on the new
carriage spindle before the accumulation of 12,000 flight cycles.
Therefore, the new carriage spindle should not accumulate more than
11,999 flight cycles before being overhauled in order to comply with
this requirement. Paragraph (g) of this AD refers to Boeing Alert
Service Bulletin 737-57A1277, Revision 1, dated November 25, 2003, for
the compliance times for the gap checks and NDT inspections. Boeing
Alert Service Bulletin 737-57A1277, Revision 1, dated November 25,
2003, states that the gap check and NDT inspections are not required
for a new flap carriage spindle that has accumulated fewer than 12,000
flight cycles without being overhauled.
    Boeing Alert Service Bulletin 737-57A1277, Revision 1, dated
November 25, 2003, requires relatively stringent gap checks and NDT
inspections for flap carriage spindles that have accumulated 12,000 or
more flight cycles on them since being overhauled. This requirement
should become obsolete as this AD requires that all spindles be
overhauled before accumulating 12,000 flight cycles since new or
overhauled.
    We have not changed the AD in regard to this issue.

Conclusion

    We have carefully reviewed the available data, including the
comments that have been received, and determined that air safety and
the public interest require adopting the AD with the changes described
previously. We have determined that these changes will neither increase
the economic burden on any operator nor increase the scope of the AD.

Costs of Compliance

    There are about 2,852 airplanes of the affected design in the
worldwide fleet. The following table provides the estimated costs for
U.S. operators to comply with this AD.

                                                                     Estimated Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                                                    Average                                            U.S.-
               Action                 Work hours   labor rate     Parts        Cost per airplane     registered                 Fleet cost
                                                    per hour                                         airplanes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspections (required by AD 2003-24-          12          $85         None  $1,020 per inspection           652  $665,040 per inspection cycle.
 08).                                                                        cycle.
Inspections and measurements (new              2           85         None  $170 per inspection             652  $110,840 per inspection and measurement
 actions).                                                                   and measurement cycle.               cycle.
Overhauls (new actions)............           16           85   \1\ 28,000  $29,360 per overhaul            652  $19,142,720 per overhaul cycle.
                                                                             cycle.
Replacements (new actions).........           16           85   \2\ 60,000  $61,360 per                     652  $40,006,720 per replacement cycle.
                                                                             replacement cycle....
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ $7,000 per spindle; 4 spindles per airplane.
\2\ $15,000 per spindle; 4 spindles per airplane.

    The cost impact figures discussed above are based on assumptions
that no operator has yet accomplished any of the actions required by
this AD, and that no operator would accomplish those actions in the
future if this AD were not adopted. However, we have been advised that
the carriage spindles are already being overhauled and replaced on some
affected airplanes. In addition, the replacement cycle is approximately
every 20 years. Therefore, the future economic cost impact of this rule
on U.S. operators is expected to be less than the cost impact figures
indicated above.

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 have 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 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. See the ADDRESSES
section for a location to examine the regulatory evaluation.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
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 Federal Aviation Administration (FAA) amends Sec.  39.13 by
removing Amendment 39-13377 (68 FR 67027, December 1, 2003) and by
adding the following new airworthiness directive (AD):

2010-15-08 The Boeing Company: Amendment 39-16374. Docket No. FAA-
2010-0173; Directorate Identifier 2010-NM-076-AD.

Effective Date

    (a) This AD becomes effective August 31, 2010.

Affected ADs

    (b) This AD supersedes AD 2003-24-08, Amendment 39-13377.

Applicability

    (c) This AD applies to all The Boeing Company Model 737-100, -
200, -200C, -300, -400, and -500 series airplanes, certificated in
any category.

Subject

    (d) Air Transport Association (ATA) of America Code 57: Wings.

Unsafe Condition

    (e) This AD results from a report indicating that the inboard
and outboard carriage spindles were fractured on the right outboard
flap during approach to landing. We are issuing this AD to detect
and correct cracked, corroded, or fractured carriage spindles and to
prevent severe flap asymmetry, which could result in reduced control
or loss of controllability of the airplane.

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 CERTAIN REQUIREMENTS OF AD 2003-24-08, WITH UPDATED
SERVICE INFORMATION

Compliance Times

    (g) The tables in paragraph 1.E., ``Compliance'' of Boeing Alert
Service Bulletin 737-57A1277, Revision 1, dated November 25, 2003,
specify the compliance times for paragraphs (g) through (k) of this
AD. For carriage spindles that have accumulated the number of flight
cycles or years in service specified in the ``Threshold'' column of
the tables, accomplish the gap check and nondestructive test (NDT)
and general visual inspections specified in paragraphs (h) and (j)
of this AD within the corresponding interval after December 4, 2003
(the effective date AD 2003-24-08), as specified in the ``Interval''
column. Repeat the gap check and NDT and general visual inspections
at the same intervals, except:
    (1) The gap check does not have to be done at the same time as
an NDT inspection; after doing an NDT inspection, the interval for
doing the next gap check can be measured from the NDT inspection;
and
    (2) As carriage spindles gain flight cycles or years in service
and move from one category in the ``Threshold'' column to another,
they are subject to the repetitive inspection intervals
corresponding to the new threshold category.

Work Package 2: Gap Check

    (h) Perform a gap check of the inboard and outboard carriage of
the left and right outboard mid-flaps to determine if there is a
positive indication of a severed carriage spindle, in accordance
with Work Package 2 of paragraph 3.B., ``Work Instructions'' of
Boeing Alert Service Bulletin 737-57A1277, Revision 1, dated
November 25, 2003.

Work Package 2: Corrective Actions

    (i) If there is a positive indication of a severed carriage
spindle during the gap check required by paragraph (h) of this AD,
before further flight, remove the carriage spindle and install a new
or serviceable carriage spindle in accordance with the ``Work
Instructions'' of Boeing Alert Service Bulletin 737-57A1277,
Revision 1, dated November 25, 2003; or Boeing Alert Service
Bulletin 737-57A1218, Revision 5, dated February 9, 2009. If, as a
result of the detailed inspection described in paragraph 4.b. of
Work Package 2 of Boeing Alert Service Bulletin 737-57A1277,
Revision 1, dated November 25, 2003, a carriage spindle is found not
to be severed and no corrosion and no cracking is present, it can be
reinstalled on the mid-flap in accordance with Boeing Alert Service
Bulletin 737-57A1277, Revision 1, dated November 25, 2003; or Boeing
Alert Service Bulletin 737-57A1218, Revision 5, dated February 9,
2009. After the effective date of this AD, use only Boeing Alert
Service Bulletin 737-57A1218, Revision 5, dated February 9, 2009.

Work Package 1: Inspections

    (j) Perform a NDT inspection and general visual inspection for
each carriage spindle of the left and right outboard mid-flaps to
detect cracks, corrosion, or severed carriage spindles, in
accordance with the ``Work Instructions'' of Boeing Alert Service
Bulletin 737-57A1277, Revision 1, dated November 25, 2003.

Work Package 1: Corrective Actions

    (k) If any corroded, cracked, or severed carriage spindle is
found during any inspection required by paragraph (j) of this AD,
before further flight, remove the carriage

spindle and install a new or serviceable carriage spindle in
accordance with the ``Work Instructions'' of Boeing Alert Service
Bulletin 737-57A1277, Revision 1, dated November 25, 2003; or Boeing
Alert Service Bulletin 737-57A1218, Revision 5, dated February 9,
2009. After the effective date of this AD, use only Boeing Alert
Service Bulletin 737-57A1218, Revision 5, dated February 9, 2009.

Parts Installation

    (l) Except as provided in paragraph (i) of this AD: As of
December 4, 2003, no person may install on any airplane a carriage
spindle that has been removed as required by paragraph (i) or (k) of
this AD, unless it has been overhauled in accordance with the ``Work
Instructions'' of Boeing Alert Service Bulletin 737-57A1277,
Revision 1, dated November 25, 2003; or Boeing Alert Service
Bulletin 737-57A1218, Revision 5, dated February 9, 2009. After the
effective date of this AD, use only Boeing Alert Service Bulletin
737-57A1218, Revision 5, dated February 9, 2009. To be eligible for
installation under this paragraph, the carriage spindle must have
been overhauled in accordance with the requirements of paragraph (m)
of this AD.
    (m) During accomplishment of any overhaul specified in paragraph
(l) of this AD, use the procedures specified in paragraphs (m)(1)
and (m)(2) of this AD during application of the nickel plating to
the carriage spindle in addition to those specified in Chapter 20-
42-09, Electrodeposited Nickel Plating, of the Boeing (737) Standard
Overhaul Practices Manual. As of the effective date of this AD, use
only Chapter 20-42-09, Electrodeposited Nickel Plating, of the
Boeing (737) Standard Overhaul Practices Manual, Revision 25, dated
July 1, 2009.
    (1) The maximum deposition rate of the nickel plating in any one
plating/baking cycle must not exceed 0.002-inches-per-hour.
    (2) Begin the hydrogen embrittlement relief bake within 10 hours
after application of the plating, or less than 24 hours after the
current was first applied to the part, whichever is first.

Exception to Reporting Recommendations in Certain Service Bulletins

    (n) Although Boeing Alert Service Bulletin 737-57A1277, Revision
1, dated November 25, 2003, recommends that operators report
inspection findings to the manufacturer, this AD does not contain
such a reporting requirement.

NEW ACTIONS REQUIRED BY THIS AD

Inspections, Measurements, and Overhauls of the Carriage Spindle

    (o) At the applicable times specified in paragraph (o)(1) or
(o)(2) of this AD: Do the detailed inspection for corrosion,
pitting, and cracking of the carriage spindle, the magnetic particle
inspection for cracking of the carriage spindle, measurements of the
spindle to determine if it meets the allowable minimum diameter, and
overhauls, and applicable corrective actions by accomplishing all
the applicable actions specified in the Accomplishment Instructions
of Boeing Alert Service Bulletin 737-57A1218, Revision 5, dated
February 9, 2009. The applicable corrective actions must be done
before further flight. Repeat these actions thereafter at intervals
not to exceed 12,000 flight cycles on the carriage spindle or 8
years, whichever comes first.
    (1) For Model 737-100, -200, -200C series airplanes, at the
later of the times specified in paragraph (o)(1)(i) or (o)(1)(ii) of
this AD:
    (i) Before the accumulation of 12,000 total flight cycles on the
carriage spindle since new or overhauled, or within 8 years after
the installation of the new or overhauled part, whichever comes
first.
    (ii) Within 1 year after the effective date of this AD.
    (2) For Model -300, -400, and -500 series airplanes, at the
later of the times specified in paragraph (o)(2)(i) or (o)(2)(ii) of
this AD:
    (i) Before the accumulation of 12,000 total flight cycles on the
carriage spindle since new or overhauled, or within 8 years after
the installation of the new or overhauled part, whichever comes
first.
    (ii) Within 2 years after the effective date of this AD.

Replacement of the Carriage Spindle

    (p) For Model 737-100, -200, -200C series airplanes: Replace the
carriage spindle with a new or documented (for which the service
life, in total flight cycles, is known) carriage spindle, in
accordance with Boeing Alert Service Bulletin 737-57A1218, Revision
5, dated February 9, 2009, at the later of the times specified in
paragraphs (p)(1) and (p)(2) of this AD, except as required by
paragraph (r) of this AD. Overhauling the carriage spindles does not
zero-out the flight cycles. Total flight cycles accumulate since
new.
    (1) Before the accumulation of 48,000 total flight cycles on the
new or overhauled carriage.
    (2) Within three years or 7,500 flight cycles after the
effective date of this AD, whichever occurs first.
    (q) For Model 737-300, -400, and -500 series airplanes: Replace
the carriage spindle with a new or documented (for which the service
life, in flight cycles, is known) carriage spindle, in accordance
with Boeing Alert Service Bulletin 737-57A1218, Revision 5, dated
February 9, 2009, at the later of the times specified in paragraphs
(q)(1) and (q)(2) of this AD, except as required by paragraph (r) of
this AD. Overhauling the carriage spindles does not zero-out the
flight cycles. Total flight cycles accumulate since new.
    (1) Before the accumulation of 48,000 total flight cycles on the
new or overhauled carriage.
    (2) Within six years or 15,000 flight cycles after the effective
date of this AD, whichever occurs first.
    (r) For airplanes with an undocumented carriage: Do the
applicable actions specified in paragraph (p) or (q) of this AD at
the applicable time specified in paragraph (r)(1) or (r)(2) of this
AD.
    (1) For Model 737-100, -200, -200C series airplanes: Do the
actions specified in paragraph (p) of this AD at the time specified
in paragraph (p)(2) of this AD.
    (2) For Model -300, -400, and -500 series airplanes: Do the
actions specified in paragraph (q) of this AD at the time specified
in paragraph (q)(2) of this AD.

Repetitive Replacements of Carriage Spindle

    (s) For all airplanes: Repeat the replacement of the carriage
spindle specified by paragraph (p) or (q) of this AD, as applicable,
thereafter at intervals not to exceed 48,000 total flight cycles on
the new or overhauled carriage spindle.

Alternative Methods of Compliance (AMOCs)

    (t)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. Send information to
ATTN: Nancy Marsh, Aerospace Engineer, Airframe Branch, ANM-120S,
FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW.,
Renton, Washington 98057-3356; telephone<PHONE_NUMBER>; fax (425)
917-6590. Or, e-mail information to 9-ANM-Seattle-ACO-AMOC-
<EMAIL_ADDRESS>    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your principal maintenance inspector (PMI) or
principal avionics inspector (PAI), as appropriate, or lacking a
principal inspector, your local Flight Standards District Office.
The AMOC approval letter must specifically reference this AD.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Seattle ACO, to make
those findings. For a repair method to be approved, the repair must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.
    (4) AMOCs previously approved in accordance with AD 2003-24-08,
Amendment 39-13377, for individual repairs are acceptable for
compliance with the corresponding provisions of this AD. All other
existing AMOCs are not acceptable.

Material Incorporated by Reference

    (u) You must use Boeing Alert Service Bulletin 737-57A1218,
Revision 5, dated February 9, 2009; Boeing Alert Service Bulletin
737-57A1277, Revision 1, dated November 25, 2003; and Chapter 20-42-
09, Electrodeposited Nickel Plating, of the Boeing (737) Standard
Overhaul Practices Manual, Revision 25, dated July 1, 2009, to do
the actions required by this AD, unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of Boeing Alert Service Bulletin 737-
57A1218, Revision 5, dated February 9, 2009; and Chapter 20-42-09,
Electrodeposited Nickel Plating, of the Boeing (737) Standard
Overhaul Practices Manual, Revision 25, dated July 1, 2009; under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) The Director of the Federal Register previously approved the
incorporation by

reference of Boeing Alert Service Bulletin 737-57A1277, Revision 1,
dated November 25, 2003, on December 4, 2003 (68 FR 67027, December
1, 2003).
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.
    (4) 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>.
    (5) 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 July 14, 2010.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-18009 Filed 7-26-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: September 3, 2010 (Volume 75, Number 171)]
[Notices]
[Page 54154-54155]
[DOCID:fr03se10-68]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-M-0244, FDA-2010-M-0220, FDA-2010-M-0219, FDA-
2010-M-0242, FDA-2010-M-0261, FDA-2010-M-0262, FDA-2010-M-0264, FDA-
2010-M-0294, FDA-2010-M-0285]

Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
agency's Division of Dockets Management.

ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in table
1 of this document when submitting a written request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
summaries of safety and effectiveness.

FOR FURTHER INFORMATION CONTACT:  Nicole Wolanski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to
discontinue individual publication of PMA approvals and denials in the
Federal Register. Instead, the agency now posts this information on the
Internet on FDA's home page at http://www.fda.gov. FDA believes that
this procedure expedites public notification of these actions because
announcements can be placed on the Internet more quickly than they can
be published in the Federal Register, and FDA believes that the
Internet is accessible to more people than the Federal Register.
    In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the act. The 30-day
period for requesting reconsideration of an FDA action under Sec.
10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA
begins on the day the notice is placed on the Internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30-day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30-day period
will begin when the applicant is notified by FDA in writing of its
decision.
    The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from April 1, 2010, through June 30, 2010.
There were no denial actions during this period. The list provides the
manufacturer's name, the product's generic name or the trade name, and
the approval date.

    Table 1.--List of Safety and Effectiveness Summaries for Approved PMAs Made Available From April 1, 2010,
                                              through June 30, 2010
----------------------------------------------------------------------------------------------------------------
 PMA No. Docket No.         Applicant                     TRADE NAME                       Approval Date
----------------------------------------------------------------------------------------------------------------
P090018               Envoy Medical Corp.   ESTEEM TOTALLY IMPLANTABLE HEARING     March 17, 2010
FDA-2010-M-0244                              SYSTEM
----------------------------------------------------------------------------------------------------------------
P080029               Interventional        QUICK CLOSE VASCULAR SUTURING SYSTEM   April 8, 2010
FDA-2010-M-0220        Therapies, LLC
----------------------------------------------------------------------------------------------------------------
P090022               Lenstec, Inc.         SOFTEC HD POSTERIOR CHAMBER            April 12, 2010
FDA-2010-M-0219                              INTRAOCULAR LENS (PCIOL)
----------------------------------------------------------------------------------------------------------------
P080032               Asthmatix, Inc.       ALAIR BRONCHIAL THERMOPLASTY           April 27, 2010
FDA-2010-0242
----------------------------------------------------------------------------------------------------------------
P090007               Roche Diagnostics     ELECSYS ANTI-HCV IMMUNOASSAY AND       April 29, 2010
FDA-2010-M-0261        Corp.                 ELECSYS PRECICONTROL ANTI-HCV FOR
                                             USE ON THE COBAS E411 IMMUNOASSAY
                                             ANALYZER
----------------------------------------------------------------------------------------------------------------
P090008               Roche Diagnostics     ELECSYS ANTI-HCV IMMUNOASSAY AND       April 29, 2010
FDA-2010-M-0262        Corp.                 ELECSYS PRECICONTROL ANTI-HCV FOR
                                             USE ON THE COBAS E601 IMMUNOASSAY
                                             ANALYZER
----------------------------------------------------------------------------------------------------------------
P090009               Roche Diagnostics     ELECSYS ANTI-HCV IMMUNOASSAY AND       April 29, 2010
FDA-2010-M-0264        Corp.                 ELECSYS PRECICONTROL ANTI-HCV FOR
                                             USE ON THE MODULAR ANALYTICS E170
                                             ANALYZER
----------------------------------------------------------------------------------------------------------------
P050027               Karl Storz            PHOTODYNAMIC DIAGNOSTIC D-LIGHT C      May 28, 2010
FDA-2010-M-0294        endoscopy--America,
                       Inc.
----------------------------------------------------------------------------------------------------------------
P060029               Ethicon, Inc.         OMNEX SURGICAL SEALANT                 June 3, 2010
FDA-2010-M-0285
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at
http://www.fda.gov/cdrh/pmapage.html.

    Dated: August 31, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-22085 Filed 9-2-10; 8:45 am]
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