[Federal Register Volume 82, Number 74 (Wednesday, April 19, 2017)]
[Notices]
[Pages 18519-18520]
[FR Doc No: 2017-07878]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-80455; File No. 4-631]

Joint Industry Plan; Order Approving the Thirteenth Amendment to
the National Market System Plan To Address Extraordinary Market
Volatility by Bats BZX Exchange, Inc., Bats BYX Exchange, Inc., Bats
EDGA Exchange, Inc., Bats EDGX Exchange, Inc., Chicago Stock Exchange,
Inc., Financial Industry Regulatory Authority, Inc., Investors Exchange
LLC, NASDAQ BX, Inc., NASDAQ PHLX LLC, The Nasdaq Stock Market LLC,
NYSE National, Inc., New York Stock Exchange LLC, NYSE MKT LLC, and
NYSE Arca, Inc.

April 13, 2017.

I. Introduction

    On February 13, 2017, NYSE Group, Inc., on behalf of the other
parties \1\ to the National Market System Plan to Address Extraordinary
Market Volatility (the ``Plan''), filed with the Securities and
Exchange Commission (``Commission'') pursuant to Section 11A of the
Securities Exchange Act of 1934 (``Act'') \2\ and Rule 608
thereunder,\3\ a proposal to amend the Plan.\4\ The proposal represents
the thirteenth amendment to the Plan, and reflects proposed changes
unanimously approved by the Participants (``Thirteenth Amendment'').
The proposed Thirteenth Amendment was published for comment in the
Federal Register on March 16, 2017.\5\ The Commission received no
comment letters regarding the amendment. This order approves the
Thirteenth Amendment to the Plan as proposed.
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    \1\ Bats BZX Exchange, Inc., Bats BYX Exchange, Inc., Bats EDGA
Exchange, Inc., Bats EDGX Exchange, Inc., Chicago Stock Exchange,
Inc., the Financial Industry Regulatory Authority, Inc., Investors
Exchange LLC, NASDAQ BX, Inc., NASDAQ PHLX LLC, The NASDAQ Stock
Market LLC, New York Stock Exchange LLC (``NYSE''), NYSE Arca, Inc.,
NYSE MKT LLC, and NYSE National Inc. (collectively, the
``Participants'').
    \2\ 15 U.S.C. 78k-1.
    \3\ 17 CFR 242.608.
    \4\ See Letter from Elizabeth King, General Counsel, NYSE, to
Brent J. Fields, Secretary, Commission, dated February 10, 2017
(``Transmittal Letter'').
    \5\ See Securities Exchange Act Release No. 80203 (March 10,
2017), 82 FR 14068.
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II. Description of the Proposal

    In the Thirteenth Amendment, the Participants propose to (1) extend
the pilot period of the Plan from April 21, 2017 to April 16, 2018; (2)
require the Processor to publish, in connection with a reopening after
a Trading Pause, the auction reference price, auction collars,

and number of extensions to the reopening auction, as provided by the
Primary Listing Exchange; and (3) amend the Plan to reflect name
changes of certain Participants.\6\
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    \6\ Unless otherwise specified, the terms used herein have the
same meaning as set forth in the Plan.
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III. Discussion and Commission Findings

    The Commission finds that the Thirteenth Amendment is consistent
with the requirements of the Act and the rules and regulations
thereunder. Specifically, the Commission finds that the Thirteenth
Amendment is consistent with Section 11A of the Act \7\ and Rule 608
thereunder \8\ in that it is appropriate in the public interest, for
the protection of investors and the maintenance of fair and orderly
markets, and that it removes impediments to, and perfects the mechanism
of, a national market system.
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    \7\ 15 U.S.C. 78k-1.
    \8\ 17 CFR 242.608.
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    The Participants propose to extend the pilot period for an
additional year to April 16, 2018. As the Participants note, the
planned implementation date for the twelfth amendment to the Plan
(``Twelfth Amendment'') \9\ and the related Primary Listing Exchanges'
amended reopening procedures is scheduled to be during the third
quarter of 2017, which is after the end date of the current pilot
period. In addition, the Participants state that an extension of the
pilot period would provide additional time for the Participants, the
Commission, and the public to consider other potential modifications to
the Plan that are currently under consideration, including changes to
how NMS Stocks are tiered under the Plan and the applicable percentage
parameters associated with such tiers, whether double-wide Price Bands
at the open and close of trading should be eliminated, and
recommendations made by the Equity Market Structure Advisory Committee
with respect to Plan operations.\10\ Finally, the Commission
understands that the Participants continue to review and analyze the
harmonization of clearly erroneous execution rules with the Plan, such
that these rules could not be used to break trades occurring within
Price Bands absent a legitimate technical failure at a Self-Regulatory
Organization.\11\
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    \9\ See Securities Exchange Act Release No. 79845 (January 19,
2017), 82 FR 8551 (January 26, 2017) (order approving the Twelfth
Amendment).
    \10\ See U.S. Securities and Exchange Commission Equity Market
Structure Advisory Committee, Recommendations for Rulemaking on
Issues of Market Quality, dated November 29, 2016, available at
https://www.sec.gov/spotlight/emsac/emsac-recommendations-rulemaking-market-quality.pdf.
    \11\ See Securities Exchange Act Release No. 77679 (April 21,
2016), 81 FR 24908, 24909 (April 27, 2016) (order approving the
Tenth Amendment).
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    The Commission believes that a one-year extension of the Plan will
allow the Participants to implement and assess the changes the Plan
under the Twelfth Amendment. In addition, the extension of the pilot
period will provide Participants with additional time to continue their
examination and analysis of the matters described above. Accordingly,
the Commission believes that it is appropriate in the public interest,
for the protection of investors and the maintenance of a fair and
orderly market to approve the amendment to extend the pilot period
until April 16, 2018.
    The Participants also propose to amend Section VII(B)(1) of the
Plan to specify that the Processor would publish certain information
that the Primary Listing Exchange would provide to the Processor in
connection with reopening an NMS Stock after a Trading Pause.
Specifically, the Processor will publish the auction reference price;
auction collars; and number of extensions to the reopening auction.
This information will provide greater transparency regarding whether an
NMS Stock will reopen at the end of the scheduled Trading Pause, or if
such Trading Pause has been extended beyond the five-minute period
contemplated in the Plan. The Commission believes that it is
appropriate in the public interest, for the protection of investors and
the maintenance of a fair and orderly market to approve this proposed
change because it should enhance transparency about the reopening
processes during a Trading Pause.
    Finally, the Participants propose to amend the Plan to reflect name
changes of certain Participants. The Commission believes that it is
appropriate in the public interest, for the protection of investors and
the maintenance of a fair and orderly market to approve this proposed
change because it ensures that the Plan remains accurate and up-to-
date.
    For the reasons noted above, the Commission finds that the
Thirteenth Amendment to the Plan is consistent with Section 11A of the
Act \12\ and Rule 608 thereunder.\13\ The Commission reiterates its
expectation that the Participants will continue to monitor the scope
and operation of the Plan and study the data produced, and will propose
any modifications to the Plan that may be necessary or appropriate.\14\
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    \12\ 15 U.S.C. 78k-1.
    \13\ 17 CFR 242.608.
    \14\ See Securities Exchange Act Release No. 67091 (May 31,
2012), 77 FR 33498 (June 6, 2012).
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IV. Conclusion

    It is therefore ordered, pursuant to Section 11A of the Act \15\
and Rule 608 thereunder,\16\ that the Thirteenth Amendment to the Plan
(File No. 4-631) be, and it hereby is, approved.
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    \15\ 15 U.S.C. 78k-1.
    \16\ 17 CFR 242.608.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
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    \17\ 17 CFR 200.30-3(a)(29).
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Brent J. Fields,
Secretary.
[FR Doc. 2017-07878 Filed 4-18-17; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 186 (Tuesday, September 25, 2018)]
[Proposed Rules]
[Pages 48403-48408]
[FR Doc No: 2018-20763]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 886

[Docket No. FDA-2018-N-3074]

Ophthalmic Devices; Reclassification of Ultrasound
Cyclodestructive Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this
proposed order to reclassify the ultrasound cyclodestructive device, a
postamendments class III device (regulated under product code LZR),
into class II (special controls), subject to premarket notification.
FDA is also identifying the proposed special controls that the Agency
believes are necessary to provide a reasonable assurance of safety and
effectiveness of the device. FDA is proposing this reclassification on
its own initiative based on new information. If finalized, this order
will reclassify these devices from class III to class II (special
controls) and reduce regulatory burdens as these types of devices will
no longer be required to submit a premarket approval application (PMA)
but can instead submit a less burdensome premarket notification
(510(k)) before marketing their device.

DATES: Submit either electronic or written comments on the proposed
order by November 26, 2018. Please see section XI for the proposed
effective date when the new requirements apply and for the proposed
effective date of a final order based on this proposed order.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before November 26, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of November 26, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2018-N-3074 for ``Ophthalmic Devices; Reclassification of
Ultrasound Cyclodestructive Device.'' Received comments, those filed in
a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     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.gpo.gov/fdsys/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.

FOR FURTHER INFORMATION CONTACT: Hina Pinto, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1652, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended,
establishes a comprehensive system for the regulation of medical
devices intended for human use. Section 513 of the FD&C Act (21 U.S.C.
360c) established three categories (classes) of devices, reflecting the
regulatory controls needed to provide reasonable assurance of their
safety and effectiveness. The three categories of devices are class I
(general controls), class II (special controls), and class III
(premarket approval).
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices) are
automatically classified by section 513(f)(1) of the FD&C Act into
class III without any FDA rulemaking process. Those devices remain in
class III and require premarket approval unless, and until, the device
is reclassified into class I or II, or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and 21 CFR part 807.
    A postamendments device that has been initially classified in class
III under section 513(f)(1) of the FD&C Act may be reclassified into
class I or class II under section 513(f)(3) of the FD&C Act. Section
513(f)(3) of the FD&C Act provides that FDA acting by order can
reclassify the device into class I or class II on its own initiative,
or in response to a petition from the manufacturer or importer of the
device. To change the classification of the device, the proposed new
class must have sufficient regulatory controls to provide reasonable
assurance of the safety and effectiveness of the device for its
intended use.
    Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent action where the reevaluation is made
in light of newly available regulatory authority (see Bell v. Goddard,
366 F.2d 177, 181 (7th Cir. 1966); Ethicon, Inc. v. FDA, 762 F. Supp.
382, 388-391 (D.D.C. 1991)), or in light of changes in ``medical
science'' (Upjohn v. Finch, 422 F.2d 944, 951 (6th Cir. 1970)). Whether
data before the Agency are old or new, the ``new information'' to
support reclassification under section 513(f)(3) of the FD&C Act must
be ``valid scientific evidence'', as defined in section 513(a)(3) of
the FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v.
FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Assoc. v. FDA, 766
F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1986)).
    FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the ``valid scientific
evidence'' upon which the Agency relies must be publicly available.
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
PMA (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c)). Section
510(m) of the FD&C Act provides that a class II device may be exempted
from the 510(k) premarket notification requirements, if the Agency
determines that premarket notification is not necessary to

reasonably assure the safety and effectiveness of the device.

II. Regulatory History of the Devices

    On June 30, 1988, FDA approved the first and only ultrasound
cyclodestructive device through its PMA process under section 515 of
the FD&C Act (21 U.S.C. 360e). On August 10, 1988 (53 FR 30101), FDA
announced a PMA order for Sonocare Inc.'s Model CST-100 Therapeutic
Ultrasound System (Sonocare CST-100) (Ref. 1). As of the date of
issuance of this proposed order, the Sonocare CST-100 is the only PMA
approved by FDA for this device type.

III. Device Description

    An ultrasound cyclodestructive device is a postamendments device
classified into class III under section 513(f)(1) of the FD&C Act. An
ultrasound cyclodestructive device is indicated for the treatment of
refractory glaucoma; it is intended for patients who are refractory to
or are poor candidates for laser or surgical treatment and fail to
achieve target intraocular pressures on maximally tolerated drug
therapy. The device is designed to reduce intraocular pressure by
producing a series of lesions in the ciliary body and trabecular
meshwork induced by high intensity focused ultrasound (HIFU) energy.
Different technologies, such as laser cyclodestruction to lower
intraocular pressure, have been studied since the 1970s (Refs. 2 and
3), which increases FDA's knowledge base for devices used to treat this
condition. As stated earlier in section II, FDA has approved only one
ultrasound cyclodestructive device through its PMA process under
section 515 of the FD&C Act (Ref. 4). More recently, reports in the
literature indicate that the HIFU technology has been modified and
currently studied in Europe for treatment of refractory glaucoma (Refs.
5 to 8). Based upon our review experience and consistent with the FD&C
Act and FDA's regulations, FDA believes that these devices should be
reclassified from class III into class II because there is sufficient
information to establish special controls that can provide reasonable
assurance of the device's safety and effectiveness.
    Conventional refractory glaucoma treatment modalities include
implantable aqueous shunts and valves, trabeculectomy and other
incisional glaucoma surgeries, cyclocryotherapy, as well as laser
transcleral cyclophotocoagulation. FDA currently regulates all of the
devices indicated for these procedures in a refractory glaucoma
population as class II devices, subject to 510(k) requirements.

IV. Proposed Reclassification

    On April 29, 2015, FDA published a document in the Federal Register
entitled ``Retrospective Review of Premarket Approval Application
Devices; Striking the Balance Between Premarket and Postmarket Data
Collection,'' in which FDA announced plans to consider reclassifying
ultrasound cyclodestructive devices identified with the LZR product
code from class III to class II (80 FR 23798) and requested comments.
FDA received no adverse comments regarding our proposed intent for LZR.
    In accordance with section 513(f)(3) of the FD&C Act and 21 CFR
part 860, subpart C, FDA is proposing to reclassify this postamendments
class III device into class II. FDA believes that there is sufficient
information available to FDA through peer-reviewed literature and
knowledge of similar devices to establish special controls that would
effectively mitigate the risks to health identified in section V.
Absent the special controls identified in this proposed order, general
controls applicable to the device are insufficient to provide
reasonable assurance of the safety and effectiveness of the device.
    FDA is proposing to create a separate classification regulation for
ultrasound cyclodestructive devices that will be reclassified from
class III to II. Under this proposed order, if finalized, the
ultrasound cyclodestructive devices will be identified as a
prescription device. As such, the prescription device must satisfy
prescription labeling requirements (see Sec.  801.109 (21 CFR 801.109),
Prescription devices). Prescription devices are exempt from the
requirement for adequate directions for use for the layperson under
section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and Sec.  801.5
(21 CFR 801.5), as long as the conditions of Sec.  801.109 are met
(referring to 21 U.S.C. 352(f)(1)). In this proposed order, if
finalized, the Agency has identified the special controls under section
513(a)(1)(B) of the FD&C Act that, together with general controls, will
provide a reasonable assurance of the safety and effectiveness for
ultrasound cyclodestructive devices.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act, if FDA determines that premarket notification
is not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary for ultrasound
cyclodestructive devices to provide reasonable assurance of safety and
effectiveness. Therefore, the Agency does not intend to exempt these
proposed class II devices from 510(k) requirements. Persons who intend
to market this type of device must submit to FDA a 510(k) and receive
clearance prior to marketing the device.
    This proposal, if finalized, will decrease regulatory burden and
will reduce private costs and expenditures required to comply with
Federal regulations. Specifically, regulated industry will no longer
have to submit a PMA but can instead submit a 510(k) to the Agency for
review prior to marketing their device. A 510(k) is a less burdensome
pathway to market a device, which typically results in a more timely
premarket review compared to a PMA and reduces the regulatory burden in
addition to providing more timely access of these types of devices to
patients.

V. Risks to Health

    After considering the information available to FDA through the
review submission, peer-reviewed literature, and knowledge of other
technologies indicated to treat the same refractory glaucoma patient
population (such as aqueous shunt and cryotherapy), FDA determined that
the probable risks to health associated with the use of ultrasound
cyclodestructive devices for treatment of refractory glaucoma are as
follows:
     Thermal Injury. Exposure of the ocular tissue to the HIFU
energy causes thermal damage of the tissue. The misdirection or
misalignment of the beam may cause temperature elevation in the non-
target ocular tissues and overall ocular tissue damage. Unsuitable
power and duration of the beam may also result in temperature
elevation, which may cause corneoscleral lesions including scleral
thinning, corneal ectasia and perforation, eyelid burns, corneal burns,
clouding of the cornea (haze) and lens (cataract formation), and
retinal and choroidal lesions.
     Physical Injury. Exposure of the ocular tissue to the HIFU
energy can cause physical damage to the ocular tissue due to cavitation
or other mechanical effects. These injuries could be caused by the
suboptimal selection of the treatment parameters, misalignment/
displacement of the probe during the treatment, device malfunction, or
other factors affecting stability of treatment. For example,
insonification of the zonular fibers may cause elongation or rupture of
ligaments, which can lead to a displacement of the lens.

     Post-treatment injury. Post-treatment injury from use of
the device may include intraocular inflammation (e.g., iritis,
uveitis), increased intraocular pressure in the immediate post-
treatment period, ciliary body hemorrhage, persistent or transient low
pressure, decreased visual acuity, worsening glaucoma, phthisis, pain/
discomfort, corneal edema, hyphema, retinal and choroidal
complications, etc.
     Electrical shock. While in operation, the device may
discharge electricity that could shock the user. Electrical shock can
be caused by use error or device malfunction.
     Electromagnetic interference. While in operation,
electromagnetic interferences from other devices operated in the same
environment may cause the device to malfunction, which could result in
patient's injury. In addition, the device may interfere with other
electrically powered devices, causing them to malfunction.
     Ocular irritation and corneal infections. Inadequate
biocompatibility of the eye contact components of the device can lead
to irritation of the ocular tissue. Inappropriately sterilized or
reprocessed eye contact components of the device can lead to
inflammation and corneal infections.

VI. Summary of Reasons for Reclassification

    FDA believes that the ultrasound cyclodestructive devices for
treatment of refractory glaucoma should be reclassified from class III
to class II in light of available information about the effectiveness
of these devices. There is sufficient information to establish special
controls for ultrasound cyclodestructive devices, in addition to
general controls, which can provide reasonable assurance of safety and
effectiveness of the device, as general controls themselves are
insufficient to provide reasonable assurance of its safety and
effectiveness. FDA believes that the risks to health associated with
ultrasound cyclodestructive devices for treatment of refractory
glaucoma can be mitigated with special controls and that these
mitigations will provide a reasonable assurance of its safety and
effectiveness.
    Based on a reconsideration of the available information and data,
FDA believes that there is valid scientific evidence of effectiveness
for ultrasound cyclodestructive devices to reduce intraocular pressure
intended for treatment of refractory glaucoma using ultrasound.

VII. Summary of Data Upon Which the Reclassification Is Based

    FDA believes that the identified special controls, in addition to
general controls, are necessary to provide reasonable assurance of
safety and effectiveness of these devices. Taking into account the
probable health benefits of the use of the device and the nature and
known incidence of the risks of the device, FDA, on its own initiative,
is proposing to reclassify this postamendments class III device into
class II. FDA has considered and analyzed the following information: An
inclusive search of the Agency's Manufacturer and User Facility Device
Experience (MAUDE) database, which shows no adverse events for
ultrasound cyclodestructive device type; no recalls have been received
for this device type; other technologies indicated to treat the same
refractory glaucoma patient population, such as aqueous shunt and
cryotherapy, and currently regulated as class II devices to compare the
probable risks (i.e., between the rate and severity of the adverse
events associated with these class II technologies and ultrasound
cyclodestructive procedures); and peer-reviewed publications (Refs. 5
to 12) to identify probable device risks (e.g., the types and rates of
adverse events) and mitigation strategies.

VIII. Proposed Special Controls

    FDA believes that the following special controls, together with
general controls, are necessary and sufficient to mitigate the risks to
health described in section V and provide a reasonable assurance of
safety and effectiveness for ultrasound cyclodestructive devices.
     Non-clinical performance testing of device features and
characteristics will demonstrate:
    [cir] The ability of the device to deposit controllable HIFU energy
to the target area to evoke the required level of thermal lesion.
    [cir] The design and geometry of the HIFU transducer and the output
characteristics of the HIFU generator, including operating frequency
and power, produce a small focal zone and a steep transition of energy
deposition between the focal zone and the untreated areas. In addition,
the total acoustic power radiated by the transducer(s), spatial
distribution of the ultrasound field (including compressional and
rarefactional pressure), and spatial peak, temporal-average intensity
will be evaluated. This may be accomplished by demonstrating compliance
with the standard International Electrotechnical Commission (IEC)
Technical Specification (TS) 62556: Ultrasonics--Field
characterization--Specification and measurement of field parameters for
high intensity therapeutic ultrasound (HITU) transducers and systems.
Thermal and physical (due to potential cavitation of gas bubbles)
safety analyses will also be evaluated.
    [cir] The appropriate alignment and focusing of the ultrasound beam
to the target tissue to minimize unintended damage to adjacent ocular
tissues.
    [cir] The function of all safety features built into the device,
including the energy monitoring system.
     Clinical performance data will validate device performance
and characterize ocular tissue thermal injuries, physical injury, and
postoperative adverse events by establishing the treatment parameters
for which the device is safe and effective.
     Electrical safety testing will minimize the risk of
electrical shock, thermal or physical injury to the patient and
healthcare provider. This may be accomplished by demonstrating
compliance with FDA-recognized consensus standard American National
Standards Institute (ANSI)/Association for the Advancement of Medical
Instrumentation (AAMI) 60601-1: Medical electrical equipment, Part 1:
General requirements for basic safety and essential performance.
     Electromagnetic compatibility testing ensures that
electromagnetic interferences do not cause device malfunction. It can
also provide assurance that electromagnetic interferences generated by
the device do not affect the other devices operated in the same
environment. This may be accomplished by demonstrating compliance with
FDA-recognized consensus standard IEC 60601-1-2: Medical electrical
equipment, Part 1-2: General requirements for safety. If the device
incorporates radiofrequency (RF) wireless technology to perform medical
functions and/or communicates medical data, testing will mitigate the
risks associated with interference or degradation when using RF
wireless technology. This may be accomplished by demonstrating
compliance with FDA-recognized consensus standard AAMI TIR69: Risk
Management of Radio-frequency Wireless Coexistence for Medical Devices
and Systems (risk assessment) and ANSI/Institute of Electrical and
Electronics Engineers (IEEE) C63.27: American National Standard for
Evaluation of Wireless Coexistence (coexistence testing).
     Software verification, validation, and hazard analysis is
necessary to

mitigate the risks of thermal and physical injury and ensures that
software performs as intended and potential software malfunctions do
not impact the safety or effectiveness of the device. If the device
incorporates internet network connectivity, testing will demonstrate
that cybersecurity concerns are mitigated (e.g., data integrity,
unauthorized access, etc.).
     Biocompatibility evaluation can help mitigate the risk of
ocular irritation and corneal infection by ensuring that the patient-
contacting components of the device are safe for contact with skin and
ocular tissue.
     Sterilization validation, for devices provided sterile,
and/or cleaning validation, for devices or components that are
reusable, help mitigate the risk of inflammation and corneal infections
(e.g., keratitis).
     The labeling will also include necessary information to
ensure safe and effective use of the ultrasound cyclodestructive device
and minimize probability of the ocular treatment-related adverse
events. Labeling needs to include sufficient information that will help
the patient and healthcare provider make an informed decision regarding
treatment-related adverse effects of the ultrasound cyclodestructive
treatment. For example, the labeling needs to include information
regarding the most common reported treatment-related injuries, which
may include intraocular inflammation (e.g., iritis, uveitis) and
increased intraocular pressure in the immediate post-treatment period.
Adverse event information related to ciliary body hemorrhage,
persistent low pressure, decreased visual acuity, worsening glaucoma,
phthisis, pain/discomfort, transient low pressure, corneal edema,
hyphema, retinal complications (such as cystoid macula edema), and
choroidal effusion or detachment need to be discussed. The labeling
will mitigate the risk associated with the intraoperative events, such
as pain/discomfort, and postoperative adverse events by providing
appropriate clinical information along with mitigation strategies
(e.g., retrobulbar or peribulbar anesthesia). Specifically, device
labeling must include:
    [cir] Appropriate warnings and precautions to ensure safe and
effective use of the device and minimize potential device malfunctions
and user errors.
    [cir] A summary of the clinical evaluation pertinent to use of the
device, including study outcomes and adverse events.
    [cir] Information regarding procedure parameters, proper
positioning of the HIFU transducer and its coupling with the eye, and
typical course of treatment to ensure the user can safely operate the
device.
    [cir] Validated reprocessing instructions to ensure the safe use of
reusable device components.
    [cir] Safety information regarding electrical safety and
electromagnetic compatibility to minimize risks to the patient and
users.
    Table 1 shows how FDA believes the risks to health identified and
described in section V will be mitigated by the proposed special
controls. This reclassification order and the identified special
controls, if finalized, would provide sufficient detail regarding FDA's
requirements to reasonably assure safety and effectiveness of
ultrasound cyclodestructive devices.

     Table 1--Risks to Health and Mitigation Measures for Ultrasound
                        Cyclodestructive Devices
------------------------------------------------------------------------
  Identified risk to health               Mitigation measures
------------------------------------------------------------------------
Thermal Injury...............  Non-clinical performance testing,
                                Clinical performance data, Electrical
                                Safety, Electromagnetic compatibility,
                                Software verification, validation, and
                                hazard analysis, Labeling.
Physical Injury..............  Non-clinical performance testing,
                                Clinical performance data, Electrical
                                safety, Electromagnetic compatibility,
                                Software verification, validation, and
                                hazard analysis, Labeling.
Post-treatment Injury........  Non-clinical performance testing,
                                Clinical performance data, Software
                                verification, validation, and hazard
                                analysis, Labeling.
Electrical Shock.............  Electrical safety, Labeling.
Electromagnetic Interference.  Electromagnetic compatibility, Labeling.
Ocular Irritation and Corneal  Biocompatibility evaluation, Sterility/
 Infections.                    reprocessing validation, Labeling.
------------------------------------------------------------------------

    In addition, FDA is proposing to limit these devices to
prescription use under Sec.  801.109. Prescription devices are exempt
from the requirement for adequate directions for use for the layperson
under section 502(f)(1) of the FD&C Act and Sec.  801.5, as long as the
conditions of Sec.  801.109 are met (referring to 21 U.S.C. 352(f)(1)).
Under 21 CFR 807.81, the device would continue to be subject to 510(k)
requirements.
    This reclassification order and the identified special controls, if
finalized, would provide sufficient detail regarding FDA's requirements
to reasonably assure safety and effectiveness of ultrasound
cyclodestructive devices for the treatment of refractory glaucoma. As
discussed below, the reclassification will be codified in 21 CFR
886.5350. FDA believes that adherence to the proposed special controls,
in addition to the general controls, is necessary to provide a
reasonable assurance of the safety and effectiveness of the devices.

IX. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

X. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed order contains no new
collections of information. Therefore, clearance by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520) is not required. This proposed order refers
to previously approved collections of information found in FDA
regulations. These collections of information are subject to review by
OMB under the PRA. The collections of information in 21 CFR part 807,
subpart E have been approved under OMB control number 0910-0120 and the
collections of information under 21 CFR part 801 have been approved
under OMB control number 0910-0485.

XI. Proposed Effective Date

    FDA proposes that any final order based on this proposal become
effective 30 days after the date of its publication in the Federal
Register.

XII. References

    The following references are on display at the Dockets Management
Staff (see ADDRESSES), and are available for viewing by interested
persons between

9 a.m. and 4 p.m., Monday through Friday; these are not available
electronically at https://www.regulations.gov as they are copyrighted
or are available through the website address. FDA has verified the
website addresses, as of the date this document publishes in the
Federal Register, but websites are subject to change over time.

1. PMA Database Reference for Sonocare. Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=319101.
2. Shields, M.B., ``Transcleral Diode Cyclophotocoagulation,'' in
Chen, T.C. (ed.), ``Surgical Techniques in Ophthalmology: Glaucoma
Surgery.'' Saunders Elsevier, 2008.
3. Chen, T.C., L.R. Pasquale, D.S. Walton, et al., ``Diode Laser
Transcleral Cyclophotocoagulation.'' International Ophthalmology
Clinics, 39(1):169-176, 1999.
4. Muratore, R.A., ``History of the Sonocare CST-100: The First FDA-
Approved HIFU Device.'' Therapeutic Ultrasound, 809:508-512, 2006.
5. Melamed, S., M. Goldenfeld, D. Cotlear, et al., ``High-Intensity
Focused Ultrasound Treatment in Refractory Glaucoma Patients:
Results at 1 Year of Prospective Clinical Study.'' European Journal
of Ophthalmology, 25(6):483-489, 2015.
6. Aptel, F., T. Charrel, C. Labon, et al., ``Miniaturized High-
Intensity Focused Ultrasound Device in Patients with Glaucoma: A
Clinical Pilot Study.'' Investigative Ophthalmology and Visual
Science, 52 (12):8747-8753, 2011.
7. Aptel, F. and C. Lafon, ``Therapeutic Applications of Ultrasound
in Ophthalmology.'' International Journal of Hyperthermia,
28(4):405-418, 2012.
8. Mastropasqua, R., V. Fasanella, A. Mastropasqua, et al., ``High-
Intensity Focused Ultrasound Circular Cyclocoagulation in Glaucoma:
A Step Forward for Cyclodestruction?'' Journal of Ophthalmology,
(2017), 1-14, 2017.
9. Burgess, SE, R.H. Silverman, D.J. Coleman, et al., ``Treatment of
Glaucoma with High Intensity Focused Ultrasound.'' Ophthalmology,
93:831-838, 1986.
10. Coleman, D.J., F.L. Lizzi, J. Driller, et al., ``Therapeutic
Ultrasound in the Treatment of Glaucoma. II. Clinical
Applications.'' Ophthalmology, 92:347-353, 1985.
11. Valtot, F., J. Kopel, and J. Haut, ``Treatment of Glaucoma with
High Intensity Focused Ultrasound.'' International
Ophthalmology,13:167-170, 1989.
12. Silverman, R.H., B. Vogelsang, M.J. Rondeau, et al.,
``Therapeutic Ultrasound for the Treatment of Glaucoma.'' American
Journal of Ophthalmology, 111:327-337, 1991.

List of Subjects in 21 CFR Part 886

    Medical devices, Ophthalmic goods and services.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 et seq., as amended) and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 886 be
amended as follows:

PART 886--OPHTHALMIC DEVICES

0
1. The authority citation for part 886 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  886.5350 to subpart F to read as follows:

Sec.  886.5350  Ultrasound cyclodestructive device.

    (a) Identification. An ultrasound cyclodestructive device is a
prescription device to reduce intraocular pressure by producing a
series of lesions in the ciliary body and trabecular meshwork induced
by high intensity focused ultrasound (HIFU) energy and that is intended
for treatment of refractory glaucoma.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The clinical performance data must demonstrate an adequate
safety profile and an appropriate reduction in intraocular pressure in
patients with refractory glaucoma and capture any adverse events
observed during clinical use.
    (2) Non-clinical performance testing of device features and
characteristics must demonstrate that the device performs as intended
under anticipated conditions of use. The following performance
characteristics must be tested:
    (i) Ultrasound field characteristics, which must include the total
acoustic power radiated by the transducer(s), the spatial distribution
of the ultrasound field (including compressional and rarefactional
pressure), and spatial-peak, temporal-average intensity;
    (ii) Thermal and physical safety characterization of the device;
and
    (iii) Simulated use testing to validate that the device performs as
intended under anticipated conditions of use, including eye movements
and positioning error.
    (3) Analysis/testing must demonstrate electrical safety in the
appropriate use-environment.
    (4) Analysis/testing must demonstrate electromagnetic compatibility
(EMC), including wireless coexistence (if applicable) in the
appropriate use-environment.
    (5) Software verification, validation, and hazard analysis must be
performed commensurate with the level of concern of the device.
    (6) The patient-contacting components must be demonstrated to be
biocompatible.
    (7) Performance data must demonstrate sterility of all patient-
contacting components labeled as sterile. If the device contains
reusable eye-contact components, the validation tests must demonstrate
adequate cleaning/reprocessing of these components.
    (8) Labeling must include:
    (i) A detailed description of the patient population for which the
device is indicated for use, as well as warnings, and precautions
regarding potential for device malfunction and use-error pertinent to
use of the device.
    (ii) A detailed summary of the clinical testing, including study
outcomes and adverse events.
    (iii) Information on how the device operates and the typical course
of treatment.
    (iv) Description of all main components of the device including
HIFU generator, transducer(s), and controls. The labeling must include
technical specification of the device including, but not limited to,
treatment frequency, total acoustic power delivered by transducer,
treatment duration, treatment zone, site targeting, power requirements,
weight, and physical dimensions of the device.
    (v) Where appropriate, validated methods and instructions for
reprocessing of any reusable components.
    (vi) Safe-use conditions for electrical safety and electromagnetic
compatibility.

    Dated: September 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20763 Filed 9-24-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: December 21, 2006 (Volume 71, Number 245)]
[Notices]
[Page 76714-76715]
[DOCID:fr21de06-110]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54917; File No. SR-NYSE-2006-45]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing of Proposed Rule Change Relating to Amendments to
Exchange Rule 638 Concerning Mediation

December 11, 2006.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that on June 22, 2006, the New York Stock Exchange LLC (``NYSE''
or the ``Exchange'') filed with the Securities and Exchange Commission
the proposed rule change as described in Items I, II, and III below,
which Items have been prepared by the NYSE. The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C.78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange is proposing amendments to Rule 638 concerning
mediation. The amendments are, in part, housekeeping in nature as they
remove references relating to an expired mediation pilot program and
reposition certain provisions of the rule. In addition, the proposed
amendments codify certain existing mediation procedures. The text of
the proposed rule change is available on the NYSE's Web site (http://www.nyse.com
), at the NYSE's principal office, and at the Commission's

Public Reference Room.

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

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

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

1. Purpose
    Mediation is offered by the Exchange to parties, on a voluntary
basis, both before and after an arbitration claim has been filed. A
neutral, impartial individual, who serves as the mediator, facilitates
discussion of the issues in an attempt to reach a settlement. The
mediator does not render a decision.
    In 1998, the Exchange adopted, on a pilot basis, Rule 638 to
provide for mandatory mediation in all intra-industry disputes and
voluntary mediation in all customer disputes for claims of $500,000 or
more. As an incentive for parties to use mediation, the pilot program
provided for the Exchange to pay the mediator's fee, up to $500 for a
single mediation session of up to four hours. In December 2000, the
pilot was amended to lower the threshold for customer disputes to
$250,000. The Exchange's experience with the pilot led to the
conclusion that mediation is most successful when parties enter into it
of their own accord. For this reason, the pilot was allowed to expire
on January 31, 2003. Thereafter, the Exchange adopted the current
mediation rules that provide for voluntary mediation pending
arbitration, as well as prior to arbitration.
    The proposal would remove references to the expired pilot program.
The proposed amendments would also codify certain existing mediation
procedures, including that: (1) The

mediator's fees and method of payment are subject to agreement of the
parties and the mediator, and all such fees and costs incurred in
mediation are the parties' responsibility; (2) an adjournment fee will
be assessed if an arbitration hearing is adjourned for purposes of the
parties pursuing mediation unless the fee is waived under Exchange Rule
617; (3) a mediator may not represent a party or act as an arbitrator
in an arbitration relating to the matter arbitrated, nor be called to
testify regarding the mediation in any proceeding; and (4) the
mediation is confidential and no record is kept of the proceeding, and,
except as may be required by law, the parties and mediator agree not to
disclose the substance of the mediation without the prior written
authorization of all parties to the mediation.
    In addition, the proposed rule would clarify that any party may
withdraw from mediation at any time prior to the execution of a
settlement agreement upon written notification to all other parties,
the mediator, and the Director of Arbitration. It also would clarify
that parties may select a mediator on their own or request a list of
potential mediators from the Exchange, and that, upon request of any
party, the Director of Arbitration would send the parties a list of
five potential mediators together with the mediators' biographical
information described in Rule 608. At that time, any party to the
mediation would be able to request additional names from the Director
of Arbitration. The proposed rule also would provide that the parties
shall advise the Exchange as to the name of the agreed-upon mediator.
In addition, it would clarify that once the parties agree to mediate,
the Exchange would facilitate the mediation, if requested, by
contacting the mediator selected and by assisting in making necessary
arrangements, as well as that parties to mediation may use the Exchange
meeting facilities in New York, when available, without charge.
2. Statutory Basis
    The proposed changes are consistent with Section 6(b)(5) \4\ of the
Act \5\ in that they promote just and equitable principles of trade by
ensuring that members and member organizations and the public have fair
and flexible alternatives for the resolution of their disputes.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78f(b)(5).
    \5\ 15 U.S.C. 78a.
---------------------------------------------------------------------------

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

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

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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) As the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (a) By order approve the proposed rule change, or
    (b) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

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

File Number SR-NYSE-2006-45 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NYSE-2006-45. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro/shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC. Copies of such filing also will be available for
inspection and copying at the principal office of the NYSE. 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-NYSE-2006-45 and should be
submitted at or before January 11, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E6-21818 Filed 12-20-06; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 105 (Monday, June 2, 2014)]
[Proposed Rules]
[Pages 31229-31231]
[FR Doc No: 2014-12740]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 79, No. 105 / Monday, June 2, 2014 / Proposed
Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0333; Directorate Identifier 2013-SW-025-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters (Previously
Eurocopter France) (Airbus Helicopters) Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Airbus Helicopters Model EC225LP, AS332C, AS332L, AS332L1, and AS332L2
helicopters. This proposed AD would require inspecting each TECALEMIT
flexible hydraulic hose (hose) installed in the main gearbox (MGB)
compartment and replacing the hose if a crack, cut, or other damage
exists. This proposed AD is prompted by reports about the loss of in-
flight hydraulic pressure on Eurocopter helicopters. The proposed
actions are intended to prevent loss of the hydraulic system and
consequently, loss of helicopter control.

DATES: We must receive comments on this proposed AD by August 1, 2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

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 this proposed AD, the European
Aviation Safety Agency (EASA) AD, the economic evaluation, any comments
received, and other information. The street address for the Docket
Operations Office (telephone<PHONE_NUMBER>) is in the ADDRESSES section.
Comments will be available in the AD docket shortly after receipt.
    For service information identified in this proposed AD, contact
Airbus Helicopters, Inc., 2701 N. Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at
http://www.airbushelicopters.com/techpub. You may review the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas
76137.

FOR FURTHER INFORMATION CONTACT: Rao Edupuganti, Aviation Safety
Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 2601
Meacham Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2013-0069, dated March 18, 2013,
to correct an unsafe condition for Eurocopter (now Airbus Helicopters)
Model AS332C, AS332C1, AS332L, AS332L1, AS332L2, and EC225LP
helicopters. EASA advises that in-flight losses of hydraulic pressure
were reported on these helicopters because of ``significant'' tears on
the protection sheath of MGB hydraulic flexible ``pipes'' manufactured
by TECALEMIT. This condition could lead to simultaneous left-hand and
right-hand hydraulic system leakage, loss of the hydraulic system, and
consequently, loss of helicopter control could occur, EASA advises.

FAA's Determination

    These helicopters have been approved by the aviation authority of
France and are approved for operation in the United States. Pursuant to
our bilateral agreement with France, EASA, its technical
representative, has notified us of the unsafe condition described in
its AD. We are proposing this AD because we evaluated all known
relevant information and determined that an unsafe condition is likely
to exist or develop on other products of the same type design.

Related Service Information

    Eurocopter issued Service Bulletin (SB) No. EC225-05-027, Revision
1, dated July 17, 2013, for Model EC225LP helicopters and SB No. AS332-
05.00.92, Revision 1, dated July 17, 2013, for Model AS332C, AS332C1,
AS332L, AS332L1, AS332L2 and military Model AS332B, AS332B1, AS332F1,
AS332M and AS332M1 helicopters. The SBs state Eurocopter received a
report concerning the loss of pressure in the left-hand hydraulic
system in-flight. Hydraulic fluid was found in the cabin, though the
flight was completed without further incident. An examination of the
hydraulic system showed that the hose located between the forward
servo-

control and the hydraulic manifold had burst. Further investigations
have shown corrosion on the metal braid located under the fire-
resistant sheath of hoses manufactured by TECALEMIT. The corrosion may
be caused by the deterioration or gaping of the fire-resistant sheath
at the hose ends, enabling humidity to enter between the sheath and the
metal braid. Eurocopter recommends inspecting the hoses regardless of
their manufacturer. As a result, the SBs require checking each hose for
a notch, tear, crack, or friction mark, measuring any damage found, and
replacing any hose that has damage.

Proposed AD Requirements

    This proposed AD would require: Within 110 hours time-in-service
(TIS) and every 110 hours TIS thereafter, visually inspecting each
TECALEMIT hose installed in the MGB compartment. If there is a cut or
crack in the hose sheath that allows you to see the metal braid
underneath, replace the hose before further flight. If there is a cut,
crack or other damage in the hose on the right hand hydraulic system
that does not allow you to see the metal braid underneath, replace the
hose with an airworthy hose within 300 hours TIS. If there is a cut,
crack or other damage in the hose on the left hand hydraulic system
that does not allow you to see the metal braid underneath, replace the
hose with an airworthy hose within 600 hours TIS.

Differences Between the Proposed AD and the EASA AD

    The EASA AD requires a one-time inspection, while the proposed AD
would require that the inspection of the hoses be repeated every 110
hours TIS. The EASA AD requires that if severe damage is found in a
hose on the right hand hydraulic system then the hose be replaced
before the next flight, while the proposed AD would require this
regardless of whether the hose is on the right hand or left hand
hydraulic system. The EASA AD applies to Airbus Helicopters Model
AS332C1 helicopter. The proposed AD would not because Model AS332C1
helicopters have no FAA type certificate. The EASA had sets some
compliance times based on months. We set compliance times based only on
hours TIS.

Costs of Compliance

    We estimate that this proposed AD would affect 19 helicopters of
U.S. Registry and that labor costs average $85 a work-hour. Based on
these estimates, we expect the following costs:
    Inspecting the hoses installed in a MGB compartment would require
1.5 work-hours for a labor cost of about $128 per helicopter, $2,432
for the U.S. fleet.
    Replacing a hose would require 2.5 work-hours for a labor cost of
about $213. Parts would cost $2,000 for a total cost of $2,213 per
helicopter.

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 proposed regulation is
within the scope of that authority because it addresses an unsafe
condition that is likely to exist or develop on products identified in
this rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

 Airbus Helicopters (Previously Eurocopter France) (Airbus
Helicopters): Docket No. FAA-2014-0333; Directorate Identifier 2013-
SW-025-AD.

(a) Applicability

    This AD applies to Airbus Helicopters Model EC225LP, AS332C,
AS332L, AS332L1, and AS332L2 helicopters with a TECALEMIT main gear
box (MGB) hydraulic flexible hose (hose) installed, certificated in
any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as loss of hydraulic
pressure because of the failure of a hose. This condition could
result in loss of the hydraulic system and consequently, loss of
helicopter control.

(c) Comments Due Date

    We must receive comments by August 1, 2014.

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    (1) Within 110 hours time-in-service (TIS), and thereafter at
intervals not to exceed 110 hours TIS, visually inspect each
TECALEMIT hose installed in the MGB compartment for a cut, crack, or
other damage.
    (2) If there is a cut, crack, or any other damage in the hose
sheath that allows you to see the metal braid underneath when
pinching or twisting the sheath, replace the hose before further
flight.
    (3) If there is a cut, crack, or any other damage in the hose
sheath on the right hand hydraulic system that does not allow you to
see the metal braid underneath, replace the hose within 300 hours
TIS.
    (4) If there is a cut, crack, or any other damage in the hose
sheath on the left hand hydraulic system that does not allow you to
see the metal braid underneath, replace the hose within 600 hours
TIS.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Rao Edupuganti, Aviation Safety
Engineer, Safety Management

Group, Rotorcraft Directorate, FAA, 2601 Meacham Blvd., Fort Worth,
Texas 76137; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    (1) Eurocopter Service Bulletin (SB) No. EC225-05-027 and SB No.
AS332-05.00.92, both Revision 1 and dated July 17, 2013; Eurocopter
SB No. AS332-29.00.17 and SB No. EC225-29-005, both Revision 0 and
both dated June 21, 2013; and Eurocopter Information Notice No.
2506-I-29, Revision 2, dated July 24, 2013; which are not
incorporated by reference, contain additional information about the
subject of this AD. For service information identified in this AD,
contact Airbus Helicopters, Inc., 2701 N. Forum Drive, Grand
Prairie, TX 75052; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax
(972) 641-3775; or at http://www.airbushelicopters.com/techpub. You
may review the referenced service information at the FAA, Office of
the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room
663, Fort Worth, Texas 76137.
    (2) The subject of this AD is addressed in the European Aviation
Safety Agency (EASA) AD No. 2013-0069, dated March 18, 2013. You may
view the EASA AD on the Internet at http://www.regulations.gov in
Docket No. FAA-2014-0333.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 2910, Main
Hydraulic System.

    Issued in Fort Worth, Texas, on May 21, 2014.
Lance T. Gant,
Acting Directorate Manager, Rotorcraft Directorate, Aircraft
Certification Service.
[FR Doc. 2014-12740 Filed 5-30-14; 8:45 am]
BILLING CODE 4910-13-P


Results from subwatershed where monitoring continued in 2007:
Preliminary results from 2007 monitoring are provided in the enclosed
document.  Included are residue data (atrazine and TSS), flow and
weather data, and assessment of the atrazine residue results relative to
the screening threshold  levels of concern (CASM_Atrazine LOC and
threshold rolling average triggers).  The results show no exceedances of
any LOC in 2007, including in 5 monitored sites within the unique
Missouri Major Land Resource Area 113 (characterized by high percentages
of vulnerable soils along with the presence high slopes and an unusually
continuous and shallow claypan layer).


[Federal Register Volume 80, Number 193 (Tuesday, October 6, 2015)]
[Proposed Rules]
[Pages 60307-60310]
[FR Doc No: 2015-25271]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-3982; Directorate Identifier 2015-NM-098-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 717-200 airplanes. This proposed AD
was prompted by multiple reports of the vertical stabilizer leading
edge showing signs of fastener distress. This proposed AD would require
a detailed inspection for any distress of the vertical stabilizer
leading edge skin, and related investigative and corrective actions, if
necessary. This proposed AD would also require, for certain airplanes,
repetitive detailed inspections of the spar cap for any loose and
missing fasteners, repetitive high frequency eddy current (HFEC) and
radiographic testing (RT) inspections of the spar cap for any crack,
and related investigative and corrective actions, if necessary. We are
proposing this AD to detect and correct any crack in the vertical
stabilizer leading edge and front spar cap, which may result in the
structure becoming unable to support limit load, and may lead to the
loss of the vertical stabilizer.

DATES: We must receive comments on this proposed AD by November 20,
2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
3855 Lakewood Boulevard, MC D800-0019, Long Beach, CA 90846-0001;
telephone:<PHONE_NUMBER>, extension 2; fax:<PHONE_NUMBER>; Internet
https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available on the
Internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2015-3982.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
3982; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday,

except Federal holidays. The AD docket contains this proposed AD, the
regulatory evaluation, any comments received, and other information.
The street address for the Docket Office (phone:<PHONE_NUMBER>) is in
the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Eric Schrieber, Aerospace Engineer,
Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification
Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone:
562-627-5348; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2015-3982;
Directorate Identifier 2015-NM-098-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We have received reports of ten cases of the vertical stabilizer
leading edge on Model 717 airplanes showing signs of fastener distress
at the splice station Zfs=52.267. The affected Model 717 airplanes had
accrued 22,594 through 40,985 flight hours and 15,352 through 34,766
landing cycles. Similar reports have been found on Model MD-80 and MD-
90 airplanes. One Model MD-90 operator reported finding elongated
fastener holes at the leading edge of the vertical stabilizer at
station Zfs=52.267. The affected Model MD-90 airplane had accrued
15,555 flight-hours and 14,310 landing cycles. Two Model MD-80
operators reported finding a cracked vertical stabilizer skin at
station Zfs=52.267; subsequent inspections revealed a severed front
spar cap and a cracked front spar web. The affected Model MD-80
airplanes had accrued between 39,749 through 56,212 flight-hours and
32,176 through 44,001 landing cycles when the crack/anomalies were
found. Missing fasteners or evidence of elongated fastener holes may be
considered an indication that there are undetected cracks in the
underlying vertical stabilizer structure. Boeing investigation
determined that high loading occurrences, such as, but not limited to,
in-flight turbulence can adversely impact the fasteners and loading at
the leading edge of the vertical stabilizer.
    This condition, if not corrected, could result in the structure
unable to support limit load, and may lead to the loss of the vertical
stabilizer.

Other Relevant Rulemaking

    On May 31, 2011, we issued AD 2011-12-12, Amendment 39-16719 (76 FR
35342, June 17, 2011), for certain The Boeing Company Model MD-90-30
airplanes. That AD requires a detailed inspection to detect distress
and existing repairs to the leading edge structure of the vertical
stabilizer at the splice at station Zfs=52.267; repetitive inspections
for cracking in the front spar cap forward flanges of the vertical
stabilizer, and either the aft flanges or side skins; repetitive
inspections for loose and missing fasteners; and related investigative
and corrective actions if necessary. We issued that AD to detect and
correct such cracking damage, which could result in the structure being
unable to support limit load, and could lead to the loss of the
vertical stabilizer.
    On July 1, 2011, we issued AD 2011-15-01, Amendment 39-16748 (76 FR
41651, July 15, 2011), for certain The Boeing Company Model DC-9-81
(MD-81), DC-9-82 (MD-82), DC-9-83 (MD-83), DC-9-87 (MD-87), and MD-88
airplanes. That AD requires a detailed inspection to detect distress
and existing repairs to the leading edge structure of the vertical
stabilizer at the splice at station Zfs=52.267; repetitive inspections
for cracking in the front spar cap forward flanges of the vertical
stabilizer, and either the aft flanges or side skins; repetitive
inspections for loose and missing fasteners; and related investigative
and corrective actions if necessary. We issued that AD to detect and
correct such cracking damage, which could result in the structure being
unable to support limit load, and could lead to the loss of the
vertical stabilizer.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 717-55A0012, dated June
12, 2015. The service information describes procedures for a detailed
inspection for any distress of the vertical stabilizer leading edge
skin, a detailed inspection for any loose and missing fasteners of the
spar cap, HFEC and RT inspections of the spar cap for any crack, and
related investigative and corrective actions. This service information
is reasonably available because the interested parties have access to
it through their normal course of business or by the means identified
in the ADDRESSES section of this NPRM.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously, except as discussed
under ``Differences Between this Proposed AD and the Service
Information.''
    The phrase ``related investigative actions'' is used in this
proposed AD. ``Related investigative actions'' are follow-on actions
that (1) are related to the primary action, and (2) further investigate
the nature of any condition found. Related investigative actions in an
AD could include, for example, inspections.
    The phrase ``corrective actions'' is used in this proposed AD.
``Corrective actions'' are actions that correct or address any
condition found. Corrective actions in an AD could include, for
example, repairs.

Differences Between This Proposed AD and the Service Information

    The service bulletin specifies to contact the manufacturer for
instructions on how to repair certain conditions, but this proposed AD
would require repairing those conditions in one of the following ways:
     In accordance with a method that we approve; or
     Using data that meet the certification basis of the
airplane, and that have been approved by the Boeing Commercial
Airplanes Organization Designation Authorization (ODA) whom we have
authorized to make those findings.

Costs of Compliance

    We estimate that this proposed AD affects 106 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost      Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspections for distress.........  11 work-hours x $85              $0  $935 per inspection  $99,110 per
                                    per hour = $935                      cycle.               inspection cycle.
                                    per inspection
                                    cycle.
Repetitive inspections for         7 work-hours x $85                0  $595 per inspection  $63,070 per
 cracking and loose and missing     per hour = $595                      cycle.               inspection cycle.
 fasteners.                         per inspection
                                    cycle.
----------------------------------------------------------------------------------------------------------------

    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this proposed
AD.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2015-3982; Directorate Identifier
2015-NM-098-AD.

(a) Comments Due Date

    We must receive comments by November 20, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 717-200 airplanes,
certificated in any category, as specified in Boeing Alert Service
Bulletin 717-55A0012, dated June 12, 2015.

(d) Subject

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

(e) Unsafe Condition

    This AD was prompted by multiple reports of the vertical
stabilizer leading edge showing signs of fastener distress. We are
issuing this AD to detect and correct any crack in the vertical
stabilizer leading edge and front spar cap, which may result in the
structure becoming unable to support limit load, and may lead to the
loss of the vertical stabilizer.

(f) Compliance

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

(g) Initial Inspection

    Except as required by paragraph (i)(1) of this AD, at the
applicable time specified in paragraph 1.E., ``Compliance,'' of
Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015: Do a
detailed inspection for any distress of the vertical stabilizer
leading edge skin and do all applicable related investigative and
corrective actions, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 717-55A0012, dated
June 12, 2015, except as required by paragraph (i)(2) of this AD. Do
all applicable related investigative and corrective actions before
further flight.

(h) Repetitive Inspections

    For all airplanes on which no cracking was found during any
related investigative action required by paragraph (g) of this AD:
At the applicable time specified in paragraph 1.E., ``Compliance,''
of Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015:
Do the actions specified in paragraphs (h)(1) and (h)(2) of this AD
and do all applicable related investigative and corrective actions,
in accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 717-55A0012, dated June 12, 2015, except as
required by paragraph (i)(2) of this AD. Do all applicable related
investigative and corrective actions before further flight. Repeat
the applicable inspection thereafter at the intervals specified in
paragraph 1.E., ``Compliance,'' of Boeing Alert Service Bulletin
717-55A0012, dated June 12, 2015.
    (1) Do detailed inspections for any for any loose and missing
fasteners of the vertical stabilizer leading edge as specified in
``Part 4'' of Boeing Alert Service Bulletin 717-55A0012, dated June
12, 2015.
    (2) Do high frequency eddy current (HFEC) and radiographic
testing (RT) inspections for any crack of the vertical stabilizer
spar cap as specified in ``Part 2'' of Boeing Alert Service Bulletin
717-55A0012, dated June 12, 2015; or do HFEC inspections for any
crack of the vertical stabilizer spar cap as specified in ``Part 3''
of Boeing Alert Service Bulletin 717-55A0012, dated June 12, 2015.

(i) Exceptions to the Service Information

    (1) Where Boeing Alert Service Bulletin 717-55A0012, dated June
12, 2015 specifies a compliance time ``after the original issue date
of this service bulletin,'' this AD requires compliance within the
specified compliance time after the effective date of this AD.
    (2) If any crack is found during any inspection required by this
AD, and Boeing Alert Service Bulletin 717-55A0012, dated June 12,
2015, specifies to contact Boeing for appropriate action: Before
further flight, repair using a method approved in accordance with
the procedures specified in paragraph (j) of this AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. In accordance
with 14 CFR 39.19, send your request to your principal inspector or
local Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (k)(1) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Los Angeles ACO, to
make those findings. For a repair method to be approved the repair
must meet the certification basis of the airplane and the approval
must specifically refer to this AD.

(k) Related Information

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

    Issued in Renton, Washington, on September 27, 2015.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-25271 Filed 10-5-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 43 (Thursday, March 5, 2015)]
[Notices]
[Page 12057]
[FR Doc No: 2015-05108]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Meeting; RTCA Program Management Committee

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

ACTION: Notice of RTCA Program Management Committee meeting.

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of RTCA Program Management Committee.

DATES: The meeting will be held March 24th 2015 from 8:30 a.m.-3:30
p.m.

ADDRESSES: The meeting will be held at RTCA, Inc., 1150 18th Street,
NW., Suite 910, Washington, DC, 20036.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-
9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a Program Management Committee meeting. The agenda
will include the following:

March 24th

 WELCOME AND INTRODUCTIONS
 REVIEW/APPROVE Meeting Summary
    [cir] December 16, 2014, RTCA Paper No. 030-14/PMC-1296
 PUBLICATION CONSIDERATION/APPROVAL
    [cir] Final Draft, New Document, Minimum Operational Performance
Standards for Flight Information Services--Broadcast (FIS-B) with the
Universal Access Transceiver (UAT), prepared by SC-206
    [cir] Final Draft, Supplement to New Document, Minimum Operational
Performance Standards for Flight Information Services--Broadcast (FIS-
B) with the Universal Access Transceiver (UAT), Test Procedures/
Electronic File only, prepared by SC-206
    [cir] Final Draft, New Document, Enhanced Flight Vision Systems and
Synthetic Vision Systems, prepared by SC-213
    [cir] Final Draft, Change 4 to DO-210D, Minimum Operational
Performance Standards for Geosynchronous Orbit Aeronautical Mobile
Satellite Services (AMSS) Avionics, prepared by SC-222
 INTEGRATION and COORDINATION COMMITTEE (ICC)
 ACTION ITEM REVIEW
    [cir] PMC Ad Hoc--Standards Overlap and Alignment--Discussion--
Workshop Status.
    [cir] RTCA Policy on Propriety Information--Discussion--Update
 DISCUSSION
    [cir] SC-147--Traffic Alert and Collision Avoidance System--Co-
Chair Nomination--Review/Approve
    [cir] SC-214--Standards for Air Traffic Data ommunication
Services--Discussion--Revised Terms of Reference (TOR)
    [cir] SC-216--Aeronautical Systems Security--Discussion--Revised
TOR
    [cir] SC-224--Airport Security Access Control Systems--Discussion--
Revised TOR--Development of Operational Guidelines
    [cir] SC-225--Rechargeable Lithium Batteries and Battery Systems--
Status--Revised TOR--Discussion
    [cir] SC-227--Standards of Navigation Performance--Discussion--
Revised TOR
    [cir] SC-229--406 MHz Emergency Locator Transmitters (ELTs)--In
Reference To TOR Discussion--Aircraft Tracking and In-Flight Triggering
    [cir] SC-230--Airborne Weather Detection--Discussion--Revised TOR
    [cir] SC-234--Portable Electronic Devices--Discussion--Status
Update
    [cir] Wake Vortex Tiger Team--Discussion--White Paper--Progress
Status
    [cir] Design Assurance Guidance for Airborne Electronic Hardware--
Status--Possible New Special Committee to Update RTCA DO-254
    [cir] NAC--Status Update
    [cir] FAA Actions Taken on Previously Published Documents--Report
    [cir] Special Committees--Chairmen's Reports and Active Inter-
Special Committee Requirements Agreements (ISRA)--Review
    [cir] European/EUROCAE Coordination--Status Update
    [cir] RTCA Award Nominations--Consideration/Approval of Nominations
 OTHER BUSINESS
 SCHEDULE for COMMITTEE DELIVERABLES and NEXT MEETING DATE

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on February 25, 2015.
Mohannad Dawoud,
Management Analyst, NextGen, Program Oversight and Administration,
Federal Aviation Administration.
[FR Doc. 2015-05108 Filed 3-4-15; 8:45 am]
 BILLING CODE 4910-13-P