[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Proposed Rules]
[Pages 24642-24648]
[FR Doc No: 2014-09909]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 884

[Docket No. FDA-2014-N-0298]

Effective Date of Requirement for Premarket Approval for Surgical
Mesh for Transvaginal Pelvic Organ Prolapse Repair

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
issuing a proposed administrative order to require the filing of a
premarket approval application (PMA) if the surgical mesh for
transvaginal pelvic organ prolapse (POP) repair device is reclassified
from class II to class III. The Agency is summarizing its proposed
findings regarding the degree of risk of illness or injury designed to
be eliminated or reduced by requiring the device to meet the statute's
PMA requirements and the benefit to the public from the use of the
device.

DATES: Submit either electronic or written comments on this proposed
order by July 30, 2014. FDA intends that, if a final order based on
this proposed order is issued, anyone who wishes to continue to market
the device will need to submit a PMA within 90 days of the effective
date of the final order or on the last day of the 30th

calendar month beginning after the month in which the classification of
the device in class III became effective, whichever occurs later. See
section VI for more information about submitting a PMA. See section X
for the effective date of any final order that may publish based on
this proposal.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2014-
N-0298, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2014-N-0298 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://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 Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Melissa Burns, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1646, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the
Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-
115), the Medical Device User Fee and Modernization Act of 2002 (Pub.
L. 107-250), the Medical Devices Technical Corrections Act of 2004
(Pub. L. 108-214), the Food and Drug Administration Amendments Act of
2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144), 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).
    Under section 513(d) of the FD&C Act, devices that were in
commercial distribution before the enactment of the 1976 amendments,
May 28, 1976 (generally referred to as preamendments devices), are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    A preamendments device that has been classified into class III and
devices found substantially equivalent by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) to such a preamendments device or to a device within that type
(both the preamendments and substantially equivalent devices are
referred to as preamendments class III devices) may be marketed without
submission of a PMA until FDA issues a final order under section 515(b)
of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval.
Section 515(b)(1) of the FD&C Act directs FDA to issue an order
requiring premarket approval for a preamendments class III device.
    Section 515(f) of the FD&C Act provides an alternative pathway for
meeting the premarket approval requirement. Under section 515(f),
manufacturers may meet the premarket approval requirement if they file
a notice of completion of a product development protocol (PDP) approved
under section 515(f)(4) of the FD&C Act and FDA declares the PDP
completed under section 515(f)(6)(B) of the FD&C Act. Accordingly, the
manufacturer of a preamendments class III device may comply with a call
for PMAs by filing a PMA or a notice of completion of a PDP. In
practice, however, the option of filing a notice of completion of a PDP
has rarely been used. For simplicity, although the PDP option remains
available to manufacturers in response to a final order under section
515(b) of the FD&C Act, this document will refer only to the
requirement for filing and obtaining approval of a PMA.
    On July 9, 2012, FDASIA was enacted. Section 608(b) of FDASIA
amended section 515(b) of the FD&C Act, changing the process for
requiring premarket approval for a preamendments class III device from
rulemaking to an administrative order.
    Section 515(b)(1) of the FD&C Act sets forth the process for
issuing a final order. Specifically, prior to the issuance of a final
order requiring premarket approval for a preamendments class III
device, the following must occur: (1) Publication of a proposed order
in the Federal Register; (2) a meeting of a device classification panel
described in section 513(b) of the FD&C Act; and (3) consideration of
comments from all affected stakeholders, including patients, payors,
and providers. In September 2011, FDA held a meeting of a device
classification panel described in section 513(b) of the FD&C Act with
respect to surgical mesh for transvaginal POP repair. As explained
further in section V, this device classification panel meeting
discussed whether surgical mesh for transvaginal POP repair should be
reclassified or remain in class II, and the discussion included whether
PMAs should be required for these devices. The panel recommended that
the device be reclassified into class III because general controls and
special controls together would not be sufficient to provide reasonable
assurance of the safety and effectiveness of the device. The panel
consensus was that premarket clinical data are needed for surgical mesh
for transvaginal POP repair, and that each individual mesh device
should be evaluated against a control arm of traditional ``native
tissue'' (non-mesh) repair to demonstrate a reasonable assurance of
safety and effectiveness. FDA is not aware of new information that
would provide a basis for a different recommendation or findings.
Indeed, the additional information received since the 2011 panel
meeting and discussed further in section V highlights the need to
review these devices under a PMA and reinforces the recommendation and
findings of the panel.
    Section 515(b)(2) of the FD&C Act provides that a proposed order to
require premarket approval shall contain: (1) The proposed order, (2)
proposed findings with respect to the degree of risk of illness or
injury designed to be eliminated or reduced by

requiring the device to have an approved PMA and the benefit to the
public from the use of the device, (3) an opportunity for the
submission of comments on the proposed order and the proposed findings,
and (4) an opportunity to request a change in the classification of the
device based on new information relevant to the classification of the
device.
    Section 515(b)(3) of the FD&C Act provides that FDA shall, after
the close of the comment period on the proposed order, consideration of
any comments received, and a meeting of a device classification panel
described in section 513(b) of the FD&C Act, issue a final order to
require premarket approval or publish a document terminating the
proceeding together with the reasons for such termination. If FDA
terminates the proceeding, FDA is required to initiate reclassification
of the device under section 513(e) of the FD&C Act, unless the reason
for termination is that the device is a banned device under section 516
of the FD&C Act (21 U.S.C. 360f).
    A preamendments class III device may be commercially distributed
without a PMA until 90 days after FDA issues a final order requiring
premarket approval for the device, or 30 months after classification of
the device in class III under section 513 of the FD&C Act becomes
effective, whichever is later. Elsewhere in this issue of the Federal
Register, FDA is proposing an order to reclassify surgical mesh for
transvaginal POP repair from class II to class III. Therefore, assuming
the reclassification order and the order to require PMAs are finalized,
the date by which a PMA for surgical mesh for transvaginal POP repair
must be filed will depend on the date the final reclassification order
becomes effective and the date the final order to require PMAs is
issued. If a PMA is not filed for such device by the later of the two
dates specified in section 501(f)(2)(B) of the FD&C Act (21 U.S.C.
351(f)(2)(B)) (i.e., the 90th day after the date the order to require
PMAs is issued and the last day of the 30th calendar month beginning
after the month in which the classification in class III becomes
effective), then the device would be deemed adulterated under section
501(f) of the FD&C Act unless the device is distributed for
investigational use under an approved application for an
investigational device exemption (IDE).
    In accordance with section 515(b) of the FD&C Act, interested
persons are being offered the opportunity to request reclassification
of surgical mesh for transvaginal POP repair.

II. Regulatory History of the Device

    Surgical mesh is a preamendments device classified into class II
(Sec.  878.3300 (21 CFR 878.3300)). Beginning in 1992, FDA cleared
premarket notification (510(k)) submissions for surgical mesh indicated
for transvaginal POP repair under the general surgical mesh
classification regulation Sec.  878.3300. FDA has cleared over 100
510(k) submissions for surgical mesh with a POP indication. Elsewhere
in this issue of the Federal Register, FDA is proposing to reclassify
this device into class III under section 513(e) of the FD&C Act.

III. Dates New Requirements Apply

    Assuming FDA finalizes the order proposing reclassification of
surgical mesh for transvaginal POP repair this device will be
classified into class III. In accordance with sections 501(f)(2)(B) and
515(b) of the FD&C Act, FDA is proposing to require that a PMA be filed
with the Agency by the last day of the 30th calendar month beginning
after the month in which the classification of the device in class III
became effective, or on the 90th day after the date of the issuance of
a final order under 515(b), whichever is later. An applicant whose
surgical mesh for transvaginal POP repair was legally in commercial
distribution before May 28, 1976, or whose surgical mesh for
transvaginal POP repair has been found to be substantially equivalent
prior to the issuance of a final order under section 515(b), will be
permitted to continue marketing such class III device during FDA's
review of the PMA, provided that a PMA is timely filed. FDA intends to
review any PMA for the device within 180 days. FDA cautions that, under
section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into
an agreement to extend the review period for a PMA beyond 180 days
unless the Agency finds that ``. . . the continued availability of the
device is necessary for the public health.''
    FDA intends that, under Sec.  812.2(d) (21 CFR 812.2(d)), the
publication in the Federal Register of any final order based on this
proposal will include a statement that, as of the date on which the
filing of a PMA is required, the exemptions in Sec.  812.2(c)(1) and
(2) from the requirements of the IDE regulations for preamendments
class III devices will cease to apply to any device that is subject to
the final order and that is: (1) Not legally on the market on or before
that date or (2) legally on the market on or before that date but for
which a PMA is not filed by that date, or for which PMA approval has
been denied or withdrawn.
    If a PMA for a class III device is not filed with FDA within 90
days of the date of issuance of the final order requiring premarket
approval for the device or 30 months after the classification of the
device into class III, whichever is later, commercial distribution of
the device must cease. The device may be distributed for
investigational use only if the requirements of the IDE regulations in
part 812 are met. The requirements for investigational use of
significant risk devices include submitting an IDE application to FDA
for review and approval. An approved IDE is required to be in effect
before an investigation of the device may be initiated or continued
under Sec.  812.30. FDA, therefore, recommends that IDE applications be
submitted to FDA at least 30 days before the date a PMA is required to
be filed to avoid interrupting investigations.

IV. Device Subject to This Proposal

    Surgical mesh for transvaginal POP repair can be placed abdominally
or transvaginally to repair POP. When placed transvaginally, surgical
mesh can be placed in the anterior vaginal wall to aid in the
correction of cystocele (anterior repair), in the posterior vaginal
wall to aid in correction of rectocele (posterior repair), or attached
to the vaginal wall and pelvic floor ligaments to correct uterine
prolapse or vaginal apical prolapse (apical repair). These devices are
made of synthetic material, non-synthetic material, or a combination of
both. They are marketed as either stand alone mesh products or mesh
kits (i.e., the product includes mesh and instrumentation to aid
insertion, placement, fixation, and/or anchoring).
    Elsewhere in this issue of the Federal Register, FDA is proposing
to identify surgical mesh for transvaginal POP repair in the new Sec.
884.5980 (21 CFR 884.5980) in the following way: Surgical mesh for
transvaginal POP repair is a prescription device intended to reinforce
soft tissue in the pelvic floor. This device is a porous implant that
is synthetic, non-synthetic, or both. This device does not include
surgical mesh for other intended uses (see Sec.  878.3300).

V. Proposed Findings With Respect to Risks and Benefits for Surgical
Mesh for Transvaginal POP Repair

    As required by section 515(b) of the FD&C Act, FDA is publishing
its proposed findings regarding: (1) The degree of risk of illness or
injury designed to be eliminated or reduced by requiring that these
devices have an

approved PMA and (2) the benefits to the public from the use of the
devices.
    These findings are based on the reports and recommendations of the
Obstetrics and Gynecological Devices Panel from the meeting on
September 8-9, 2011, and any additional information that FDA has
obtained. Additional information regarding the risks as well as the
classification of this device can be found in section V.3 as well as in
the proposed order, published elsewhere in this issue of the Federal
Register, proposing to reclassify these devices into class III. The
device has the potential to benefit the public by aiding in the
correction of cystocele (anterior repair), rectocele (posterior
repair), uterine prolapse, or vaginal apical prolapse (apical repair).
The risks associated with the device include perioperative risks (organ
perforation or injury and bleeding); mesh exposure; mesh extrusions;
vaginal scarring, shrinkage, and tightening; pelvic pain; infection; de
novo dyspareunia; de novo voiding dysfunction (e.g., incontinence);
neuromuscular problems (including groin and leg pain); recurrent
prolapse; and resurgery.

A. Summary of Data

    In October 2008, as a result of over 1,000 adverse events received,
FDA issued a Public Health Notification (PHN) informing clinicians and
their patients of the adverse event findings related to use of
urogynecologic surgical mesh (Ref. 1). The PHN also provided
recommendations for clinicians on how to mitigate the risks associated
with these devices and information for their patients. On July 13,
2011, based on an updated adverse event search, FDA issued a Safety
Communication entitled ``UPDATE on Serious Complications Associated
With Transvaginal Placement of Surgical Mesh for Pelvic Organ
Prolapse'' (Ref. 2).
    The continued reports of adverse events also prompted FDA to
consider other available information regarding the use of surgical mesh
for transvaginal POP repair and to evaluate whether the classification
of this device type should be reconsidered. FDA systematically
evaluated the peer-reviewed scientific literature to revisit the
fundamental question of the safety and effectiveness of surgical mesh
for transvaginal POP repair. Based on its review, FDA believes that the
rate and severity of mesh-specific adverse events following vaginal POP
repair with mesh calls into question the safety of these devices.
Additionally, the available scientific literature does not provide
evidence that surgical mesh used for vaginal POP repair offers a clear
improvement in effectiveness when compared to traditional repair. FDA's
detailed evaluation of the scientific literature is discussed in FDA's
executive summary for the September 8-9, 2011, panel meeting which is
discussed further in this document (Ref. 3).
    On September 8-9, 2011, FDA convened a meeting of the Obstetrics
and Gynecological Devices Panel (the Panel), a device classification
panel described in section 513(b) of the FD&C Act, and referred the
proposed reclassification of surgical mesh for transvaginal POP repair
to the Panel for its recommendations on the proposed change in the
device's classification from class II to class III (Ref. 4). The Panel
consensus was that a favorable benefit-risk profile for surgical mesh
used for transvaginal POP repair has not been well established. The
Panel discussed the number of serious adverse events associated with
the use of these devices and concluded that their safety is in
question. In addition, the Panel consensus was that the effectiveness
of surgical mesh for transvaginal POP repair has not been well
established, and the device may not be more effective than traditional
non-mesh surgery, especially for the apical and posterior vaginal
compartments.
    Additionally, the Panel consensus was that premarket clinical data
are needed for surgical mesh for transvaginal POP repair, and the
majority of panel members recommended that each individual mesh be
evaluated against a control arm of traditional ``native-tissue'' (non-
mesh) repair to demonstrate a reasonable assurance of safety and
effectiveness for the device. Panel members emphasized that these
studies should evaluate both anatomic outcomes and patient satisfaction
and that the duration of followup should be at least 1 year, with
additional followup in a postmarket setting.
    The Panel's consensus was that each individual mesh device needed
to undergo a comparison to native tissue repair in order to establish a
reasonable assurance of safety and effectiveness. The Panel also
emphasized that additional work should be focused on patient labeling
and informed consent, including providing patients with benefit-risk
information on available treatment options for POP--surgical and non-
surgical options so patients understand long-term safety and
effectiveness outcomes. Panel members also recommended mandatory
registration of implanted devices, as well as surgeon training and
credentialing. They encouraged FDA to work with other stakeholders,
such as clinical professional organizations and industry, to use
existing databases and new data collection tools (e.g., registries) to
develop a meaningful database on postmarket clinical outcomes.

B. Risks to Health

    FDA has evaluated the risks to health associated with use of
surgical mesh indicated for transvaginal POP repair. In doing so, FDA
considered information from the reports and recommendations of the
Panel meeting on September 8, 2011 (Ref. 4), the adverse event reports
for these devices in FDA's Manufacturer and User Facility Device
Experience Database, and the published scientific literature which is
discussed in FDA's executive summary for the September 2011 Panel
meeting (Ref. 3). Based on this information, FDA has identified the
following risks:
    1. Perioperative risks: Organ perforation or injury and bleeding
(including hemorrhage/hematoma)
    2. Vaginal mesh exposure: Clinical sequelae include pelvic pain,
infection, de novo dyspareunia (painful sex for patient or partner), de
novo vaginal bleeding, atypical vaginal discharge, and the need for
additional corrective surgeries (possibly including mesh excision).
    3. Mesh extrusion (e.g., into the bladder or rectum): Clinical
sequelae include pelvic pain, infection, de novo dyspareunia, fistula
formation, and the need for additional corrective surgeries (possibly
including suprapubic catheter, diverting colostomy).
    4. Other risks that can occur without mesh exposure or extrusion:
Vaginal scarring, shrinkage, and tightening (possibly caused by mesh/
tissue contraction); pelvic pain; infection (including pelvic abscess);
de novo dyspareunia; de novo voiding dysfunction (e.g., incontinence);
recurrent prolapse; and neuromuscular problems (including groin and leg
pain).

C. Benefits of the Device

    Surgical mesh for transvaginal POP repair has the potential to
benefit the public by aiding in the correction of cystocele (anterior
repair), rectocele (posterior repair), uterine prolapse, or vaginal
apical prolapse (apical repair). These findings are based on the
reports and recommendations of the Panel meeting (Ref. 4), and the
published scientific literature, which is discussed in FDA's executive
summary for the Panel meeting (Ref. 3).

D. Summary of FDA Findings

    FDA tentatively concludes that surgical mesh for transvaginal POP

repair should be reclassified from class II to class III. FDA
tentatively agrees with the Panel's consensus that the safety and
effectiveness of this device type has not been established. FDA
tentatively concludes that insufficient information exists regarding
the risks and benefits of the device in order for FDA to determine that
general and special controls together will provide reasonable assurance
of the safety and effectiveness of surgical mesh intended for
transvaginal POP repair. In addition, FDA tentatively determines that
the risks to health identified previously in this document for the use
of surgical mesh for transvaginal POP repair, in the absence of an
established positive benefit-risk profile, present a potential
unreasonable risk of illness or injury. Further, because FDA
tentatively finds that there is insufficient valid scientific evidence,
as defined in Sec.  860.7 (21 CFR 860.7), for FDA to determine the
probable risks and the effectiveness of the device type, FDA is
proposing to require an individual demonstration that a reasonable
assurance of safety and effectiveness exists for each device within
this type. The manufacturer of each individual device will have the
opportunity to demonstrate the safety and effectiveness of the device
for its intended use by submitting a premarket approval application.

VI. PMA Requirements

    A PMA for surgical mesh for transvaginal POP repair would need to
include the information required by section 515(c)(1) of the FD&C Act.
Such a PMA should also include a detailed discussion of the risks
identified previously, as well as a discussion of the effectiveness of
the device for which premarket approval is sought. In addition, a PMA
must include all data and information on the following: (1) Any risks
known, or that should be reasonably known, to the applicant that have
not been identified in this document; (2) the effectiveness of the
device that is the subject of the application; and (3) full reports of
all preclinical and clinical information from investigations on the
safety and effectiveness of the device for which premarket approval is
sought.
    A PMA must include valid scientific evidence to demonstrate
reasonable assurance of the safety and effectiveness of the device for
its intended use (see Sec.  860.7(c)(2)). Valid scientific evidence is
evidence from well-controlled investigations, partially controlled
studies, studies and objective trials without matched controls, well-
documented case histories conducted by qualified experts, and reports
of significant human experience with a marketed device, from which it
can fairly and responsibly be concluded by qualified experts that there
is reasonable assurance of the safety and effectiveness of a device
under its conditions of use. Isolated case reports, random experience,
reports lacking sufficient details to permit scientific evaluation, and
unsubstantiated opinions are not regarded as valid scientific evidence
to show safety or effectiveness. (See Sec.  860.7(c)(2).)
    To present reasonable assurance of safety and effectiveness of
surgical mesh for transvaginal POP repair, FDA tentatively concludes
that manufacturers should provide the information summarized in this
document. In addition, FDA strongly encourages manufacturers to meet
with the Agency early through the presubmission program for any
assistance in preparation of their PMA.

A. Indications for Use

    Manufacturers should provide indications for use statements that
include the route of placement for the mesh (i.e., transvaginal), the
anatomical site of repair (e.g., anterior/apical, posterior/apical, or
total), and specify any instrumentation required for implantation.

B. Device Description

    A detailed description of the mesh design (e.g., material, material
source, colorants) and use (i.e., mode of operation), as well as a
brief description of the manufacturing processes, including a flowchart
that describes how the mesh is assembled, should be provided.
    If introducer instrumentation is packaged with the mesh, then a
detailed description of the introducer instrumentation (e.g., material,
material source, colorants) and the manufacturing processes for the
instrumentation should be provided. Instrumentation that is packaged
with the mesh will be reviewed in the PMA application. Introducer
instrumentation that is provided separately and not packaged with the
mesh will be reviewed separately in a 510(k) notification.

C. Sterilization and Shelf Life

    Manufacturers should provide data that demonstrates that the mesh
and the accessory introducer instrumentation retain their mechanical
characteristics following sterilization and for the entire length of
the intended shelf life. The mechanical characteristics for the mesh
include at minimum: Compliance (i.e., elastic modulus), tensile
strength, suture pullout strength, mesh arm(s) strength, burst
strength, and tear resistance. If the introducer instrumentation
includes a mesh-deployment mechanism, this mechanism should function
throughout the shelf life of the device.

D. Reprocessing

    If the introducer instrumentation is intended for reuse, the
manufacturer should provide data to validate the cleaning and
disinfection/sterilization instructions.

E. Biocompatibility

    Manufacturers should conduct biocompatibility testing on the
device, including the mesh implant and introducer instrumentation, to
fully characterize its safety profile prior to initiation of animal and
clinical studies. This includes appropriate testing as outlined in Blue
Book Memo G-95-1 ``Use of International Standard ISO-10993,
'Biological Evaluation of Medical Devices Part 1: Evaluation and
Testing''' (Ref. 5) (e.g., cytotoxicity, genotoxicity, hemolysis,
sensitization, irritation or intracutaneous reactivity, acute systemic
toxicity, subchronic toxicity, chronic toxicity, implantation and
materials-mediated pyrogenicity).

F. Preclinical Bench Testing

    Manufacturers should perform testing to obtain the following
information on the mesh implant: Thickness, weave characteristics
(i.e., woven or nonwoven), fiber type (i.e., monofilament or
multifilament) exact pore size, density, compliance (i.e., elastic
modulus), tensile strength, suture pullout strength, mesh arm(s)
strength, burst strength, and tear resistance.
    For devices composed of materials from animal sources,
manufacturers should provide information on the species and tissue from
which the animal material was derived, details on how the health of the
herd is maintained, and how the health of each animal is maintained.
Furthermore, manufacturers should test for residual cellular/DNA/
protein matter on animal-derived mesh.
    For devices containing degradable/absorbable components,
manufacturers should provide in vitro and in vivo degradation rate data
with supporting mechanical data (as described previously) to
demonstrate adequate strength over time.

G. Preclinical Animal Studies

    Manufacturers should conduct animal studies to evaluate in vivo
performance of mesh in an appropriate animal model. If designed
appropriately, these studies may also obviate the need for

separate implantation studies to assess biocompatibility as indicated
previously. The animal studies should be conducted for 6 months'
duration to evaluate shrinking and/or calcification of the mesh,
histology of the surrounding tissue, and extraction of the mesh. In
addition, implantation of the mesh should occur in an appropriate
anatomic location (i.e., not a subcutaneous pocket). Complete study
reports for all the preclinical studies should include, but not be
limited to: (1) A prospectively designed protocol and all protocol
amendments; (2) a detailed description of the study design (e.g.,
description of animal species/animal models, control and test articles
used, dose levels, detailed procedures for test article administration
and collection of all study protocol parameters); (3) results for all
parameters evaluated for each animal in the study; and (4) the analysis
and interpretation of the study data.

H. Premarket Clinical Studies

    FDA tentatively concludes that premarket clinical data is needed
for all surgical mesh indicated for transvaginal POP repair to
demonstrate a reasonable assurance of safety and effectiveness. FDA
anticipates that these data may need to be collected in a patient- and
evaluator-masked study that compares surgical mesh to a non-mesh
control (i.e., traditional native tissue transvaginal repair) with
respect to safety and effectiveness. This study should evaluate a
clinically relevant measure(s) of effectiveness (e.g., prolapse at or
above the hymenal ring, subjective cure, and quality of life, no
recurrent prolapse), key safety outcomes (e.g., serious adverse events,
defined as hospital readmission or return to operating room), urinary
and bowel function, sexual function, etc., as outcome measures. At
least 1 year of outcome data should be provided in the PMA and an
additional 2-4 years of followup should be conducted postmarket.
    FDA intends to consider proposals for different study designs that
meet the intent of the previously mentioned list and will decide on a
case-by-case basis whether each proposed study design is likely to
generate data adequate to support a PMA. FDA also intends to consider
the use of study data collected by manufacturers in response to FDA
issued postmarket surveillance study orders issued beginning on January
3, 2012, under section 522 of the FD&C Act (21 U.S.C. 360l) for
transvaginal POP mesh products that are already legally marketed.

I. Professional Labeling

    FDA would expect the professional (physician) labeling to include
the following elements:
     Indications for Use statement;
     Contraindications;
     Device description (e.g., material type, introducer
instrumentation included, and degradation rate when applicable);
     Images of the mesh and introducer instrumentation;
     Warnings;
     Precautions;
     Adverse event rates, including:
    [cir] Perioperative risks:
    [ssquf] Organ perforation or injury;
    [ssquf] Bleeding (including hemorrhage and hematoma);
    [cir] Mesh exposure in the vagina;
    [cir] Mesh extrusion into another organ;
    [cir] Pelvic pain;
    [cir] Infection (by type);
    [cir] de novo dyspareunia;
    [cir] Vaginal scarring, shrinkage, and tightening;
    [cir] de novo vaginal bleeding;
    [cir] Atypical vaginal discharge;
    [cir] Fistula formation;
    [cir] de novo voiding dysfunction (e.g., incontinence);
    [cir] Neuromuscular problems (including groin and leg pain);
    [cir] Revision/resurgery;
    [cir] Recurrent prolapse;
     Summary of clinical data; and
     Step-by-step instructions, with images, on proper
placement of the mesh.

J. Patient Labeling

    FDA would also expect patient labeling to be provided for each
device, and it should include, but not be limited to: (1) An
explanation of POP, including anatomical issues, causes, and symptoms;
a discussion regarding all available treatment options, including known
risks and benefits of mesh placement based on the results of the
clinical trial conducted; (2) a statement that surgical mesh is a
permanent implant; instructions for postoperative care; and (3) a
notice of availability of an FDA Safety Communication. Patient labeling
should also include a patient identification card that contains at a
minimum the following information: Device name and lot number; patient
name; date of implant; the type of repair performed (e.g., anterior or
posterior); and the name and contact information for implanting
physician and the device manufacturer.

VII. Opportunity To Request a Change in Classification

    Before requiring the filing of a PMA for a device, FDA is required
by section 515(b)(2)(D) of the FD&C Act to provide an opportunity for
interested persons to request a change in the classification of the
device based on new information relevant to the classification. Any
proceeding to reclassify the device will be under the authority of
section 513(e) of the FD&C Act.
    A request for a change in the classification of surgical mesh for
transvaginal POP repair devices is to be in the form of a
reclassification petition containing the information required by Sec.
860.123, including new information relevant to the classification of
the device. Interested persons may also submit a reclassification
petition related to the classification of the device to docket number
for the proposed order reclassifying surgical mesh for transvaginal POP
repair that is published elsewhere in this issue of the Federal
Register.

VIII. 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.

IX. Paperwork Reduction Act of 1995

    This proposed order refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
    The collections of information in 21 CFR part 807, subpart E, have
been approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 814, subpart B, have been approved under OMB
control number 0910-0231; the collections of information in part 812
have been approved under OMB control number 0910-0078; the collections
of information under 21 CFR part 822 have been approved under OMB
control number 0910-0449; and the collections of information under 21
CFR part 801 have been approved under OMB control number 0910-0485.

X. Proposed Effective Date

    FDA is proposing that any final order based on this proposal become
effective on the date of its publication in the Federal Register or at
a later date if stated in the final order.

XI. Codification of Orders

    Prior to the amendments by FDASIA, section 515(b) of the FD&C Act
provided for FDA to issue regulations to require approval of an
application for premarket approval for preamendments devices or devices
found substantially equivalent to preamendments devices. Section 515(b)
of the FD&C Act, as amended by FDASIA, provides for FDA to require
approval of an application for premarket approval for such devices by
issuing a final order, following the issuance of a proposed order in
the Federal Register. FDA will continue to codify the requirement for
an application for premarket approval, resulting from changes issued in
a final order, in the Code of Federal Regulations (CFR). Therefore,
under section 515(b)(1)(A) of the FD&C Act, as amended by FDASIA, in
this proposed order, we are proposing to require approval of an
application for premarket approval for surgical mesh for transvaginal
POP repair and, if this proposed order is finalized, we will make the
language in Sec.  884.5980 consistent with the final version of this
proposed order.

XII. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

XIII. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified all the Web site addresses in this reference section, but
we are not responsible for any subsequent changes to the Web sites
after this document publishes in the Federal Register.)

1. ``FDA Public Health Notification: Serious Complications
Associated With Transvaginal Placement of Surgical Mesh in Repair of
Pelvic Organ Prolapse and Stress Urinary Incontinence'', October 20,
2008, available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm.
2. ``FDA Safety Communication: UPDATE on Serious Complications
Associated With Transvaginal Placement of Surgical Mesh for Pelvic
Organ Prolapse,'' July 13, 2011, available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm.
3. ``FDA Executive Summary: Surgical Mesh for Treatment of Women
With Pelvic Organ Prolapse and Stress Urinary Incontinence,
Obstetrics & Gynecological Devices Advisory Committee Meeting'',
September 8-9, 2011, available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/ucm262488.htm.
4. FDA Meeting of the Obstetrics & Gynecological Devices Panel,
September 8-9, 2011, available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/ucm262488.htm.
5. Blue Book Memo G-95-1 ``Use of International Standard
ISO-10993, Biological Evaluation of Medical Devices Part 1:
Evaluation and Testing,'' May 1, 1995, available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080735.htm.

List of Subjects in 21 CFR Part 884

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 884 be amended as follows:

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

0
1. The authority citation for 21 CFR part 884 continues to read as
follows:

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

0
2. Add paragraph (c) to Sec.  884.5980, Subpart F, to read as follows:

Sec.  884.5980  Surgical mesh for transvaginal pelvic organ prolapse
repair.

* * * * *
    (c) Date premarket application approval or notice of completion of
a product development protocol is required. A premarket application
approval or notice of completion of a product development protocol for
a device is required to be filed with the Food and Drug Administration
on or before [90 DAYS AFTER DATE OF PUBLICATION OF FINAL ORDER FOR
PREMARKET APPLICATION OR 30 MONTHS AFTER DATE OF PUBLICATION OF FINAL
ORDER RECLASSIFYING INTO CLASS III, WHICHEVER IS LATER], for any
surgical mesh described in paragraph (a) of this section that was in
commercial distribution before May 28, 1976, or that has, on or before
[90 DAYS AFTER DATE OF PUBLICATION OF FINAL ORDER FOR PREMARKET
APPROVAL APPLICATIONS OR 30 MONTHS AFTER DATE OF PUBLICATION OF FINAL
ORDER RECLASSIFYING INTO CLASS III, WHICHEVER IS LATER] been found
substantially equivalent to a surgical mesh described in paragraph (a)
of this section that was in commercial distribution before May 28,
1976. Any other surgical mesh intended for transvaginal pelvic organ
prolapse repair shall have an approved premarket application or
declared completed product development protocol in effect before being
placed in commercial distribution.

    Dated: April 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09909 Filed 4-29-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Proposed Rules]
[Pages 52051-52052]
[FR Doc No: 2019-21286]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-0625; Airspace Docket No. 19-AWP-2]
RIN 2120-AA66

Proposed Amendment of Class E Airspace; Redding, CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace designated as
an extension to a Class D or Class E surface area, and Class E airspace
extending upward from 700 feet above the surface at Redding Municipal
Airport, Redding CA. This action also proposes to remove Class E
airspace extending upward from 1,200 feet above the surface as this
airspace is wholly contained within the Rogue Valley en route airspace
and duplication is not necessary. Additionally, this action proposes to
update the geographic coordinates of the airport to match the FAA's
database. Lastly, this action proposes to remove the Redding VOR/DME
and the Lassen NDB and the extensions associated with those
navigational aids from the legal description of the airspace. Removing
the VOR/DME and NDB simplifies the airspace's legal description. These
changes are necessary to accommodate airspace redesign for the safety
and management of Instrument Flight Rules (IFR) operations at the
airport.

DATES: Comments must be received on or before November 15, 2019.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1-800-647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2019-0625; Airspace Docket No. 19-AWP-2, at the beginning of your
comments. You may also submit comments through the internet at http://www.regulations.gov.
    FAA Order 7400.11D, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Matthew Van Der Wal, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S 216th Street, Des Moines, WA 98198; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend Class E airspace at Redding Municipal Airport,
Redding, CA, to ensure safety and management of Instrument Flight Rules
(IFR) operations at the airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Persons wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2019-0625;
Airspace

Docket No. 19-AWP-2''. The postcard will be date/time stamped and
returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA
98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11D, Airspace
Designations and Reporting Points, dated August 8, 2019, and effective
September 15, 2019. FAA Order 7400.11D is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11D lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) Part 71 by amending Class E airspace designated as
an extension to a Class D or Class E surface area within 2.3 miles west
and 2.5 miles east of the 193[deg] bearing from the Redding Municipal
Airport, extending from the 4.3-mile radius of the airport to 7.3 miles
south of the airport. This action also proposes to amend the Class E
airspace extending upward from 700 feet above the surface within a 6.8-
mile radius of the airport and within 1.1 miles west and 1 mile east of
the 360[deg] bearing from the airport, extending from the 6.8 mile
radius to 12.5 miles north of the airport and within 8.1 miles west and
4 miles east of the 193[deg] bearing extending from the airport to 16
miles south of the Redding Municipal Airport. Additionally, this action
proposes to remove Class E airspace extending upward from 1,200 feet
above the surface as this airspace is wholly contained within the Rogue
Valley en route airspace and duplication is not necessary. Lastly, this
action proposes to remove the Redding VOR/DME and the Lassen NDB and
the extensions associated with those navigational aids from the legal
description of the airspace. Removing the VOR/DME and NDB simplifies
the airspace's legal description.
    Class E airspace designations are published in paragraphs 6004 and
6005 of FAA Order 7400.11D, dated August 8, 2019, and effective
September 15, 2019, which is incorporated by reference in 14 CFR 71.1.
The Class E airspace designations listed in this document will be
published subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019, and
effective September 15, 2019, is amended as follows:

Paragraph 6004 Class E Airspace Areas Designated as an Extension to
a Class D or Class E Surface Area.

* * * * *

AWP CA E4 Redding, CA

Redding Municipal Airport, CA
    (Lat. 40[deg]30'32'' N, long. 122[deg]17'36'' W)

    That airspace extending upward from the surface within 2.3 miles
west and 2.5 miles east of the 193[deg] bearing from the airport,
extending from the 4.3-mile radius of airport to 7.3 miles south of
the Redding Municipal Airport. This Class E airspace area is
effective during the specific dates and times established in advance
by a Notice to Airmen. The effective date and time will thereafter
be continuously published in the Chart Supplement.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AWP CA E5 Redding, CA

Redding Municipal Airport, CA
    (Lat. 40[deg]30'32'' N, long. 122[deg]17'36'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.8-mile radius of the airport and within 1.1 miles west
and 1 mile east of the 360[deg] bearing from the airport, extending
from the 6.8 mile radius to 12.5 miles north of the airport and
within 8.1 miles west and 4 miles east of the 193[deg] bearing
extending from the airport to 16 miles south of the Redding
Municipal Airport.

    Issued in Seattle, Washington, on September 24, 2019.
Shawn M. Kozica,
Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2019-21286 Filed 9-30-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 79 (Friday, April 24, 2015)]
[Rules and Regulations]
[Pages 22893-22894]
[FR Doc No: 2015-09401]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2014-0537; Airspace Docket No. 13-AGL-38]

Establishment of Class E Airspace; Edgeley, ND

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action establishes Class E airspace at Edgeley, ND.
Controlled airspace is necessary to accommodate new Standard Instrument
Approach Procedures (SIAPs) at Edgeley Municipal Airport. The FAA is
taking this action to enhance the safety and management of Instrument
Flight Rules (IFR) operations for SIAPs at the airport.

DATES: Effective date: 0901 UTC, June 25, 2015. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

ADDRESSES: FAA Order 7400.9Y, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed on line at http://www.faa.gov/airtraffic/publications/. The Order is also available for
inspection at the National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, call 202-
741-6030, or go to http://www.archives.gov/federal_register/code_of_federal-regulations/ibr_locations.html.
    FAA Order 7400.9, Airspace Designations and Reporting Points, is
published yearly and effective on September 15. For further
information, you can contact the Airspace Policy and ATC Regulations
Group, Federal Aviation Administration, 800 Independence Avenue SW.,
Washington, DC 29591; telephone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Rebecca Shelby, Central Service
Center, Operations Support Group, Federal Aviation Administration,
Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone:
817-321-7740.

SUPPLEMENTARY INFORMATION:

History

    On October 8, 2014, the FAA published in the Federal Register a
notice of proposed rulemaking (NPRM) to establish Class E airspace for
SIAPs at Edgeley Municipal Airport, Edgeley, ND (79 FR 60793) Docket
No. FAA-2014-0537. Interested parties were invited to participate in
this rulemaking effort by submitting written comments on the proposal
to the FAA. No comments were received. Class E airspace designations
are published in paragraph 6005 of FAA Order 7400.9Y dated August 6,
2014, and effective September 15, 2014, which is incorporated by
reference in 14 CFR part 71.1. The Class E airspace designations listed
in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.9Y, airspace Designations and
Reporting Points, dated August 6, 2014, and effective September 15,
2014. FAA Order 7400.9Y is publicly available as listed in the
ADDRESSES section of this final rule. FAA Order 7400.9Y lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by establishing Class E airspace designated as a surface area
within a 6.5-mile radius of Edgeley Municipal Airport, Edgeley, ND.
Controlled airspace is necessary to accommodate new Standard Instrument
Approach Procedures at Edgeley Municipal Airport. The FAA is taking
this action to enhance the safety and management of IFR operations at
the airport.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is

certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it establishes controlled airspace at Edgeley Municipal Airport,
Edgeley, ND.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1E, ``Environmental Impacts: Policies and
Procedures'' paragraph 311a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

     Authority:  49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.9Y,
Airspace Designations and Reporting Points, dated August 6, 2014 and
effective September 15, 2014, is amended as follows:

Paragraph 6005 Class E Airspace areas extending upward from 700
feet or more above the surface of the earth.

* * * * *

AGL ND E5 Edgeley, ND [New]

Edgeley Municipal Airport, ND
    (Lat. 46[deg]20'59'' N., long. 098[deg]44'06'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Edgeley Municipal Airport.

    Issued in Fort Worth, TX, on April 14, 2015.
Walter Tweedy,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2015-09401 Filed 4-23-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: November 12, 2009 (Volume 74, Number 217)]
[Rules and Regulations]
[Page 58195-58200]
[DOCID:fr12no09-3]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-1039; Directorate Identifier 2009-CE-059-AD;
Amendment 39-16085; AD 2009-23-11]
RIN 2120-AA64

Airworthiness Directives; Empresa Brasileira de Aeronautica S.A.
(EMBRAER) Model EMB-500 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for the
products listed above. This AD results from mandatory continuing
airworthiness information (MCAI) issued by the aviation authority of
another country to identify and correct an unsafe condition on an
aviation product. The MCAI describes the unsafe condition as:

    It has been found the possibility of heating deactivation of Air
Data System (ADS) sensors due to its inadequate automatic logic,
when ADS/AOA knob is on AUTO position associated with the following
messages:

--DC BUS 1 OFF displayed on Crew Alerting System--CAS in conjunction
with STBY HTR FAIL (which means loss of power on DC BUS 1); or
--EMER BUS OFF displayed on CAS (which means loss of power on
EMERGENCY BUS); or
--ELEC EMERGENCY displayed on CAS (which means Electrical
Emergency).

    The loss of airplane air data sensors heating may cause ice
buildup on their surfaces, which in turn may cause wrong pressure
acquisitions resulting in erroneous flight parameters indication to
the flight crew. Since this condition may occur in other airplanes
of the same type and affects flight safety, an immediate corrective
action is required. Thus, sufficient reason exists to request
compliance with this AD in the indicated time limit.

    This AD requires actions that are intended to address the unsafe
condition described in the MCAI.

DATES: This AD becomes effective December 2, 2009.
    We must receive comments on this AD by December 28, 2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, 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 Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Karl Schletzbaum, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    The AG[Ecirc]NCIA NACIONAL DE AVIA[Ccedil][Atilde]O CIVIL--BRAZIL,
which is the aviation authority for Brazil, has issued AD No.: 2009-10-
01R1, dated October 16, 2009 (referred to after this as ``the MCAI''),
to correct an unsafe condition for the specified products. The MCAI
states:

    It has been found the possibility of heating deactivation of Air
Data System (ADS) sensors due to its inadequate automatic logic,
when ADS/AOA knob is on AUTO position associated with the following
messages:

--DC BUS 1 OFF displayed on Crew Alerting System--CAS in conjunction
with STBY HTR FAIL (which means loss of power on DC BUS 1); or
--EMER BUS OFF displayed on CAS (which means loss of power on
EMERGENCY BUS); or
--ELEC EMERGENCY displayed on CAS (which means Electrical
Emergency).

    The loss of airplane air data sensors heating may cause ice
buildup on their surfaces, which in turn may cause wrong pressure
acquisitions resulting in erroneous flight parameters indication to
the flight crew. Since this condition may occur in other airplanes
of the same type and affects flight safety, an immediate corrective
action is required. Thus, sufficient reason exists to request
compliance with this AD in the indicated time limit.

    This AD action requires inserting information into the Abnormal
Procedures section of the FAA-approved airplane flight manual (AFM).
You may obtain further information by examining the MCAI in the AD
docket.

FAA's Determination and Requirements of the AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information

referenced above. We are issuing this AD because we evaluated all
information provided by the State of Design Authority and determined
the unsafe condition exists and is likely to exist or develop on other
products of the same type design.

Differences Between This AD and the MCAI or Service Information

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

FAA's Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD. The FAA has found that the risk to the flying public justifies
waiving notice and comment prior to adoption of this rule because the
loss of airplane air data sensors heating may cause ice buildup on
their surface. This condition may cause wrong pressure acquisitions,
resulting in erroneous flight parameters indication to the flight crew.
Therefore, we determined that notice and opportunity for public comment
before issuing this AD are impracticable and that good cause exists for
making this amendment effective in fewer than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not precede it by notice and opportunity for public
comment. We invite you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
the ADDRESSES section. Include ``Docket No. FAA-2009-1039; Directorate
Identifier 2009-CE-059-AD'' at the beginning of your comments. We
specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this AD. We will consider all
comments received by the closing date and may amend this 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 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 AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979); and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

2009-23-11 Empresa Brasileira de Aeron[aacute]utica S.A. (EMBRAER):
Amendment 39-16085; Docket No. FAA-2009-1039; Directorate Identifier
2009-CE-059-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective December
2, 2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Model EMB-500 airplanes, all serial
numbers, certificated in any category.

Subject

    (d) Air Transport Association of America (ATA) Code 30: Ice and
Rain Protection.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:

    ``It has been found the possibility of heating deactivation of
Air Data System (ADS) sensors due to its inadequate automatic logic,
when ADS/AOA knob is on AUTO position associated with the following
messages:

--DC BUS 1 OFF displayed on Crew Alerting System--CAS in conjunction
with STBY HTR FAIL (which means loss of power on DC BUS 1); or
--EMER BUS OFF displayed on CAS (which means loss of power on
EMERGENCY BUS); or
--ELEC EMERGENCY displayed on CAS (which means Electrical
Emergency).

    The loss of airplane air data sensors heating may cause ice
buildup on their surfaces, which in turn may cause wrong pressure
acquisitions resulting in erroneous flight parameters indication to
the flight crew. Since this condition may occur in other airplanes
of the same type and affects flight safety, an immediate corrective
action is required. Thus, sufficient reason exists to request
compliance with this AD in the indicated time limit.''

    This AD action requires inserting information into the Abnormal
Procedures section of the FAA-approved airplane flight manual (AFM).

Actions and Compliance

    (f) Unless already done, before further flight, incorporate into
the AFM the following procedures section revisions. You may insert a
copy of this AD into the appropriate sections of the AFM to comply
with the requirements of this AD.
    (1) Revise the AFM by replacing the ELECTRICAL EMERGENCY
procedures in

AFM section 4-08, Abnormal Procedures, pages 3 and 4, with Figure 1:

BILLING CODE 4910-13-P
[GRAPHIC] [TIFF OMITTED] TR12NO09.055

[GRAPHIC] [TIFF OMITTED] TR12NO09.056

    (2) Revise the AFM by replacing the DC BUS 1 OFF procedure in
AFM section 4-08, Abnormal Procedures, pages 6 and 7, with Figure 2:

[GRAPHIC] [TIFF OMITTED] TR12NO09.057

    (3) Revise the AFM by replacing the EMERGENCY BUS OFF procedure
in AFM section 4-08, Abnormal Procedures, page 9, with Figure 3:

[GRAPHIC] [TIFF OMITTED] TR12NO09.058

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to Attn: Karl Schletzbaum, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et.seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI ANAC, AD No.: 2009-10-01R1, dated October 16,
2009, for related information.

    Issued in Kansas City, Missouri on November 2, 2009.
Kim Smith,
Manager, Small Airplane Directorate, Aircraft Certification Service.
[FR Doc. E9-26795 Filed 11-10-09; 8:45 am]

BILLING CODE 4910-13-C


[Federal Register: November 9, 2010 (Volume 75, Number 216)]
[Proposed Rules]
[Page 68728-68731]
[DOCID:fr09no10-23]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-1108; Directorate Identifier 2010-NM-151-AD]
RIN 2120-AA64

Airworthiness Directives; Bombardier, Inc. Model CL-215-1A10 (CL-
215), CL-215-6B11 (CL-215T Variant), and CL-215-6B11 (CL-415 Variant)
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as:

    Seven cases of on-ground hydraulic accumulator screw cap or end
cap failure have been experienced * * * resulting in loss of the
associated hydraulic system and high-energy impact damage to
adjacent systems and structure. * * *
* * * * *
    A detailed analysis of the systems and structure in the
potential line of trajectory of a failed screw cap/end cap for each
accumulator has been conducted. It has identified that the worst-
case scenarios would be impact damage to various components,
potentially resulting in fuel spillage, uncommanded flap movement,
or loss of aileron control [and consequent reduced controllability
of the airplane].
* * * * *

The proposed AD would require actions that are intended to address the
unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by December 27,
2010.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-40, 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Bombardier, Inc., 400 C[ocirc]te-Vertu Road West, Dorval, Qu[eacute]bec
H4S 1Y9, Canada; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet http://www.bombardier.com. You
may review copies of the referenced service information at the FAA,
Transport Airplane Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Operations office
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 Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

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

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2010-1108;
Directorate Identifier 2010-NM-151-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 based on 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

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian Airworthiness Directive CF-
2009-42R1, dated May 14, 2010 (referred to after this as ``the MCAI''),
to correct an unsafe condition for the specified products. The MCAI
states:
* * * * *
    Seven cases of on-ground hydraulic accumulator screw cap or end
cap failure have been experienced on CL-600-2B19 (CRJ) aircraft,
resulting in loss of the associated hydraulic system and high-energy
impact damage to adjacent systems and structure. To date, the lowest
number of flight cycles accumulated at the time of failure has been
6991.
    Although there have been no failures to date on any CL-215-1A10
(CL-215) or CL-215-6B11 (CL-215T and CL-415) aircraft, similar
accumulators, Part Number (P/N) 08-8423-010 (MS28700-3), to those
installed on the CL-600-2B19, are installed on the aircraft listed
in the Applicability section of this directive [MCAI].
    A detailed analysis of the systems and structure in the
potential line of trajectory of a failed screw cap/end cap for each
accumulator has been conducted. It has identified that the worst-
case scenarios would be impact damage to various components,
potentially resulting in fuel spillage, uncommanded flap movement,
or loss of aileron control [and consequent reduced controllability
of the airplane].
    This directive [MCAI] mandates repetitive [ultrasonic]
inspections of the accumulators for cracks and replacement of any
accumulator in which a crack is detected.
* * * * *
You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Bombardier has issued Service Bulletins 215-541, 215-3155, and 215-
4414, all Revision 1, all dated March 12, 2010. The actions described
in this service information are intended to correct the unsafe
condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Differences Between This AD and the MCAI or Service Information

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

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 6 products of U.S. registry. We also estimate that
it would take about 7 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Based on these figures, we estimate the cost of the proposed
AD on U.S. operators to be $3,570, or $595 per product per inspection
cycle.
    In addition, we estimate that any necessary follow-on actions would
take about 6 work-hours and require parts costing $4,055, for a cost of
$4,565 per product. We have no way of determining the number of
products that may need these actions.

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

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

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

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Bombardier, Inc.: Docket No. FAA-2010-1108; Directorate Identifier
2010-NM-151-AD.

Comments Due Date

    (a) We must receive comments by December 27, 2010.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Bombardier, Inc. airplanes, certificated
in any category, identified in paragraphs (c)(1), (c)(2), and (c)(3)
of this AD.
    (1) Model CL-215-1A10 (CL-215) airplanes, serial numbers 1001
through 1990 inclusive;
    (2) Model CL-215-6B11 (CL-215T Variant) airplanes, serial
numbers 1056 through 1125 inclusive;
    (3) Model CL-215-6B11 (CL-415 Variant) airplanes, serial numbers
2001 through 2990 inclusive.

Subject

    (d) Air Transport Association (ATA) of America Code 27: Flight
controls; and 32: Landing gear.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    Seven cases of on-ground hydraulic accumulator screw cap or end
cap failure have been experienced * * * resulting in loss of the
associated hydraulic system and high-energy impact damage to
adjacent systems and structure. * * *
* * * * *
    A detailed analysis of the systems and structure in the
potential line of trajectory of a failed screw cap/end cap for each
accumulator has been conducted. It has identified that the worst-
case scenarios would be impact damage to various components,
potentially resulting in fuel spillage, uncommanded flap movement,
or loss of aileron control [and consequent reduced controllability
of the airplane].
* * * * *

Compliance

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

Inspection To Determine Flight Hours

    (g) Within 50 flight hours after the effective date of this AD,
inspect to determine the number of flight cycles accumulated by each
of the applicable accumulators (i.e., brake, aileron, elevator, and
rudder accumulators) having part number (P/N) 08-8423-010 (MS28700-
3) installed on the airplane. A review of airplane maintenance
records is acceptable in lieu of this inspection if the number of
flight cycles accumulated can be conclusively determined from that
review.

Initial Ultrasonic Inspection

    (h) For Model CL-215-1A10 (CL-215) and CL-215-6B11 (CL-215T)
airplanes: Do an ultrasonic inspection for cracking of the
accumulator at the applicable time specified in paragraph (h)(1) or
(h)(2) of this AD, in accordance with Part B of the Accomplishment
Instructions of the applicable service bulletin listed in Table 1 of
this AD.

                                           Table 1--Service Bulletins
----------------------------------------------------------------------------------------------------------------
                                           Use Bombardier
              For model--                Service Bulletin--     Revision--                  Dated--
----------------------------------------------------------------------------------------------------------------
CL-215-1A10 (CL-215)..................               215-541               1  March 12, 2010.
CL-215-6B11 (CL-215T).................              215-3155               1  March 12, 2010.
CL-600-6B11 (CL-415)..................              215-4414               1  March 12, 2010.
----------------------------------------------------------------------------------------------------------------

     (1) For any accumulator on which the inspection required by
paragraph (g) of this AD shows an accumulation of more than 875
total flight cycles or on which it is not possible to determine the
number of total accumulated flight cycles, do the inspection within
125 flight cycles after the effective date of this AD.
    (2) For any accumulator on which the inspection required by
paragraph (g) of this AD shows an accumulation of 875 total flight
cycles or fewer, do the inspection before the accumulation of 1,000
flight cycles on the accumulator.
    (i) For Model CL-215-6B11 (CL-415) airplanes, do an ultrasonic
inspection for cracking of the accumulator at the applicable time
specified in paragraph (i)(1) or (i)(2) of this AD, in accordance
with Part B of the Accomplishment Instructions of the applicable
service bulletin listed in Table 1 of this AD.
    (1) For any accumulator on which the inspection required by
paragraph (g) of this AD shows an accumulation of more than 750
flight cycles or on which it is not possible to determine the number
of total accumulated flight cycles, do the inspection within 250
flight cycles after the effective date of this AD.
    (2) For any accumulator on which the inspection required by
paragraph (g) of this AD shows an accumulation of 750 total flight
cycles or fewer, do the inspection before the accumulation of 1,000
flight cycles on the accumulator.

Repetitive Inspections

    (j) If no cracking is found during any inspection required by
paragraph (h) or (i) of this AD, repeat the inspection thereafter at
intervals not to exceed 750 flight cycles.

    (k) If any cracking is found during any inspection required by
paragraph (h) or (i) of this AD, before further flight, replace the
accumulator with a serviceable accumulator, in accordance with Part
B of the Accomplishment Instructions of the applicable service
bulletin listed in Table 1 of this AD. Doing the replacement does
not end the inspection requirements of this AD. Repeat the
inspections required by paragraph (h) or (i) of this AD at intervals
not to exceed 750 flight cycles.

Parts Installation

    (l) As of the effective date of this AD, no person may install
an accumulator (P/N) 08-8423-010 (MS28700-3) on any airplane unless
the accumulator has been inspected in accordance with the
requirements of this AD.

Credit for Actions Accomplished in Accordance With Previous Service
Information

    (m) Inspections accomplished before the effective date of this
AD in accordance with the applicable service bulletin listed in
Table 2 of this AD are considered acceptable for compliance with the
corresponding action specified in this AD.

                                        Table 2--Credit Service Bulletins
----------------------------------------------------------------------------------------------------------------
                                                   Use Bombardier
                  For model--                    Service Bulletin--                     Dated--
----------------------------------------------------------------------------------------------------------------
CL-215-1A10 (CL-215)..........................               215-541  July 9, 2009.
CL-215-6B11 (CL-215T).........................              215-3155  July 9, 2009.
CL-600-6B11 (CL-415)..........................              215-4414  July 9, 2009.
----------------------------------------------------------------------------------------------------------------

FAA AD Differences

    Note 1:  This AD differs from the MCAI and/or service
information as follows:
    No differences.

Other FAA AD Provisions

    (n) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York Aircraft Certification Office (ACO), ANE-170, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. Send information to ATTN: Program
Manager, Continuing Operational Safety, FAA, New York ACO, 1600
Stewart Avenue, Suite 410, Westbury, New York 11590; telephone 516-
228-7300; fax<PHONE_NUMBER>. Before using any approved AMOC on any
airplane to which the AMOC applies, notify your principal
maintenance inspector (PMI) or principal avionics inspector (PAI),
as appropriate, or lacking a principal inspector, your local Flight
Standards District Office. The AMOC approval letter must
specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (o) Refer to MCAI Transport Canada Civil Aviation Airworthiness
Directive CF-2009-42R1, dated May 14, 2010; and the service
bulletins listed in Table 1 of this AD; for related information.

    Issued in Renton, Washington, on November 2, 2010.
Dionne Palermo,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2010-28275 Filed 11-8-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: August 7, 2007 (Volume 72, Number 151)]
[Notices]
[Page 44131-44132]
[DOCID:fr07au07-40]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RC07-2-000]

City of Tampa, FL; Notice of Filing

July 31, 2007.
    Take notice that on July 26, 2007, the City of Tampa, Florida
(Tampa) filed an appeal from the July 5, 2007 decision of the North
American Electric Reliability Corporation (NERC) to include Tampa's
McKay Bay Resource Recovery facility (McKay Bay) on the NERC compliance
registry within the Florida Reliability Coordinating Council for the
function of generator owner. Tampa asks the Commission to reverse the
NERC's inclusion of McKay Bay on the compliance registry to stay the
effectiveness of the NERC decision pending resolution of the appeal by
the Commission.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.

    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on August 21, 2007.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-15285 Filed 8-6-07; 8:45 am]

BILLING CODE 6717-01-P