[Federal Register Volume 80, Number 109 (Monday, June 8, 2015)]
[Rules and Regulations]
[Pages 32307-32311]
[FR Doc No: 2015-13889]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2013-N-1518]

Cardiovascular Devices; Reclassification of Nonroller-Type
Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and Circulatory
Bypass; Effective Date of Requirement for Premarket Approval for
Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Temporary
Ventricular Support

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final
order to reclassify nonroller-type cardiopulmonary bypass blood pump
(NRP) devices for cardiopulmonary and circulatory bypass, a
preamendments class III device, into class II (special controls), and
to require the filing of a premarket approval application (PMA) for NRP
devices for temporary ventricular support. FDA is also revising the
title and identification of the regulation for NRP devices in this
order.

DATES: This order is effective June 8, 2015.

FOR FURTHER INFORMATION CONTACT: Fernando Aguel, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1234, 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 (FDAMA) (Pub. L.
105-115), the Medical Device User Fee and Modernization Act of 2002
(Pub. L. 107-250), the Medical Devices Technical Corrections Act (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), among other amendments,
established 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) (the Panel); (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.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as ``postamendments devices''), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new

devices are substantially equivalent to predicate devices by means of
premarket notification procedures in section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 CFR part 807).
    A preamendments device that has been classified into class III and
devices found substantially equivalent by means of premarket
notification (510(k)) procedures 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 or until the device is subsequently
reclassified into class I or class II. Section 515(b)(1) of the FD&C
Act directs FDA to issue an order requiring premarket approval for a
preamendments class III device.
    Although, under the FD&C Act, the manufacturer of class III
preamendments device may respond to the call for PMAs by filing a PMA
or a notice of completion of a product development protocol (PDP), in
practice, the option of filing a notice of completion of a PDP has not
been used. For simplicity, although corresponding requirements for PDPs
remain 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 the filing and receiving approval of a PMA.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA
amended section 513(e) of the FD&C Act, changing the process for
reclassifying a device from rulemaking to an administrative order.
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.

A. Reclassification

    FDA is reclassifying NRP devices for cardiopulmonary and
circulatory bypass from class III to class II (special controls) and
renaming these devices from ``Nonroller-type cardiopulmonary bypass
blood pump'' to ``Nonroller-type blood pump.''
    Section 513(e) of the FD&C Act governs reclassification of
classified preamendments devices. This section provides that FDA may,
by administrative order, reclassify a device based upon ``new
information.'' FDA can initiate a reclassification under section 513(e)
of the FD&C Act or an interested person may petition FDA to reclassify
a preamendments device. The term ``new information,'' as used in
section 513(e) of the FD&C Act, includes information developed as a
result of a reevaluation of the data before the Agency when the device
was originally classified, as well as information not presented, not
available, or not developed at that time. (See, e.g., Holland-Rantos
Co. v. United States Department of Health, Education, and Welfare, 587
F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944
(6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent action where the reevaluation is made
in light of newly available authority (see Bell, 366 F.2d at 181;
Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991)), or in
light of changes in ``medical science'' (Upjohn, 422 F.2d at 951).
Whether data before the Agency are old or new data, the ``new
information'' to support reclassification under section 513(e) of the
FD&C Act must be ``valid scientific evidence,'' as defined in section
513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2). (See, e.g., General
Medical Co. v. FDA, 770 F.2d at 214 (D.C. Cir. 1985); Contact Lens
Manufacturers Association v. FDA, 766 F.2d at 592 (D.C. Cir. 1985),
cert. denied, 474 U.S. 1062 (1986).)
    FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the ``valid scientific
evidence'' upon which the Agency relies must be publicly available.
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
PMA. (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).) Section
520(h)(4) of the FD&C Act, added by FDAMA, provides that FDA may use,
for reclassification of a device, certain information in a PMA 6 years
after the application has been approved. This can include information
from clinical and non-clinical tests or studies that demonstrate the
safety or effectiveness of the device but does not include descriptions
of methods of manufacture or product composition and other trade
secrets.
    Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final order for reclassifying a device. Specifically, prior
to the issuance of a final order reclassifying a 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 to a
public docket. FDA held a meeting of a device classification panel
described in section 513(b) of the FD&C Act with respect to NRP devices
on December 6, 2012 (Ref. 1). The Panel unanimously recommended that
NRP devices for cardiopulmonary and circulatory bypass be reclassified
from class III to class II with special controls because the
application of general and special controls are sufficient to provide
reasonable assurance of safety and effectiveness for NRP devices when
intended for these uses. The Panel believed that the special controls
identified by FDA were appropriate to mitigate the relevant risks to
health for these uses. FDA published a proposed order in the Federal
Register on January 7, 2014 (79 FR 765). FDA received and has
considered two comments on the proposed order as discussed in section
II of this document (Ref. 2).

B. Requirement for Premarket Approval Application

    FDA is requiring PMAs for NRP devices for temporary ventricular
support. Section 515(b)(1) of the FD&C Act sets forth the process for
issuing a final order requiring PMAs. 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.
    FDA held a meeting of a device classification panel described in
section 513(b) of the FD&C Act with respect to NRP devices on December
6, 2012 (Ref. 1). The majority of the Panel recommended that NRP
devices for temporary ventricular support remain in class III (subject
to premarket approval application) because there was insufficient
information to establish special controls, and that the application of
general controls is insufficient to provide a reasonable assurance of
safety and effectiveness for NRP devices, which are life-supporting
devices (Ref. 2).
    FDA published a proposed order in the Federal Register of January
7, 2014, that satisfied the requirements of section 515(b)(2) of the
FD&C Act, which 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. FDA received and has considered two comments on the proposed
order as discussed in section II of this document.
    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 final
classification of the device under section 513 of the FD&C Act,
whichever is later. Since NRP devices (the preamendments class III
devices that are the subject of this final order) were classified in
1980, the 30-month period has expired (45 FR 7959, February 5, 1980).
Thus, for these devices, the later of these two time periods is the 90-
day period. Therefore, section 501(f)(2)(B) of the FD&C Act (21 U.S.C.
351(f)(2)(B)) requires that a PMA for such devices be filed within 90
days of the date of issuance of this final order. If a PMA is not filed
for such devices within 90 days after the issuance of this final order,
the device will be deemed adulterated under section 501(f) of the FD&C
Act.
    Also, a preamendments device subject to a call for PMAs under
section 515(b) of the FD&C Act is not required to have an approved
investigational device exemption (IDE) (see part 812 (21 CFR part 812))
contemporaneous with its interstate distribution until the date
identified by FDA in the final order requiring the filing of a PMA for
the device. At that time, an IDE is required only if a PMA has not been
filed for NRP devices for temporary ventricular support. If the
manufacturer, importer, or other sponsor of the device submits an IDE
application and FDA approves it, the device may be distributed for
investigational use. If a PMA is not filed by the later of the two
dates, and the device is not distributed for investigational use under
an IDE, the device is deemed to be adulterated within the meaning of
section 501(f)(1)(A) of the FD&C Act, and subject to seizure and
condemnation under section 304 of the FD&C Act (21 U.S.C. 334) if its
distribution continues. Other enforcement actions include, but are not
limited to, the following: Shipment of devices in interstate commerce
may be subject to injunction under section 302 of the FD&C Act (21
U.S.C. 332), and the individuals responsible for such shipment may be
subject to prosecution under section 303 of the FD&C Act (21 U.S.C.
333). FDA requests that manufacturers take action to prevent the
further use of devices for which no PMA has been filed.

II. Public Comments in Response to the Proposed Order

    In response to the January 7, 2014, proposed order to reclassify
NRP devices for cardiopulmonary and circulatory bypass into class II
and to require the filing of a PMA for NRP devices for temporary
ventricular support, FDA received two comments. One comment disagreed
with FDA's proposal to reclassify NRP devices for cardiopulmonary and
circulatory bypass as a class II medical device. The comment stated
general concerns that reclassification would result in the loss of
important safeguards that are provided by authorities under the PMA
regime, including proof of safety and efficacy based on short-term
clinical trials, reporting of postmarket long-term clinical data as a
condition of approval, inspection of manufacturing facilities prior to
approval of a device, and the ability to rescind the approval of
devices if the device is later found to be unsafe. FDA disagrees with
this comment. Currently, NRP devices are typically regulated through
the 510(k) pathway; therefore, reclassification of NRP devices for
cardiopulmonary and circulatory bypass to class II will not result in
the loss of current safeguards, as the regulatory pathway for these
devices will remain the same. FDA places a device in the lowest
classification that would provide reasonable assurance of the safety
and effectiveness of the device. Under section 513(a)(1)(B) of the FD&C
Act, a class II device is defined as a device which cannot be
classified as a class I device because the general controls by
themselves are insufficient to provide reasonable assurance of the
safety and effectiveness of the device, and for which there is
sufficient information to establish special controls to provide such
assurance. The Panel recommended that NRP devices for cardiopulmonary
and circulatory bypass be classified as class II because they believed
that there is significant knowledge and data regarding the safety and
effectiveness of NRP devices for cardiopulmonary and circulatory
bypass, based on the device's long history of use in cardiopulmonary
and circulatory bypass procedures (Ref. 2). The Panel believed that the
application of general and special controls is sufficient to provide
reasonable assurance of safety and effectiveness for NRP devices for
cardiopulmonary and circulatory bypass (Ref. 2). FDA agrees with the
Panel's recommendation and believes that because special controls are
able to provide a reasonable assurance of safety and effectiveness, the
requirement of a PMA for these devices is not necessary. By contrast,
the majority of the Panel believed there remains insufficient valid
scientific evidence to determine that general and special controls
would provide a reasonable assurance of safety and effectiveness of NRP
devices for temporary ventricular support. FDA agrees with the Panel's
recommendation and as a result, NRP devices for temporary ventricular
support will remain in class III and require premarket approval.
    Another comment supported FDA's proposal to call for PMAs for NRP
devices for temporary ventricular support, but disagreed with FDA's
intent to reclassify NRP devices for cardiopulmonary and circulatory
bypass, stating that ``down-classification . . . would create an
enormous and dangerous loophole'' by which devices cleared by the
510(k) process for a ``particular indication'' could be used ``off-
label for treatments that require a PMA.'' FDA notes in response to
this comment that generally, FDA regulates the use of a device as
indicated by the party offering the device for interstate commerce. The
indications for NRP devices for cardiopulmonary and circulatory bypass
will be limited by the codified identification in Sec.  870.4360(a)(1)
(21 CFR 870.4360(a)(1)).
    The commenter also expressed concern that special controls were
insufficient to mitigate the risk of stroke, peripheral emboli, or
death associated with NRP devices for cardiopulmonary and circulatory
bypass. FDA disagrees with the commenter. Under section 513(a)(1)(C) of
the FD&C Act, a class III device is defined as a device which (1)
cannot be classified as a class I device because insufficient
information exists to determine that the application of general
controls are sufficient to provide reasonable assurance of the safety
and effectiveness of the device; (2) cannot be classified as a class II
device because insufficient information exists to determine that the
special controls would provide reasonable assurance of its safety and
effectiveness; and (3) is purported or represented to be for a use in
supporting or sustaining human life or for a use that is of substantial
importance in preventing impairment of human health, or presents a
potential unreasonable risk of illness or injury. FDA believes that
sufficient information exists for NRP devices used for

cardiopulmonary and circulatory bypass to establish special controls
that, together with general controls, can provide a reasonable
assurance of safety and effectiveness and mitigate the risks to health
identified in the proposed order (79 FR 765 at 769, January 7, 2014).
Stroke, peripheral emboli, and death are potential clinical
consequences of the identified risks to health and are therefore
addressed by mitigating the risks to health through the general and
special controls. Specifically, in the proposed order (79 FR 765 at
769), FDA determined that embolism was a risk to health associated with
use of NRP devices for temporary cardiopulmonary and circulatory
bypass. We explicitly noted that improper design of the device may
cause the generation of gaseous, particular, or thrombotic emboli,
which can result in debilitating or fatal complications such as stroke,
peripheral emboli, or death. However, this risk to health is mitigated
through non-clinical performance testing and labeling (special controls
(a)(2)(i) and (iv) in the codified section of this document). Non-
clinical performance testing evaluates the design of the device to
ensure that the device does not generate gaseous, particular, or
thrombotic emboli, which could cause stroke, peripheral emboli, or
death. Further, the labeling will provide information regarding the
duration of use to minimize the risk of embolism. The Panel concluded
that these special controls were sufficient to mitigate the identified
risks to health and provide reasonable assurance of safety and
effectiveness for NRP devices for cardiopulmonary and circulatory
bypass (Ref. 2). FDA agrees with the Panel's recommendation.
    The commenter also provided a summary of adverse event reports for
this device type from FDA's Manufacturer and User Facility Device
Experience (MAUDE) database to support the perspective that
reclassification is inappropriate for NRP devices for cardiopulmonary
and circulatory bypass. FDA is aware of this data, fully considered
this information prior to the proposed reclassification, and presented
the adverse event information to the 2012 Panel that ultimately
recommended that FDA reclassify NRP devices for cardiopulmonary and
circulatory bypass from class III to class II (special controls). FDA
agrees with this recommendation because special controls established by
this final order can provide a reasonable assurance of safety and
effectiveness.
    The commenter further expressed concern that ``down-classification
of these devices means that companies manufacturing new models with
unique characteristics in the future would not be required to prove
that their products are safe or effective. The companies would only
need to prove that their products are substantially equivalent to other
NRPs for cardiopulmonary and circulatory bypass already on the market,
and would not require scientific evidence to ensure equivalent safety
or efficacy.'' FDA disagrees with this comment. FDA believes that the
special controls will provide a reasonable assurance of safety and
effectiveness for NRP devices indicated for cardiopulmonary and
circulatory bypass. Conformance with the identified special controls
will provide a reasonable assurance of safety and effectiveness for the
available predicate NRPs when indicated for cardiopulmonary and
circulatory bypass. Future devices claiming substantial equivalence to
an available predicate(s) must demonstrate that they are substantially
equivalent, as defined under section 513(i) of the FD&C Act, to the
predicate device and comply with all applicable FDA regulations. Future
devices will also need to comply with the special controls in order to
be classified into class II.

III. The Final Order

    Under sections 513(e) and 515(b) of the FD&C Act, FDA is adopting
its findings as published in the proposed order (79 FR 765). FDA is
issuing this final order to reclassify NRP devices for cardiopulmonary
and circulatory bypass from class III to class II and establish special
controls. In addition, FDA is issuing this final order to require the
filing of a PMA for NRP devices for temporary ventricular support.
    In accordance with the proposed order, this final order will revise
the title and identification of the regulation for NRP devices in 21
CFR part 870 to reflect the different types of NRP devices, their
respective intended uses, and their respective classifications.

A. NRP Device for Temporary Ventricular Support

    Under the final order, a PMA is required to be filed on or before
90 days after the date of publication of the final order in the Federal
Register for any class III preamendments NRP devices for temporary
ventricular support that were in commercial distribution before May 28,
1976, or that have been found by FDA to be substantially equivalent to
such a device on or before 90 days after the date of publication of the
final order in the Federal Register. An approved PMA is required to be
in effect for these devices on or before 180 days after FDA files the
application. Any other class III preamendments device subject to this
order that was not in commercial distribution before May 28, 1976, is
required to have an approved PMA in effect before it may be marketed.
    If a PMA or a notice of completion of a PDP for any of the class
III preamendments NRP devices intended for temporary ventricular
support is not filed on or before the 90th day after the effective date
of this final order, that device will be deemed adulterated under
section 501(f)(1)(A) of the FD&C Act, and commercial distribution of
the device must cease. The device may, however, be distributed for
investigational use, if the requirements of the IDE regulations (part
812) are met.

B. NRP Device for Cardiopulmonary and Circulatory Bypass

    Following the effective date of this final order, firms submitting
a 510(k) premarket notification for a NRP device for cardiopulmonary
and circulatory bypass must comply with the particular mitigation
measures set forth in the codified special controls.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the devices. FDA has determined that premarket
notification is necessary to provide reasonable assurance of safety and
effectiveness of NRP devices for cardiopulmonary and circulatory
bypass, and therefore, this device type is not exempt from premarket
notification requirements.
    An applicant whose device was legally in commercial distribution
before May 28, 1976, or whose device has been found to be substantially
equivalent to such a device, and who does not intend to market such
device for uses other than cardiopulmonary and circulatory bypass, must
remove uses other than cardiopulmonary and circulatory bypass from the
device's labeling and comply with the special controls to remain
legally on the market.

IV. Environmental Impact

    The Agency has determined under 21 CFR 25.30 (h) and 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.

V. Paperwork Reduction Act of 1995

    This final 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 part 812 have been approved under OMB
control number 0910-0078; the collections of information in 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; and the collections of
information under 21 CFR part 801 have been approved under OMB control
number 0910-0485.

VI. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) provided for FDA
to issue regulations to reclassify devices and section 515(b) of the
FD&C Act provided for FDA to issue regulations to require approval of
an application for premarket approval for preamendment devices or
devices found to be substantially equivalent to preamendments devices.
Sections 513(e) and 515(b) as amended require FDA to issue final orders
rather than regulations, and FDASIA provided for FDA to revoke
previously issued regulations by order. FDA will continue to codify
classifications and reclassifications in the Code of Federal
Regulations. Changes resulting from final orders will appear in the CFR
as changes to codified classification determinations or as newly
codified orders. Therefore, under section 513(e)(1)(A)(i) of the FD&C
Act, as amended by FDASIA, in this final order, we are revoking the
requirements in Sec.  870.4360 related to the classification of NRP
devices for cardiopulmonary and circulatory bypass as class III devices
and codifying the reclassification of these devices into class II.

VII. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 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 the Web site addresses, but we are not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)

1. FDA Circulatory System Devices Panel of the Medical Devices
Advisory Committee Meeting, December 5-6, 2012, available at http://www.fda.gov/AdvisoryCommittees/Calendar/ucm327178.htm.
2. Transcript of the December 6, 2012, meeting of the Circulatory
System Devices Panel, available at http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/UCM335464.pdf.

List of Subjects in 21 CFR Part 870

    Medical devices.

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

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for 21 CFR part 870 continues to read as
follows:

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

0
2. Revise Sec.  870.4360 to read as follows:

Sec.  870.4360  Nonroller-type blood pump.

    (a) Nonroller-type cardiopulmonary and circulatory bypass blood
pump--(1) Identification. A nonroller-type cardiopulmonary and
circulatory bypass blood pump is a prescription device that uses a
method other than revolving rollers to pump the blood through an
extracorporeal circuit for periods lasting less than 6 hours for the
purpose of providing either:
    (i) Full or partial cardiopulmonary bypass (i.e., circuit includes
an oxygenator) during open surgical procedures on the heart or great
vessels; or
    (ii) Temporary circulatory bypass for diversion of flow around a
planned disruption of the circulatory pathway necessary for open
surgical procedures on the aorta or vena cava.
    (2) Classification--Class II (special controls). The special
controls for this device are:
    (i) Non-clinical performance testing must perform as intended over
the intended duration of use and demonstrate the following: Operating
parameters, dynamic blood damage, heat generation, air entrapment,
mechanical integrity, and durability/reliability;
    (ii) The patient-contacting components of the device must be
demonstrated to be biocompatible;
    (iii) Sterility and shelf life testing must demonstrate the
sterility of patient-contacting components and the shelf life of these
components; and
    (iv) Labeling must include information regarding the duration of
use, and a detailed summary of the device- and procedure-related
complications pertinent to use of the device.
    (b) Nonroller-type temporary ventricular support blood pump--(1)
Identification. A nonroller-type temporary ventricular support blood
pump is a prescription device that uses any method resulting in blood
propulsion to provide the temporary ventricular assistance required for
support of the systemic and/or pulmonary circulations during periods
when there is ongoing or anticipated hemodynamic instability due to
immediately reversible alterations in ventricular myocardial function
resulting from mechanical or physiologic causes. Duration of use would
be less than 6 hours.
    (2) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of
completion of product development protocol (PDP) is required. A PMA or
notice of completion of a PDP is required to be filed with FDA on or
before September 8, 2015, for any nonroller-type temporary ventricular
support blood pump that was in commercial distribution before May 28,
1976, or that has, on or before September 8, 2015, been found to be
substantially equivalent to any nonroller-type temporary ventricular
support blood pump that was in commercial distribution before May 28,
1976. Any other nonroller-type temporary ventricular support blood pump
shall have an approved PMA or declared completed PDP in effect before
being placed in commercial distribution.

    Dated: June 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13889 Filed 6-5-15; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 121 (Monday, June 26, 2023)]
[Notices]
[Pages 41433-41434]
[FR Doc No: 2023-13442]

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SECURITIES AND EXCHANGE COMMISSION

[Investment Company Act Release No. 34946; File No. 812-15323]

Vista Credit Strategic Lending Corp. et al.

June 20, 2023.
AGENCY: Securities and Exchange Commission (``Commission'' or ``SEC'').

ACTION: Notice.

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    Notice of application for an order under sections 17(d) and 57(i)
of the Investment Company Act of 1940 (the ``Act'') and rule 17d-1
under the Act to permit certain joint transactions otherwise prohibited
by sections 17(d) and 57(a)(4) of the Act and rule 17d-1 under the Act.

Summary of Application: Applicants request an order to permit certain
business development companies and closed-end management investment
companies to co-invest in portfolio companies with each other and with
certain affiliated investment entities.

Applicants: Vista Credit Strategic Lending Corp., Vista Credit BDC
Management, L.P., Vista Credit Partners, L.P., Vista Credit CLO
Management LLC, Vista Credit Partners Fund III, L.P., Vista Credit
Opportunities Fund II, L.P., Vista Opportunistic Credit Fund I, L.P.,
Vista Opportunistic Credit Fund II, L.P., Vista Opportunistic Credit
Fund II-A, L.P., Vista Opportunistic Credit Fund II (2), L.P., Vista
Opportunistic Credit Fund II-A (2), L.P., Vista Opportunistic Credit
Fund III, L.P., Vista Opportunistic Credit Fund III, L.P., Vista
Opportunistic Credit Fund IV, L.P., Vista Capital Solutions Fund L.P.,
Vista Capital Solutions Fund-A, L.P., VCPF III Co-Invest 1-A, L.P.,
VCPF III Co-Invest 2-A, L.P., VCPF III Co-Invest 4-A, L.P., VCPF III
Co-Invest 5-A, L.P., Vista Co-Invest Fund 2022-1, L.P., Vista Co-Invest
Fund 2022-2, L.P., Vista Co-Invest Fund 2022-3, L.P., VCP CLO III,
Ltd., Vista Platform Fund I, L.P., Vista Platform Partners, L.P.

Filing Dates: The application was filed on April 15, 2022, and amended
on November 10, 2022 and April 21, 2023.

Hearing or Notification of Hearing: An order granting the requested
relief will be issued unless the Commission orders a hearing.
Interested persons may request a hearing on any application by emailing
the SEC's Secretary at [email protected] and serving the
Applicants with a copy of the request by email, if an email address is
listed for the relevant Applicant below, or personally or by mail, if a
physical address is listed for the relevant Applicant below. Hearing
requests should be received by the Commission by 5:30 p.m. on July 17,
2023, and should be accompanied by proof of service on Applicants, in
the form of an affidavit or, for lawyers, a certificate of service.
Pursuant to rule 0-5 under the Act, hearing requests should state the
nature of the writer's interest, any facts bearing upon the
desirability of a hearing on the matter, the reason for the request,
and the issues contested. Persons who wish to be notified of a hearing
may request notification by emailing the SEC's Secretary at [email protected].

ADDRESSES: The Commission: [email protected]. Applicants:
Norman Champ, P.C., at [email protected].

FOR FURTHER INFORMATION CONTACT: Jean E. Minarick, Senior Counsel, or
Kyle R. Ahlgren, Branch Chief, at<PHONE_NUMBER> (Division of
Investment Management, Chief Counsel's Office).

SUPPLEMENTARY INFORMATION: For Applicants' representations, legal
analysis, and conditions, please refer to Applicants' second amended
and restated application, dated April 21, 2023, which may be obtained
via the Commission's website by searching for the file number at the
top of this document, or for an Applicant, using the Company name
search field on the SEC's EDGAR system. The SEC's EDGAR system may be
searched at http://www.sec.gov/edgar/searchedgar/legacy/companysearch.html. You may

also call the SEC's Public Reference Room at<PHONE_NUMBER>.

    For the Commission, by the Division of Investment Management,
under delegated authority.
J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2023-13442 Filed 6-23-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 240 (Wednesday, December 14, 2011)]
[Notices]
[Pages 77861-77862]
[FR Doc No: 2011-31997]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-65910; File No. SR-FICC-2011-08]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Order Approving Proposed Rule Change To Expand the Applicability of the
Fails Charge to Agency Debt Securities Transactions

 December 8, 2011.

I. Introduction

    On October 20, 2011, the Fixed Income Clearing Corporation
(``FICC'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change SR-FICC-2011-08 pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'').\1\
The proposed rule change was published for comment in the Federal
Register on November 1, 2011.\2\ No comment letters were received on
the proposal. This order approves the proposal.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ Securities Exchange Act Release No. 34-65632 (October 26,
2011), 76 FR 67519 (November 1, 2011).
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II. Description

    The purpose of this rule change is to expand the applicability of
the fails charge to Agency debt securities transactions. The Treasury
Markets Practices Group (the ``TMPG''), a group of market participants
active in the Treasury securities market sponsored by the Federal
Reserve Bank of New York (the ``FRBNY''), has been addressing the
persistent settlement fails in Agency debt securities transactions that
have arisen, in part, due to low interest rates.
    To encourage market participants to resolve fails promptly, the
TMPG recommended expanding the applicability of the fails charge (which
currently applies to Treasury securities transactions) to Agency debt
with the objective of reducing the incidence of delivery failures and
supporting liquidity in this market.
    The TMPG had previously recommended a charge for fails on Treasury
securities, which the Government Securities Division (the ``GSD'')
implemented after Commission approval.\3\ At that time, the TMPG
recommendation did not extend to Agency securities and, therefore, the
GSD's 2009 rule filing did not cover Agency debt. However, the TMPG
recently has expanded its recommendation to cover certain Agency
securities and, therefore, the GSD is proposing to apply the existing
fails charge regime to Agency debt transactions as recommended by the
TMPG. Specifically, transactions in debentures issued by Fannie Mae,
Freddie Mac, and the Federal Home Loan Banks now will be subject to
this charge. The proposed fails charge for Agencies will be the same as
that currently in place for Treasuries and is equal to the greater of:
(a) 0 percent or (b) 3 percent per annum minus the federal funds target
rate. The charge will accrue each calendar day a fail is outstanding.
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    \3\ See Securities Exchange Act Release No. 34-59802 (April 20,
2009), 74 FR 19248 (April 28, 2009).
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    The following examples illustrate the manner in which the proposed
fails charge will apply:

    Example 1: A settlement obligation fails and the next calendar
date is a valid FICC business date. The GSD calculates the TMPG fail
charge from the date the fail occurs to the next valid FICC business
date. As the next valid business date is the next calendar date, the
member's credit/debit resulting from the TMPG fail charge is
assessed for one day.
    Example 2: A settlement obligation fails and the next calendar
date is a holiday occurring on a Tuesday, Wednesday or Thursday. The
GSD calculates the TMPG fail charge from the date the fail occurs to
the next valid FICC business date. The TMPG fail charge is assessed
for two days; the day the fail occurs and the date of the holiday.
    Example 3: A settlement obligation fails on Friday and the
following Monday is not a holiday. The GSD calculates the TMPG fail
charge from the date the fail occurs to the next valid FICC business
date. The TMPG fail charge is assessed for three days; Friday,
Saturday and Sunday.

    FICC's Board of Directors (or appropriate Committee thereof) will
retain the right to revoke application of the proposed charges if
industry events or practices warrant such revocation.
    The expansion of the fails charge trading practice to the Agency
debt market requires that Rule 11 (Netting System), Section 14 (Fails
Charge) of the GSD rulebook be amended to make such rule applicable to
debentures issued by any of Fannie Mae, Freddie Mac or the Federal Home
Loan Banks. The current GSD rule states that the fails charge shall be
the product of the (i) funds associated with a failed position and (ii)
3 percent per annum minus the target fed funds rate that is effective
at 5 p.m. EST on the business day prior to the originally scheduled
settlement date, capped at 3 percent per annum. FICC is proposing to
restate the formula to make it clearer by amending section (ii) of the
formula to read ``the greater of (a) 0 percent or (b) 3 percent per
annum minus the fed funds target rate . * * *'' This change is not
meant to affect the result of the formula in any way but rather is a
more precise way of stating the formula.
    The proposed rule change makes clear that FICC will not guaranty
fails charge proceeds in the event of a default (i.e., if a defaulting
member does not pay its fail charge, members due to receive fails
charge proceeds will have those proceeds reduced pro-rata by the
defaulting member's unpaid amount).

Timing of Implementation

    The fails charges will apply to transactions in Agency debentures
entered into on or after February 1, 2012, as well as to transactions
that were entered into, but remain unsettled as of, February 1, 2012.
For transactions entered into prior to, and unsettled as of, February
1, 2012, the fails charge will begin accruing on the later of February
1, 2012, or the contractual settlement date.

III. Discussion

    Section 17A(b)(3)(F) of the Act \4\ requires, among other things,
that the rules of a clearing agency be designed to promote the prompt
and accurate clearance and settlement of security transactions and to
generally protect investors and the public interest. Because the
proposed rule discourages persistent fails in the marketplace by
expanding the application of the fails charge to Agency debt securities
transactions, the proposed rule change promotes the prompt and accurate
clearance and settlement of security transactions and generally
protects investors and the public interest and therefore is consistent
with the requirements of Section 17A(b)(3)(F) of the Act.
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    \4\ 15 U.S.C. 78q-1(b)(3)(F).
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IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act and in
particular with the requirements of Section 17A of the Act \5\ and the
rules and regulations thereunder.
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    \5\ 15 U.S.C. 78q-1.
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    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\6\ that the proposed rule change (File No. SR-FICC-2011-08) be,
and hereby is, approved.\7\
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    \6\ 15 U.S.C. 78s(b)(2).
    \7\ In approving the proposed rule change, the Commission
considered the proposal's impact on efficiency, competition and
capital formation. 15 U.S.C. 78c(f).

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\8\
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    \8\ 17 CFR 200.30-3(a)(12).
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Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-31997 Filed 12-13-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 17, 2008 (Volume 73, Number 243)]
[Notices]
[Page 76634-76636]
[DOCID:fr17de08-73]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2008-0719, FRL-8753-1]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; National Pollutant Discharge
Elimination System (NPDES) Program (Renewal); EPA ICR No. 0229.19; OMB
Control No. 2040-0004

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. This ICR describes the nature of the information
collection and its estimated burden and cost.

DATES: Additional comments may be submitted on or before January 16,
2009.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2008-0719 to (1) EPA online using FDMS (our preferred method), by e-
mail to<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, Water Docket, Mail Code 28221T, 1200
Pennsylvania Ave., NW., Washington, DC 20460, and (2) OMB at: Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Amelia Letnes, State and Regional
Branch, Water Permits Division, OWM Mail Code: 4203M, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On September 29, 2008 (73 FR 56568), EPA sought comments on
this ICR pursuant to 5 CFR 1320.8(d). EPA received one comment during
the comment period, which is address in the ICR supporting statement.
Any additional comments on this ICR should be submitted to EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OW-2008-0719, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Water Docket in
the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Reading Room is<PHONE_NUMBER>,
and the telephone number for the Water Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov to submit or view public comments, access the index
listing of the contents of the docket, and to access those documents in
the docket that are available electronically. Once in the system,
select ``search,'' then key in the docket ID number identified in this
document. Please note that EPA's policy is that public comments,
whether submitted electronically or in paper, will be made available
for public viewing at www.regulations.gov as EPA receives them and
without change, unless the comment contains copyrighted material,
confidential business information (CBI), or other information whose
public disclosure is restricted by statute. For further information
about the electronic docket, go to www.regulations.gov.
    Title: National Pollutant Discharge Elimination System (NPDES)
Program (Renewal).
    ICR Number: EPA ICR No. 0229.19, OMB Control No. 2040-0004.
    ICR Status: This ICR is currently scheduled to expire on December
31, 2008. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: The purpose of this ICR is to consolidate, streamline,
and update EPA's NPDES-related ICRs into the currently approved ICR for
NPDES and Sewage Sludge Monitoring Reports (OMB Control No.: 2040-
0004). EPA identified 15 NPDES-related ICRs consisting of program-based
(i.e., Pretreatment Program), activity-based (i.e., Applications,
Discharge Monitoring Reports [DMRs]), and rule-based (i.e., Cooling
Water Intake-Phase II, Stormwater Program Phase II) ICRs. Historically,
EPA identified the five activity-based ICRs as representing the base
NPDES program. Those ICRs include: (1) Applications ICR (OMB Control
No. 2040-0086); (2) DMR ICR (OMB Control No. 2040-0004); (3)
Modification/Variance ICR (OMB Control No. 2040-0068); (4) Compliance
Assessment/Certification ICR (OMB Control No. 2040-0110); and (5) State
Program ICR (OMB Control No. 2040-0057). Several additional ICRs
include activities that contain similar activities to those identified
in the five base NPDES program ICRs and as such, are being consolidated
into this ICR. Those four ICRs include: (1) Stormwater Program Phase II
(OMB Control No. 2040-0211); (2) Stormwater discharges associated with
construction activities (OMB Control No. 2040-0188); (3) CSO Control
Policy (OMB Control No. 2040-0170); and (4) NPDES Great Lakes Water
Quality Guidance (OMB Control No. 2040-0180). In addition, the revised
ICR accounts for the burden related to EPA's Eligible Commercial and
Other Non-recreational Vessels General Permit.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 3.2
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements which have subsequently changed; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.
    Respondents/Affected Entities: Facilities required to have NPDES
permit coverage, including but not limited to publicly owned treatment
works (POTWs), privately owned treatment works (PrOTWs), manufacturing
and commercial dischargers, mining operation, Concentrated Animal
Feeding Operations (CAFOs), stormwater dischargers, and vessels.
    Estimated Number of Respondents: 565,432 (564,814 facilities and
618 States/Tribes/Territories).
    Frequency of Response: Once, every five years, annually, semi-
annually, quarterly, bimonthly, monthly, biweekly, weekly, daily,
ongoing, occasionally/as needed.
    Estimated Total Annual Hour Burden: 30,943,308 hours.
    Estimated Total Annual Cost: $1,403,683,489, includes $211,074
annualized capital costs and $18,397,153 annualized O&M costs.
    Changes in the Estimates: There is an increase of 16,749,765 hours
in this ICR, reflecting the consolidation of eight additional ICRs. In
addition, the revised ICR accounts for the burden related to EPA's
Eligible Commercial and Other Non-recreational Vessels General Permit.
The current burden approved by OMB for the ICRs being consolidated is
31,342,736 hours. This consolidated ICR estimates a total burden that
is 399,428 hours less than the currently approved burden for the same
nine NPDES ICRs. This decrease in burden corresponds to 1.3 percent of
the overall burden. The main overarching reason for the change in
burden is EPA's continuous effort to improve the quality of data in its
PCS, ICIS-NPDES, and stormwater databases. This change reflects more
accurate data rather than a significant change in the number of permits
actually administered. Some specific changes with significant impact on
the overall result are: (1) Previous NPDES Modification and Variance
Requests ICR (OMB Control No. 2040-0068) did not account for the burden
related to standard permit conditions to all types of permittees. EPA
is now correcting this and assuming that all permittees have the
potential to incur time to report planned facility changes, anticipated
noncompliances, facility and permit transfers, and inaccurate previous
information. (2) In the previous Applications for the NPDES Discharge
Permits and the Sewage Sludge Management Permits ICR (OMB Control No.
2040-0086), EPA assumed that the burden for Phase I MS4s to renew their
permits was the same as the

burden estimated for a first time permit application. As specified in
EPA's Interpretive Policy Memorandum (61 FR 41698), Phase I MS4s may
use the fourth year annual report, which emphasizes changes to the
stormwater management program, with the additional required basic
information, as the MS4 permit reapplication. EPA has adjusted the
burden assumptions, which significantly reduces the burden for
permittees and states resulting from permit reapplication for Phase I
MS4s.

    Dated: December 11, 2008.
Joseph A. Sierra,
Acting Director, Collection Strategies Division.
[FR Doc. E8-29964 Filed 12-16-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Rules and Regulations]
[Pages 16191-16194]
[FR Doc No: 2018-07639]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0906; Product Identifier 2017-NM-039-AD; Amendment
39-19252; AD 2018-07-21]
RIN 2120-AA64

Airworthiness Directives; Fokker Services B.V. Airplanes

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

ACTION: Final rule.

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SUMMARY: We are superseding Airworthiness Directive (AD) 2005-12-16,
which applied to all Fokker Services B.V. Model F28 Mark 0100
airplanes. AD 2005-12-16 required an inspection to determine the part
number of the passenger service unit (PSU) panels for the PSU
modification status, and corrective actions if applicable. This new AD
requires an inspection of the PSU panels and the PSU panel/airplane
interface connectors for discrepancies, and corrective actions if
necessary. This AD also removes airplanes from the applicability. This
AD was prompted by reports of smoke in the passenger compartment during
ground operations and in-flight, and a determination that the
modification actions required by AD 2005-12-16 might not have been
implemented correctly. We are issuing this AD to address the unsafe
condition on these products.

DATES: This AD is May 21, 2018.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of May 21, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of July
20, 2005 (70 FR 34642, June 15, 2005).

ADDRESSES: For Fokker service information identified in this final
rule, contact Fokker Services B.V., Technical Services Dept., P.O. Box
1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-350;
fax +31 (0)88-6280-111; email [email protected]; internet
http://www.myfokkerfleet.com. For Grimes Aerospace service information
identified in this final rule, contact Grimes Aerospace Company,
Product Support Group, 240 Twain Avenue, Urbana, OH 43078; phone 513-
653-5225; fax<PHONE_NUMBER>. You may view this referenced service
information at the FAA, Transport Standards Branch, 2200 South 216th
St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available on the
internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2017-0906.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0906; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (telephone 800-
647-5527) is Docket Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Tom Rodriguez, Aerospace Engineer,
International Section, Transport Standards Branch, FAA, 2200 South
216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to supersede AD 2005-12-16, Amendment 39-14132 (70 FR 34642,
June 15, 2005) (``AD 2005-12-16''). AD 2005-12-16 applied to all Fokker
Services B.V. Model F28 Mark 0100 airplanes. The NPRM published in the
Federal Register on November 3, 2017 (82 FR 51172). The NPRM was
prompted by reports of smoke in the passenger compartment during ground
operations and in flight, and the determination that the modification
actions required by AD 2005-12-16 might not have been implemented
correctly. The NPRM proposed to continue to require an inspection to
determine the part number of the PSU panels for the PSU modification
status, and corrective actions if applicable. The NPRM also proposed to
require an inspection of the PSU panels and the PSU panel/airplane
interface connectors for discrepancies, and corrective actions if
necessary. We are issuing this AD to detect and correct overheating of
the PSU panel due to moisture ingress, which could result in smoke or
fire in the passenger cabin.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent

for the Member States of the European Union, has issued EASA
Airworthiness Directive 2017-0043, dated March 6, 2017 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for certain Fokker
Services B.V. Model F28 Mark 0100 airplanes. The MCAI states:

    Reports were received of burning smell and smoke in the
passenger compartment during flight as a result of overheating of
passenger service units (PSU). These were attributed to moisture
ingress into the interface electrical connectors of an unsealed PSU
panel.
    This condition, if not detected and corrected, could lead to
further incidents of smoke in the passenger compartment, possibly
resulting in injury to occupants.
    To address this potential unsafe condition, Grimes Aerospace
Company, the PSU manufacturer (currently Honeywell) issued SB 10-
1178-33-0040 and SB 10-1571-33-0041, and Fokker Services issued
SBF100-25-097, to provide instructions for installation of improved
sealing of the PSU and its interface electrical connectors.
Subsequently, CAA-NL [Civil Aviation Authority--The Netherlands]
issued AD (BLA) 2004-022 [which corresponds to FAA AD 2005-12-16] to
require modification, cleaning and sealing of the affected PSU.
    Since that [CAA-NL] AD was issued, following a new occurrence of
burning smell and smoke in the passenger compartment during
disembarking of the passengers, the investigation revealed that, on
several aeroplanes, the modification instructions of Honeywell and
Fokker Services (SB listed above) were not, or not correctly,
implemented. Prompted by these findings, Fokker Services published
SBF100-25-128, providing inspection instructions to detect non-
accomplishment and any discrepancy with the original modification
instructions.
    For the reasons described above, this [EASA] AD retains the
requirement of CAA-NL AD (BLA) 2004-022, which is superseded, and
requires a one-time inspection [for discrepancies] of the PSU panels
and their interface with the aeroplane, and, depending on findings,
the accomplishment of applicable corrective action(s).

    Discrepancies include incorrect application of the sealant on the
PSU panels, uninstalled gaskets, inability to properly lock the
connectors, and incorrectly applied sealant on the connectors.
Corrective actions include restoring the sealing of the affected PSU
panel, repairing the PSU panel, or installing a new PSU panel with a
replaced receptacle, and installing gaskets; making sure the connecter
can properly lock; and applying sealant on the connector.
    The MCAI also revised the applicability by specifying certain line
numbers and excluding airplanes on which certain modifications were
done. You may examine the MCAI in the AD docket on the internet at
http://www.regulations.gov by searching for and locating Docket No.
FAA-2017-0906.

Comments

    We gave the public the opportunity to participate in developing
this AD. We received no comments on the NPRM or on the determination of
the cost to the public.

Conclusion

    We reviewed the available data and determined that air safety and
the public interest require adopting this AD as proposed except for
minor editorial changes. We have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Fokker Services B.V. has issued Fokker Service Bulletin SBF100-25-
128, dated July 21, 2016. This service information describes procedures
for inspection of the PSU panels and the PSU panel/airplane interface
connectors for discrepancies, and for incorrectly applied sealant on
the connectors, and corrective actions.
    Grimes Aerospace has issued Service Bulletin 10-1178-33-0040, dated
October 15, 1993; Service Bulletin 10-1178-33-0040, Revision 1, dated
March 25, 1996; and Service Bulletin 10-1571-33-0041, dated October 15,
1993. This service information describes procedures for inspection of
the PSU panels and the PSU panel/airplane interface connectors for
discrepancies, and corrective actions. This service information is
distinct since it applies to different part numbers.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 8 airplanes of U.S. registry.
    The actions required by AD 2005-12-16, and retained in this AD take
about 5 work-hours per product, at an average labor rate of $85 per
work-hour. Required parts cost about $6 per product. Based on these
figures, the estimated cost of the actions that are required by AD
2005-12-16 is $431 per product.
    We also estimate that it would take about 13 work-hours per product
to comply with the basic requirements of this AD. The average labor
rate is $85 per work-hour. Based on these figures, we estimate the cost
of this AD on U.S. operators to be $8,840, or $1,105 per product.
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in 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.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes to
the Director of the System Oversight Division.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);

    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2005-12-16, Amendment 39-14132 (70 FR 34642, June 15, 2005), and adding
the following new AD:

2018-07-21 Fokker Services B.V.: Amendment 39-19252; Docket No. FAA-
2017-0906; Product Identifier 2017-NM-039-AD.

(a) Effective Date

    This AD is effective May 21, 2018.

(b) Affected ADs

    This AD replaces 2005-12-16, Amendment 39-14132 (70 FR 34642,
June 15, 2005) (``AD 2005-12-16'').

(c) Applicability

    This AD applies to Fokker Services B.V. Model F28 Mark 0100
airplanes, certificated in any category, serial numbers 11244
through 11527 inclusive, except those airplanes modified in service
as specified in Fokker Service Bulletin SBF100-25-070, or Fokker
Service Bulletin SBF100-25-109, or Fokker Modification Report FS-
N545 or FS-N571.

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
furnishings.

(e) Reason

    This AD was prompted by reports of smoke in the passenger
compartment during ground operations and in flight, and a
determination that the modification actions required by AD 2005-12-
16 might not have been implemented correctly. We are issuing this AD
to detect and correct overheating of the passenger service unit
(PSU) panel due to moisture ingress, which could result in smoke or
fire in the passenger cabin.

(f) Compliance

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

(g) Retained Inspection and Corrective Actions, With Clarified Note

    This paragraph restates the requirements of paragraph (f) of AD
2005-12-16, with clarified note. Within 36 months after July 20,
2005 (the effective date of AD 2005-12-16), inspect to determine if
Grimes Aerospace PSU panels having part number (P/N) 10-1178-() or
P/N 10-1571-() are installed and the PSU modification status if
applicable, and do any corrective actions if applicable, by doing
all of the actions specified in the Accomplishment Instructions of
Fokker Service Bulletin SBF100-25-097, dated December 30, 2003.

    Note 1 to paragraph (g) of this AD: Guidance on modifying the
PSU panel can be found in Fokker Service Bulletin SBF100-25-097,
dated December 30, 2003, which refers to Grimes Aerospace Service
Bulletin 10-1178-33-0040, Revision 1, dated March 25, 1996 (for PSU
panels having P/N 10-1178-()); and Grimes Aerospace Service Bulletin
10-1571-33-0041, dated October 15, 1993 (for PSU panels having P/N
10-1571-()).

(h) Retained Parts Installation Limitation, With No Changes

    This paragraph restates the requirements of paragraph (g) of AD
2005-12-16, with no changes. As of July 20, 2005 (the effective date
of AD 2005-12-16), no person may install a PSU panel having P/N 10-
1178-() or P/N 10-1571-() on any airplane, unless it has been
inspected and any applicable corrective actions have been done in
accordance with paragraph (g) of this AD.

(i) New Affected PSU Identification

    For the purpose of this AD, Grimes (Honeywell) PSUs having P/N
10-1178-() with a serial number below 4000, and PSUs having P/N 10-
1571-() with a serial number below 1000, are referred to as affected
PSUs in paragraphs (j) through (l) of this AD.

(j) New Inspections

    Within 24 months after the effective date of this AD: Do the
actions required by paragraphs (j)(1) and (j)(2) of this AD.
    (1) Do a general visual inspection of the panel of each affected
PSU for incorrect application of the sealant, in accordance with the
Accomplishment Instructions of Fokker Service Bulletin SBF100-25-
097, dated December 30, 2003; and, as applicable, Grimes Aerospace
Service Bulletin 10-1178-33-0040, dated October 15, 1993 (for PSUs
having P/N 10-1178-()); Grimes Aerospace Service Bulletin 10-1178-
33-0040, Revision 1, dated March 25, 1996 (for PSUs having P/N 10-
1178-()); or Grimes Aerospace Service Bulletin 10-1571-33-0041,
dated October 15, 1993 (for PSUs having P/N 10-1571-()).
    (2) Do a general visual inspection of the electrical connectors
of each affected PSU panel for discrepancies; i.e., uninstalled
gaskets, inability to properly lock the connectors, and incorrectly
applied sealant on the connectors; in accordance with the
Accomplishment Instructions of Fokker Service Bulletin SBF100-25-
128, dated July 21, 2016.

(k) Corrective Actions

    If, during any inspection required by paragraph (j) of this AD,
any discrepancy is found, before further flight, restore the sealing
of the affected PSU panels and accomplish all applicable corrective
actions to correct the PSU panel interface, in accordance with the
Accomplishment Instructions of Fokker Service Bulletin SBF100-25-
128, dated July 21, 2016. Do all applicable corrective actions
before further flight.

(l) Parts Installation Limitation

    As of the effective date of this AD, an affected PSU panel may
be installed on any airplane, provided that before further flight
after installation, it has been inspected in accordance with
paragraph (j) of this AD and all applicable corrective actions have
been done in accordance with paragraph (k) of this AD.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (n)(2) of this AD. Information
may be emailed to: [email protected].
    (i) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (ii) AMOCs approved previously for AD 2005-12-16 are approved as
AMOCs for the corresponding provisions of this AD.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the Manager, International Section, Transport Standards
Branch, FAA; or the European Aviation Safety Agency (EASA); or
Fokker Services B.V.'s Design Organization Approval (DOA). If
approved by the DOA, the approval must include the DOA-authorized
signature.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2017-0043, dated March 6, 2017,
for related information. This MCAI may be found in the AD docket on
the internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2017-0906.
    (2) For more information about this AD, contact Tom Rodriguez,
Aerospace Engineer, International Section, Transport Standards
Branch, FAA, 2200 South 216th St., Des

Moines, WA 98198; telephone and fax<PHONE_NUMBER>.

(o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
May 21, 2018.
    (i) Fokker Service Bulletin SBF100-25-128, dated July 21, 2016.
    (ii) Grimes Aerospace Service Bulletin 10-1178-33-0040, dated
October 15, 1993.
    (iii) Grimes Aerospace Service Bulletin 10-1178-33-0040,
Revision 1, dated March 25, 1996.
    (iv) Grimes Aerospace Service Bulletin 10-1571-33-0041, dated
October 15, 1993.
    (4) The following service information was approved for IBR on
July 20, 2005 (70 FR 34642, June 15, 2005).
    (i) Fokker Service Bulletin SBF100-25-097, dated December 30,
2003.
    (ii) Reserved.
    (5) For Fokker service information identified in this AD,
contact Fokker Services B.V., Technical Services Dept., P.O. Box
1357, 2130 EL Hoofddorp, the Netherlands; telephone +31 (0)88-6280-
350; fax +31 (0)88-6280-111; email [email protected];
internet http://www.myfokkerfleet.com. For Grimes Aerospace service
information identified in this AD, contact Grimes Aerospace Company,
Product Support Group, 240 Twain Avenue, Urbana, OH 43078; phone
513-653-5225; fax<PHONE_NUMBER>.
    (6) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (7) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on March 30, 2018.
Chris Spangenberg,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-07639 Filed 4-13-18; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 69 (Monday, April 11, 2016)]
[Rules and Regulations]
[Pages 21244-21246]
[FR Doc No: 2016-07375]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-1277; Directorate Identifier 2014-NM-155-AD;
Amendment 39-18459; AD 2016-07-14]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Airbus Model A319, A320, and A321 series airplanes. This AD is intended
to complete certain mandated programs intended to support the airplane
reaching its limit of validity (LOV) of the engineering data that
support the established structural maintenance program. This AD was
prompted by fatigue testing that determined fatigue damage could appear
on clips, shear webs, and angles at certain rear fuselage sections and
certain frames. This AD requires replacing the clips, shear webs, and
angles, including doing all applicable related investigative actions,
and repair if necessary. We are issuing this AD to prevent fatigue
damage on the clips, shear webs, and angles; such damage could affect
the structural integrity of the airplane.

DATES: This AD becomes effective May 16, 2016.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 16,
2016.

ADDRESSES: For service information identified in this final rule,
contact Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax
+33 5 61 93 44 51; email<EMAIL_ADDRESS>Internet
http://www.airbus.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
1277.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
1277; 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 Operations office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, WA 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Airbus Model A319,
A320, and A321 series airplanes. The NPRM published in the Federal
Register on May 8, 2015 (80 FR 26487) (``the NPRM'').
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2014-0177, dated July 25, 2014 (referred to
after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for certain Airbus Model
A319, A320, and A321 series airplanes. The MCAI states:

    During the A320 fatigue test campaign for Extended Service Goal
(ESG), it was determined that fatigue damage could appear on the
clips, shear webs and angles at rear fuselage section 19, on Frame
(FR) 72 and FR74.
    This condition, if not detected and corrected, could affect the
structural integrity of the aeroplane.
    To address this potential unsafe condition, Airbus developed a
modification, which has been published through Airbus Service
Bulletin (SB) A320-53-1266 for in-service application to allow
aeroplanes to operate up to the new ESG limit.
    For the reasons described above, this [EASA] AD requires
replacement of the affected clips, shear webs and angles at rear
fuselage section 19, FR72 and FR74 [including all applicable related
investigative actions and repair if any cracking is found].

    Related investigative actions include rotating probe testing for
cracking of the fastener holes and high frequency eddy current
inspections for cracking of the stringers. You may examine the MCAI in
the AD docket on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2015-1277.

Actions Since NPRM was Issued

    Since the NPRM was issued, Airbus has issued Airbus Service
Bulletin A320-53-1266, Revision 03, dated May 7, 2015. We have revised
paragraph (g) of this AD to reference this revised service information.
We have revised paragraph (i) of this AD to give credit for actions
done before the effective date of this AD using the following service
information.
     Airbus Service Bulletin A320-53-1266, dated January 11,
2013.
     Airbus Service Bulletin A320-53-1266, Revision 01, dated
June 20, 2013.
     Airbus Service Bulletin A320-53-1266, Revision 02, dated
August 13, 2014.

Comments

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

Support for the NPRM

    An anonymous commenter provided support for the NPRM.

Request To Omit Part Replacement Requirement

    United Airlines requested that we revise paragraph (h) of the
proposed AD to omit the additional part replacement. United Airlines
noted that paragraph (h) of the proposed AD states that the replacement
of clips, shear webs, and angles must be accomplished again before
30,000 flight cycles or 60,000 flight hours, whichever occurs first, if
the replacement was accomplished before 30,000 flight cycles or 60,000
flight hours, whichever occurred first from airplane's first flight.
The commenter stated that this paragraph suggests that the installation
of new parts does not constitute terminating action. The commenter
expressed that paragraph (g) of the proposed AD has no repetitive
requirement for replacement

of new parts if accomplished between 30,000 and 48,000 flight cycles or
60,000 and 96,000 flight hours since the airplane's first flight. The
commenter suggested that this requirement will encourage operators to
replace the part when the airplane has accumulated more than 30,000
total flight cycles and 60,000 total flight hours in order to avoid the
possibility of additional part replacement. The commenter added that
installation of new parts twice, increases the risk of damage during
the part replacement.
    United Airlines stated further that the additional replacement in
paragraph (h) of the proposed AD could potentially result in the
requirement to replace the part twice before the threshold defined in
paragraph (g) of the proposed AD. By way of example, the commenter
stated that if the part replacement were accomplished before 18,000
flight cycles and 36,000 flight hours since the airplane's first
flight, the replacement would be required again before 48,000 flight
cycles or 96,000 flight hours since the airplane's first flight. This
scenario implies that the new parts reduce the fatigue life compared to
an unmodified aircraft. United Airlines stated that it is not clear how
the additional replacement in paragraph (h) of the proposed AD meets
the intent of the NPRM. The replacement part modification prevents
fatigue damage on the clips, shear webs, and angles to support
operation reaching the LOV. However, there is no explanation in the AD
that these new parts are life limited.
    We disagree to omit the additional part replacement required by
paragraph (h) of this AD. We agree with United Airlines' assessment
that this AD would require replacement of the clips, shear webs, and
angles twice, if those parts are first replaced prior to 30,000 total
flight cycles or 60,000 total flight hours, whichever occurs first.
Replacement of clips, shear webs, and angles prior to 30,000 total
flight cycles or 60,000 total flight hours may have been required due
to reasons other than this AD. However, this AD does not require
replacement of the parts before 30,000 total flight cycles or 60,000
total flight hours. We have determined that if the parts are replaced
before 30,000 total flight cycles or 60,000 total flight hours,
whichever occurs first, a repeat replacement of those parts is
necessary to support the airplane reaching its LOV of the engineering
data.
    We also disagree that requiring replacement of the parts twice,
will increase the risk of damage. The procedures specified in Airbus
Service Bulletin A320-53-1266, Revision 03, dated May 7, 2015, for
replacing clips, shear webs, and angles are appropriate for supporting
the continued operational safety of the affected Airbus fleet and do
not introduce additional risk to the structural integrity of the
airplane. We have made no changes to this AD in this regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this AD as proposed except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    Airbus has issued Airbus Service Bulletin A320-53-1266, Revision
03, dated May 7, 2015. The service information describes procedures for
replacing clips, shear webs, and angles at rear fuselage section 19,
FR72 and FR74. This service information is reasonably available because
the interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 44 airplanes of U.S. registry.
    We also estimate that it will take about 110 work-hours per product
to comply with the basic requirements of this AD. The average labor
rate is $85 per work-hour. Based on these figures, we estimate the cost
of this AD on U.S. operators to be $411,400, or $9,350 per product.
    We have received no definitive data on the costs of required parts.

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 the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2016-07-14 Airbus: Amendment 39-18459. Docket No. FAA-2015-1277;
Directorate Identifier 2014-NM-155-AD.

(a) Effective Date

    This AD becomes effective May 16, 2016.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to the airplanes identified in paragraphs
(c)(1), (c)(2), and (c)(3) of this AD, certificated in any category,
all manufacturer serial numbers, except those on

which Airbus Modification 30975 has been embodied in production.
    (1) Airbus Model A319-111, -112, -113, -114, -115, -131, -132,
and -133 airplanes.
    (2) Airbus Model A320-211, -212, -214, -231, -232, and -233
airplanes.
    (3) Airbus Model A321-111, -112, -131, -211, -212, -213, -231,
and -232 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

    This AD was prompted by fatigue testing that determined that
fatigue damage could appear on clips, shear webs, and angles at
certain rear fuselage sections and certain frames. This AD is
intended to complete certain mandated programs intended to support
the airplane reaching its limit of validity of the engineering data
that support the established structural maintenance program. We are
issuing this AD to prevent fatigue damage on the clips, shear webs,
and angles, which could affect the structural integrity of the
airplane.

(f) Compliance

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

(g) Replacement

    At the later of the times specified in paragraphs (g)(1) and
(g)(2) of this AD: Replace the clips, shear webs, and angles at rear
fuselage section 19, frame FR72 and FR74, and do all applicable
related investigative actions before further flight, in accordance
with the Accomplishment Instructions of Airbus Service Bulletin
A320-53-1266, Revision 03, dated May 7, 2015. If any crack is found
during any related investigative action required by this AD: Before
further flight, repair using a method approved by the Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA;
or the European Aviation Safety Agency (EASA); or Airbus's EASA
Design Organization Approval (DOA).
    (1) Before exceeding 48,000 flight cycles or 96,000 flight
hours, whichever occurs first since the airplane's first flight.
    (2) Within 30 days after the effective date of this AD.

(h) Additional Replacement for Certain Airplanes

    For airplanes on which the replacement of clips, shear webs, and
angles specified in Airbus Service Bulletin A320-53-1266 is done
before accumulating 30,000 flight cycles or 60,000 flight hours,
whichever occurred first since the airplane's first flight: Within
30,000 flight cycles or 60,000 flight hours, whichever occurs first
after that replacement, do the replacement specified in paragraph
(g) of this AD.

(i) Credit for Previous Actions

    Except as required by paragraph (h) of this AD: This paragraph
provides credit for the replacement required by paragraph (g) of
this AD, if those actions were performed before the effective date
of this AD using the service information identified in paragraph
(i)(1), (i)(2), or (i)(3) of this AD. This service information is
not incorporated by reference in this AD.
    (1) Airbus Service Bulletin A320-53-1266, dated January 11,
2013.
    (2) Airbus Service Bulletin A320-53-1266, Revision 01, dated
June 20, 2013.
    (3) Airbus Service Bulletin A320-53-1266, Revision 02, dated
August 13, 2014.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
has the authority to approve AMOCs for this AD, if requested using
the procedures found in 14 CFR 39.19. In accordance with 14 CFR
39.19, send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Branch, send it to ATTN: Sanjay
Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport
Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-
3356; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>. Information may be
emailed to<EMAIL_ADDRESS>Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office. The
AMOC approval letter must specifically reference this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Branch, ANM-116, Transport Airplane Directorate, FAA; or the EASA;
or Airbus's EASA DOA. If approved by the DOA, the approval must
include the DOA-authorized signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2014-0177, dated July 25, 2014,
for related information. This MCAI may be found in the AD docket on
the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2015-1277.
    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (l)(3) and (l)(4) of this AD.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Airbus Service Bulletin A320-53-1266, Revision 03, dated May
7, 2015.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Airbus, Airworthiness Office--EIAS, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on March 25, 2016.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2016-07375 Filed 4-8-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 6 (Friday, January 9, 2015)]
[Notices]
[Page 1407]
[FR Doc No: 2015-00090]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER15-745-000]

Supplemental Notice That Initial Market-Based Rate Filing
Includes Request for Blanket Section 204 Authorization; AM Commodities
Corporation

    This is a supplemental notice in the above-referenced proceeding,
of AM Commodities Corporation's application for market-based rate
authority, with an accompanying rate schedule, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability is January 20, 2015.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding(s) are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also 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 email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: December 31, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2015-00090 Filed 1-8-15; 8:45 am]
BILLING CODE 6717-01-P