[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Proposed Rules]
[Pages 13799-13803]
[FR Doc No: 2015-05720]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-0490; Directorate Identifier 2014-NM-018-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to supersede Airworthiness Directive (AD) 2008-22-
20, for certain Airbus Model A330-200, A330-300, and A340-300 series
airplanes. AD 2008-22-20 currently requires repetitive high frequency
eddy current (HFEC) inspections for cracking, repair if necessary, and
modification of the upper shell structure of the fuselage. Since we
issued AD 2008-22-20, we have determined from a fatigue and damage
tolerance evaluation that the compliance times must be reduced. This
proposed AD would shorten certain compliance times. We are proposing
this AD to prevent fatigue cracking of the upper shell structure of the
fuselage, which could result in reduced structural integrity of the
airplane.

DATES: We must receive comments on this proposed AD by May 1, 2015.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus SAS, Airworthiness Office--EAL, 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 45 80; 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
425-227-1221.

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-
0490; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Vladimir Ulyanov, 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:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2015-0490;
Directorate Identifier 2014-NM-018-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    On October 20, 2008, we issued AD 2008-22-20, Amendment 39-15717
(73 FR 66747, November 12, 2008). AD 2008-22-20 requires actions
intended to address an unsafe condition on certain Airbus Model A330-
200, A330-300, and A340-300 series airplanes.
    Since we issued AD 2008-22-20, Amendment 39-15717 (73 FR 66747,
November 12, 2008), it has been determined from a fatigue and damage
tolerance evaluation that the compliance times for certain inspections
and modification must be reduced.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Airworthiness Directive 2014-0012R1, dated January 24, 2014 (referred
to after this as the Mandatory Continuing Airworthiness Information, or
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    During fatigue tests (EF3) on the A340-600, damage was found in
the longitudinal doubler at the Vertical Tail Plane (VTP) attachment
cut out between Frame (FR) 80 and FR86. This damage occurred between
58,341 and 72,891 simulated flight cycles (FC).
    Due to the higher Design Service Goal and different design of
the affected structural area (e.g., doubler thickness) for A330-200/
-300 and A340-300 airplane series, the damage assessment concluded
that these airplanes may be also potentially affected.
    This condition, if not detected and corrected, could affect the
structural integrity of the upper shell structure between FR80 and
FR86.
    Prompted by these findings, EASA issued AD 2007-0284 [(http://ad.easa.europa.eu/blob/easa_ad_2007_0284_superseded.pdf/AD_2007-0284_1)] to require implementation of an inspection programme of
this structural area using a high frequency eddy current (HFEC)
method and a modification to improve the upper shell structure.
    Since that [EASA] AD was issued, in the frame of a new fatigue
and damage tolerance evaluation, taking into account the airplane

utilisation, the inspection threshold and intervals have been
reassessed and the conclusion was that the thresholds and intervals
for inspection, as well as the threshold for modifying the airplane,
must be reduced.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2007-0284, which is superseded and
introduces redefined thresholds and intervals.
    This [EASA] AD is revised to clarify that, under some
conditions, accomplishment of a repair constitutes terminating
action for the repetitive inspections. One of the outcome of this
clarification is the deletion of paragraph (5) of this [EASA] AD.

    You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating it in Docket No.
FAA-2015-0490.
    Initial compliance time thresholds range from 7,300 flight cycles
or 47,600 flight hours, and up to 25,400 flight cycles or 76,300 flight
hours, depending on configuration and range.
    Repetitive compliance time thresholds range from 1,700 flight
cycles or 11,300 flight hours, and up to 4,500 flight cycles or 13,500
flight hours, depending on configuration.

Widespread Fatigue Damage

    Structural fatigue damage is progressive. It begins as minute
cracks, and those cracks grow under the action of repeated stresses.
This can happen because of normal operational conditions and design
attributes, or because of isolated situations or incidents such as
material defects, poor fabrication quality, or corrosion pits, dings,
or scratches. Fatigue damage can occur locally, in small areas or
structural design details, or globally. Global fatigue damage is
general degradation of large areas of structure with similar structural
details and stress levels. Multiple-site damage is global damage that
occurs in a large structural element such as a single rivet line of a
lap splice joining two large skin panels. Global damage can also occur
in multiple elements such as adjacent frames or stringers. Multiple-
site-damage and multiple-element-damage cracks are typically too small
initially to be reliably detected with normal inspection methods.
Without intervention, these cracks will grow, and eventually compromise
the structural integrity of the airplane, in a condition known as
widespread fatigue damage (WFD). As an airplane ages, WFD will likely
occur, and will certainly occur if the airplane is operated long enough
without any intervention.
    The FAA's WFD final rule (75 FR 69746, November 15, 2010) became
effective on January 14, 2011. The WFD rule requires certain actions to
prevent structural failure due to WFD throughout the operational life
of certain existing transport category airplanes and all of these
airplanes that will be certificated in the future. For existing and
future airplanes subject to the WFD rule, the rule requires that DAHs
establish a limit of validity (LOV) of the engineering data that
support the structural maintenance program. Operators affected by the
WFD rule may not fly an airplane beyond its LOV, unless an extended LOV
is approved.
    The WFD rule (75 FR 69746, November 15, 2010) does not require
identifying and developing maintenance actions if the DAHs can show
that such actions are not necessary to prevent WFD before the airplane
reaches the LOV. Many LOVs, however, do depend on accomplishment of
future maintenance actions. As stated in the WFD rule, any maintenance
actions necessary to reach the LOV will be mandated by airworthiness
directives through separate rulemaking actions.
    In the context of WFD, this action is necessary to enable DAHs to
propose LOVs that allow operators the longest operational lives for
their airplanes, and still ensure that WFD will not occur. This
approach allows for an implementation strategy that provides
flexibility to DAHs in determining the timing of service information
development (with FAA approval), while providing operators with
certainty regarding the LOV applicable to their airplanes.

Related Service Information Under 1 CFR Part 51

    Airbus has issued the following service information. The actions
described in this service information are intended to correct the
unsafe condition identified in the MCAI. This service information is
reasonably available; see ADDRESSES for ways to access this service
information.
     Airbus Service Bulletin A330-53-3159, Revision 02, dated
March 29, 2010. The service information describes procedures for a
modification of the fuselage, which includes inspections (e.g., eddy
current rotating probe test of fastener holes for cracking, high
frequency eddy current (HFEC) inspections for cracking of the upper
shell structure of the fuselage, and checks of the fastener position
for clearance) and applicable corrective actions (e.g., repair and
rework).
     Airbus Service Bulletin A330-53-3160, Revision 03, dated
January 6, 2012. The service information describes procedures for
applicable actions, including an eddy current rotating probe test for
cracking of the fastener holes and an HFEC inspection for cracks in the
upper shell of the fuselage (and including checks of the fastener
position for clearance and applicable corrective actions (e.g., repair
and rework)), and a modification of the airplane upper shell structure
of the fuselage between FR80 and FR86.
     Airbus Service Bulletin A330-53-3168, Revision 02, dated
December 21, 2011. The service information describes procedures for a
HFEC inspection for cracking of the upper shell structure of the
fuselage between FR80 and FR86.
     Airbus Service Bulletin A340-53-4165, Revision 02, dated
March 29, 2010. The service information describes procedures for a
modification of the fuselage, which includes inspections (e.g., eddy
current rotating probe test of fastener holes for cracking, HFEC
inspections for cracking of the upper shell structure of the fuselage,
and checks of the fastener position for clearance) and applicable
corrective actions (e.g., repair and rework).
     Airbus Service Bulletin A340-53-4172, Revision 01, dated
July 8, 2009. The service information describes procedures for
inspections (e.g., rototest inspections of fastener holes for cracking,
HFEC inspections for cracking of the upper shell structure of the
fuselage, and checks of the fastener position for clearance) and
modification of the airplane upper shell structure between FR80 and
FR86 (including applicable corrective actions (e.g., repair and
rework).
     Airbus Service Bulletin A340-53-4174, Revision 02, dated
December 21, 2011. The service information describes procedures for a
HFEC inspection for cracking of the upper shell structure of the
fuselage between FR80 and FR86.

FAA's Determination and Requirements of This Proposed AD

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

Differences Between This Proposed AD and the MCAI or Service
Information

    Unlike the procedures described in the service information, this
proposed AD would not permit further flight if cracks are detected in
the upper shell structure. We have determined that, because of the
safety implications and consequences associated with that cracking, any
cracked upper shell structure must be repaired before further flight.
This difference has been coordinated with the EASA and Airbus.

Explanation of Compliance Time for Modification

    The compliance time for the modification specified in this proposed
AD for addressing WFD was established to ensure that discrepant
structure is modified before WFD develops in airplanes. Standard
inspection techniques cannot be relied on to detect WFD before it
becomes a hazard to flight. We will not grant any extensions of the
compliance time to complete any AD-mandated service bulletin related to
WFD without extensive new data that would substantiate and clearly
warrant such an extension.

Costs of Compliance

    We estimate that this proposed AD affects 26 airplanes of U.S.
registry. We also estimate that it would take about 208 work-hours per
product to comply with the basic requirements (inspection and
modification) of this proposed AD. The average labor rate is $85 per
work-hour. Required parts would cost about $28,360 per product. Based
on these figures, we estimate the cost of this proposed AD on U.S.
operators to be $1,197,040, or $46,040 per product.
    We have received no definitive data that would enable us to provide
cost estimates for the on-condition actions specified in this proposed
AD.
    According to the manufacturer, some of the costs of this proposed
AD may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all costs in our cost
estimate.

Authority for This Rulemaking

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

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2008-22-20, Amendment 39-15717 (73 FR 66747, November 12, 2008), and
adding the following new AD:

Airbus: Docket No. FAA-2015-0490; Directorate Identifier 2014-NM-
018-AD.

(a) Comments Due Date

    We must receive comments by May 1, 2015.

(b) Affected ADs

    This AD replaces AD 2008-22-20, Amendment 39-15717 (73 FR 66747,
November 12, 2008).

(c) Applicability

    This AD applies to Airbus Model A330-201, -202, -203, -223, -
243, -301, -302, -303, -321, -322, -323, -341, -342, and -343; and
Model A340-311, -312, and -313 airplanes; certificated in any
category; all manufacturer serial numbers on which Airbus
Modification 44205 has been embodied in production, except those on
which Airbus Modification 52974 or 53223 has been embodied in
production.

(d) Subject

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

(e) Reason

    This AD was prompted by the results of a fatigue and damage
tolerance evaluation that concluded existing compliance times must
be reduced. We are issuing this AD to prevent fatigue cracking of
the upper shell structure of the fuselage, which could result in
reduced structural integrity of the airplane.

(f) Compliance

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

(g) Inspection for Airbus Model A330-300 and A340-300 Airplanes, Except
Model A340-300 Weight Variant (WV) 027 Airplanes

    For Model A330-300 and A340-300 airplanes, except Model A340-300
WV 027 airplanes: At the applicable time specified in paragraph
(g)(1) or (g)(2) of this AD, do a high frequency eddy current (HFEC)
inspection for cracking of the upper shell structure between frame
(FR) 80 and FR86, in accordance with the Accomplishment Instructions
of Airbus Service Bulletin A330-53-3168, Revision 02, dated December
21, 2011; or Airbus Service Bulletin A340-53-4174, Revision 02,
dated December 21, 2011; as applicable. Repeat the inspection
thereafter at the applicable time specified in paragraph 1.E.,
``COMPLIANCE,'' of Airbus Service Bulletin A330-53-3168, Revision
02, dated December 21, 2011; or Airbus Service Bulletin A340-53-
4174, Revision 02, dated December 21, 2011; as applicable.
    (1) For airplanes that, as of the effective date of this AD,
have not been inspected in accordance with Airbus Service Bulletin
A330-53-3168; or Airbus Service Bulletin A340-53-4174; as
applicable: Inspect at the later of the times specified in
paragraphs (g)(1)(i) and (g)(1)(ii) of this AD.
    (i) Before reaching the applicable threshold specified in
paragraph 1.E., ``COMPLIANCE,'' of Airbus Service Bulletin A330-53-
3168, Revision 02, dated December 21, 2011; or Airbus Service
Bulletin A340-53-4174, Revision 02, dated December 21, 2011; as
applicable for airplane model, configuration, and utilization, since
the airplane's first flight.
    (ii) Within the threshold defined in paragraph 1.E,
``COMPLIANCE,'' of Airbus

Service Bulletin A330-53-3168, Revision 01, dated February 15, 2008;
or Airbus Service Bulletin A340-53-4174, Revision 01, dated February
15, 2008; as applicable for airplane model, configuration, and
utilization since the airplane's first flight; or within 12 months
after the effective date of this AD; whichever occurs first.
    (2) For airplanes that, as of the effective date of this AD,
have been inspected in accordance with Airbus Service Bulletin A330-
53-3168; or Airbus Service Bulletin A340-53-4174; as applicable:
Inspect at the later of the times specified in paragraphs (g)(2)(i)
and (g)(2)(ii) of this AD.
    (i) Within the applicable interval specified in paragraph 1.E.,
``COMPLIANCE,'' of Airbus Service Bulletin A330-53-3168, Revision
02, dated December 21, 2011; or Airbus Service Bulletin A340-53-
4174, Revision 02, dated December 21, 2011; as applicable; to be
counted from the last inspection.
    (ii) Within 12 months after the effective date of this AD
without exceeding the intervals defined in paragraph 1.E,
``COMPLIANCE,'' of Airbus Service Bulletin A330-53-3168, Revision
01, dated February 15, 2008; or Airbus Service Bulletin A340-53-
4174, Revision 01, dated February 15, 2008; as applicable for
airplane model, configuration, and utilization to be counted from
the last inspection.

(h) Corrective Action for Airbus Model A330-300 and A340-300 Airplanes,
Except Model A340-300 WV 027 Airplanes

    If any crack is detected during any HFEC inspection required by
the introductory text to paragraph (g) of 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). Accomplishment of a repair for a
specific area, as required by this paragraph, is terminating action
for the repetitive HFEC inspections required by the introductory
text to paragraph (g) of this AD, as applicable, for that specific
repaired area only. The need and definition of subsequent repetitive
inspections (if any) for that specific repaired area will be defined
in the applicable repair 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).

(i) Optional Terminating Action

    For Airbus Model A330-300 and A340-300 airplanes, except Model
A340-300 WV 027 airplanes: Modification, which includes inspections
and applicable corrective actions, in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A330-53-3159,
Revision 02, dated March 29, 2010; or Airbus Service Bulletin A340-
53-4165, Revision 02, dated March 29, 2010; as applicable;
terminates the repetitive HFEC inspections required by the
introductory text to paragraph (g) of this AD, except where Airbus
Service Bulletin A330-53-3159, Revision 02, dated March 29, 2010; or
Airbus Service Bulletin A340-53-4165, Revision 02, dated March 29,
2010; as applicable; specifies to contact the manufacturer, repair
using a method approved by the Manager, International Branch, ANM-
116, Transport Airplane Directorate, FAA; or EASA; or Airbus's EASA
DOA.

(j) Inspection and Modification for Airbus Model A330-200 Airplanes

    (1) Within the compliance times specified in paragraph (j)(1)(i)
or (j)(1)(ii) of this AD, whichever occurs later: Do all applicable
actions, including an eddy current rotating probe test and an HFEC
inspection for cracks, and modify the airplane upper shell structure
between FR80 and FR86; in accordance with the Accomplishment
Instructions of Airbus Service Bulletin A330-53-3160, Revision 03,
dated January 6, 2012.
    (i) Within the compliance times identified in paragraph 1.E.,
``COMPLIANCE,'' of Airbus Service Bulletin A330-53-3160, Revision
03, dated January 6, 2012, as applicable for airplane configuration
and utilization since the airplane's first flight.
    (ii) Within 12 months after the effective date of this AD
without exceeding the threshold, defined in paragraph 1.E,
``COMPLIANCE,'' of Airbus Service Bulletin A330-53-3160, Revision
02, dated March 29, 2010, since the airplane's first flight.

(k) Inspection and Modification for Airbus Model A340-300 Airplanes,
Only WV 027

    For Model A340-300 airplanes, WV 027 only: Before the
accumulation of 14,200 total flight cycles from the airplane's first
flight, do all applicable inspections and modify the airplane upper
shell structure between FR80 and FR86; in accordance with the
Accomplishment Instructions of Airbus Service Bulletin A340-53-4172,
Revision 01, dated July 8, 2009.

(l) Corrective Action for Airbus Model A330-200 Airplanes; and Model
A340-300 Airplanes, Only WV 027

    If any crack is detected during the inspection required by
paragraph (j) or (k) of this AD, before further flight, repair using
a method approved by the Manager, International Branch, ANM-116,
Transport Airplane Directorate, FAA; or EASA; or Airbus's EASA DOA;
concurrently with modification required by paragraph (j) or (k) of
this AD.

(m) Definition of ``Threshold'' and ``Interval''

    (1) For the purposes of this AD, the term ``Threshold,'' as used
in paragraph 1.E., ``COMPLIANCE,'' of the service information
specified in paragraphs (m)(2)(i) through (m)(2)(vi) of this AD
means the total flight cycles or flight hours accumulated since the
airplane's first flight.
    (2) For the purposes of this AD, the term ``Interval'' as used
in paragraph 1.E., ``COMPLIANCE,'' of the service information
specified in paragraphs (m)(2)(i) through (m)(2)(vi) of this AD
means the total flight cycles or flight hours accumulated since the
last inspection, as applicable.
    (i) Airbus Service Bulletin A330-53-3168, dated September 19,
2007.
    (ii) Airbus Service Bulletin A330-53-3168, Revision 01, dated
February 15, 2008.
    (iii) Airbus Service Bulletin A330-53-3168, Revision 02, dated
December 21, 2011.
    (iv) Airbus Service Bulletin A340-53-4174, dated September 19,
2007.
    (v) Airbus Service Bulletin A340-53-4174, Revision 01, dated
February 15, 2008.
    (vi) Airbus Service Bulletin A340-53-4174, Revision 02, dated
December 21, 2011.

(n) Credit for Previous Actions

    (1) For Model A330-300 and A340-300 airplanes, except Model
A340-300 WV 027 airplanes: This paragraph provides credit for the
modification specified in paragraph (i) of this AD, if those actions
were performed before the effective date of this AD using the
service information identified in paragraph (n)(1)(i), (n)(1)(ii),
(n)(1)(iii), or (n)(1)(iv) of this AD, as applicable. This service
information is not incorporated by reference in this AD.
    (i) Airbus Service Bulletin A330-53-3159, dated September 19,
2007.
    (ii) Airbus Service Bulletin A330-53-3159, Revision 01, dated
June 15, 2009.
    (iii) Airbus Service Bulletin A340-53-4165, dated September 19,
2007.
    (iv) Airbus Service Bulletin A340-53-4165, Revision 01, dated
June 17, 2009.
    (2) For Model A330-200 airplanes: This paragraph provides credit
for the inspection and modification required by paragraph (j) of
this AD, if those actions were performed before the effective date
of this AD using the service information identified in paragraph
(n)(2)(i), (n)(2)(ii), or (n)(2)(iii) of this AD, as applicable.
This service information is not incorporated by reference in this
AD.
    (i) Airbus Service Bulletin A330-53-3160, dated July 9, 2007.
    (ii) Airbus Service Bulletin A330-53-3160, Revision 01, dated
April 28, 2009.
    (iii) Airbus Service Bulletin A330-53-3160, Revision 02, dated
March 29, 2010.
    (3) For Model A340-300 airplanes, WV 027 only: This paragraph
provides credit for the inspection and modification required by
paragraph (k) of this AD, if those actions were performed before the
effective date of this AD using Airbus Service Bulletin A340-53-
4172, dated July 10, 2007, which is not incorporated by reference in
this AD.

(o) 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: Vladimir
Ulyanov, 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: 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 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.

(p) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA Airworthiness Directive 2014-0012R1, dated January 24,
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-2015-0490.
    (2) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAL, 1 Rond Point Maurice
Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96;
fax +33 5 61 93 45 80; email<EMAIL_ADDRESS>
Internet http://www.airbus.com. 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<PHONE_NUMBER>.

    Issued in Renton, Washington, on March 2, 2015.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-05720 Filed 3-16-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 79, Number 223 (Wednesday, November 19, 2014)]
[Notices]
[Page 68890]
[FR Doc No: 2014-27384]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1840]

Electronic Study Data Submission; Data Standards; Validation
Rules for Study Data Tabulation Model Formatted Studies; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA) Center for Drug
Evaluation and Research (CDER) is announcing the availability of a
document entitled ``Validation Rules for Study Data Tabulation Model
(SDTM) Formatted Studies.'' CDER is making this document available to
improve the standardization and quality of clinical data submitted to
CDER, as well as to improve the predictability of data quality and
usefulness.

FOR FURTHER INFORMATION CONTACT: Office of Strategic Programs, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, Rm. 1192, Silver Spring, MD 20993, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: CDER supports the regulatory submission of
standardized clinical study data based on the Clinical Data Interchange
Standards Consortium SDTM. Upon receipt of the data, CDER validates the
data using a set of validation rules. The ``Validation Rules for SDTM
Formatted Studies'' is an Excel file that provides a human readable
description of a rule set for validation. Submitters of clinical study
data can use this information to understand how FDA validates the data.
The file is available on FDA's Study Data Standards Resources Web page
at http://www.fda.gov/ForIndustry/DataStandards/StudyDataStandards/default.htm. It contains a combination of conformance rules (i.e., how
well the data conform to the standard) and business rules (i.e.,
quality checks; how well the data may support useful analysis). The
rules may be updated periodically as new or updated validation rules
are developed. The Change History tab will provide a descriptive change
history of the document.

    Dated: November 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-27384 Filed 11-18-14; 8:45 am]
BILLING CODE 4164-01-P


US ENVIRONMENTAL PROTECTION AGENCY

HUMAN STUDIES REVIEW BOARD

JUNE 2010 PUBLIC MEETING

Environmental Protection Agency Conference Center

Lobby Level - One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202

JUNE 23, 2010

10:00 AM 	Convene Meeting and Administrative Procedures – Jim Downing
(Designated Federal Officer, EPA Human Studies Review Board, Office of
the Science Advisor)

10:05 AM*	Introduction and Identification of Board Members – Sean
Philpott, Ph.D. (HSRB Chair)

10:15 AM 	Welcome –Pai-Yei Whung, Ph.D. (Chief Scientist, Office of
the Science Advisor)

10:20 AM 	Opening Remarks – Steven Bradbury, Ph.D. (Director, Office
of Pesticide Programs (OPP), Office of Chemical Safety and Pollution
Prevention, EPA)

10:25 AM 	EPA Follow-up on Previous HSRB Recommendations – Mr. William
Jordan (OPP, EPA)

Completed Carroll-Loye Biological Research, Inc. Study LNX-002: Field
Repellency of Two Picaridin-Based Personal Insect Repellents to Black
Flies

10:30 AM 	EPA Science and Ethics Reviews – Mr. Kevin Sweeney (OPP,
EPA) and Mr. John Carley (OPP, EPA)

11:00 AM 	Board Questions of Clarification – Sean Philpott, Ph.D.
(HSRB Chair), EPA, Principal Investigator/Sponsor

11:30 AM 	Public Comments

11:45 AM	Board Discussion

Charge to the Board:

1. 	Is the CLBR study LNX-002 sufficiently sound, from a scientific
perspective, to be used to estimate the duration of complete protection
against black flies provided by the tested repellents?

2. 	Does available information support a determination that study
LNX-002 was conducted in substantial compliance with subparts K and L 40
CFR Part 26?

12:15 PM 	Lunch

Completed Carroll-Loye Biological Research, Inc. Study LNX-003:
Laboratory Repellency of Two Picaridin-Based Personal Insect Repellents
to Two Species of Ticks

1:15 PM 	EPA Science and Ethics Reviews – Mr. Kevin Sweeney (OPP, EPA)
and Mr. John Carley (OPP, EPA)

1:45 PM 	Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB
Chair), EPA, Principal Investigator/Sponsor

2:15 PM 	Public Comments

2:30 PM	Board Discussion

Charge to the Board:

1. 	Is the CLBR study LNX-003 sufficiently sound, from a scientific
perspective, to be used to estimate the duration of complete protection
against ticks provided by the tested repellents?

2. 	Does available information support a determination that study
LNX-003 was conducted in substantial compliance with subparts K and L 40
CFR Part 26?

3:00 PM	Break

3:15 PM	OPP Presentation: Revised Product Performance Test Guidelines
for Insect Repellents to be Applied to Human Skin – Mr. John Carley
(OPP, EPA) and Mr. William Jordan (OPP, EPA), with Clara Fuentes, Ph.D.
(OPP, EPA), and Mr. Kevin Sweeney (OPP, EPA)

3:45 PM 	Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB
Chair)

4:15 PM	OPP Presentation: Settlement Agreement in Litigation Against
EPA’s Human Studies Rule – Mr. William Jordan (OPP, EPA)

4:45 PM 	Board Questions of Clarification – Sean Philpott, Ph.D. (HSRB
Chair)

5:15 PM	Preview of Upcoming Meetings - Ms. Kelly Sherman (OPP, EPA)

5:20 PM	Adjournment

* Agenda times are approximate and subject to change. For further
information, please contact the Designated Federal Officer for this
meeting, Jim Downing, via telephone:<PHONE_NUMBER> or email:
HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
HSRB WEB SITE:   http://www.epa.gov/osa/hsrb/

Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ-ORD-2010-0381


[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)]
[Notices]
[Pages 71771-71772]
[FR Doc No: 2016-25083]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-79085; File No. SR-NYSE-2016-44]

Self-Regulatory Organizations; New York Stock Exchange LLC; Order
Instituting Proceedings To Determine Whether To Approve or Disapprove a
Proposed Rule Change, as Modified by Amendments No. 1 and 2, Allowing
the Exchange To Trade Pursuant to Unlisted Trading Privileges Any NMS
Stock Listed on Another National Securities Exchange; Establishing
Listing and Trading Requirements for Exchange Traded Products; and
Adopting New Equity Trading Rules Relating to Trading Halts of
Securities Traded Pursuant to UTP on the Pillar Platform

October 12, 2016.
    On June 30, 2016, New York Stock Exchange LLC (``Exchange'' or
``NYSE'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'' or ``Exchange Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to (1) allow the Exchange to
trade pursuant to unlisted trading privileges (``UTP'') any NMS Stock
listed on another national securities exchange; (2) establish listing
and trading requirements for exchange-traded products (``ETPs'' or
``Exchange Traded Products''); and (3) adopt new equity trading rules
relating to trading halts of securities traded pursuant to UTP on the
Exchange's Pillar trading platform. The proposed rule change was
published for comment in the Federal Register on July 14, 2016.\3\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 78263 (Jul. 8,
2016), 81 FR 45580 (``Notice'').
---------------------------------------------------------------------------

    On July 26, 2016, the Exchange filed Amendment No. 1 to the
proposed rule change.\4\ On August 23, 2016, pursuant to Section
19(b)(2) of the Act,\5\ the Commission designated a longer period
within which to approve the proposed rule change, disapprove the
proposed rule change, or institute proceedings to determine whether to
disapprove the proposed rule change.\6\ On August 26, 2016, the
Exchange filed Amendment No. 2 to the proposed rule change.\7\ The
Commission has received no comments on the proposed rule change.
---------------------------------------------------------------------------

    \4\ In Amendment No. 1, the Exchange: (1) Added a bullet point
stating that ``[b]ecause the Exchange's rules regarding the
production of books and records are described in Rule 440, the
Exchange is proposing to refer to Rule 440 in its proposed rules
wherever NYSE Arca Equities Rule 4.4 is referenced in the rules of
NYSE Arca Equities proposed in this filing;'' (2) deleted the
sentence stating, ``If an exchange has approved trading rules,
procedures and listing standards in place that have been approved by
the Commission for the product class that would include a new
derivative securities product, the listing and trading of such `new
derivative securities product,' does not require a proposed rule
change under Section 19b-4 of the Act'' and made conforming changes
to the rest of that paragraph; (3) deleted the bullet point that
stated, ``Correction of a typographical error in NYSE Arca Equities
Rule 8.400(a) so that proposed Rule 8.400(a) reads `as such terms
are used in Rule 5.1(b)' in the last sentence, rather than `as such
terms are used in the Rule 5.1(b)' as is currently drafted in NYSE
Arca Equities Rule 8.400(a)''; (4) noted that ``for new ETPs to be
traded pursuant to UTP, which are listed and traded on another
exchange pursuant to Rule 19b-4(e), the Exchange would be required
to file Form 19b-4(e) with the Commission in accordance with the
requirements therein.'' Amendment No. 1 is available at: https://www.sec.gov/comments/sr-nyse-2016-44/nyse201644-1.pdf. Because
Amendment No. 1 to the proposed rule change does not materially
alter the substance of the proposed rule change or raise unique or
novel regulatory issues, Amendment No. 1 is not subject to notice
and comment.
    \5\ 15 U.S.C. 78s(b)(2).
    \6\ See Securities Exchange Act Release No. 78641, 81 FR 59259
(Aug. 29, 2016). The Commission designated October 12, 2016, as the
date by which it should approve, disapprove, or institute
proceedings to determine whether to disapprove the proposed rule
change.
    \7\ In Amendment No. 2, the Exchange: (1) Added the clause
``pursuant to UTP'' at the end of the sentence that states, ``The
Exchange would have to file a Form 19b-4(e) with the Commission to
trade these ETPs;'' (2) in the first footnote that follows that
sentence, deleted the clause ``pursuant to Rule 19b-4(e);'' and (3)
at the end of that same footnote, added the reference, ``See
proposed Rule 5.1(a)(2); supra note 19 and accompanying text.''
Amendment No. 2 is available at: https://www.sec.gov/comments/sr-nyse-2016-44/nyse201644-2.pdf. Because Amendment No. 2 to the
proposed rule change does not materially alter the substance of the
proposed rule change or raise unique or novel regulatory issues,
Amendment No. 2 is not subject to notice and comment.
---------------------------------------------------------------------------

    This order institutes proceedings under Section 19(b)(2)(B) of the
Act \8\ to determine whether to approve or disapprove the proposed rule
change, as modified by Amendments No. 1 and 2.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(2)(B).
---------------------------------------------------------------------------

I. Summary of the Proposed Rule Change \9\
---------------------------------------------------------------------------

    \9\ The Commission notes that additional statements and
information describing the specific proposed changes to the
Exchange's rules, among other things, can be found in the Notice and
Amendments No. 1 and 2 to the proposed rule change. See Notice and
Amendments No. 1 and 2 to the proposed rule change, supra notes 3,
4, and 7, respectively.
---------------------------------------------------------------------------

    The Exchange states that it does not currently trade any securities
on a UTP basis. The Exchange proposes new rules to trade all Tape B and
Tape C symbols, on a UTP basis, on its new trading platform,
Pillar.\10\ In addition, the Exchange proposes to adopt rules for the
listing and trading of the following types of Exchange Traded Products:
\11\ Equity Linked Notes; Investment Company Units; Index-Linked
Exchangeable Notes; Equity Gold Shares; Equity Index-Linked Securities;
Commodity-Linked Securities; Currency-Linked Securities; Fixed-Income
Index-Linked Securities; Futures-Linked Securities; Multifactor-Index-
Linked Securities; Trust Certificates; Currency and Index Warrants;
Portfolio Depositary Receipts; Trust Issued Receipts; Commodity-Based
Trust Shares; Currency Trust Shares; Commodity Index Trust Shares;
Commodity Futures Trust Shares; Partnership Units; Paired Trust Shares;
Trust Units; Managed Fund Shares; and Managed Trust Securities.\12\
---------------------------------------------------------------------------

    \10\ According to the Exchange, on January 29, 2015, the
Exchange announced the implementation of Pillar, which is an
integrated trading technology platform designed to use a single
specification for connecting to the equities and options markets
operated by the Exchange and its affiliates, NYSE Arca, Inc. (``NYSE
Arca'') and NYSE MKT LLC. See Trader Update dated January 29, 2015,
available at: http://www1.nyse.com/pdfs/Pillar_Trader_Update_Jan_2015.pdf.
    \11\ The Exchange is proposing to define the term ``Exchange
Traded Product'' to mean a security that meets the definition of
``derivative securities product'' in Rule 19b-4(e) under the
Exchange Act. This proposed definition is identical to the
definition of ``Derivatives Securities Product'' in NYSE Arca
Equities Rule 1.1(bbb).
    \12\ See Notice, supra note 3.
---------------------------------------------------------------------------

    The Exchange represents that the proposed rules for these ETPs are
substantially identical (other than with respect to certain non-
substantive and technical amendments) to the rules of the NYSE Arca
Equities exchange for the qualification, listing, and trading of these
ETPs.\13\
---------------------------------------------------------------------------

    \13\ See Notice, supra note 3, at 45580-45581, n.7 (citing NYSE
Equities Rules 5 (Listings) and 8 (Trading of Certain Equities
Derivatives)).
---------------------------------------------------------------------------

    According to the Exchange, it will trade securities pursuant to UTP
only on its Pillar platform, not on its current trading platform.
Further, at this time, the Exchange states that it does not intend to
list ETPs pursuant to the proposed rules. The Exchange does not
proposing to change any of the current rules of the Exchange pertaining
to the listing and trading of ETPs in the NYSE Listed Company Manual or
in its other rules.

II. Proceedings To Determine Whether To Approve or Disapprove SR-NYSE-
2016-44 and Grounds for Disapproval Under Consideration

    The Commission is instituting proceedings pursuant to Section
19(b)(2)(B) of the Act \14\ to determine whether the proposed rule
change, as modified by Amendments No. 1 and 2, should be approved or
disapproved. Institution of such proceedings is appropriate at this
time in view of the

legal and policy issues raised by the proposed rule change, as modified
by Amendments No. 1 and 2. Institution of proceedings does not indicate
that the Commission has reached any conclusions with respect to any of
the issues involved. Rather, as described below, the Commission seeks
and encourages interested persons to provide comments on the proposed
rule change, as modified by Amendments No. 1 and 2.
---------------------------------------------------------------------------

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

    Pursuant to Section 19(b)(2)(B) of the Act,\15\ the Commission is
providing notice of the grounds for disapproval under consideration.
The Commission is instituting proceedings to allow for additional
analysis of the proposed rule change's consistency with Section 6(b)(5)
of the Act, which requires, among other things, that the rules of a
national securities exchange be ``designed to prevent fraudulent and
manipulative acts and practices, to promote just and equitable
principles of trade,'' and ``to protect investors and the public
interest.'' \16\
---------------------------------------------------------------------------

    \15\ Id.
    \16\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

III. Procedure: Request for Written Comments

    The Commission requests that interested persons provide written
submissions of their views, data, and arguments with respect to the
issues identified above, as well as any other concerns they may have
with the proposal. In particular, the Commission invites the written
views of interested persons concerning whether the proposal is
consistent with Section 6(b)(5) or any other provision of the Act, or
the rules and regulations thereunder. Although there do not appear to
be any issues relevant to approval or disapproval that would be
facilitated by an oral presentation of views, data, and arguments, the
Commission will consider, pursuant to Rule 19b-4, any request for an
opportunity to make an oral presentation.\17\
---------------------------------------------------------------------------

    \17\ Section 19(b)(2) of the Act, as amended by the Securities
Act Amendments of 1975, Public Law 94-29 (June 4, 1975), grants the
Commission flexibility to determine what type of proceeding--either
oral or notice and opportunity for written comments--is appropriate
for consideration of a particular proposal by a self-regulatory
organization. See Securities Act Amendments of 1975, Senate Comm. on
Banking, Housing & Urban Affairs, S. Rep. No. 75, 94th Cong., 1st
Sess. 30 (1975).
---------------------------------------------------------------------------

    Interested persons are invited to submit written data, views, and
arguments regarding whether the proposal should be approved or
disapproved by November 8, 2016. Any person who wishes to file a
rebuttal to any other person's submission must file that rebuttal by
November 22, 2016. The Commission asks that commenters address the
sufficiency of the Exchange's statements in support of the proposal,
which are set forth in the Notice,\18\ in addition to any other
comments they may wish to submit about the proposed rule change, as
modified by Amendments No. 1 and 2.\19\
---------------------------------------------------------------------------

    \18\ See Notice, supra note 3.
    \19\ See Amendments No. 1 and 2 to the proposed rule change,
supra notes 4 and 7, respectively.
---------------------------------------------------------------------------

    In particular, the Commission seeks comment on whether the proposed
rules regarding ETPs, which would not expressly apply on a continuing
basis, are consistent with the Act.\20\ The Commission notes that,
while the Exchange represents that it ``does not intend to list ETPs on
its Pillar platform,'' \21\ the proposed rule text contains no such
limitation, and the Exchange's Form 19b-4 filing also describes the
standards being proposed as governing the ``listing and trading'' of
ETPs.\22\
---------------------------------------------------------------------------

    \20\ The Commission's orders approving the generic listing and
trading of actively managed ETFs relied upon the listing exchange's
representation that the listing criteria would apply on a continuing
basis. See, e.g., Securities Exchange Act Releases No. 78396 (July
22, 2016), 81 FR 49698, 49701 (July 28, 2016) (File No. SR-BATS-
2015-100); No. 78397 (July 22, 2016), 81 FR 49320, 49324 (July 27,
2016) (File No. SR-NYSEArca-2015-110); and No. 78918 (Sept. 23,
2016), 81 FR 67033, 67035 (Sept. 29, 2016) (File No. SR-NASDAQ-2016-
104). Recent Commission orders approving the listing and trading of
individual ETPs have similarly relied upon representations by the
listing exchange that all statements and representations made
regarding (a) the description of the portfolio, (b) limitations on
portfolio holdings or reference assets, or (c) the applicability of
exchange rules and surveillance procedures shall constitute
continued listing requirements. See, e.g., Securities Exchange Act
Release No. 77920 (May 25, 2016), 81 FR 35086, 35090 (June 1, 2016)
(SR-NYSEArca-2016-46; approving listing and trading of shares of the
AdvisorShares Cornerstone Small Cap ETF); No. 78847 (Sept. 15,
2016), 81 FR 64560, 64562 (Sept. 20, 2016) (File No. SR-BATS-2016-
34; approving listing and trading of shares of the ProShares Crude
Oil Strategy ETF).
    \21\ See Notice, supra note 3, at 45581.
    \22\ See, e.g., Notice, supra note 3, at 45580, 45583 (emphasis
added).
---------------------------------------------------------------------------

    Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2016-44 on the subject line.

Paper Comments

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

All submissions should refer to File Numbers SR-NYSE-2016-44. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of these filings also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2016-44 and should be
submitted on or before November 8, 2016. Rebuttal comments should be
submitted by November 22, 2016.
---------------------------------------------------------------------------

    \23\ 17 CFR 200.30-3(a)(57).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\23\
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-25083 Filed 10-17-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 86 (Monday, May 5, 2014)]
[Rules and Regulations]
[Pages 25506-25508]
[FR Doc No: 2014-10111]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2014-0005; FRL-9910-33-Region 3]

Approval and Promulgation of Implementation Plans; Delaware;
Regional Haze Five-Year Progress Report State Implementation Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision submitted by the State of Delaware
through the Delaware Department of Natural Resources and Environmental
Control (DNREC). Delaware's SIP revision addresses requirements of the
Clean Air Act (CAA) and EPA's rules that require states to submit
periodic reports describing progress towards reasonable progress goals
(RPGs) established for regional haze and a determination of the
adequacy of the state's existing implementation plan addressing
regional haze (regional haze SIP). EPA is approving Delaware's SIP
revision on the basis that it addresses the progress report and
adequacy determination requirements for the first implementation period
for regional haze.

DATES: This final rule is effective on June 4, 2014.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2014-0005. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the electronic
docket, some information is not publicly available, i.e., confidential
business information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection Agency, Region III,
1650 Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State
submittal are available at the Delaware Department of Natural Resources
and Environmental Control, 89 Kings Highway, P.O. Box 1401, Dover,
Delaware 19903.

FOR FURTHER INFORMATION CONTACT: Irene Shandruk,<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On February 25, 2014 (79 FR 10442), EPA published a notice of
proposed rulemaking (NPR) for the State of Delaware. In the NPR, EPA
proposed approval of Delaware's progress report SIP, a report on
progress made in the first implementation period towards RPGs for the
Class I area outside the State that is affected by emissions from

Delaware's sources. This progress report SIP and accompanying cover
letter also included a determination that Delaware's existing regional
haze SIP requires no substantive revision to achieve the established
regional haze visibility improvement and emissions reduction goals for
2018.
    States are required to submit a progress report in the form of a
SIP revision every five years that evaluates progress towards the RPGs
for each mandatory Class I Federal area within the state and in each
mandatory Class I Federal area outside the state which may be affected
by emissions from within the state. See 40 CFR 51.308(g). In addition,
the provisions under 40 CFR 51.308(h) require states to submit, at the
same time as the 40 CFR 51.308(g) progress report, a determination of
the adequacy of the state's existing regional haze SIP. The first
progress report SIP is due five years after submittal of the initial
regional haze SIP. On September 25, 2008, Delaware DNREC submitted the
State's first regional haze SIP in accordance with 40 CFR 51.308(b).\1\
The progress report SIP revision was submitted by Delaware on September
24, 2013, and EPA finds that it satisfies the requirements of 40 CFR
51.308(g) and 308(h).
---------------------------------------------------------------------------

    \1\ On July 19, 2011, EPA finalized an approval of Delaware's
September 25, 2008 regional haze SIP to address the first
implementation period for regional haze. See 76 FR 42557.
---------------------------------------------------------------------------

II. Summary of SIP Revision

    Delaware's September 24, 2013 progress report SIP addresses
progress made towards RPGs of the Class I area outside the State that
is affected by emissions from Delaware's sources. This progress report
SIP also includes a determination of the adequacy of the State's
existing regional haze SIP. Delaware does not have any Class I areas
within its borders. However, in Delaware's September 25, 2008 regional
haze SIP submittal, DNREC had identified, through an area of influence
modeling analysis based on back trajectories in consultation with the
regional planning organization, Mid-Atlantic/Northeast Visibility Union
(MANE-VU), only one Class I area, Edwin B. Forsythe National Wildlife
Refuge (Brigantine Wilderness Area), in the neighboring State of New
Jersey, that can be potentially impacted by Delaware sources. See 76 FR
42557 (July 19, 2011).
    The provisions in 40 CFR 51.308(g) require a progress report SIP to
address seven elements. EPA finds that Delaware's progress report SIP
addressed each element under 40 CFR 51.308(g). The seven elements and
EPA's conclusion are briefly summarized below; however, the detailed
rationale for EPA's action is explained in the NPR and will not be
restated here. No public comments were received on the NPR.
    The provisions in 40 CFR 51.308(g) require progress report SIPs to
include a description of the status of measures in the approved
regional haze SIP; a summary of emissions reductions achieved; an
assessment of visibility conditions for each Class I area in the state;
an analysis of changes in emissions from sources and activities within
the state; an assessment of any significant changes in anthropogenic
emissions within or outside the state that have limited or impeded
progress in Class I areas impacted by the state's sources; an
assessment of the sufficiency of the approved regional haze SIP; and a
review of the state's visibility monitoring strategy. As explained in
detail in the NPR, EPA finds that Delaware's progress report SIP
addressed each element and has therefore satisfied the requirements
under 40 CFR 51.308(g).
    In addition, pursuant to 40 CFR 51.308(h), states are required to
submit, at the same time as the progress report SIP, a determination of
the adequacy of their existing regional haze SIP and to take one of
four possible actions based on information in the progress report. One
possible action is submission of a negative declaration to EPA that no
further substantive revision to the state's existing regional haze SIP
is needed. In its progress report SIP, Delaware submitted a negative
declaration that it had determined that the existing regional haze SIP
requires no further substantive revision to achieve the RPGs for the
Class I area affected by Delaware's sources. As explained in detail in
the NPR, EPA concludes Delaware has adequately addressed 40 CFR
51.308(h) because the visibility data trends at the Class I area
impacted by Delaware's sources and the emissions trends of Delaware's
largest emitters of visibility-impairing pollutants both indicate that
Brigantine Wilderness Area, which is the Class I area impacted by
Delaware sources, will be able to meet or exceed the RPGs for 2018.

III. Final Action

    EPA is approving Delaware's Regional Haze five-year progress report
SIP revision, submitted September 24, 2013, as meeting the applicable
regional haze requirements as set forth in 40 CFR 51.308(g) and
51.308(h).

IV. Statutory and Executive Order Reviews

A. General Requirements

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct

costs on tribal governments or preempt tribal law.

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by July 7, 2014. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action.
    This action to approve Delaware's regional haze five-year progress
report SIP revision may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen oxides, Particulate
matter, Reporting and recordkeeping requirements, Sulfur dioxide,
Volatile organic compounds.

    Dated: April 21, 2014.
W.C. Early,
Acting Regional Administrator, Region III.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart I--Delaware

0
2. In Sec.  52.420, the table in paragraph (e) is amended by adding the
entry for Regional Haze Five-Year Progress Report at the end of the
table to read as follows:

Sec.  52.420  Identification of plan.

* * * * *
    (e) * * *

----------------------------------------------------------------------------------------------------------------
                                        Applicable          State
    Name of non-regulatory SIP         geographic or      submittal     EPA approval date        Additional
             revision               nonattainment area       date                                explanation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Regional Haze Five-Year Progress   Statewide...........      9/24/13  5/5/14 [Insert page   ....................
 Report.                                                               number where the
                                                                       document begins].
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2014-10111 Filed 5-2-14; 8:45 am]
BILLING CODE 6560-50-P


May 27, 2015
MEETING ON 1,4-DIOXANE PROBLEM FORMULATION AND INITIAL ASSESSMENT
EPA OCSPP/OPPT RISK ASSESSMENT DIVISION

PURPOSE: Meeting of industry representatives with EPA to discuss the 1,4-Dioxane Problem Formulation and Initial Assessment.

ATTENDEES:
   EPA/OCSPP/OPPT/RAD
   Tala Henry
   Stanley Barone
   Yvette Selby-Mohamadu
   Susan Laessig
   Scott Prothero
   Charles Bevington

   INDUSTRY ATTENDING IN PERSON
   Christina Franz, ACC
   Sarah Brozena, ACC
   Paul DeLeo, American Cleaning Institute (ACI)
   Steve Bennett, Consumer Specialty Products Association (CSPA)
   Stephen Wieroniey and Javaneh Nekoomaram, American Coatings Association (ACA)
   Kerry Kelly, Waste Management
   Mark Collatz, Adhesive and Sealant Council (ASC)

   INDUSTRY ATTENDING ON PHONE
   Shaun Clancy, Evonik
   Julie Froehlicher, Proctor & Gamble
   Connie Deford, Dow Chemical
   Jeff Brown, BASF
   Sangeeta Khattar, BASF
   Iain Davies, Personal Care Products Council (PCPC)


[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Page 877]
[FR Doc No: 2019-00502]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-84988; File No. SR-CboeBZX-2018-040]

Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of
Withdrawal of a Proposed Rule Change To List and Trade Shares of SolidX
Bitcoin Shares Issued by the VanEck SolidX Bitcoin Trust Under BZX Rule
14.11(e)(4), Commodity-Based Trust Shares

January 23, 2019.
    On June 20, 2018, Cboe BZX Exchange, Inc. (``BZX'') filed with the
Securities and Exchange Commission (``Commission''), pursuant to
Section 19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\
and Rule 19b-4 thereunder,\2\ a proposed rule change to list and trade
shares of SolidX Bitcoin Shares issued by the VanEck SolidX Bitcoin
Trust under BZX Rule 14.11(e)(4), Commodity-Based Trust Shares.
---------------------------------------------------------------------------

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

    The proposed rule change was published for comment in the Federal
Register on July 2, 2018.\3\ On August 7, 2018, pursuant to Section
19(b)(2) of the Act,\4\ the Commission designated a longer period
within which to approve the proposed rule change, disapprove the
proposed rule change, or institute proceedings to determine whether to
disapprove the proposed rule change.\5\ On September 20, 2018, the
Commission instituted proceedings to determine whether to approve or
disapprove the proposed rule change.\6\ And on December 6, 2018, the
Commission designated a longer period for Commission action on the
proposed rule change.\7\
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 83520 (June 26,
2018), 83 FR 31014 (July 2, 2018).
    \4\ 15 U.S.C. 78s(b)(2).
    \5\ See Securities Exchange Act Release No. 83792 (Aug. 7,
2018), 83 FR 40112 (Aug. 13, 2018). The Commission designated
September 30, 2018, as the date by which it should approve,
disapprove, or institute proceedings to determine whether to
disapprove the proposed rule change.
    \6\ See Securities Exchange Act Release No. 84231 (Sept. 20,
2018), 83 FR 48665 (Sept. 26, 2018).
    \7\ See Exchange Act Release No. 84731 (Dec. 6, 2018), 83 FR
63933 (Dec. 12, 2018).
---------------------------------------------------------------------------

    On January 22, 2019, BZX withdrew the proposed rule change (SR-
CboeBZX-2018-040).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-00502 Filed 1-30-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: June 22, 2009 (Volume 74, Number 118)]
[Rules and Regulations]
[Page 29422]
[DOCID:fr22jn09-4]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2009-0449]
RIN 1625-AA09

Drawbridge Operation Regulation; Mermentau River, Mile 68.0, at
Mermentau, Acadia and Jefferson Davis Parishes, LA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, Eighth Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
BNSF Swing Bridge across the Mermentau River, mile 68.0, in Mermentau,
Acadia and Jefferson Davis Parishes, Louisiana. The deviation is
necessary to repair the pinion gear that turns the center pivot pier of
the bridge. This deviation allows the bridge to remain closed for 34
hours to accomplish the work.

DATES: This deviation is effective from 5 a.m. on June 29, 2009 until 5
p.m. on June 30, 2009.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2009-0449 and are available online
by going to http://www.regulations.gov, selecting the Advanced Docket
Search option on the right side of the screen, inserting USCG-2009-0414
in the Docket ID box, pressing Enter, and then clicking on the item in
the Docket ID column. This material is also available for inspection or
copying at the Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail David M. Frank, Bridge Administration Branch, Coast
Guard; telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>If you
have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The BNSF Railway Company has requested a
temporary deviation from the operating schedule of the BNSF Swing
Bridge across the Mermentau River, mile 68.0, in Mermentau, Acadia and
Jefferson Davis Parishes, Louisiana. The closure is necessary to allow
for repairs to the bridge.
    Presently, the bridge opens on signal for the passage of vessels.
This deviation will allow the bridge to remain in the closed-to-
navigation position from 7 a.m. on Monday, June 29, 2009 until 5 p.m.
on Tuesday, June 30, 2009. Navigation on the waterway consists of tugs
with tows, fishing vessels and recreational craft. Due to prior
experience and coordination with waterway users it has been determined
that this closure will not have a significant effect on these vessels.
    The vertical clearance of the swing bridge in the closed-to-
navigation position is 10.0 feet and unlimited in the open-to-
navigation position. No alternate routes are available. As this work is
proposed during hurricane season, if any storms are in the Gulf of
Mexico, the work may be postponed and rescheduled.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: May 28, 2009.
David M. Frank,
Bridge Administrator.
[FR Doc. E9-14550 Filed 6-19-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 79, Number 186 (Thursday, September 25, 2014)]
[Notices]
[Pages 57558-57559]
[FR Doc No: 2014-22808]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0155]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Veterinary Feed Directive

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on reporting and recordkeeping
requirements for distribution and use of Veterinary Feed Directive
(VFD) drugs and animal feeds containing VFD drugs.

DATES: Submit electronic or written comments on the collection of
information by November 24, 2014.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Veterinary Feed Directive--21 CFR 558; OMB Control Number 0910-0363--
Extension

    With the passage of the Animal Drug Availability Act, Congress
enacted legislation establishing a new class of restricted feed use
drugs, VFD drugs, which may be distributed without involving state
pharmacy laws. Although controls on the distribution and use of VFD
drugs are similar to those for prescription drugs regulated under
section 503(f) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
353(f)), the implementing VFD regulation (21 CFR 558.6) was tailored to
the unique circumstances relating to the distribution of medicated
feeds. All distributors of medicated feed containing VFD drugs must
notify FDA of their intent to distribute, and records must be
maintained of the distribution of all medicated feeds containing VFD
drugs. The VFD regulation ensures the protection of public health while
enabling animal producers to obtain and use needed drugs as efficiently
and cost effectively as possible.
    On December 12, 2013, FDA published a proposed rule in the Federal
Register (78 FR 75515) intended to improve the efficiency of FDA's VFD
program. The provisions included in the proposed rule were based on
stakeholder input received in response to solicitations for public
comment, including an advance notice of proposed rulemaking on March
29, 2010 (75 FR 15387), and draft text of proposed amendments to the
current VFD regulations on April 13, 2012 (77 FR 22247).
    While FDA intends to finalize the VFD rulemaking in 2015, the
current

information collection request supporting the program expires on
December 31, 2014. At this time, the burden for this information
collection remains unchanged.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                      21 CFR Section                           Number of        responses per       Total annual      Average burden      Total hours
                                                              respondents         respondent         responses         per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(a)(3) through (a)(5)...............................             15,000                 25            375,000  0.25 (15 minutes)             93,750
558.6(d)(1)(i) through (d)(1)(iii).......................                300                  1                300  0.25 (15 minutes)                 75
558.6(d)(1)(iv)..........................................                 20                  1                 20  0.25 (15 minutes)                  5
558.6(d)(2)..............................................              1,000                  5               5000  0.25 (15 minutes)              1,250
514.1(b)(9)..............................................                  1                  1                  1               3.00                  3
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total................................................  .................  .................  .................  .................             95,083
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2 --Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of      Number of records     Total annual      Average burden
                      21 CFR Section                         recordkeepers     per recordkeeper       records       per recordkeeping     Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
558.6(c)(1) through (c)(4)...............................            112,500                 10          1,125,000  0.0167 (1 minute)             18,788
558.6(e)(1) through (e)(4)...............................              5,000                 75            375,000  0.0167 (1 minute)              6,263
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total................................................  .................  .................  .................  .................             25,051
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimate of time required for record preparation and
maintenance is based on Agency communication with industry and Agency
records and experience.

    Dated: September 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22808 Filed 9-24-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 220 (Wednesday, November 14, 2018)]
[Notices]
[Pages 56913-56914]
[FR Doc No: 2018-24715]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2017-0002-N-20]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of information collection; request for comment.

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

SUMMARY:  Under the Paperwork Reduction Act of 1995 (PRA), this notice
announces that FRA is forwarding the Information Collection Request
(ICR) abstracted below to the Office of Management and Budget (OMB) for
review and comment. The ICR describes the information collections and
their expected burden. On March 14, 2017, FRA published a notice
providing a 60-day period for public comment and on September 13, 2017,
published a notice providing a 30-day period for public comment on the
ICR.

DATES: Interested persons are invited to submit comments on or before
December 14, 2018.

ADDRESSES: Submit written comments on the ICR to the Office of
Information and Regulatory Affairs, Office of Management and Budget,
725 17th Street NW, Washington, DC 20503, Attention: FRA Desk Officer.
Comments may also be sent via email to OMB at the following address:
[email protected].

FOR FURTHER INFORMATION CONTACT: Mr. Michael Jones, Information
Collection Clearance Officer, Office of Research, Development, and
Technology, Human Factors Division, RPD-34, Federal Railroad
Administration, 1200 New Jersey Avenue SE, Room W38-119, Washington, DC
20590 (telephone:<PHONE_NUMBER>); or Ms. Kim Toone, Information
Collection Clearance Officer, Office of Administration, Office of
Information Technology, RAD-20, Federal Railroad Administration, 1200
New Jersey Avenue SE, Room W34-212, Washington, DC 20590 (telephone:
(202) 493-6132).

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
issue two notices seeking public comment on information collection
activities before OMB may approve paperwork packages. See 44 U.S.C.
3506, 3507; 5 CFR 1320.8 through 1320.12. The required 60- and 30-Day
Federal Register Notices were published in the Federal Register on
March 14, 2017 (see 82 FR 20530) and September 13, 2017 (see 82 FR
43078), respectively. FRA received comments from the Association of
American Railroads (AAR) in a letter dated October 13, 2017, outlining
some concerns with the research approach in the human error study. FRA
replied by letter clarifying the research approach.
    Specifically, AAR commented that it was concerned that the proposed
study on automated locomotive technology was not fully developed and
that results of such a study might lead to unnecessary roadblocks to
the development of the technology positive train control (PTC).
Further, AAR stated ``FRA should also include in the study a control
group demonstrating the number of errors that occur in locomotives
absent autonomous technology.'' In response, FRA explained that under
the planned research approach at the time, it was not necessary to
include a manual operation condition as FRA did not intend to compare
performance with vs. without automation. The purpose of the study was
to understand the nature of possible design-induced errors for existing
system automation in the locomotive cab, with an eye toward future
improved systems. These errors are likely, absent of any human factors
engineering in the system design and development process. For this
examination, a control group was unnecessary. However, FRA now proposes
to expand the study approach to address AAR's concern and include a
manual condition control group. In this context, FRA's reference to
automation means an operation assisted by autonomous technology that
offers some level of automation less than full automation. This
condition will provide a baseline of performance to address two
hypotheses:

(H1) Automation provides specific performance benefits (e.g., an energy
management software system reduces fuel usage; PTC prevents
overspeeding and transgressions into workzones or past a red signal)
compared with manual control, but does not reduce workload in the
locomotive cab compared with manual control.
(H2) Automation usage results in more errors in high workload
situations than in low workload situations (e.g., distractions lead to
failure to notice mode transitions) and these errors have no direct
counterpart in manual conditions.

    Workload is defined as task loading, or the number of tasks in a
scenario. The high workload scenarios have more tasks than the low
workload scenarios. Based on the initial FRA pilot study, preceding the
current study, and on research and operational experiences in other
industries, high workload is often associated with error, thus, FRA's
concern and interest in conducting the current study.
    Before OMB decides whether to approve this proposed collection of
information, an additional 30 days is being provided for public
comment. Federal law requires OMB to approve or disapprove paperwork
packages between 30 and 60 days after the 30-day notice is published.
44 U.S.C. 3507(b)-(c); 5 CFR 1320.10(b); see also 60 FR 44978, 44983,
Aug. 29, 1995. OMB believes the 30-day notice informs the regulated
community to file relevant

comments and affords the agency adequate time to digest public comments
before it renders a decision. 60 FR 44983, Aug. 29, 1995. Therefore,
respondents should submit their respective comments to OMB within 30
days of publication to best ensure having their full effect.
    Comments are invited on the following ICR regarding: (1) Whether
the information collection activities are necessary for FRA to properly
execute its functions, including whether the information will have
practical utility; (2) the accuracy of FRA's estimates of the burden of
the information collection activities, including the validity of the
methodology and assumptions used to determine the estimates; (3) ways
for FRA to enhance the quality, utility, and clarity of the information
being collected; and (4) ways to minimize the burden of information
collection activities on the public, including the use of automated
collection techniques or other forms of information technology.
    The summary below describes the ICR that FRA will submit for OMB
clearance as the PRA requires:
    Title: Experimental Investigation of Automation-Induced Human Error
in Locomotive Cab.
    OMB Control Number: 2130-XXXX.
    Abstract: The purpose of this collection is to identify and
evaluate the potential for human error associated with the operation of
systems and automation in the locomotive cab. This research addresses
DOT's strategic goal of safety. Once the nature and risk of the human
error in locomotive cab systems and automation is better understood,
error mitigating steps can be taken to provide safer systems and reduce
the risk of accidents or incidents involving these systems. FRA will
use the research's results to identify training, operational
procedures, or automation design standards that will improve the safety
of automated systems in locomotive cabs.
    Type of Request: New information collection request.
    Affected Public: Railroad Engineers and Conductors.
    Form(s): FRA F 6180.3.
    Respondent Universe: 24.
    Frequency of Submission: Once.
    Total Estimated Annual Responses: 24.
    Total Estimated Annual Burden: 48 hours.
    Under 44 U.S.C. 3507(a) and 5 CFR 1320.5(b) and 1320.8(b)(3)(vi),
FRA informs all interested parties that it may not conduct or sponsor,
and a respondent is not required to respond to a collection of
information unless it displays a currently valid OMB control number.

    Authority:  44 U.S.C. 3501-3520.

Juan D. Reyes III,
Chief Counsel.
[FR Doc. 2018-24715 Filed 11-13-18; 8:45 am]
 BILLING CODE 4910-06-P