[Federal Register: September 13, 2010 (Volume 75, Number 176)]
[Rules and Regulations]
[Page 55488-55491]
[DOCID:fr13se10-11]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Parts 385 and 395

[Docket No. FMCSA-2004-18940]
RIN 2126-AA89

Electronic On-Board Recorders for Hours-of-Service Compliance

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Final rule; Technical amendments and response to petitions for
reconsideration.

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SUMMARY: FMCSA amends its April 5, 2010, final rule that established
new performance standards for electronic on-board recorders (EOBRs)
installed in commercial motor vehicles (CMVs). In response to petitions
for reconsideration from Qualcomm Incorporated, XATA Corporation, and a
group of industry stakeholders, FMCSA amends requirements relating to
the temperature range in which EOBRs must be able to operate, and the
connector type specified for the Universal Serial Bus (USB) interface.

DATES: The amendments in this final rule become effective September 13,
2010.

ADDRESSES: Public Access to the Docket: You may view, print, and
download this final rule and all related documents and background
material on-line at http://www.regulations.gov, using the Docket ID
Number FMCSA-2004-18940. These documents can also be examined and
copied for a fee at the U.S. Department of Transportation, Docket
Operations, 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 FURTHER INFORMATION CONTACT: Ms. Deborah M. Freund, Vehicle and
Roadside Operations Division, Office of Bus and Truck Standards and
Operations (MC-PSV), Federal Motor Carrier Safety Administration, 1200
New Jersey Avenue, SE., Washington, DC 20590; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Legal Basis

    The legal basis of the April 2010 final rule is also applicable to
this final rule. See 75 FR 17208-17252, April 5, 2010.

Background

    The FMCSA was notified about two technical errors in the April 5,
2010, ``Electronic On-board Recorders for Hours of Service Compliance''
final rule. (75 FR 17208). The FMCSA also received several petitions
for reconsideration of the final rule that are discussed further in
this final rule.

Technical Corrections

    (1) The first sentence in Sec.  385.807(a) currently reads
``Following the close of the compliance review described in Sec.
385.805(a), FMCSA will issue the motor carrier a written notice of
remedial directive and proposed determination of unfitness.'' The
regulatory citation should read ``Sec.  385.805,'' not ``Sec.
385.805(a)''
    (2) Section 385.815(e) currently reads ``The exemption granted
under this section shall not apply to CMVs manufactured on or after the
date 2 years from the effective date of this rule.'' The effective date
referenced should be June 4, 2012, as is stated elsewhere in the final
rule.

Petitions for Reconsideration

    FMCSA received petitions for reconsideration, timely filed, from
Qualcomm Incorporated (Qualcomm), XATA Corporation (XATA), and a group
of industry stakeholders, including the American Trucking Associations'
Technology & Maintenance Council (TMC) EOBR Task Force \1\
(Stakeholders). Qualcomm and Stakeholders requested that FMCSA
reconsider the final rule's requirements for (1) the temperature range
in which EOBRs must be able to operate, and (2) the connector type
specified for the USB interface. XATA's petition covered the same
matters as those of Qualcomm and Stakeholders, but further requested
that FMCSA (1) clarify certain reportable events in the diagnostic
table, and (2) consider offering an additional alternative for the data
transfer between an EOBR and a roadside safety official's portable
computer. FMCSA met with the stakeholders on June 2, 2010 (a list of
the attendees and a summary of the meeting has been placed in the
docket) in response to their request for an opportunity to present
their concerns in person.
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    \1\ Companies and organizations submitting the petition included
Qualcomm Enterprise Services, PeopleNet, XATA Corporation,
Continental Corporation, American Trucking Associations, American
Bus Association, Commercial Vehicle Safety Alliance, National
Private Truck Council, and United Motorcoach Association.
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    A discussion of each of the petitioner's issues, followed by the
Agency's assessment and decision, follows.

Operating Temperature Range

    On January 18, 2007 (72 FR 2340), FMCSA published a notice of
proposed rulemaking (NPRM) that proposed to amend the Federal Motor
Carrier Safety Regulations to incorporate new performance standards for
EOBRs. Among other things, the NPRM proposed to require an EOBR to be
able to operate in temperatures ranging from -20 [deg]F to 120 [deg]F
(-29 [deg]C to 49 [deg]C) (72 FR 2340, at 2393).
    In comments to the docket, International Truck and Engine
Corporation stated ``Typical industry standards for commercial vehicles
(See Society of Automotive Engineers (SAE) recommended practice J1455,
``Surface Vehicle Recommended Practice: Recommended Environmental
Practices for Electronic Equipment Design in Heavy-Duty Vehicle
Applications'') exceed the minimum requirements stated for operating
temperature. Interior spaces are rated from-40 degrees C to +85 degrees
C. International notes that under the minimum temperature specification
there will be occasions where the EOBR may not operate until the
vehicle interior is heated (or cooled) to the operating temperature
given.'' Qualcomm stated ``We recommend that environmental requirements
defer to industry standards for comparable equipment and not be
specified in this regulation. Specifically, SAE standard J1455--
Recommended Environmental Practices for Electronic Equipment Design in
Heavy-Duty Vehicle Applications should be referenced.'' TMC offered a
similar comment in a Technical Policy Advisory submitted to the docket:
``The environmental factors should be based on industry standards for
similar types of equipment.''
    In the April 2010 final rule, FMCSA revised the EOBR operating
temperature range to -40 [deg]C to 85 [deg]C (-40 [deg]F to 185
[deg]F). (75 FR 17208, at 17232). In doing so, the Agency referred to
the detailed discussion in Section 5.2 of the SAE standard, which
addresses temperature ranges in the forward interior of the vehicle, an
area that includes the floor, instrument panel, and headliner. The
instrument panel, discussed in Section 5.2.1, ``includes the top of the
dashboard

and the near vertical section carrying the instruments and steering
wheel.'' The applicable design guidelines for this area, shown in Table
5 of the SAE standard, include a nominal temperature range of -40
[deg]C to 85 [deg]C (-40 [deg]F to 185 [deg]F), and a top surface
temperature of -40 [deg]C to 115 [deg]C (-40 [deg]F to 240 [deg]F).\2\
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    \2\ The SAE standard notes that components on the top surface of
the instrument panel experience a greater heat buildup when closed
vehicles are parked in the bright sun. Heat radiated, incident
sunlight, and re-radiated energy from the windshield can cause the
temperature to build up to 115 [deg]C (240 [deg]F) in this region.
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    In the April 2010 final rule, the Agency adopted the nominal
temperature range of -40 [deg]C to 85 [deg]C (-40 [deg]F to 185 [deg]F)
based on the SAE standard. Qualcomm, Stakeholders, and XATA all
addressed the operating temperature range in their petitions for
reconsideration. Qualcomm's description of its concern was
representative. Qualcomm stated the final rule's EOBR temperature
operating range, -40 [deg]C to 85 [deg]C, (40 [deg]F to 185 [deg]F), is
beyond the range of the leading commercially-available systems today.
Qualcomm noted that off-the-shelf telematics and on-board recorder
systems are typically designed for -20 [deg]C to 60 [deg]C (-4 [deg]F
to 140 [deg]F), and that it would require significant added technical
features and costs in such devices to meet the requirements of the new
regulation. Qualcomm also stated that it has been providing on-board
computer systems to trucking companies operating throughout the United
States and Canada for over 20 years, and that its units have not
experienced any significant degradation in performance due to extreme
weather conditions. Qualcomm added that its devices typically support a
temperature operating range of -30 [deg]C to 70 [deg]C, (-22 [deg]F to
158 [deg]F), although some components of wireless communications
systems are specified to operate in a -20 [deg]C to 60 [deg]C (-4
[deg]F to 140 [deg]F) range. During the June 2, 2010 meeting, the
industry participants elaborated on the technical rationale for their
statements and recommendation. Among other things, they noted that the
operating temperature range is particularly important for the proper
operation of displays, batteries, and the hardware components to
support the Institute of Electrical and Electronics Engineers (IEEE)
802.11 wireless communications requirement.

Agency's Assessment and Decision

    The -40 [deg]C to 85 [deg]C (-40 [deg]F to 185 [deg]F) operating
temperature range requirement established in the April 2010 final rule
was adopted based upon the Agency's review of the SAE standard
referenced above. However, it is not the Agency's intention to require
an EOBR to be so rugged that it is operable at extreme temperatures
that will not realistically be seen in a truck's normal operating
environment. As noted earlier, the Agency believes that drivers will be
heating or cooling the cab to more reasonable temperatures prior to
driving.
    The petitioners note that there will be significant additional
costs and transitional time delays associated with the production of
EOBRs that are compliant with the operating temperature range specified
in the April 2010 final rule. The Agency does not believe that the cost
increases and time delays associated with producing EOBRs that comply
with the temperature range specified in the April 2010 rule are
commensurate with any potential benefits that might be derived from
operability of EOBRs at these extreme temperatures.
    For these reasons, FMCSA amends Appendix A of Sec.  395.16 to
delete the requirement for a specific operating temperature range.

USB Connector

    In the 2007 NPRM, FMCSA proposed to require that EOBRs be capable
of transferring records of duty status (RODS) using either the USB 2.0
or the RS-232 wired communication standards, as well as IEEE 802.11g or
Bluetooth wireless communication standards. The NPRM did not specify
the type of USB connector.
    Most of the comments received expressed a preference for wireless
standards, rather than wired. Of those that addressed wired standards,
the main concern was that the RS-232 standard was outdated. No
commenters addressed the type of USB connector.
    Based upon the best information available to the Agency at the
time, the final rule requires (1) a single USB compliant interface
featuring a Type B connector, and (2) that the USB interface must (a)
comply with USB V1.1 and V2.0 USB signaling standards, and (b)
implement the Mass Storage class (08h) for software driverless
operation.
    All petitioners requested that FMCSA reconsider the requirement for
a Type B connector. They noted that, although many EOBRs and related
devices on the market support USB, these devices generally use a Type A
connector. Very few, if any, EOBRs in the marketplace today would meet
the final rule's requirement, and there would be significant added
costs to retrofit current units, or to replace them with new devices
that are Type B connector compliant. The petitioners noted that if the
regulation were to be amended to permit the use of Type A connectors,
existing devices would be immediately compliant with this provision.

Agency's Assessment and Decision

    FMCSA amends Appendix A, Paragraph 2.2, to delete the requirement
for a Type B connector, and replaces it with a requirement for a Type A
connector. Although the Type B connector has sometimes been used to
connect portable and handheld computing devices to printers, the Type A
connector is much more appropriate for a computer-to-computer (or EOBR-
to-computer) communications interface.

Fault Codes

    XATA requests that FMCSA more clearly define the frequency,
duration, and availability for capture of five EOBR Diagnostic Event
Codes listed in Table 3 of Appendix A. Those codes are Low Voltage
(LOWVLT), Battery Low (BATLOW), Communications Error (COMERR), Display
Error (DYPERR), and Keyboard Error (KEYERR). The first two of these
diagnostic events could occur when a vehicle is being started during
cold weather, but would be resolved when the vehicle is warmed up. The
third diagnostic events could occur when a CMV is operating in areas
with limited cellular carrier coverage. [XATA notes that truckload
motor carriers operate on irregular routes and in areas of the country
where cellular communications coverage is sparse, and asks FMCSA to
clarify how frequently gaps in coverage would have to occur to trigger
an EOBR error report. [XATA is also concerned that the fourth and fifth
diagnostic events, associated with malfunctions of the EOBR display and
the keyboard or input device, are not sufficiently defined in the final
rule to indicate what conditions needed to be reported.]]

Agency's Assessment and Decision

    FMCSA agrees with XATA that there is a need to clarify thresholds
and frequencies for the diagnostic events that would trigger fault
codes for these various conditions. The Agency is aware that CMVs are
equipped with sensors to detect these diagnostic events, and that
setting or adjusting the reporting thresholds would be accomplished
though software revisions. In contrast, the resolution of the
petitioners' questions concerning the operating temperature range and
the USB connector must be implemented through the EOBR hardware.
Hardware

changes (operating temperature range and USB connecter) take
considerably more lead time to address than the software changes that
are the subject of XATA's request. Therefore, the Agency has determined
that it would be more appropriate to consider the fault-code reporting
thresholds during the implementation period prior to the June 4, 2012
compliance date of the final rule. Prior to the compliance date the
Agency will make a determination if it is necessary to have a separate
rulemaking or other regulatory action to address this matter.

Additional Data Transfer Options

    XATA recommended that FMCSA consider adding an additional option
for EOBR data transfer that would use the internet or internet-enabled
technology. XATA's main concern is that this method would provide a
longer-term solution than the wired and wireless methods specified in
the final rule. Although this requested option would not take the place
of the data transfer requirements specified in the April 2010 final
rule, it could provide an alternative method, although it would require
safety officials to be trained and provided the appropriate
communications hardware to take advantage of it.

Agency's Assessment and Decision

    FMSCA acknowledges the importance of using communications and data-
transfer methods that are robust and have long-term implementability.
The Agency is aware that some providers of EOBRs and support services
currently use internet (Web) based storage and archiving of Hours of
Service records. Unlike the fault-codes question, the resolution of
this matter relates to the availability of communications hardware and
software for roadside safety officials, rather than for the EOBR
itself. The Agency will make a determination if it is necessary to have
a separate rulemaking or other regulatory action to address this matter
prior to the June 4, 2012 compliance date of the final rule.
    FMCSA has notified Qualcomm Incorporated, XATA Corporation, and the
group of industry stakeholders of the disposition of their respective
petitions. Copies of these letters have been placed in the docket.

Rulemaking Analyses and Notices

Administrative Procedure Act

    If an agency determines that the prior notice and opportunity for
public comment on a rule normally required by the Administrative
Procedure Act are impracticable, unnecessary, or contrary to the public
interest (the so-called ``good cause'' finding), it may publish the
rule without providing such notice and opportunity for comment. (See 5
U.S.C. 553 (b).) The amendments made by this final rule make changes to
correct inadvertent errors and to respond to petitions for
reconsideration. For these reasons, FMCSA finds good cause that notice
and public comment are unnecessary. Further, the Agency finds good
cause under 5 U.S.C. 553 (d) (3) to make the amendments effective upon
publication.

Executive Order 12866 (Regulatory Planning and Review) and DOT
Regulatory Policies and Procedures

    FMCSA has determined that this action is not a significant
regulatory action within the meaning of Executive Order 12866 or within
the meaning of Department of Transportation regulatory policies and
procedures. The Office of Management and Budget (OMB) did not review
this document. We expect the final rule will have minimal costs;
therefore, a full regulatory evaluation is unnecessary.

Regulatory Flexibility Act

    The Regulatory Flexibility Act of 1980 (Pub. L. 96-354, 5 U.S.C.
601 et seq.), requires agencies to consider the impact of regulations
on small businesses, small non-profit organizations, and small
governmental jurisdictions, unless the Agency determines that a rule is
not expected to have a significant economic impact on a substantial
number of small entities (SEISNOSE). This rule will not have a
SEISNOSE.

Unfunded Mandates Reform Act of 1995

    This rulemaking does not impose an unfunded Federal mandate, as
defined by the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532, et
seq.), that will result in the expenditure by State, local, and tribal
governments, in the aggregate, or by the private sector, of $140.8
million or more in any 1 year.

Executive Order 12988 (Civil Justice Reform)

    This action meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Executive Order 13045 (Protection of Children)

    FMCSA analyzed this action under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. We
determined that this rulemaking does not concern an environmental risk
to health or safety that may disproportionately affect children.

Executive Order 12630 (Taking of Private Property)

    This rulemaking will not affect a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

Executive Order 13132 (Federalism)

    FMCSA analyzed this rule in accordance with the principles and
criteria contained in Executive Order 13132. We determined that this
rulemaking does not create 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.

Executive Order 12372 (Intergovernmental Review)

    The regulations implementing Executive Order 12372 regarding
intergovernmental consultation on Federal programs and activities do
not apply to this action.

Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), a Federal Agency must consider the impact of paperwork and other
information collection burdens imposed on the public. FMCSA has
determined that no new information collection requirements are
associated with the technical amendments to this final rule.

National Environmental Policy Act

    FMCSA analyzed this final rule for the purpose of the National
Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and
determined under our environmental procedures Order 5610.1 the National
Environmental Policy Act Implementing Procedures and Policy for
Considering Environmental Impacts, published March 1, 2004 (69 FR
9680), that this action does not have any effect on the quality of the
environment. Therefore, this final rule is categorically excluded from
further analysis and documentation in an environmental assessment or
environmental impact statement under FMCSA Order 5610.1, paragraph 6.x
of Appendix 2. The CE under paragraph 6.x relates to regulations
implementing procedures for the issuance, amendment, revision

and rescission of Federal motor carrier regulations (e.g., the
establishment of procedural rules that would provide general guidance
on how the agency manages its notice-and-comment rulemaking
proceedings, including the handling of petitions for rulemakings,
waivers, exemptions, and reconsiderations, and how it manages
delegations of authority to carry out certain rulemaking functions.). A
Categorical Exclusion Determination is available for inspection or
copying in the Regulations.gov website listed under ADDRESSES.
    FMCSA also analyzed this rule under the Clean Air Act, as amended
(CAA), section 176(c) (42 U.S.C. 7401 et seq.), and implementing
regulations promulgated by the Environmental Protection Agency.
Approval of this action is exempt from the CAA's general conformity
requirement since it has no effect on the environment.

Executive Order 13211 (Energy Effects)

    FMCSA analyzed this action under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We determined that it is not a ``significant
energy action'' under that Executive Order because it is not
economically significant and is not likely to have an adverse effect on
the supply, distribution, or use of energy.

List of Subjects

49 CFR Part 385

    Administrative practice and procedure, Highway safety, Motor
carriers, Motor vehicle safety, Reporting and recordkeeping.

49 CFR Part 395

    Highway safety, Incorporation by reference, Motor carriers,
Reporting and recordkeeping.

0
In consideration of the foregoing, FMCSA amends title 49, Code of
Federal Regulations, chapter III, as follows:

PART 385--SAFETY FITNESS PROCEDURES

0
1. The authority citation for part 385 continues to read as follows:

    Authority:  49 U.S.C. 113, 504, 521(b), 5105(e), 5109, 13901-
13905, 31133, 31135, 31136, 31137(a), 31144, 31148, and 31502; Sec.
113(a), Pub. L. 103-311; Sec. 408, Pub. L. 104-88; Sec. 350, Pub. L.
107-87; and 49 CFR 1.73.

0
2. In Sec.  385.807, revise paragraph (a) to read as follows:

Sec.  385.807  Notice and issuance of remedial directive.

    (a) Following the close of the compliance review described in Sec.
385.805, FMCSA will issue the motor carrier a written notice of
remedial directive and proposed determination of unfitness. FMCSA will
issue the notice and proposed determination as soon as practicable, but
not later than 30 days after the close of the review.
* * * * *

0
3. In Sec.  385.815, revise paragraph (e) to read as follows:

Sec.  385.815  Exemption for AOBRD users.

* * * * *
    (e) The exemption granted under this section shall not apply to
CMVs manufactured on or after June 4, 2012.

PART 395--HOURS OF SERVICE OF DRIVERS

0
4. The authority citation for part 395 continues to read as follows:

    Authority:  49 U.S.C. 31133, 31136, 31151, and 31502; and 49 CFR
1.73.

0
5. In Appendix A to part 395:
0
a. Revise paragraph 2.2, and
0
b. Remove and reserve paragraph <IP_ADDRESS> to read as follows:

Appendix A to Part 395--Electronic On-Board Recorder Performance
Specifications

* * * * *
    2.2 Wired. EOBRs must be capable of transferring RODS using the
``Universal Serial Bus Specification (Revision 2.0)'' (incorporated
by reference, see Sec.  395.18). Each EOBR device must implement a
single USB compliant interface featuring a Type A connector. The USB
interface must implement the Mass Storage class (08h) for driverless
operation.
* * * * *
    <IP_ADDRESS> [Reserved.]
* * * * *

    Issued on: September 7, 2010.
Anne S. Ferro,
Administrator.
[FR Doc. 2010-22736 Filed 9-10-10; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 210 (Wednesday, October 30, 2019)]
[Notices]
[Pages 58189-58194]
[FR Doc No: 2019-23629]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-87393; File No. SR-DTC-2019-008]

Self-Regulatory Organizations; The Depository Trust Company;
Notice of Filing of Proposed Rule Change To Require Confirmation of
Cybersecurity Program

October 24, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\

notice is hereby given that on October 15, 2019, The Depository Trust
Company (``DTC'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by the clearing agency.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Clearing Agency's Statement of the Terms of Substance of the
Proposed Rule Change

    The proposed rule change consists of modifications to the Rules,
By-Laws and Organization Certificate of DTC (``Rules'') \3\ in order to
(1) define ``Cybersecurity Confirmation'' as a signed, written
representation that addresses the submitting firm's cybersecurity
program; and (2) enhance the DTC application requirements and ongoing
requirements for Participants and Pledgees to (a) require that a
Cybersecurity Confirmation be provided as part of the application
materials for all Participants and Pledgees, and (b) require that
Participants and Pledgees deliver to DTC a complete, updated
Cybersecurity Confirmation at least every two years, as described in
greater detail below.
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    \3\ Capitalized terms not defined herein are defined in the
Rules, available at http://www.dtcc.com/legal/rules-and-procedures.
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II. Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

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

(A) Clearing Agency's Statement of the Purpose of, and Statutory Basis
for, the Proposed Rule Change

1. Purpose
(i) Overview
    DTC is proposing to modify the Rules in order to (1) define
``Cybersecurity Confirmation'' as a signed, written representation that
addresses the submitting firm's cybersecurity program; and (2) enhance
the DTC application requirements and ongoing requirements for
Participants and Pledgees to (a) require that a Cybersecurity
Confirmation be provided as part of the application materials for all
Participants and Pledgees, and (b) require that Participants and
Pledgees deliver to DTC a complete, updated Cybersecurity Confirmation
at least every two years.
    The proposed change would require all Participants, Pledgees and
applicants to deliver to DTC a signed, written Cybersecurity
Confirmation, which includes representations regarding the submitting
firm's cybersecurity program and framework. The Cybersecurity
Confirmation would be required to be (1) delivered with the application
materials for every applicant for membership as a Participant and
applicant to be a Pledgee, and (2) updated and re-delivered at least
every two years by all Participants and Pledgees.
    As described in more detail below, the Cybersecurity Confirmation
would help DTC to assess the cybersecurity risks that may be introduced
to it by Participants and Pledgees that connect to DTC either through
the Securely Managed and Reliable Technology (``SMART'') network \4\ or
through other connections. The proposed Cybersecurity Confirmation
would allow DTC to better understand its Participants' and Pledgees'
cybersecurity programs and frameworks and identify possible
cybersecurity risk exposures. Based on this information, DTC would be
able to establish appropriate controls to mitigate these risks and
their possible impacts to DTC's operations.
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    \4\ The SMART network is a technology managed by DTC's parent
company, The Depository Trust & Clearing Corporation (``DTCC''),
that connects a nationwide complex of networks, processing centers
and control facilities. This network extends between DTC's and its
Participants' and Pledgees' operating premises. DTCC operates on a
shared services model with respect to DTC and DTCC's other
subsidiaries pursuant to intercompany agreements under which it is
generally DTCC that provides a relevant service to its subsidiaries,
including DTC.
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(ii) Background of Proposal
    DTC believes it is prudent to better understand the cybersecurity
risks that it may face through its interconnections to Participants and
Pledgees. As a designated systemically important financial market
utility, or ``SIFMU,'' DTC occupies a unique position in the
marketplace such that a failure or a disruption to DTC could increase
the risk of significant liquidity problems spreading among financial
institutions or markets and thereby threaten the stability of the
financial system in the United States.\5\ Given its designation as a
SIFMU, DTC believes it is prudent to develop an enhanced endpoint
security framework designed so that its SMART network or other
connectivity is adequately protected against cyberattacks.
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    \5\ DTC and its affiliates, Fixed Income Clearing Corporation
and National Securities Clearing Corporation, were designated SIFMUs
under Title VIII of the Dodd-Frank Wall Street Reform and Consumer
Protection Act of 2010. 12 U.S.C. 5465(e)(1).
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    Currently, DTC does not obtain any information regarding the
security of a firm's systems or cybersecurity program prior to
permitting that firm to connect either directly to the SMART network or
to DTC through another means, such as through a third party service
provider, service bureau, network, or the internet. Given DTC's
critical role in the marketplace, DTC is proposing to address the risks
that could be posed by these connections.
    Participants and Pledgees may currently be subject to regulations
that are designed, in part, to enhance the safeguards used by these
entities to protect themselves against cyberattacks.\6\ In order to
comply with such regulations, Participants, Pledgees and applicants
would be required to follow standards established by national or
international organizations focused on information security management,
and would have already established protocols to allow their senior
management to verify that they have sufficient cybersecurity programs
in place to fulfill existing regulatory obligations. Other Participants
and Pledgees have established and follow substantially similar
protocols because of evolving expectations by regulators or by
institutional customers as to the sufficiency of their cyber
safeguards. DTC believes that it should require confirmation of the
cybersecurity standards utilized by its Participants, Pledgees and
applicants that connect to its network.
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    \6\ For example, depending on the type of entity, Participants
and Pledgees may be subject to one or more of the following
regulations: (1) Regulation S-ID, which requires ``financial
institutions'' or ``creditors'' under the rule to adopt programs to
identify and address the risk of identity theft of individuals (17
CFR 248.201-202); (2) Regulation S-P, which requires broker-dealers,
investment companies, and investment advisers to adopt written
policies and procedures that address administrative, technical, and
physical safeguards for the protection of customer records and
information (17 CFR 248.1-30); and (3) Rule 15c3-5 under the Act,
known as the ``Market Access Rule,'' which requires broker-dealers
to establish, document, and maintain a system for regularly
reviewing the effectiveness of its management controls and
supervisory procedures (17 CFR 240.15c3-5).
---------------------------------------------------------------------------

    The proposed Cybersecurity Confirmation would require

Participants, Pledgees and applicants to represent that they have
established adequate controls and security to help limit (1)
cybersecurity risks to DTC and to the other Participants' and Pledgees'
networks and (2) access by unauthorized third parties while the firm is
connected to DTC either directly through the SMART network or through
other connectivity such as a service provider, service bureau, network,
or the internet.
(iii) Proposed Rule Changes
    DTC is proposing to modify its Rules to (1) define ``Cybersecurity
Confirmation;'' and (2) require that firms deliver a completed
Cybersecurity Confirmation (a) as part of their initial application
with DTC, and (b) on an ongoing basis, at least every two years. Each
of these proposed rule changes is described in greater detail below.
(1) Proposed Cybersecurity Confirmation
    DTC is proposing to adopt a definition of ``Cybersecurity
Confirmation.'' Each Cybersecurity Confirmation would be required to be
in writing on a form provided by DTC and signed by a designated senior
executive of the submitting firm who is authorized to attest to these
matters. Based on the form provided by DTC, each Cybersecurity
Confirmation would contain representations regarding the submitting
firm's cybersecurity program and framework. Such representations by the
submitting firm would cover the two years prior to the date of the most
recently provided Cybersecurity Confirmation.
    DTC is proposing to require that the following representations be
included in the form of Cybersecurity Confirmation:
    First, the Cybersecurity Confirmation would include a
representation that the submitting firm has defined and maintains a
comprehensive cybersecurity program and framework that considers
potential cyber threats that impact the organization and protects the
confidentiality, integrity and availability requirements of its systems
and information.
    Second, the Cybersecurity Confirmation would include a
representation that the submitting firm has implemented and maintains a
written enterprise cybersecurity policy or policies approved by the
submitting firm's senior management or board of directors, and the
organization's cybersecurity framework is in alignment with standard
industry best practices and guidelines.\7\
---------------------------------------------------------------------------

    \7\ Examples of recognized frameworks, guidelines and standards
that DTC believes are adequate include the Financial Services Sector
Coordinating Council Cybersecurity Profile, the National Institute
of Standards and Technology Cybersecurity Framework (``NIST CSF''),
International Organization for Standardization (``ISO'') standard
27001/27002 (``ISO 27001''), Federal Financial Institutions
Examination Council (``FFIEC'') Cybersecurity Assessment Tool,
Critical Security Controls Top 20, and Control Objectives for
Information and Related Technologies. DTC would identify recognized
frameworks, guidelines and standards in the form of Cybersecurity
Confirmation and in an Important Notice that DTC would issue from
time to time. DTC would also consider accepting other standards upon
request by a Participant, Pledgee or applicant.
---------------------------------------------------------------------------

    Third, the Cybersecurity Confirmation would include a
representation that, if the submitting firm is using a third party
service provider or service bureau(s) to connect or transact business
or to manage the connection with DTC, the submitting firm has an
appropriate program to (a) evaluate the cyber risks and impact of these
third parties, and (b) review the third party assurance reports.
    Fourth, the Cybersecurity Confirmation would include a
representation that the submitting firm's cybersecurity program and
framework protect the segment of their system that connects to and/or
interacts with DTC.
    Fifth, the Cybersecurity Confirmation would include a
representation that the submitting firm has in place an established
process to remediate cyber issues identified to fulfill the submitting
firm's regulatory and/or statutory requirements.
    Sixth, the Cybersecurity Confirmation would include a
representation that the submitting firm's cybersecurity program's and
framework's risk processes are updated periodically based on a risk
assessment or changes to technology, business, threat ecosystem, and/or
regulatory environment.
    And, finally, the Cybersecurity Confirmation would include a
representation that the review of the submitting firm's cybersecurity
program and framework has been conducted by one of the following: (1)
The submitting firm, if it has filed and maintains a current
Certification of Compliance with the Superintendent of the New York
State Department of Financial Services confirming compliance with its
Cybersecurity Requirements for Financial Services Companies; \8\ (2) a
regulator who assesses the program against an industry cybersecurity
framework or industry standard, including those that are listed on the
form of Cybersecurity Confirmation and in an Important Notice that is
issued by DTC from time to time; \9\ (3) an independent external entity
with cybersecurity domain expertise in relevant industry standards and
practices, including those that are listed on the form of Cybersecurity
Confirmation and in an Important Notice that is issued by DTC from time
to time; \10\ or (4) an independent internal audit function reporting
directly to the submitting firm's board of directors or designated
board of directors committee, such that the findings of that review are
shared with these governance bodies.
---------------------------------------------------------------------------

    \8\ 23 N.Y. Comp. Codes R. & Regs. tit. 23, Sec.  500 (2017).
This regulation requires firms to confirm that they have a
comprehensive cybersecurity program, as described in the regulation,
which DTC believes is sufficient to meet the objectives of the
proposed Cybersecurity Confirmation.
    \9\ Industry cybersecurity frameworks and industry standards
could include, for example, the Office of the Comptroller of the
Currency or the FFIEC Cybersecurity Assessment Tool. DTC would
identify acceptable industry cybersecurity frameworks and standards
in the form of Cybersecurity Confirmation and in an Important Notice
that DTC would issue from time to time. DTC would also consider
accepting other industry cybersecurity frameworks and standards upon
request by a Participant, Pledgee or applicant.
    \10\ A third party with cybersecurity domain expertise is one
that follows and understands industry standards, practices and
regulations that are relevant to the financial sector. Examples of
such standards and practices include ISO 27001 certification or NIST
CSF assessment. DTC would identify acceptable industry standards and
practices in the form of Cybersecurity Confirmation and in an
Important Notice that DTC would issue from time to time. DTC would
also consider accepting other industry standards and practices upon
request by a Participant, Pledgee or applicant.
---------------------------------------------------------------------------

    Together, the required representations are designed to provide DTC
with evidence of each Participant's, Pledgee's or applicant's
management of cybersecurity with respect to their connectivity to DTC.
By requiring these representations from Participants, Pledgees and
applicants the proposed Cybersecurity Confirmation would provide DTC
with information that it could use to make decisions about risks or
threats, perform additional monitoring, target potential
vulnerabilities, and protect the DTC network.
    DTC is proposing to amend the Rules to include a definition of
``Cybersecurity Confirmation,'' as described above, in a new Section 11
of Rule 2 (Participants and Pledgees).
(2) Initial and Ongoing Requirement
    DTC is proposing to require that a Cybersecurity Confirmation be
submitted to DTC by any applicant, as part of their application
materials, and at least every two years by all Participants and
Pledgees. With respect

to the requirement to deliver a Cybersecurity Confirmation at least
every two years, DTC would provide all Participants and Pledgees with
notice of the date on which such Cybersecurity Confirmations would be
due no later than 180 calendar days prior to such due date.
    In order to implement these proposed changes, DTC would amend the
Rules to include a new Section 11 of Rule 2 (Participants and Pledgees)
to require that (1) applicants complete and deliver a Cybersecurity
Confirmation as part of their application materials; and (2) each
Participant and Pledgee complete and deliver a Cybersecurity
Confirmation at least every two years, on a date that is set by DTC and
following notice that is provided no later than 180 calendar days prior
to such due date.
(iv) Implementation Timeframe
    Subject to approval by the Commission, the proposed rule change
would become effective immediately. The proposed requirement that
applicants deliver a Cybersecurity Confirmation with their application
materials would be implemented immediately and would apply to
applications that have been submitted at that time but have not yet
been approved or rejected. Following the effective date of the proposed
rule change, DTC would provide Participants and Pledgees with notice of
the due date of their Cybersecurity Confirmations, no later than 180
days prior to such due date, and would provide such notice at least
every two years going forward.
2. Statutory Basis
    DTC believes the proposed rule changes are consistent with the
requirements of the Act and the rules and regulations thereunder
applicable to a registered clearing agency. In particular, DTC believes
that the proposed rule changes are consistent with Section 17A(b)(3)(F)
of the Act,\11\ and Rules 17Ad-22(e)(17)(i) and (e)(17)(ii), each
promulgated under the Act,\12\ for the reasons described below.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78q-1(b)(3)(F).
    \12\ 17 CFR 240.17Ad-22(e)(17)(i) and (e)(17)(ii).
---------------------------------------------------------------------------

    Section 17A(b)(3)(F) of the Act requires that the rules of DTC be
designed to, among other things, promote the prompt and accurate
clearance and settlement of securities transactions and assure the
safeguarding of securities and funds which are in the custody or
control of the clearing agency or for which it is responsible.\13\
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    As described above, the proposed requirement that Participants,
Pledgees and applicants provide a Cybersecurity Confirmation regarding
their cybersecurity program that includes the representations described
above would provide DTC with evidence of each Participant's, Pledgee's
or applicant's management of endpoint security with respect to the
SMART network or other connectivity and would enhance the protection of
DTC against cyberattacks. The proposed Cybersecurity Confirmation would
provide DTC with information that it could use to make decisions about
risks or threats, perform additional monitoring, target potential
vulnerabilities, and protect the DTC network. The proposed
Cybersecurity Confirmation would give DTC the ability to further
identify its exposure and enable it to take steps to mitigate risks.
These requirements would help reduce risk to DTC's network with respect
to its communications with Participants and Pledgees and their
submission of instructions and transactions to DTC by requiring all
Participants and Pledgees connecting to DTC to have appropriate
cybersecurity programs in place.
    Risks, threats and potential vulnerabilities could impact DTC's
ability to clear and settle securities transactions, or to safeguard
the securities and funds which are in its custody or control, or for
which it is responsible. Therefore, by implementing a tool that would
help to mitigate these risks, DTC believes the proposal would promote
the prompt and accurate clearance and settlement of securities
transactions and assure the safeguarding of securities and funds which
are in the custody or control of the clearing agency or for which it is
responsible, consistent with the requirements of Section 17A(b)(3)(F)
of the Act.\14\
---------------------------------------------------------------------------

    \14\ Id.
---------------------------------------------------------------------------

    Rule 17Ad-22(e)(17)(i) under the Act requires that each covered
clearing agency establish, implement, maintain and enforce written
policies and procedures reasonably designed to manage the covered
clearing agency's operational risks by identifying the plausible
sources of operational risk, both internal and external, and mitigating
their impact through the use of appropriate systems, policies,
procedures, and controls.\15\ The proposed Cybersecurity Confirmation
would reduce cybersecurity risks to DTC by requiring all Participants,
Pledgees and applicants to confirm they have defined and maintain
cybersecurity programs that meet standard industry best practices and
guidelines. The proposed representations in the Cybersecurity
Confirmations would help DTC to mitigate its exposure to cybersecurity
risk and, thereby, decrease the operational risks to DTC that are
presented by connections to DTC through the SMART network or otherwise.
The proposed Cybersecurity Confirmations would identify to DTC
potential sources of external operational risks and enable it to
mitigate these risks and their possible impacts to DTC's operations. As
a result, DTC believes the proposal is consistent with the requirements
of Rule 17Ad-22(e)(17)(i) under the Act.\16\
---------------------------------------------------------------------------

    \15\ 17 CFR 240.17Ad-22(e)(17)(i).
    \16\ Id.
---------------------------------------------------------------------------

    Rule 17Ad-22(e)(17)(ii) under the Act requires that each covered
clearing agency establish, implement, maintain and enforce written
policies and procedures reasonably designed to manage the covered
clearing agency's operational risks by ensuring, in part, that systems
have a high degree of security, resiliency, and operational
reliability.\17\ The proposed Cybersecurity Confirmation would enhance
the security, resiliency, and operational reliability of the endpoint
security with respect to the SMART network or other connectivity
because, as noted above, by making the Cybersecurity Confirmation an
application requirement and an ongoing membership requirement, DTC
would be able to prevent the connection by any applicant, and take
action against any Participant and Pledgee, that may pose an increased
cyber risk to DTC by not having a defined and ongoing cybersecurity
program that meets appropriate standards. Participants, Pledgees or
applicants that are not in alignment with a recognized framework,
guideline, or standard that DTC believes is adequate to guide and
assess such organization's cybersecurity program may present increased
risk to DTC. By enabling DTC to identify these risks, the proposed
changes would allow DTC to more effectively secure its environment
against potential vulnerabilities. DTC's controls are strengthened when
DTC's Participants and Pledgees have similar technology risk management
controls and programs within their computing environment. Control
weaknesses within a Participant's or Pledgee's environment could allow
for malicious or unauthorized usage of the link between DTC and the
Participant or Pledgee. As a result, DTC believes the proposal would
improve DTC's ability to ensure that its systems have a high degree of
security, resiliency, and operational reliability, and, as such, is

consistent with the requirements of Rule 17Ad-22(e)(17)(ii) under the
Act.\18\
---------------------------------------------------------------------------

    \17\ 17 CFR 240.17Ad-22(e)(17)(ii).
    \18\ Id.
---------------------------------------------------------------------------

(B) Clearing Agency's Statement on Burden on Competition

    DTC believes the proposed rule change could have an impact on
competition. Specifically, DTC believes that the proposed rule change
could burden competition because it would require Participants,
Pledgees and applicants that do not already have cybersecurity programs
that meet the standards set out in the Cybersecurity Confirmation to
incur additional costs including, but not limited to, establishing a
cybersecurity program and framework, engaging an internal audit
function or appropriate third party to review that program and
framework, and remediating any findings from such review. In addition,
those Participants, Pledgees and applicants that do not connect
directly to the SMART network, but connect through a third party
service provider or service bureau would have the additional burden of
evaluating the cyber risks and impact of these third parties and
reviewing the third party's assurance reports.
    DTC believes the above described burden on competition that could
be created by the proposed changes would be both necessary and
appropriate in furtherance of the purposes of the Act, as permitted by
Section 17A(b)(3)(I) of the Act, for the reasons described below.\19\
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78q-1(b)(3)(I).
---------------------------------------------------------------------------

    First, DTC believes the proposed rule change would be necessary in
furtherance of the Act, specifically Section 17A(b)(3)(F) of the Act,
because the Rules must be designed to promote the prompt and accurate
clearance and settlement of securities transactions and assure the
safeguarding of securities and funds which are in the custody or
control of the clearing agency or for which it is responsible.\20\ By
requiring that applicants, Participants and Pledgees provide a
Cybersecurity Confirmation, the proposed rule change would allow DTC to
better understand, assess, and, therefore, mitigate the cyber risks
that DTC could face through its connections to its Participants and
Pledgees. As described above, these risks could impact DTC's ability to
clear and settle securities transactions, or to safeguard the
securities and funds which are in DTC's custody or control, or for
which it is responsible. Implementing a tool as described above would
help to mitigate these risks, and therefore DTC believes the proposal
is necessary in furtherance of the requirements of Section 17A(b)(3)(F)
of the Act.\21\
---------------------------------------------------------------------------

    \20\ 15 U.S.C. 78q-1(b)(3)(F).
    \21\ Id.
---------------------------------------------------------------------------

    The proposed changes are also necessary in furtherance of the
purposes of Rules 17Ad-22(e)(17)(i) and (e)(17)(ii) under the Act.\22\
The proposed Cybersecurity Confirmations would identify to DTC
potential sources of external operational risks and allow it to
establish appropriate controls that would mitigate these risks and
their possible impacts to DTC's operations. The proposed changes would
also improve DTC's ability to ensure that its systems have a high
degree of security, by enabling DTC to identify the cybersecurity risks
that may be presented to it by Participants and Pledgees that connect
to DTC.
---------------------------------------------------------------------------

    \22\ 17 CFR 240.17Ad-22(e)(17)(i) and (e)(17)(ii).
---------------------------------------------------------------------------

    Second, DTC believes that the proposed rule change would be
appropriate in furtherance of the purposes of the Act. The proposed
rule change would apply equally to all Participants, Pledgees and
applicants. As described above, DTC believes Participants and Pledgees
may already be subject to one or more regulatory requirements that
include the implementation of a cybersecurity program, and these firms
would already follow a widely recognized framework, guideline, or
standard to guide and assess their organization's cybersecurity program
to comply with these regulations. Therefore, DTC believes any burden
that may be imposed by the proposed rule change would be appropriate.
    Further, while the proposed Cybersecurity Confirmation would
identify certain standards and guidelines that would be appropriate,
DTC would consider requests by applicants, Participants and Pledgees to
allow other standards in accepting a Cybersecurity Confirmation.
Additionally, the proposed Cybersecurity Confirmation would provide
differing options to conduct the review of the applicant's,
Participant's or Pledgee's cybersecurity program. As such, DTC has
endeavored to design the Cybersecurity Confirmation in a way that is
reasonable and does not require one approach for meeting its
requirements.
    Finally, DTC is proposing to provide Participants and Pledgees with
a minimum of 180 calendar days' notice before the deadline for
providing a Cybersecurity Confirmation. This notice would allow
Participants and Pledgees to address any impact this change may have on
their business. Applicants to be Participants or Pledgees would be
required to provide the Cybersecurity Confirmation as part of their
application materials upon the effective date of this proposed rule
change. This implementation schedule is designed to be fair and not
disproportionately impact any Participants or Pledgees more than
others. The proposal is designed to provide all impacted Participants
and Pledgees with time to review their cybersecurity programs with
respect to the required representations, and identify, if necessary,
internal or third party cybersecurity reviewers.
    For the reasons described above, DTC believes any burden on
competition that may result from the proposed rule change would be both
necessary and appropriate in furtherance of the purposes of the Act, as
permitted by Section 17A(b)(3)(I) of the Act.\23\
---------------------------------------------------------------------------

    \23\ 15 U.S.C. 78q-1(b)(3)(I).
---------------------------------------------------------------------------

(C) Clearing Agency's Statement on Comments on the Proposed Rule Change
Received From Members, Participants, or Others

    DTC has not solicited or received any written comments relating to
this proposal. DTC will notify the Commission of any written comments
received.

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

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or

     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-DTC-2019-008 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-DTC-2019-008. 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 website (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 website 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 the filing also will be available for inspection
and copying at the principal office of DTC and on DTCC's website
(http://dtcc.com/legal/sec-rule-filings.aspx). All comments received
will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-DTC-2019-008 and should be submitted on
or before November 20, 2019.
---------------------------------------------------------------------------

    \24\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-23629 Filed 10-29-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 83, Number 32 (Thursday, February 15, 2018)]
[Notices]
[Pages 6861-6863]
[FR Doc No: 2018-03134]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-E-2604 and FDA-2015-E-2619]

Determination of Regulatory Review Period for Purposes of Patent
Extension; ZYDELIG--New Drug Application 205858

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for ZYDELIG based on new drug
application (NDA) 205858 and is publishing this notice of that
determination as required by law. FDA has made the determination
because of the submission of applications to the Director of the U.S.
Patent and Trademark Office (USPTO), Department of Commerce, for the
extension of a patent which claims that human drug product and that
NDA.

DATES: Anyone with knowledge that any of the dates as published (see
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
16, 2018. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by August 14, 2018.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 16, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 16, 2018. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos.
FDA-2015-E-2604 and FDA-2015-E-2619 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; ZYDELIG--NDA 205858.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information

redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with Sec.
10.20 (21 CFR 10.20) and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6250, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) and the Generic Animal Drug and Patent Term
Restoration Act (Pub. L. 100-670) generally provide that a patent may
be extended for a period of up to 5 years so long as the patented item
(human drug product, animal drug product, medical device, food
additive, or color additive) was subject to regulatory review by FDA
before the item was marketed. Under these acts, a product's regulatory
review period forms the basis for determining the amount of extension
an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of USPTO may award
(for example, half the testing phase must be subtracted as well as any
time that may have occurred before the patent was issued), FDA's
determination of the length of a regulatory review period for a human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human drug product ZYDELIG
(idelalisib). As approved in both NDA 206545 and NDA 205858, ZYDELIG is
indicated for treatment of patients with:
     Relapsed chronic lymphocytic leukemia in combination with
rituximab, in patients for whom rituximab alone would be considered
appropriate therapy due to other co-morbidities.
     Relapsed follicular B-cell non-Hodgkin lymphoma (FL) in
patients who have received at least two prior systemic therapies.
     Relapsed small lymphocytic lymphoma (SLL) in patients who
have received at least two prior systemic therapies.
    Accelerated approval was granted for FL and SLL based on overall
response rate. Improvement in patient survival or disease related
symptoms has not been established. Continued approval for these
indications may be contingent upon verification of clinical benefit in
confirmatory trials.
    Subsequent to the approvals, the USPTO received patent term
restoration applications for ZYDELIG (U.S. Patent Nos. RE44599 and
RE44638) from ICOS Corporation, and the USPTO requested FDA's
assistance in determining the patents' eligibility for patent term
restoration. In a letter dated November 4, 2015, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approvals of ZYDELIG under NDA 206545 and NDA 205858
represented the first permitted commercial marketing or use of the
product. Thereafter, the USPTO requested that FDA determine the
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for
ZYDELIG based on NDA 205858 is 2,247 days. Of this time, 1,931 days
occurred during the testing phase of the regulatory review period,
while 316 days occurred during the approval phase. These periods of
time were derived from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
May 30, 2008. FDA has verified the applicant's claim that the date the
investigational new drug application (IND) became effective was on May
30, 2008. This is the same IND and the same date FDA determined as the
beginning of the regulatory review period for ZYDELIG approved under
NDA 206545. The regulatory review period for ZYDELIG approved under NDA
206545 is publishing in this issue of the Federal Register.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: September
11, 2013. FDA has verified the applicant's claim that NDA 205858 for
ZYDELIG was initially submitted on September 11, 2013.
    3. The date the application was approved: July 23, 2014. FDA has
verified the applicant's claim that NDA 205858 was approved on July 23,
2014.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the USPTO
applies several statutory limitations in its calculations of the actual
period for patent extension. In its application for patent extension,
this applicant seeks 537 days or 751 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec.  60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec.  60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec.  10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
    Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305),

Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.

    Dated: February 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03134 Filed 2-14-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 24 (Wednesday, February 5, 2020)]
[Notices]
[Pages 6580-6582]
[FR Doc No: 2020-02179]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2009-0043]

Access to Employee Exposure and Medical Records; Extension of the
Office of Management and Budget's (OMB) Approval of Information
Collection (Paperwork) Requirements

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning the proposal to
extend the Office of Management and Budget's (OMB) approval of the
information collection requirements contained in the Access to Employee
Exposure and Medical Records Standard.

DATES: Comments must be submitted (postmarked, sent, or received) by
April 6, 2020.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit a copy of your comments and
attachments to the OSHA Docket Office, Docket No. OSHA-2009-0043,
Occupational Safety and Health Administration, U.S. Department of
Labor, Room N-3653, 200 Constitution Avenue NW, Washington, DC 20210.
Deliveries (hand, express mail, messenger, and courier service) are
accepted during the OSHA Docket Office's normal business hours, 10 a.m.
to 3 p.m., ET.
    Instructions: All submissions must include the agency name and the
OSHA docket number (OSHA-2009-0043) for the Information Collection
Request (ICR). All comments, including any personal information you
provide, such as social security numbers and dates of birth, are placed
in the public docket without change, and may be made available online
at http://www.regulations.gov. For further information on submitting
comments, see the ``Public Participation'' heading in the section of
this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the above address. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the website. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Theda Kenney at
(202) 693-2222 to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Seleda Perryman or Theda Kenney,
Directorate of Standards and Guidance, OSHA, U.S. Department of Labor,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of a continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance process to provide the public with an opportunity to
comment on proposed and continuing information collection requirements
in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3506(c)(2)(A)). This program ensures that information is in the desired
format, the reporting burden (time and costs) is minimal, the
collection instruments are clearly understood, and OSHA's estimate of
the information collection burden is accurate. The Occupational Safety
and Health Act of 1970 (OSH Act) (29 U.S.C. 651 et seq.) authorizes
information collection by employers as necessary or appropriate for
enforcement of the OSH Act or for developing information regarding the
causes and prevention of occupational injuries, illnesses, and
accidents (see 29 U.S.C. 657). The OSH Act also requires OSHA to obtain
such information with a minimum burden upon employers, especially those
operating small businesses, and to reduce to the maximum extent
feasible unnecessary duplication of effort in obtaining said
information (29 U.S.C. 657).
    Under the authority granted by the OSH Act, OSHA published a health
regulation governing access to employee exposure monitoring data and
medical records. This regulation does not require employers to collect
any information or to establish any new systems of records. Rather, it
requires that employers provide workers, their designated
representatives, and OSHA with access to employee exposure monitoring
and medical records, and any analyses resulting from these records that
employers must maintain under OSHA's toxic chemical and harmful
physical agent standards. In this regard, the regulation specifies
requirements for record access, record retention, worker information,
trade secret management, and record transfer. Accordingly, the agency
attributes the burden hours and costs associated with exposure
monitoring and measurement, medical surveillance, and the other
activities required to generate the data governed by the regulation to
the standards that specify these activities; therefore, OSHA did not
include these burden hours and costs in this ICR.
    Access to exposure and medical information enables employees and
their designated representatives to become directly involved in
identifying and controlling occupational health hazards, as well as
managing and preventing occupationally-related health impairment and
disease. Providing the agency with access to the records permits the
agency to ascertain whether or not employers are complying with the
regulation, as well as with the recordkeeping requirements of OSHA's
other health standards; therefore, OSHA access provides additional
assurance that workers and their designated representatives are able to
obtain the data they need to conduct their analyses.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply--
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    The agency is requesting a burden hour adjustment increase of
38,254 burden hours from 717,221 to 755,475 hours. This is the result
of an adjustment of the number of establishments used in this analysis
based on updated data. The total estimated number of establishments
affected by the regulation increased from 739,432 to 766,684, a total
adjustment increase of 27,252 establishments.
    Type of Review: Extension of a currently approved collection.
    Title: Access to Employee Exposure and Medical Records (29 CFR
1910.1020).
    OMB Control Number: 1218-0065.
    Affected Public: Business or other for-profits.
    Number of Respondents: 766,684.
    Frequency: Initially; Annually; On occasion.
    Average Time per Response: Various.
    Estimated Number of Responses: 6,688,963.
    Estimated Total Burden Hours: 755,475.
    Estimated Cost (Operation and Maintenance): $0.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) Electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other material must identify the agency name
and the OSHA docket number (Docket No. OSHA-2009-0043) for the ICR. You
may supplement electronic submissions by uploading document files
electronically. If you wish to mail additional materials in reference
to an electronic or facsimile submission, you must submit them to the
OSHA Docket Office (see the section of this notice titled ADDRESSES).
The additional materials must clearly identify electronic comments by
your name, date, and the docket number so that the agency can attach
them to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>; TTY<PHONE_NUMBER>.
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as social security numbers and
dates of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publicly available to read or download through this
website. All submissions, including copyrighted material, are available
for inspection and copying at the OSHA Docket Office. Information on
using the http://www.regulations.gov website to submit comments and
access the docket is available at the website's ``User Tips'' link.
Contact the OSHA Docket Office for information about materials not
available through the website, and for assistance in using the internet
to locate docket submissions.

V. Authority and Signature

    Loren Sweatt, Principal Deputy Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 1-2012
(77 FR 3912).

    Signed at Washington, DC, on January 30, 2020.
Loren Sweatt,
Principal Deputy Assistant Secretary of Labor for Occupational Safety
and Health.
[FR Doc. 2020-02179 Filed 2-4-20; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 83, Number 228 (Tuesday, November 27, 2018)]
[Rules and Regulations]
[Pages 60754-60756]
[FR Doc No: 2018-25392]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0759; Product Identifier 2018-NM-055-AD; Amendment
39-19501; AD 2018-23-14]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

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

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Airbus SAS Model A330-200 series airplanes; Model A330-200 Freighter
series airplanes; and Model A330-300 series airplanes. This AD was
prompted by revisions to certain airworthiness limitation item (ALI)
documents, which specify more restrictive instructions and/or
airworthiness limitations. This AD requires revising the existing
maintenance or inspection program, as applicable, to incorporate new or
more restrictive instructions and/or airworthiness limitation
requirements. We are issuing this AD to address the unsafe condition on
these products.

DATES: This AD is effective January 2, 2019.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of January 2,
2019.

ADDRESSES: For service information identified in this final rule,
contact Airbus SAS, Airworthiness Office--EAL, Rond-Point Emile
Dewoitine No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36
96; fax +33 5 61 93 45 80; email [email protected];
internet http://www.airbus.com. You may view this service information
at the FAA, Transport Standards Branch, 2200 South 216th St., Des
Moines, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0759.

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-2018-
0759; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

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

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain Airbus SAS Model
A330-200 series airplanes; Model A330-200 Freighter series airplanes;
and Model A330-300 series airplanes. The NPRM published in the Federal
Register on August 24, 2018 (83 FR 42812). The NPRM was prompted by
revisions to certain ALI documents, which specify more restrictive
instructions and/or airworthiness limitations. The NPRM proposed to
require revising the existing maintenance or inspection program, as
applicable, to incorporate new or more restrictive instructions and/or
airworthiness limitation requirements.
    We are issuing this AD to address fatigue cracking, accidental
damage, or corrosion in principal structural elements, and possible
failure of certain life limited parts, which could result in reduced
structural integrity of the airplane.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2018-0034, dated February 5, 2018 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for Airbus SAS Model A330-200 series
airplanes; Model A330-200 Freighter series airplanes; and Model A330-
300 series airplanes. The MCAI states:

    The airworthiness limitations for Airbus A330 and A340
aeroplanes, which are approved by EASA, are currently defined and
published in the A330 and A340 ALS document(s). The Safe Life
Airworthiness Limitation Items are specified in ALS Part 1. These
instructions have been identified as mandatory for continued
airworthiness. Failure to accomplish these instructions could result
in an unsafe condition.
    EASA previously issued [EASA] AD 2014-0009 [which corresponds to
FAA AD 2017-10-24, Amendment 39-18898 (82 FR 24035, May 25, 2017)
(``AD 2017-10-24'')] to require the implementation of the
instructions and airworthiness limitations as specified in Airbus
A330 and A340 ALS Part 1 documents at Revision 07.
    Since that [EASA] AD was issued, improvement of safe life
component selection and life extension campaigns resulted in life
limitations changes, among others new or more restrictive life
limitations, approved by EASA. Consequently, Airbus successively
issued Revision 08 and Revision 09 of the A330 and A340 ALS Part 1,
compiling all ALS Part 1 changes approved since previous Revision
07.
    In addition, Airbus published Variation 9.2 to remove from ALS
Part 1 some life limits connected to a deficiency in the fatigue
performance of 300M high strength steel used in forgings. These life
limits, applicable only for a specific batch of parts, are required
by EASA AD 2017-0185.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2014-0009, which is superseded, and requires
accomplishment of the actions specified in the applicable ALS.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0759.

Comments

    We gave the public the opportunity to participate in developing
this final rule. We have considered the comments received. The
commenter Michael Josefik indicated support for the NPRM.

Conclusion

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

Related Service Information Under 1 CFR Part 51

    Airbus has issued A330 Airworthiness Limitations Section (ALS) Part
1, Safe Life Airworthiness Limitation Items (SL-ALI), Revision 09,
dated September 18, 2017. This service information describes SL-ALI for
the landing gear.
    Airbus has also issued A330 ALS Part 1, SL-ALI, Variation 9.2,
dated November 28, 2017; and A330 ALS Part 1, SL-ALI, Variation 9.3,
dated November 29, 2017. This service information describes revised
life limits for certain parts. These documents are distinct because
they apply to different life limited parts.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 105 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:
    We have determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although we recognize that this number may vary from operator to
operator. In the past, we have estimated that this action takes 1 work-
hour per airplane. Since operators incorporate maintenance or
inspection program changes for their affected fleet(s), we have
determined that a per-operator estimate is more accurate than a per-
airplane estimate. Therefore, we estimate the total cost per operator
to be $7,650 (90 work-hours x $85 per work-hour).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

2018-23-14 Airbus SAS: Amendment 39-19501; Docket No. FAA-2018-0759;
Product Identifier 2018-NM-055-AD.

(a) Effective Date

    This AD is effective January 2, 2019.

(b) Affected ADs

    This AD affects AD 2017-10-24, Amendment 39-18898 (82 FR 24035,
May 25, 2017) (``AD 2017-10-24'').

(c) Applicability

    This AD applies to the Airbus SAS airplanes identified in
paragraphs (c)(1), (c)(2), and (c)(3) of this AD, certificated in
any category, with an original certificate of airworthiness or
original export certificate of airworthiness issued on or before
November 29, 2017.
    (1) Airbus SAS Model A330-201, -202, -203, -223, and -243
airplanes.
    (2) Airbus SAS Model A330-223F and -243F airplanes.
    (3) Airbus SAS Model A330-301, -302, -303, -321, -322, -323, -
341, -342, and -343 airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by revisions to certain airworthiness
limitation item (ALI) documents, which specify more restrictive
instructions and/or airworthiness limitations. We are issuing this
AD to address fatigue cracking, accidental damage, or corrosion in
principal structural elements, and possible failure of certain life
limited parts, 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) Maintenance or Inspection Program Revision

    Within 90 days after the effective date of this AD, revise the
existing maintenance or inspection program, as applicable, to
incorporate the information specified in the service information
identified in paragraphs

(g)(1), (g)(2), and (g)(3) of this AD. The initial compliance times
for accomplishing the tasks are at the applicable times specified in
the service information identified in paragraphs (g)(1), (g)(2), and
(g)(3) of this AD, or within 90 days after the effective date of
this AD, whichever occurs later.
    (1) Airbus A330 Airworthiness Limitations Section (ALS) Part 1,
Safe Life Airworthiness Limitation Items (SL-ALI), Revision 09,
dated September 18, 2017.
    (2) Airbus A330 ALS Part 1, SL-ALI, Variation 9.2, dated
November 28, 2017.
    (3) Airbus A330 ALS Part 1, SL-ALI, Variation 9.3, dated
November 29, 2017.

(h) Terminating Actions for AD 2017-10-24

    Accomplishing the actions required by paragraph (g) of this AD
terminates all of the requirements of AD 2017-10-24.

(i) No Alternative Actions or Intervals

    After the maintenance or inspection program, as applicable, has
been revised as required by paragraph (g) of this AD, no alternative
actions (e.g., inspections) or intervals may be used unless the
actions or intervals are approved as an alternative method of
compliance (AMOC) in accordance with the procedures specified in
paragraph (j)(1) of this AD.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (k)(2) of this AD. Information
may be emailed to: [email protected].
    (i) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (ii) AMOCs approved previously for AD 2017-10-24 are not
approved as AMOCs for this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain corrective actions from a manufacturer, the action must be
accomplished using a method approved by the Manager, International
Section, Transport Standards Branch, FAA; or the European Aviation
Safety Agency (EASA); or Airbus SAS's EASA Design Organization
Approval (DOA). If approved by the DOA, the approval must include
the DOA-authorized signature.

(k) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2018-0034, February 5, 2018, 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-
2018-0759.
    (2) For more information about this AD, contact Vladimir
Ulyanov, Aerospace Engineer, International Section, Transport
Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>.

(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Airbus A330 Airworthiness Limitations Section (ALS) Part 1,
Safe Life Airworthiness Limitation Items (SL-ALI), Revision 09,
dated September 18, 2017.
    (ii) Airbus A330 ALS Part 1, SL-ALI, Variation 9.2, dated
November 28, 2017.
    (iii) Airbus A330 ALS Part 1, SL-ALI, Variation 9.3, dated
November 29, 2017.
    (3) For service information identified in this AD, contact
Airbus SAS, Airworthiness Office--EAL, Rond-Point Emile Dewoitine
No: 2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax
+33 5 61 93 45 80; email [email protected];
internet http://www.airbus.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on November 8, 2018.
Chris Spangenberg,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-25392 Filed 11-26-18; 8:45 am]
 BILLING CODE 4910-13-P