[Federal Register Volume 78, Number 118 (Wednesday, June 19, 2013)]
[Proposed Rules]
[Pages 36698-36702]
[FR Doc No: 2013-14552]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2013-N-0544]

Microbiology Devices; Reclassification of Nucleic Acid-Based
Systems for Mycobacterium tuberculosis Complex in Respiratory Specimens

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify nucleic acid-based in vitro diagnostic devices for the
detection of Mycobacterium tuberculosis complex in respiratory
specimens from class III (premarket approval) into class II (special
controls). FDA is also issuing the draft special controls guideline
entitled ``Class II Special Controls Guideline: Nucleic Acid-Based In
Vitro Diagnostic Devices for the Detection of Mycobacterium
tuberculosis Complex in Respiratory Specimens.'' These devices are
intended to be used as an aid in the diagnosis of pulmonary
tuberculosis.

DATES: Submit either electronic or written comments on the proposed
rule by August 19, 2013. See section XIII for the proposed effective
date of any final rule that may publish based on this proposal.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-0544, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:

     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2013-N-0544 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Janice A. Washington, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 5554, Silver Spring, MD 20993-0002,
301-796-6207

SUPPLEMENTARY INFORMATION:

I. Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Public
Law 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629),
and the Food and Drug Administration Modernization Act of 1997 (Pub. L.
105-115), the Medical Device User Fee and Modernization Act of 2002
(Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub.
L. 108-214), and the Food and Drug Administration Amendments Act of
2007 (Pub. L. 110-85), establish a comprehensive system for the
regulation of medical devices intended for human use. Section 513 of
the FD&C Act (21 U.S.C. 360c) established three categories (classes) of
devices, reflecting the regulatory controls needed to provide
reasonable assurance of their safety and effectiveness. The three
categories of devices are class I (general controls), class II (special
controls), and class III (premarket approval).
    Under the FD&C Act, FDA clears or approves the three classes of
medical devices for commercial distribution in the United States
through three regulatory processes: Premarket approval (PMA), product
development protocol, and premarket notification (a premarket
notification is generally referred to as a ``510(k)'' after the section
of the FD&C Act where the requirement is found). The purpose of a
premarket notification is to demonstrate that the new device is
substantially equivalent to a legally marketed predicate device. Under
section 513(i) of the FD&C Act, a device is substantially equivalent if
it has the same intended use and technological characteristics as a
predicate device, or has different technological characteristics but
data demonstrate that the new device is as safe and effective as the
predicate device and does not raise different issues of safety or
effectiveness.
    FDA determines whether new devices are substantially equivalent to
previously offered devices by means of premarket notification
procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and
part 807 of the regulations (21 CFR part 807). Section 510(k) of the
FD&C Act and the implementing regulations in part 807, subpart E,
require a person who intends to market a medical device to submit a
premarket notification submission to FDA before proposing to begin the
introduction, or delivery for introduction into interstate commerce,
for commercial distribution of a device intended for human use.
    In accordance with section 513(f)(1) of the FD&C Act, devices that
were not in commercial distribution before May 28, 1976, the date of
enactment of the 1976 amendments, generally referred to as
postamendment devices, are classified automatically by statute into
class III without any FDA rulemaking process. These devices remain in
class III and require premarket approval, unless FDA classifies the
device into class I or class II by issuing an order finding the device
to be substantially equivalent, in accordance with section 513(i) of
the FD&C Act, to a predicate device that does not require premarket
approval or the device is reclassified into class I or class II. The
Agency determines whether new devices are substantially equivalent to
predicate devices by means of premarket notification procedures in
section 510(k) of the FD&C Act and part 807 of FDA's regulations.
    Section 513(f)(2) of the FD&C Act establishes procedures for ``de
novo'' risk-based review and classification of postamendment devices
automatically classified into class III by section 513(f)(1). Under
these procedures, any person whose device is automatically classified
into class III by section 513(f)(1) of the FD&C Act may seek
reclassification into class I or II, either after receipt of an order
finding the device to be not substantially equivalent, in accordance
with section 513(i) of the FD&C Act, to a predicate device that does
not require premarket approval, or at any time after determining there
is no legally marketed device upon which to base a determination of
substantial equivalence. In addition, under section 513(f)(3) of the
FD&C Act, FDA may initiate, or the manufacturer or importer of a device
may petition for, the reclassification of a device classified into
class III under section 513(f)(1).

II. Regulatory Background of the Device

    A nucleic acid-based in vitro diagnostic device for the detection
of M. tuberculosis complex in respiratory specimens is a postamendment
device classified into class III under section 513(f)(1) of the FD&C
Act in 1995. Consistent with the FD&C Act and FDA's regulations in 21
CFR 860.130(a), FDA believes that these devices should be reclassified
from class III into class II because there is sufficient information
from FDA's accumulated experience with these devices to establish
special controls that can provide reasonable assurance of the device's
safety and effectiveness.

III. Identification

    Nucleic acid-based in vitro diagnostic devices for the detection of
M. tuberculosis complex in respiratory specimens are qualitative
nucleic acid-based in vitro diagnostic devices intended to detect M.
tuberculosis complex nucleic acids extracted from human respiratory
specimens. These devices are non-multiplexed and intended to be used as
an aid in the diagnosis of pulmonary tuberculosis when used in
conjunction with clinical and other laboratory findings. These devices
do not include devices intended to detect the presence of organism
mutations associated with drug resistance. Respiratory specimens may
include sputum (induced or expectorated), bronchial specimens (e.g.,
bronchoalveolar lavage or bronchial aspirate), or tracheal aspirates.

IV. Background for Proposed Reclassification Decision

    At an FDA/Centers for Disease Control (CDC)/National Institute of
Allergy and Infectious Diseases public

workshop entitled ``Advancing the Development of Diagnostic Tests and
Biomarkers for Tuberculosis'', held in Silver Spring, MD, on June 7 and
8, 2010, the class III designation for nucleic acid-based in vitro
diagnostic devices for the detection of M. tuberculosis complex in
respiratory specimens was raised as a barrier to advancing M.
tuberculosis diagnostics (Ref. 1). Based on discussion at the public
workshop, FDA agreed to consider this issue further and subsequently
convened a meeting of the Microbiology Devices Panel of the Medical
Devices Advisory Committee on June 29, 2011. Panel members were asked
to discuss if sufficient risk mitigation was possible for FDA to
initiate the reclassification process from class III to class II
devices for this intended use through the drafting of a special
controls guidance. All panel members expressed the opinion that
sufficient data and information exist such that the risks of false
positive and false negative results can be mitigated to allow a special
controls guideline to be created that would support reclassification
from class III to class II for nucleic acid-based in vitro diagnostic
devices for the detection of M. tuberculosis complex in respiratory
specimens (Ref. 2). All outside speakers at the open public hearing
session during the meeting also spoke in favor of reclassification.

V. Classification Recommendation

    FDA is proposing that nucleic acid-based in vitro diagnostic
devices for the detection of M. tuberculosis complex in respiratory
specimens be reclassified from class III to class II. FDA believes that
class II with special controls (guideline document) would provide
reasonable assurance of the safety and effectiveness of the device.
Section 510(m) of the FD&C Act provides that a class II device may be
exempt from the premarket notification requirements under section
510(k), if the Agency determines that premarket notification is not
necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this device, FDA believes that
premarket notification is necessary to provide reasonable assurance of
safety and effectiveness and, therefore, does not intend to exempt the
device from the premarket notification requirements.

VI. Risks to Health

    After considering the information discussed by the Microbiology
Devices Panel during the June 29, 2011, meeting, the published
literature, and the Medical Device Reporting system reports, FDA
believes the following risks are associated with nucleic acid-based in
vitro diagnostic devices for the detection of M. tuberculosis complex
in respiratory specimens: (1) False positive test results may lead to
incorrect treatment of the individual with possible adverse effects.
The patient may be subjected to unnecessary isolation and/or other
human contact limitations. Unnecessary contact investigations may also
occur; (2) False negative test results could result in disease
progression and the risk of transmitting disease to others; and (3)
Biosafety risks to health care workers handling specimens and control
materials with the possibility of transmission of tuberculosis
infection to health care workers.

VII. Summary of the Reasons for Reclassification

    FDA, consistent with the opinions expressed by the Microbiology
Devices Panel of the Medical Devices Advisory Committee, believes that
the establishment of special controls, in addition to general controls,
provides reasonable assurance of the safety and effectiveness of
nucleic acid-based in vitro diagnostic devices for the detection of M.
tuberculosis complex in respiratory specimens.
    1. The safety and effectiveness of nucleic acid-based systems for
M. tuberculosis complex have become well-established since approval of
the first device for this use in 1995.
    2. The risk of false positive test results can be mitigated by
specifying minimum performance standards in the special controls
guideline and including information regarding patient populations
appropriate for testing in the device labeling. Additional risk
mitigation strategies include the indication for use that the device be
used as an aid to the diagnosis of pulmonary tuberculosis in
conjunction with other clinical and laboratory findings. The device
also should be accurately described and have labeling that addresses
issues specific to these types of devices.
    3. The risk of false negative test results can be mitigated by
specifying minimum performance standards for test sensitivity in the
special controls guideline and ensuring that different patient
populations are included in clinical trials. Additional risk mitigation
strategies include the indication for use that the device be used as an
aid to the diagnosis of pulmonary tuberculosis in conjunction with
other clinical and laboratory findings. The device also should be
accurately described and have appropriate labeling that addresses
issues specific to these types of devices.
    4. Biosafety risks to health care workers handling specimens and
control materials with the possibility of transmission of tuberculosis
infection to health care workers could be addressed similarly to
existing devices of this type that we have already approved. It is
believed there are no additional biosafety risks introduced by
reclassification from class III to class II. The need for appropriate
biosafety measures can be addressed in labeling recommendations that
are included in the special controls guideline and by adherence to
recognized laboratory biosafety procedures.
    Based on FDA's review of published literature, the information
presented by outside speakers invited to the Microbiology Devices
meeting, and the opinions of panel members expressed at that meeting,
FDA believes that there is a reasonable basis to determine that nucleic
acid-based in vitro diagnostic devices for the detection of M.
tuberculosis complex in respiratory specimens can provide the
significant benefit of rapid detection of infection in patients with
suspected tuberculosis as compared to traditional means of diagnosis.
For patients with acid-fast smear negative tuberculosis, nucleic acid-
based in vitro diagnostic devices for the detection of M. tuberculosis
complex in respiratory specimens are currently the only laboratory
tests available for rapid detection of active pulmonary tuberculosis.
Rapid identification of patients with active tuberculosis may have
significant benefits to the infected patient by earlier diagnosis and
management as well as potentially significant effects on the public
health by limiting disease spread.
    Nucleic acid-based in vitro diagnostic devices for the detection of
M. tuberculosis complex in respiratory specimens have been approved for
marketing by FDA for over 15 years. There is substantial scientific and
medical information available regarding the nature, complexity, and
problems associated with these devices. Revised public health
recommendations for use, published by CDC on January 16, 2009,
recommended the use of nucleic acid amplification testing in
conjunction with acid-fast microscopy and culture and specifically
states that ``Nucleic acid amplification testing should be performed on
at least one respiratory specimen from each patient with signs and
symptoms of pulmonary [tuberculosis] for whom a diagnosis of
[tuberculosis] is being considered but has not yet been established,
and for whom the test result would alter case

management or [tuberculosis] control activities'' (Ref 3).

VIII. Special Controls

    FDA believes that the measures set forth in the special controls
guideline entitled ``Nucleic Acid-Based In Vitro Diagnostic Devices for
the Detection of Mycobacterium tuberculosis Complex in Respiratory
Specimens'' are necessary, in addition to general controls, to mitigate
the risks to health described in section VI in this document. As seen
in table 1, the special controls set forth in the guideline for this
device address each of the identified risks.

            Table 1--Risks to Health and Mitigation Measures
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                                                  Recommended mitigation
                Identified risks                         measures
------------------------------------------------------------------------
False positive test results may lead to           Device Description.
 incorrect treatment of the individual with       Performance Studies.
 possible adverse effects. The patient may be     Labeling.
 subjected to unnecessary isolation and/or other
 human contact limitations. Unnecessary contact
 investigations may also occur.
False negative test results could result in       Device Description.
 disease progression, and the risk of             Performance Studies.
 transmitting disease to others.                  Labeling.
Biosafety risks to health care workers handling   Labeling.
 specimens and control materials with the
 possibility of transmission of tuberculosis
 infection to health care workers.
------------------------------------------------------------------------

    If this proposed rule is finalized, nucleic acid-based in vitro
diagnostic devices for the detection of M. tuberculosis complex in
respiratory specimens will be reclassified into class II. As discussed
in this document, the reclassification will be codified in 21 CFR
866.3372. Firms submitting a 510(k) for a nucleic acid-based in vitro
diagnostic devices for the detection of M. tuberculosis complex in
respiratory specimens will need either to: (1) Comply with the
particular mitigation measures set forth in the special controls
guideline or (2) use alternative mitigation measures, but demonstrate
to the Agency's satisfaction that alternative measures identified by
the firm will provide at least an equivalent assurance of safety and
effectiveness. Adherence to the criteria in the guideline, when
finalized, in addition to the general controls, is necessary to provide
a reasonable assurance of the safety and effectiveness of the devices.

IX. Electronic Access to the Special Controls Guideline

    Persons interested in obtaining a copy of the draft guideline may
do so by using the Internet. A search capability for all Center for
Devices and Radiological Health guidelines and guidance documents is
available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. The
guideline is also available at http://www.regulations.gov.
    To receive ``Class II Special Controls Guideline: Nucleic Acid-
Based In Vitro Diagnostic Devices for the Detection of Mycobacterium
tuberculosis Complex in Respiratory Specimens,'' you may either send an
email request to<EMAIL_ADDRESS>to receive an electronic copy of
the document or send a fax request to<PHONE_NUMBER> to receive a hard
copy. Please use the document number 1788 to identify the guideline you
are requesting.

X. Environmental Impact

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

XI. Paperwork Reduction Act of 1995

    This proposed rule refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 56.115 have been approved under
OMB control number 0910-0130; the collections of information in 21 CFR
part 807, subpart E have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 812 have been
approved under OMB control number 0910-0078; the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073; and the collections of information in 21 CFR part 801
and 21 CFR 809.10 have been approved under OMB control number 0910-
0485.

XII. Clarifications to Special Controls Guidelines

    This special controls guideline reflects changes the Agency is
making to clarify its position on the binding nature of special
controls. The changes include referring to the document as a
``guideline,'' as that term is used in section 513(a) of the FD&C Act,
which the Secretary has developed and disseminated to provide a
reasonable assurance of safety and effectiveness for class II devices,
and not a ``guidance,'' as that term is used in 21 CFR 10.115. The
guideline clarifies that firms will need either to: (1) Comply with the
particular mitigation measures set forth in the special controls
guideline or (2) use alternative mitigation measures, but demonstrate
to the Agency's satisfaction that those alternative measures identified
by the firm will provide at least an equivalent assurance of safety and
effectiveness. Finally, the guideline uses mandatory language to
emphasize that firms must comply with special controls to legally
market their class II devices. These revisions do not represent a
change in FDA's position about the binding effect of special controls,
but rather are intended to address any possible confusion or
misunderstanding.

XIII. Proposed Effective Date

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

XIV. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this proposed rule is not a

significant regulatory action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the proposed reclassification would relieve
manufacturers of premarket approval requirements of section 515 of the
FD&C Act (21 U.S.C. 360e) it would not create new burdens. Thus, the
Agency proposes to certify that the proposed rule, if finalized, will
not have a significant economic impact on a substantial number of small
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $139 million, using the most current (2011) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule, if finalized, to result in any 1-year expenditure that
would meet or exceed this amount.
    Our estimate of benefits annualized over 20 years is $11.85 million
at a 3 percent discount rate and $7.83 million at a 7 percent discount
rate. The change in pre- and post-marketing requirements between a
510(k) and a PMA lead to benefits in the form of reduced submission
costs, review-related activities, and inspections. Another
unquantifiable benefit from the rule is that a decrease in entry could
lead to further product innovation. FDA is unable to quantify the costs
that could arise if there is a change in risk which could lead to
adverse events, recalls, warning letters, or unlisted letters.
    The full discussion of economic impacts is available in docket FDA-
2013-N-0544 at http://www.regulations.gov, and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref.
4).

XV. Comments

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

XVI. References

    The following references have been placed on display in the Dockets
Management Branch (see ADDRESSES) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday, and are available
electronically at http://www.regulations.gov. (FDA has verified all the
Web site addresses in this reference section, but we are not
responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.)
    1. Transcript of the Tuberculosis Public Workshop, June 7, 2010,
(Available at: http://www.fda.gov/downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/UpcomingEventsonCPI/UCM289182.doc, accessed on January 25, 2012.)
    2. Transcript of FDA's Microbiology Devices Panel Meeting, June
29, 2011. (Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MicrobiologyDevicesPanel/UCM269469.pdf.)
    3. ``Updated Guidelines for the Use of Nucleic Acid
Amplification Tests in the Diagnosis of Tuberculosis,'' Morbidity
and Mortality Weekly Report (MMWR), vol. 58, pp. 7-10, January 16,
2009. (Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5801a3.htm, accessed on July 26, 2011.)
    4. Full Disclosure Preliminary Regulatory Impact Analysis of the
proposed rule ``Microbiology Devices; Reclassification of Nucleic
Acid-Based Systems for Mycobacterium tuberculosis Complex in
Respiratory Specimens,'' Docket No. FDA-2013-N-0544.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Add Sec.  866.3372 to subpart D to read as follows:

Sec.  866.3372  Nucleic acid-based in vitro diagnostic devices for the
detection of Mycobacterium tuberculosis complex in respiratory
specimens.

    (a) Identification. Nucleic acid-based in vitro diagnostic devices
for the detection of Mycobacterium tuberculosis complex in respiratory
specimens are qualitative nucleic acid-based in vitro diagnostic
devices intended to detect Mycobacterium tuberculosis complex nucleic
acids extracted from human respiratory specimens. These devices are
non-multiplexed and intended to be used as an aid in the diagnosis of
pulmonary tuberculosis when used in conjunction with clinical and other
laboratory findings. These devices do not include devices intended to
detect the presence of organism mutations associated with drug
resistance. Respiratory specimens may include sputum (induced or
expectorated), bronchial specimens (e.g., bronchoalveolar lavage or
bronchial aspirate), or tracheal aspirates.
    (b) Classification. Class II (special controls). The special
control for this device is the FDA document entitled ``Class II Special
Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for
the Detection of Mycobacterium tuberculosis Complex in Respiratory
Specimens.'' For availability of the guideline document, see Sec.
866.1(e).

    Dated: June 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-14552 Filed 6-18-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 78, Number 21 (Thursday, January 31, 2013)]
[Rules and Regulations]
[Pages 6745-6748]
[FR Doc No: 2013-02071]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 67

[Docket ID FEMA-2013-0002]

Final Flood Elevation Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: Base (1% annual-chance) Flood Elevations (BFEs) and modified
BFEs are made final for the communities listed below. The BFEs and
modified BFEs are the basis for the floodplain management measures that
each community is required either to adopt or to show evidence of being
already in effect in order to qualify or remain qualified for
participation in the National Flood Insurance Program (NFIP).

DATES: The date of issuance of the Flood Insurance Rate Map (FIRM)
showing

BFEs and modified BFEs for each community. This date may be obtained by
contacting the office where the maps are available for inspection as
indicated in the table below.

ADDRESSES: The final BFEs for each community are available for
inspection at the office of the Chief Executive Officer of each
community. The respective addresses are listed in the table below.

FOR FURTHER INFORMATION CONTACT: Luis Rodriguez, Chief, Engineering
Management Branch, Federal Insurance and Mitigation Administration,
Federal Emergency Management Agency, 500 C Street SW., Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final determinations listed below for the modified
BFEs for each community listed. These modified elevations have been
published in newspapers of local circulation and ninety (90) days have
elapsed since that publication. The Deputy Associate Administrator for
Mitigation has resolved any appeals resulting from this notification.
    This final rule is issued in accordance with section 110 of the
Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part
67. FEMA has developed criteria for floodplain management in floodprone
areas in accordance with 44 CFR part 60.
    Interested lessees and owners of real property are encouraged to
review the proof Flood Insurance Study and FIRM available at the
address cited below for each community. The BFEs and modified BFEs are
made final in the communities listed below. Elevations at selected
locations in each community are shown.
    National Environmental Policy Act. This final rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Consideration. An environmental impact assessment has not been
prepared.
    Regulatory Flexibility Act. As flood elevation determinations are
not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-
612, a regulatory flexibility analysis is not required.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This final rule involves no
policies that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This final rule meets
the applicable standards of Executive Order 12988.

List of Subjects in 44 CFR Part 67

    Administrative practice and procedure, Flood insurance, Reporting
and recordkeeping requirements.

    Accordingly, 44 CFR part 67 is amended as follows:

PART 67--[AMENDED]

0
1. The authority citation for part 67 continues to read as follows:

    Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of
1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp., p. 376.

Sec.  67.11  [Amended]

0
2. The tables published under the authority of Sec.  67.11 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                                      * Elevation in
                                                                     feet  (NGVD)  +
                                                                    Elevation in feet
                                                                      (NAVD)   Depth in feet
           Flooding source(s)                    elevation             above ground      Communities  affected
                                                                    [caret] Elevation
                                                                    in  meters  (MSL)
                                                                         modified

----------------------------------------------------------------------------------------------------------------
                                 Monroe County, Pennsylvania (All Jurisdictions)
                                             Docket No.: FEMA-B-1232
----------------------------------------------------------------------------------------------------------------
Appenzell Creek........................  Approximately 100 feet                  +486  Township of Hamilton,
                                          upstream of the                               Township of Jackson.
                                          McMichaels Creek
                                          confluence.
                                         Approximately 975 feet                  +871
                                          upstream of LR 45056.
Aquashicola Creek......................  At the Carbon County                    +467  Township of Eldred,
                                          Boundary (approximately                       Township of Ross.
                                          2.2 miles downstream of
                                          Lower Smith Gap Road).
                                         Approximately 1.2 miles                 +580
                                          upstream of the most
                                          upstream Upper Smith Gap
                                          Road crossing.
Brodhead Creek Reach 1.................  At the Delaware River                   +323  Township of Smithfield.
                                          confluence.
                                         Approximately 0.5 mile                  +323
                                          upstream of State Route
                                          2028.
Buck Hill Creek........................  Approximately 160 feet                 +1017  Township of Barrett,
                                          upstream of the Brodhead                      Township of Coolbaugh.
                                          Creek Reach 2 and Middle
                                          Branch Tributary
                                          confluence.
                                         Approximately 2.2 miles                +2012
                                          upstream of State Route
                                          191.
Bushkill Creek.........................  Approximately 1,100 feet                +470  Township of Middle
                                          downstream of Club House                      Smithfield.
                                          Drive.
                                         Approximately 1,130 feet                +756
                                          upstream of State Route
                                          402.
Cherry Creek...........................  At the Delaware River                   +323  Borough of Delaware Water
                                          confluence.                                   Gap, Township of
                                                                                Hamilton, Township of
                                                                                Smithfield, Township of
                                                                                Stroud.
                                         Approximately 1,250 feet                +635
                                          upstream of Spring
                                          Mountain Lane.
Cranberry Creek at Paradise............  At the upstream side of                 +715  Township of Paradise.
                                          Browns Hill Road.
                                         Approximately 200 feet                 +1092
                                          upstream of Snowbird
                                          Lane.
Cranberry Creek at Pocono..............  At the Pocono Creek                     +796  Township of Pocono.
                                          confluence.
                                         Approximately 580 feet                  +817
                                          downstream of State
                                          Route 611.

Delaware River.........................  Approximately 1.3 miles                 +315  Borough of Delaware Water
                                          downstream of I-80.                           Gap, Township of Middle
                                                                                Smithfield, Township of
                                                                                Smithfield.
                                         Approximately 14.8 miles                +357
                                          upstream of I-80.
Kettle Creek...........................  At the Appenzell Creek                  +491  Township of Hamilton.
                                          confluence.
                                         Approximately 200 feet                  +492
                                          upstream of the
                                          Appenzell Creek
                                          confluence.
Lehigh River Reach 2...................  Approximately 1.4 miles                +1512  Township of Coolbaugh,
                                          downstream of State                           Township of Tobyhanna.
                                          Route 4003.
                                         Approximately 780 feet                 +1617
                                          upstream of T-303.
Marshalls Creek........................  At the Brodhead Creek                   +323  Township of Middle
                                          Reach 1 confluence.                           Smithfield, Township of
                                                                                Smithfield.
                                         Approximately 2.6 miles                +1144
                                          upstream of Wooddale
                                          Road.
Pocono Creek...........................  Approximately 1,000 feet                +416  Borough of Stroudsburg,
                                          upstream of the                               Township of Hamilton,
                                          McMichaels Creek                              Township of Pocono,
                                          confluence.                                   Township of Stroud.
                                         Approximately 0.8 mile                 +1441
                                          upstream of Wilke Road.
Sambo Creek............................  Approximately 60 feet                   +444  Township of Stroud.
                                          downstream of the
                                          railroad.
                                         Approximately 1,500 feet                +451
                                          upstream of State Route
                                          447 (extended).
Scot Run...............................  At the Pocono Creek                     +955  Township of Pocono.
                                          confluence.
                                         Approximately 450 feet                  +955
                                          downstream of State
                                          Route 611.
Shawnee Creek Reach 1..................  At the Delaware River                   +326  Township of Smithfield.
                                          confluence.
                                         Approximately 100 feet                  +326
                                          upstream of River Road.
Swiftwater Creek.......................  Approximately 1,580 feet               +1163  Township of Pocono,
                                          downstream of State                           Township of Tobyhanna.
                                          Route 314.
                                         Approximately 2.7 miles                +1736
                                          upstream of Lake
                                          Minausin Dam.
Tributary 4 to Pocono Creek............  At the Pocono Creek                     +861  Township of Pocono.
                                          confluence.
                                         Approximately 110 feet                  +865
                                          downstream of Alger
                                          Avenue.
* National Geodetic Vertical Datum.
----------------------------------------------------------------------------------------------------------------
+ North American Vertical Datum.
 Depth in feet above ground.
[caret] Mean Sea Level, rounded to the nearest 0.1 meter.

                                                    ADDRESSES
Borough of Delaware Water Gap
Maps are available for inspection at the Municipal Building, 49 Main Street, Delaware Water Gap, PA 18327.

Borough of Stroudsburg
Maps are available for inspection at the Municipal Building, 700 Sarah Street, Stroudsburg, PA 18360.

Township of Barrett
Maps are available for inspection at the Barrett Township Hall, 993 State Route 390, Cresco, PA 18326.

Township of Coolbaugh
Maps are available for inspection at the Coolbaugh Township Municipal Center, 5550 Memorial Boulevard,
 Tobyhanna, PA 18466.

Township of Eldred
Maps are available for inspection at the Eldred Township Office, 490 Kunkletown Road, Kunkletown, PA 18058.

Township of Hamilton
Maps are available for inspection at the Hamilton Township Municipal Building, 229 Fenner Avenue, Sciota, PA
 18354.

Township of Jackson
Maps are available for inspection at the Jackson Township Municipal Building, 2162 State Route 715, Stroudsburg,
 PA 18360.

Township of Middle Smithfield
Maps are available for inspection at the Middle Smithfield Township Office, Schoonover Municipal Building, 25
 Municipal Drive, East Stroudsburg, PA 18301.

Township of Paradise
Maps are available for inspection at the Paradise Township Municipal Building, 5912 Paradise Valley Road,
 Cresco, PA 18326.

Township of Pocono
Maps are available for inspection at the Pocono Township Municipal Building, 112 Township Way, Tannersville, PA
 18372.

Township of Ross
Maps are available for inspection at the Ross Township Municipal Building, 258 Anchorage Road, Saylorsburg, PA
 18353.

Township of Smithfield
Maps are available for inspection at the Smithfield Township Municipal Center, 1155 Red Fox Road, East
 Stroudsburg, PA 18301.

Township of Stroud
Maps are available for inspection at the Stroud Township Municipal Center, 1211 North 5th Street, Stroudsburg,
 PA 18360.

Township of Tobyhanna
Maps are available for inspection at the Tobyhanna Township Municipal Building, 105 Government Center Way,
 Pocono Pines, PA 18350.
----------------------------------------------------------------------------------------------------------------

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

James A. Walke,
Acting Deputy Associate Administrator for Mitigation, Department of
Homeland Security, Federal Emergency Management Agency.
[FR Doc. 2013-02071 Filed 1-30-13; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 84, Number 141 (Tuesday, July 23, 2019)]
[Notices]
[Pages 35436-35438]
From the Federal Register Online via the Government Publishing Office [http://www.gpo.gov/]
[FR Doc No: 2019-15563]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-86398; File No. SR-ISE-2019-20]

Self-Regulatory Organizations; Nasdaq ISE, LLC; Notice of Filing
and Immediate Effectiveness of Proposed Rule Change To Amend Options 2
(Options Market Participants) and Options 3 (Options Trading Rules)

July 17, 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 July 10, 2019, Nasdaq ISE, LLC (``ISE'' or ``Exchange'') filed with
the Securities and Exchange Commission (``SEC'' or ``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by the Exchange. The Commission is publishing
this notice to solicit comments on the proposed rule change from
interested persons.
---------------------------------------------------------------------------

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

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

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

    The Exchange proposes to amend Options 2 (Options Market
Participants) and Options 3 (Options Trading Rules) relating to certain
order types.
    The text of the proposed rule change is available on the Exchange's
website at http://ise.cchwallstreet.com/, at the principal office of
the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the Exchange 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 Exchange has prepared summaries, set forth in
sections A, B, and C below, of the most significant aspects of such
statements.

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

1. Purpose
    The purpose of the proposed rule change is amend Options 2 (Options
Market Participants) and Options 3 (Options Trading Rules) relating to
certain order types. Each change is described in more detail below.
Stopped Orders
    The Exchange proposes to amend its rules to remove Stopped Orders
as an order type. A Stopped Order is a limit order that meets the
requirements of Options 5, Section 2(b)(8).\3\ As provided in Options
5, Section 2(b)(8), a ``stopped order'' is defined as an order for
which, at the time of receipt for the order, a Member had guaranteed an
execution at no worse than a specified price, where: (i) The stopped
order was for the account of a Customer; (ii) the Customer agreed to
the specified price on an order-by-order basis; and (iii) the price of
the Trade-Through was, for a stopped buy order, lower than the national
Best Bid in the options series at the time of execution, or, for a
stopped sell order, higher than the national Best Offer in the options
series at the time of execution. To execute Stopped Orders, Members
must enter them into the Facilitation Mechanism or Solicited Order
Mechanism pursuant to Options 3, Section 11.\4\
---------------------------------------------------------------------------

    \3\ See Options 3, Section 7(b)(5). The current rule text
erroneously refers to Options 1, Section 2(b)(8) instead of Options
5, Section 2(b)(8).
    \4\ Stopped orders were originally introduced on the Exchange as
a Trade-Through exception under the Options Order Protection and
Locked/Crossed Market Plan (the ``Plan''). See Securities Exchange
Act Release No. 60559 (August 21, 2009), 74 FR 44425 (August 28,
2009) (SR-ISE-2009-27) (stating that customer stopped orders permit
broker-dealers to execute large orders over time at a price agreed
upon by a customer, even though the price of the option may change
before the order is executed in its entirety). The Exchange
subsequently amended its rules to implement the Trade-Through
exception for stopped orders as an order type. See Securities
Exchange Act Release No. 62027 (May 4, 2010), 75 FR 25897 (May 10,
2010) (SR-ISE-2010-28).
---------------------------------------------------------------------------

    Due to a lack of demand for Stopped Orders, the Exchange plans to
decommission the functionality supporting this order type.\5\ To
reflect this elimination, the Exchange proposes to delete all
references to Stopped Orders as follows:
---------------------------------------------------------------------------

    \5\ No member has used this order type since the Exchange's
previous trading system migrated over to Nasdaq INET technology in
2017.
---------------------------------------------------------------------------

     Options 2, Section 6(a), which currently allows Market
Makers to enter all order types in the options classes to which they
are appointed, except for Stopped Orders, Reserve Orders, and Customer
Cross Orders.
     Options 3, Section 7(b)(5), which defines a Stopped Order.
    The Exchange proposes to implement the amendments relating to
Stopped Orders by November 1, 2019.
All-Or-None Orders
    The Exchange also proposes to amend Options 3, Section 8 (Opening)
to remove specific references to the manner in which All-Or-None Orders
\6\ (``AONs'') will be treated in the Exchange's opening process. The
Exchange previously amended its rules to provide that an AON may only
be entered into the System with a time-in-force designation of
Immediate-Or-Cancel,\7\ and deleted related rule text that described an
AON as persisting in the Exchange's order book.\8\ The Exchange,
however, inadvertently did not remove such AON references from the
opening rule in Options 3, Section 8. At the time the Exchange's
opening process was adopted, AONs were not restricted and could trade
as a limit or market order to be executed in its entirety or not at
all.\9\ With the amendments in SR-ISE-2017-03, an AON does not persist
in the order book and is therefore treated the same as any other
Immediate-or-Cancel Order. As such, the carve-outs specified in Section
8(b), (g) and (j)(6) are unnecessary since an All-or-None Order would
execute immediately or cancel similar to other orders which trade in
the same manner. The Exchange believes removing these references will
eliminate confusion.
---------------------------------------------------------------------------

    \6\ An All-Or-None Order is a limit or market order that is to
be executed in its entirety or not at all. An All-Or-None Order may
only be entered as an Immediate-or-Cancel Order. See Options 3,
Section 7(c).
    \7\ An Immediate-Or-Cancel Order is a limit order that is to be
executed in whole or in part upon receipt. Any portion not so
executed is to be treated as cancelled. See Options 3, Section
7(b)(3).
    \8\ See Securities Exchange Act Release No. 80432 (April 11,
2017), 82 FR 18191 (April 17, 2017) (SR-ISE-2017-03).
    \9\ See Securities Exchange Act Release No. 80225 (March 13,
2017), 82 FR 14243 (March 17, 2017) (SR-ISE-2017-02).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal is consistent with Section
6(b) of the Act,\10\ in general, and furthers the objectives of Section
6(b)(5) of the Act,\11\ in particular, in that it is designed to
promote just and equitable principles of trade, to remove impediments
to and perfect the mechanism of a free and open market and a national
market system, and, in general to protect investors and the public
interest.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that removing Stopped Orders as an order type
is consistent with the Act because it would simplify the functionality
available on the Exchange and reduce the complexity of its order types.
The Exchange's affiliated options markets, Nasdaq BX (``BX''), The
Nasdaq Options Market (``NOM''), and Nasdaq PHLX (``Phlx'') do not
offer stopped orders as an order type.
    The Exchange also believes that it is consistent with the Act to
remove unnecessary and confusing references to AONs in the opening rule
set forth in Options 3, Section 8 as AONs will now immediately trade or
cancel. The Exchange originally specified the manner in which AONs
would trade in the opening because at the time the opening process was
adopted, this order type traded differently as compared to other order
types. That distinction has become unnecessary because AONs trade the
same as other Immediate-or-Cancel Orders. Updating Options 3, Section 8
to remove an unnecessary and inaccurate distinction will protect
investors and the public interest by clarifying the rule.

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

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

proposed rule change would allow the Exchange to remove an order type
that no Member uses today, and eliminate unnecessary and inaccurate
references to AONs within its opening rule, thereby making clear the
order types available for trading on the Exchange and reducing
potential confusion.

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

    No written comments were either solicited or received.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A)(iii) of the Act \12\ and
subparagraph (f)(6) of Rule 19b-4 thereunder.\13\
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \13\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change at
least five business days prior to the date of filing of the proposed
rule change, or such shorter time as designated by the Commission.
The Exchange has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or 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 protected]. Please include
File Number SR-ISE-2019-20 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-ISE-2019-20. 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 the Exchange. 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-ISE-2019-20 and should be submitted on
or before August 13, 2019.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 2019-15563 Filed 7-22-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 47 (Thursday, March 10, 2011)]
[Notices]
[Pages 13201-13202]
[FR Doc No: 2011-5418]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2011-0009]

Agency Information Collection Activities: Proposed Collection;
Comment Request, 1660-0039; FEMA Form 078-0-2A, National Fire Academy
(NFA) Long-Term Evaluation Student/Trainee; FEMA Form 078-0-2, NFA
Long-Term Evaluation Supervisors

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice; 60-day notice and request for comments; extension,
without change, of a currently approved information collection; OMB No.
1660-0039; FEMA Form 078-0-2A (Presently FEMA Form 95-59), NFA Long-
Term Evaluation Student/Trainee; FEMA Form 078-0-2 (Presently FEMA Form
95-58), NFA Long-Term Evaluation Supervisors.

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

SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a proposed extension, without change, of a currently
approved information collection. In accordance with the Paperwork
Reduction Act of 1995, this notice seeks comments concerning the long-
term evaluation forms used to evaluate all NFA resident training.

DATES: Comments must be submitted on or before May 9, 2011.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at http://www.regulations.gov under
Docket ID FEMA-2011-0009. Follow the instructions for submitting
comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street, SW., Room 835, Washington, DC
20472-3100.
    (3) Facsimile. Submit comments to<PHONE_NUMBER>.
    (4) E-mail. Submit comments to<EMAIL_ADDRESS>Include Docket
ID FEMA-2011-0009 in the subject line.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Laura Chevalier, Program Analyst, U.S.
Fire Administration,<PHONE_NUMBER>, for additional information. You may
contact the Records Management Division for copies of the proposed
collection of information at facsimile number<PHONE_NUMBER> or e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The NFA is mandated under the Fire
Prevention and Control Act of 1974 (Pub. L. 93-498) to provide training
and education to the Nation's fire service and emergency service
personnel. The state-of-the-art programs offered by the NFA serve as
models of excellence and state and local fire service agencies rely
heavily on the curriculum to train their personnel. To maintain the
quality of these training programs, it is critical that courses be
evaluated after students have had the opportunity to apply the
knowledge and skills gained from their training.

Collection of Information

    Title: National Fire Academy Long-term Evaluation Form for
Supervisors and National Fire Academy Long-term Evaluation Form for
Students/Trainees.
    Type of Information Collection: Extension, without change, of a
currently approved information collection.
    OMB Number: OMB No. 1660-0039.
    Form Titles and Numbers: FEMA Form 078-0-2A, NFA Long-Term
Evaluation Student/Trainee; FEMA Form 078-0-2, NFA Long-Term Evaluation
Supervisors.
    Abstract: The National Fire Academy Long-Term Evaluation Form will
be used to evaluate all National Fire Academy (NFA) on-campus resident
training courses. Course graduates and their supervisors will be asked
to evaluate the impact of the training on both individual job
performance and the fire and emergency response department/community
where the student works. The data provided by students and supervisors
is used to update existing NFA course materials and to develop new
courses that reflect the emerging issues/needs of the Nation's fire
service.
    Affected Public: State, local or Tribal Government.
    Estimated Total Annual Burden Hours: 697.5 burden hours.

                                               Annual Hour Burden
----------------------------------------------------------------------------------------------------------------
    Data collection activity/         No. of       Frequency of     Hour burden       Annual       Total annual
           instrument               respondents      responses     per response      responses     burden hours
----------------------------------------------------------------------------------------------------------------
NFA Long Term Evaluation                   2,250               1              .2           2,250             450
 Students/Trainees/FEMA Form 078-
 0-2A (Formerly FEMA Form 95-59)
NFA Long Term Evaluation                   2,250               1             .11           2,250           247.5
 Supervisors/FEMA Form 078-0-2
 (Formerly FEMA Form 95-58).....
                                 -------------------------------------------------------------------------------
    Total.......................           4,500  ..............  ..............           4,500           697.5
----------------------------------------------------------------------------------------------------------------

    Estimated Cost: There are no annual start-up or capital costs.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) Evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: March 3, 2011.
Lesia M. Banks,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2011-5418 Filed 3-9-11; 8:45 am]
BILLING CODE 9110-45-P


[Federal Register Volume 79, Number 10 (Wednesday, January 15, 2014)]
[Notices]
[Pages 2655-2656]
[FR Doc No: 2014-00544]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP14-35-000]

Southern Star Central Gas Pipeline, Inc.; Notice of Request Under
Blanket Authorization

    Take notice that on December 30, 2013, Southern Star Central Gas
Pipeline, Inc., (Southern Star), 4700 State Highway 56, Owensboro,
Kentucky 42301, filed in Docket No. CP14-35-000, a prior notice request
pursuant to sections 157.205 and 157.216 of the Commission's
regulations under the Natural Gas Act. Southern Star seeks
authorization to relocate, replace, and abandon sections of its 16-inch
EK Pipeline, 16-inch ES Pipeline and 26-inch E Pipeline to facilitate
the Kansas Department of Transportation's plan to construct and modify
Highway K-10 and various interchanges, collectively known as the South
Lawrence Trafficway Project (STL Project) located in Douglas County,
Kansas. Southern Star will construct approximately 3.2 miles of new
pipeline that will be rerouted around and lowered through the STL
Project and tied into existing lines, all as more fully set forth in
the application which is on file with the Commission and open to public
inspection. The filing may also be viewed on the Web at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Any questions regarding this Application should be directed to
Phyllis K. Medley, Senior Analyst, Regulatory Compliance, Southern Star
Central Gas Pipeline, Inc., 4700 State Highway 56, Owensboro, Kentucky
42301, or by calling<PHONE_NUMBER>, or by fax<PHONE_NUMBER>, or by
email<EMAIL_ADDRESS>    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the NGA (18 CFR 157.205) file a protest to the request. If no protest
is filed within the time allowed therefore, the proposed activity shall
be deemed to be authorized effective the day after the time allowed for
protest. If a protest is filed and not withdrawn within 30 days after
the time allowed for filing a protest, the instant request shall be

treated as an application for authorization pursuant to section 7 of
the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenter's will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with he Commission's environmental review process.
Environmental commenter's will not be required to serve copies of filed
documents on all other parties. However, the non-party commentary, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the internet in lieu of paper. See 18
CFR 385.2001(a) (1) (iii) and the instructions on the Commission's Web
site (www.ferc.gov) under the ``e-Filing'' link. Persons unable to file
electronically should submit an original and 5 copies of the protest or
intervention to the Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426.

    Dated: January 8, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-00544 Filed 1-14-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 91 (Tuesday, May 12, 2015)]
[Rules and Regulations]
[Pages 27069-27072]
[FR Doc No: 2015-11137]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

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

Federal Register / Vol. 80, No. 91 / Tuesday, May 12, 2015 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-1278; Directorate Identifier 2014-NM-223-AD;
Amendment 39-18155; AD 2015-09-09]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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

SUMMARY: We are superseding Airworthiness Directive (AD) 2004-07-11 for
all The Boeing Company Model 767-400ER series airplanes. AD 2004-07-11
requires repetitive high frequency eddy current (HFEC) inspections of
the aft lower lugs of the deflection control track of the outboard flap
for cracks, and replacement of any cracked deflection control track
with a new track assembly. This AD retains those requirements, provides
optional terminating action for the repetitive inspections, and adds
airplane models to the applicability. This AD was prompted by our
determination that additional airplane models require repetitive HFEC
inspections of the aft lower lugs of the deflection control track of
the outboard flap for cracks, and replacement of any cracked deflection
control track with a new track assembly. We are issuing this AD to
detect and correct fatigue cracking in the aft lower lug run-out region
of the deflection control track, which could result in the loss of the
secondary load path for the outboard flap, resulting in the loss of the
outboard flap and consequent reduced controllability of the airplane in
the event that the primary load path also fails.

DATES: This AD is effective May 27, 2015.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of May 27,
2015.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of May
11, 2004 (69 FR 17911, April 6, 2004).
    We must receive any comments on this AD by June 26, 2015.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Boeing
Commercial Airplanes, Attention: Data & Services Management, P.O. Box
3707, MC 2H-65, Seattle, WA 98124-2207; telephone<PHONE_NUMBER>,
extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
You may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information
on the availability of this material at the FAA, call<PHONE_NUMBER>. It
is also available on the Internet at http://www.regulations.gov by
searching for and locating Docket No. FAA-2015-1278.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
1278; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Office (phone:
800-647-5527) is in the ADDRESSES section. Comments will be available
in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Berhane Alazar, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-
6577; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    On March 22, 2004, we issued AD 2004-07-11, Amendment 39-13555 (69
FR 17911, April 6, 2004), for all The Boeing Company Model 767-400ER
series airplanes. AD 2004-07-11 required repetitive HFEC inspections of
the aft lower lugs of the deflection control track of the outboard flap
for cracks, and replacement of any cracked deflection control track
with a new track assembly. AD 2004-07-11 resulted from reports of
fatigue cracking in the aft lower lug run-out region of the deflection
control track. We issued AD 2004-07-11 to detect and correct fatigue
cracking of the deflection control track, which could result in the
loss of the secondary load path for the outboard flap, resulting in the
loss of the outboard flap and consequent reduced controllability of the
airplane in the event that the primary load path also fails.

Actions Since AD 2004-07-11, Amendment 39-13555 (69 FR 17911, April 6,
2004) Was Issued

    Since we issued AD 2004-07-11, Amendment 39-13555 (69 FR 17911,
April 6, 2004), we have determined that additional airplane models are
subject to the identified unsafe condition. The flap installations on
certain Model 767-200 and -300 series airplanes, serial numbers 922
through 933 inclusive, are identical to those installed on Model 767-
400ER series airplanes. Therefore, all of these models may be subject
to the identified unsafe condition. We are issuing this AD to detect
and correct fatigue cracking in the aft lower lug run-out region of the
deflection control track, which could result in the loss of the
secondary load path for the outboard flap, resulting in the loss of the
outboard

flap and consequent reduced controllability of the airplane in the
event that the primary load path also fails, on certain Model 767-200
and -300 series airplanes, serial numbers 922 through 933 inclusive.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Service Bulletin 767-27A0183, Revision 2, dated
September 25, 2014. The service information describes procedures for
repetitive HFEC inspections of the aft lower lugs of the deflection
control track of the outboard flap for cracks, and replacement of any
cracked deflection control track with a new track assembly, part number
113T8333-9, which eliminates the need for the repetitive HFEC
inspections. This service information is reasonably available at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
1278. Or see ADDRESSES for other ways to access this service
information.

FAA's Determination

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

AD Requirements

    This AD retains all of the requirements of AD 2004-07-11, Amendment
39-13555 (69 FR 17911, April 6, 2004). This AD continues to require
repetitive HFEC inspections of the aft lower lugs of the deflection
control track of the outboard flap for cracks, and replacement of any
cracked deflection control track with a new track assembly. This AD
adds airplane models to the applicability, and provides optional
terminating action for the repetitive HFEC inspections even if no crack
is found.

Change to AD 2004-07-11, Amendment 39-13555 (69 FR 17911, April 6,
2004)

    Since AD 2004-07-11, Amendment 39-13555 (69 FR 17911, April 6,
2004) was issued, the AD format has been revised, and certain
paragraphs have been rearranged. As a result, the corresponding
paragraph designations have been redesignated in this AD, as listed in
the following table:

                     Revised Paragraph Designations
------------------------------------------------------------------------
   Requirement in AD 2004-07-11,
  Amendment 39-13555 (69 FR 17911,   Corresponding  requirement  in this
           April 6, 2004)                             AD
------------------------------------------------------------------------
           paragraph (a)                        paragraph (g)
           paragraph (b)                        paragraph (h)
           paragraph (c)                        paragraph (i)
------------------------------------------------------------------------

Clarification of Paragraph (c) of AD 2004-07-11, Amendment 39-13555 (69
FR 17911, April 6, 2004)

    We have added a reference to paragraph (h) of this AD to the
corrective action requirements of paragraph (i) of this AD (which we
referred to as paragraph (c) of AD 2004-07-11, Amendment 39-13555 (69
FR 17911, April 6, 2004)). We have made this change to clarify the
corrective action.

FAA's Justification and Determination of the Effective Date

    This AD revises the applicability by adding airplanes that are not
on the U.S. Register. Therefore, we find that notice and opportunity
for prior public comment are unnecessary and that good cause exists for
making this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments before it becomes effective. However, we invite
you to send any written data, views, or arguments about this AD. Send
your comments to an address listed under the ADDRESSES section. Include
Docket No. FAA-2015-1278 and directorate identifier 2014-NM-223-AD at
the beginning of your comments. We specifically invite comments on the
overall regulatory, economic, environmental, and energy aspects of this
AD. We will consider all comments received by the closing date and may
amend this AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this AD.

Costs of Compliance

    The actions specified by this AD were previously required by AD
2004-07-11, Amendment 39-13555 (69 FR 17911, April 6, 2004), which was
applicable to approximately 38 airplanes. The actions required by AD
2004-07-11 take about 5 work-hours per airplane. In consideration of
the compliance time and effective date of AD 2004-07-11, we assume that
operators of the 38 airplanes subject to that AD have already initiated
the required actions.
    This AD would add no new costs associated with the airplanes of
U.S. registry, but would be applicable to approximately 11 additional
airplanes of the affected design in the worldwide fleet. The current
costs for this AD are repeated for the convenience of affected
operators, as follows:

                                        Estimated Costs--Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                    Labor cost         Parts cost      Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Retained inspections from AD      5 work-hours x $85               $0   $425 per inspection  $16,150 per
 2004-07-11, Amendment 39-13555    per hour = $425                       cycle.               inspection cycle.
 (69 FR 17911, April 6, 2004).     per inspection
                                   cycle.
----------------------------------------------------------------------------------------------------------------

    We estimate that it would take about 12 work-hours to do any
necessary replacement that would be required based on the results of
the inspection. We have received no definitive data that would enable
us to provide cost estimates for the on-condition actions specified in
this AD. We have no way of determining the number of aircraft that
might need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with

promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (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 part 39 of the Federal Aviation
Regulations (14 CFR part 39) as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2004-07-11, Amendment 39-13555 (69 FR 17911, April 6, 2004) and adding
the following new AD:

2015-09-09 The Boeing Company: Amendment 39-18155; Docket No. FAA-
2015-1278; Directorate Identifier 2014-NM-223-AD.

(a) Effective Date

    This AD is effective May 27, 2015.

(b) Affected ADs

    This AD replaces AD 2004-07-11, Amendment 39-13555 (69 FR 17911,
April 6, 2004).

(c) Applicability

    This AD applies to The Boeing Company Model 767-200, -300, and -
400ER series airplanes, certificated in any category, as identified
in Boeing Service Bulletin 767-27A0183, Revision 2, dated September
25, 2014.

(d) Subject

    Air Transport Association (ATA) of America Code 27, Flight
controls; 57, Wings.

(e) Unsafe Condition

    This AD was prompted by our determination that additional
airplane models require repetitive high frequency eddy current
(HFEC) inspections of the aft lower lugs of the deflection control
track of the outboard flap for cracks, and replacement of any
cracked deflection control track with a new track assembly. We are
issuing this AD to detect and correct fatigue cracking in the aft
lower lug run-out region of the deflection control track, which
could result in the loss of the secondary load path for the outboard
flap, resulting in the loss of the outboard flap and consequent
reduced controllability of the airplane in the event that the
primary load path also fails.

(f) Compliance

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

(g) Retained Initial Inspection for Model 767-400ER Series Airplanes

    This paragraph restates the requirements of paragraph (a) of AD
2004-07-11, Amendment 39-13555 (69 FR 17911, April 6, 2004), with
revised service information. For airplanes identified in Group 1 in
Boeing Service Bulletin 767-27A0183, Revision 2, dated September 25,
2014: Before the accumulation of 12,000 total flight cycles, or
within 1,200 flight cycles after May 11, 2004 (the effective date of
AD 2004-07-11), whichever occurs later, perform an HFEC inspection
for cracks in the aft lower lug of the deflection control track on
the outboard flap, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 767-27A0183, dated May
9, 2002; or Boeing Service Bulletin 767-27A0183, Revision 2, dated
September 25, 2014. As of the effective date of this AD, only Boeing
Service Bulletin 767-27A0183, Revision 2, dated September 25, 2014,
may be used.

(h) Retained Repetitive Inspections With New Service Information

    This paragraph restates the requirements of paragraph (b) of AD
2004-07-11, Amendment 39-13555 (69 FR 17911, April 6, 2004), with
new service information. For airplanes identified in Group 1 in
Boeing Service Bulletin 767-27A0183, Revision 2, dated September 25,
2014: If no crack is detected during any HFEC inspection required in
paragraph (g) of this AD, repeat the inspection at intervals not to
exceed 1,200 flight cycles.

(i) Retained Corrective Action and Added Terminating Action

    This paragraph restates the requirements of paragraph (c) of AD
2004-07-11, Amendment 39-13555 (69 FR 17911, April 6, 2004), with
revised service information, added terminating action, and added
paragraph reference. For airplanes identified in Group 1 in Boeing
Service Bulletin 767-27A0183, Revision 2, dated September 25, 2014:
If any crack is detected during any HFEC inspection required by
paragraph (g) or (h) of this AD, before further flight, replace the
deflection control track with a new track assembly, in accordance
with the Accomplishment Instructions of Boeing Alert Service
Bulletin 767-27A0183, dated May 9, 2002; or Boeing Service Bulletin
767-27A0183, Revision 2, dated September 25, 2014. Within 12,000
flight cycles following the replacement of deflection control track
with a deflection control track, part number (P/N) 113T7333-3 or
113T8333-7, perform the HFEC inspection specified in paragraph (g)
of this AD, and repeat inspections as specified in paragraph (h) of
this AD until the deflection control track is replaced with a
deflection control track, P/N 113T8333-9, as specified in paragraph
(m) of this AD. As of the effective date of this AD, only Boeing
Service Bulletin 767-27A0183, Revision 2, dated September 25, 2014,
may be used.

(j) New Initial Inspection for Model 767-200 and -300 Series Airplanes

    For airplanes identified in Group 2 in Boeing Service Bulletin
767-27A0183, Revision 2, dated September 25, 2014: Before the
accumulation of 12,000 total flight cycles, or within 1,200 flight
cycles after the effective date of this AD, whichever occurs later,
do an HFEC inspection for cracks in the aft lower lug of the
deflection control track on the outboard flap, in accordance with
the Accomplishment Instructions of Boeing Service Bulletin 767-
27A0183, Revision 2, dated September 25, 2014.

(k) New Repetitive Inspections

    For airplanes identified in Group 2 in Boeing Service Bulletin
767-27A0183, Revision 2, dated September 25, 2014: If no crack is
detected during any HFEC inspection required in paragraph (j) of
this AD, repeat the inspection thereafter at intervals not to exceed
1,200 flight cycles.

(l) New Corrective Action and Terminating Action

    For airplanes identified in Group 2 in Boeing Service Bulletin
767-27A0183, Revision 2, dated September 25, 2014: If any crack is
detected during any HFEC inspection required by paragraph (j) or (k)
of this AD, before further flight, replace the deflection control
track with a new track assembly, part number 113T8333-9, in
accordance with the Accomplishment Instructions of Boeing Service
Bulletin 767-27A0183, Revision 2, dated September 25, 2014. This
replacement terminates the inspection requirements of paragraphs (j)
and (k) of this AD.

(m) Optional Terminating Action

    Replacement of the deflection control track with a new track
assembly, P/N 113T8333-

9, in accordance with the Accomplishment Instructions of Boeing
Service Bulletin 767-27A0183, Revision 2, dated September 25, 2014,
terminates the inspection requirements of paragraphs (g), (h), (j),
and (k) of this AD.

(n) Credit for Previous Actions

    This paragraph provides credit for the actions specified in
paragraphs (g), (h), (i), and (m) of this AD, if those actions were
performed before the effective date of this AD using Boeing Service
Bulletin 767-27A0183, Revision 1, dated April 4, 2014, which is not
incorporated by reference in this AD.

(o) Alternative Methods of Compliance (AMOCs)

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

(p) Related Information

    (1) For more information about this AD, contact Berhane Alazar,
Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft
Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-
3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (q)(5) and (q)(6) of this AD.

(q) 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 the AD specifies otherwise.
    (3) The following service information was approved for IBR on
May 27, 2015.
    (i) Boeing Service Bulletin 767-27A0183, Revision 2, dated
September 25, 2014.
    (ii) Reserved.
    (4) The following service information was approved for IBR on
May 11, 2004, (69 FR 17911, April 6, 2004).
    (i) Boeing Alert Service Bulletin 767-27A0183, dated May 9,
2002.
    (ii) Reserved.
    (5) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (6) You may view this service information at FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (7) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on April 29, 2015.
Jeffrey E. Duven,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-11137 Filed 5-11-15; 8:45 am]
 BILLING CODE 4910-13-P