[Federal Register Volume 83, Number 149 (Thursday, August 2, 2018)]
[Proposed Rules]
[Pages 37774-37776]
[FR Doc No: 2018-16482]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-0345; Airspace Docket No. 17-AAL-1]
RIN-2120-AA66

Proposed Modification of Class E Airspace for the Following
Alaska Towns; Barrow, AK; Chevak, AK; Clarks Point, AK; Elim, AK; and
Golovin, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify Class E airspace extending
upward from 1,200 feet above the surface in Alaska at Wiley Post/Will
Rogers Memorial Airport, Barrow; Chevak Airport; Clarks Point Airport;
Elim Airport; and Golovin Airport. This proposal would add exclusionary
language to the legal descriptions of these airports to exclude Class E
airspace extending beyond 12 miles from the shoreline, and would ensure
the safety and management of aircraft within the National Airspace
System. Also, an editorial change would be made in the associated
airspace designation for Chevak Airport.

DATES: Comments must be received on or before September 17, 2018.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2017-0345; Airspace Docket No. 17-AAL-1, at the beginning of your
comments. You may also submit comments through the internet at http://www.regulations.gov.
    FAA Order 7400.11B, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11B at NARA, call<PHONE_NUMBER>, or go
to https://

www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Richard Roberts, Federal Aviation
Administration, Operations Support Group, Western Service Center, 2200
S 216th St., Des Moines, WA 98198-6547; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority,
as it would amend Class E airspace extending upward from 1,200 feet
above the surface at Wiley Post/Will Rogers Memorial Airport, Barrow;
Chevak Airport, Clarks Point Airport, Elim Airport, and Golovin
Airport, AK, to support IFR operations in standard instrument approach
and departure procedures at these airports.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Persons wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2017-0345;
Airspace Docket No. 17-AAL-1.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 2200 S 216th St., Des Moines, WA
98198-6547.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace
Designations and Reporting Points, dated August 3, 2017, and effective
September 15, 2017. FAA Order 7400.11B is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11B lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by modifying Class E airspace extending
upward from 1,200 feet above the surface at Wiley Post/Will Rogers
Memorial Airport, Barrow, AK; Chevak Airport, Clarks Point Airport,
Elim Airport, and Golovin Airport, AK. This action would add language
to the legal descriptions of these airports that reads ``excluding that
airspace that extends beyond 12 miles from the shoreline''.
    An editorial change also would be made to the Chevak airspace
designation removing the city from the airport name to comply with a
change to FAA Order 7400.2L, Procedures for Handling Airspace Matters.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11B, dated August 3, 2017, and effective September 15,
2017, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

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

Environmental Review

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

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

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

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

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

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

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B,
Airspace Designations and Reporting

Points, dated August 3, 2017, and effective September 15, 2017, is
amended as follows:

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

* * * * *

AAL AK E5 Barrow, AK [Amended]

Wiley Post/Will Rogers Memorial Airport, AK
    (Lat. 71[deg]17'06'' N, long. 156[deg]46'07'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.6-mile radius of the Wiley Post/Will Rogers Memorial
Airport; and that airspace extending upward from 1,200 feet above
the surface within a 73-mile radius of the Wiley Post/Will Rogers
Memorial Airport, excluding that airspace extending beyond 12 miles
of the shoreline.

AAL AK E5 Chevak, AK [Amended]

Chevak Airport, AK
    (Lat. 61[deg]32'27'' N, long. 165[deg]36'03'' W)

    That airspace extending upward from 700 feet above the surface
within a 7.0-mile radius of Chevak Airport; and that airspace
extending upward from 1,200 feet above the surface within a 73-mile
radius of Chevak Airport, excluding that airspace extending beyond
12 miles of the shoreline.

AAL AK E5 Clarks Point, AK [Amended]

Clarks Point Airport, AK
    (Lat. 58[deg]50'01'' N, long. 158[deg]31'46'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.3-mile radius of Clarks Point Airport; and that airspace
extending upward from 1,200 feet above the surface within a 73-mile
radius of the Clarks Point Airport, excluding that airspace
extending beyond 12 miles of the shoreline.

AAL AK E5 Elim, AK [Amended]

Elim Airport, AK
    (Lat. 64[deg]36'54'' N, long. 162[deg]16'14'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.8-mile radius of Elim Airport, and within 3.7 miles
either side of the 015[deg] bearing from the Elim Airport, extending
from the 6.8-mile radius, to 12.6 miles north of Elim Airport; and
that airspace extending upward from 1,200 feet above the surface
within a 74-mile radius of the Elim Airport, excluding that airspace
extending beyond 12 miles of the shoreline.

AAL AK E5 Golovin, AK [Amended]

Golovin Airport, AK
    (Lat. 64[deg]33'02'' N, long. 163[deg]00'26'' W)

    That airspace extending upward from 700 feet above the surface
within a 7.4-mile radius of Golovin Airport, and that airspace
extending upward from 1,200 feet above the surface within a 30-mile
radius of lat. 64[deg]43'47'' N, long. 163[deg]15'17'' W and a 30-
mile radius of lat. 64[deg]17'57'' N, long. 163[deg]01'41'' W,
excluding that airspace extending beyond 12 miles of the shoreline.

    Issued in Seattle, Washington, on July 25, 2018.
Shawn M. Kozica,
Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2018-16482 Filed 8-1-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 73 (Tuesday, April 16, 2013)]
[Rules and Regulations]
[Page 22423]
[FR Doc No: 2013-08843]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2013-0236]

Drawbridge Operation Regulations; Taunton River, Fall River and
Somerset, MA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulation.

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SUMMARY: The Coast Guard is issuing a temporary deviation from the
regulation governing the operation of the Brightman Street Bridge
across the Taunton River, mile 1.8, between Fall River and Somerset,
Massachusetts. The deviation is necessary to facilitate power equipment
upgrades. During this temporary deviation, the bridge may remain in the
closed position for five hours.

DATES: This deviation is effective from 4:30 p.m. until 9:30 p.m. on
April 16, 2013.

ADDRESSES: The docket for this deviation, [USCG-2013-0236] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation. You may also visit the Docket
Management Facility in Room W12-140, on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. John McDonald, Project Officer,
First Coast Guard District<EMAIL_ADDRESS>or (617) 223-
8364. If you have questions on viewing the docket, call Barbara
Hairston, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Brightman Street Bridge has a vertical
clearance of 27 feet at mean high water and 31 feet at mean low water
in the closed position. Currently, in accordance with 33 CFR 117.619,
the draw opens on signal between 5 a.m. and 9 p.m. From 9 p.m. until 5
a.m. the draw opens on signal with at least one hour advance notice.
    The bridge owner, Massachusetts Department of Transportation,
requested a five hour closure to facilitate electrical upgrades by the
local power company, National Grid.
    Under this temporary deviation the Brightman Street Bridge may
remain in the closed position from 4:30 p.m. until 9:30 p.m. on April
16, 2013.
    The Taunton River is a recreational waterway. The bridge rarely
opens during the time period this temporary deviation will be in
effect.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
repair period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: April 4, 2013.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2013-08843 Filed 4-15-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Rules and Regulations]
[Pages 63034-63036]
[FR Doc No: 2014-25049]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2014-N-1440]

Medical Devices; Immunology and Microbiology Devices;
Classification of Nucleic Acid-Based Devices for the Detection of
Mycobacterium Tuberculosis Complex and the Genetic Mutations Associated
With Antibiotic Resistance

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is classifying nucleic
acid-based in vitro diagnostic devices for the detection of
Mycobacterium tuberculosis complex (MTB-complex) and the genetic
mutations associated with MTB-complex antibiotic resistance in
respiratory specimens devices into class II (special controls). The
Agency is classifying the device into class II (special controls)
because special controls, in addition to general controls, will provide
a reasonable assurance of safety and effectiveness of the device.

DATES: This order is effective November 21, 2014. The classification
was applicable July 25, 2013.

FOR FURTHER INFORMATION CONTACT: Janice 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. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments 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 and until the
device is classified or reclassified into class I or II, or FDA issues
an order finding the device to be substantially equivalent, in
accordance with section 513(i) of the FD&C Act, to a predicate device
that does not require premarket approval. The Agency determines whether
new devices are substantially equivalent to predicate devices by means
of premarket notification procedures in section 510(k) of the FD&C Act
(21 U.S.C. 360(k)) and part 807 (21 CFR part 807) of the regulations.
    Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1) of
the FD&C Act. Under the first procedure, the person submits a premarket
notification under section 510(k) of the FD&C Act for a device that has
not previously been classified and, within 30 days of receiving an
order classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person requests a classification under section
513(f)(2). Under the second procedure, rather than first submitting a
premarket notification under section 510(k) of the FD&C Act and then a
request for classification under the first procedure, the person
determines that there is no legally marketed device upon which to base
a determination of substantial equivalence and requests a
classification under section 513(f)(2) of the FD&C Act. If the person
submits a request to classify the device under this second procedure,
FDA may decline to undertake the classification request if FDA
identifies a legally marketed device that could provide a reasonable
basis for review of substantial equivalence with the device or if FDA
determines that the device submitted is not of ``low-moderate risk'' or
that general controls would be inadequate to control the risks and
special controls to mitigate the risks cannot be developed.
    In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device. Within
30 days after the issuance of an order classifying the device, FDA must
publish a notice in the Federal Register announcing this
classification.
    On June 13, 2013, Cepheid submitted a request for de novo
classification of the Xpert[supreg] MTB/RIF Assay under section
513(f)(2) of the FD&C Act.
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request for de novo classification in order to classify the device
under the criteria for classification set forth in section 513(a)(1) of
the FD&C Act. FDA classifies devices into class II if general controls
by themselves are insufficient to provide reasonable assurance of
safety and effectiveness, but there is sufficient information to
establish special controls to provide reasonable assurance of the
safety and effectiveness of the device for its intended use. After
review of the information submitted in the request, FDA determined that
the device can be classified into class II with the establishment of
special controls. FDA believes these special controls will provide
reasonable assurance of the safety and effectiveness of the device.
    The device is assigned the generic name nucleic acid-based in vitro
diagnostic devices for the detection of MTB-complex and the genetic
mutations associated with MTB-complex antibiotic resistance in
respiratory specimens, and it is identified as qualitative nucleic
acid-based devices that detect the presence of MTB-complex-associated
nucleic acid sequences in respiratory samples. These devices are
intended to aid in the diagnosis of pulmonary tuberculosis and the
selection of an initial treatment regimen when used in conjunction with
clinical findings and other laboratory results. These devices do not
provide confirmation of antibiotic susceptibility since other
mechanisms of resistance may exist that may be associated with a lack
of clinical response to treatment other than those detected by the
device.
    FDA has identified the following risks to health associated with
this type of device and the measures required to mitigate these risks:

       Table 1--Identified Risks to Health and Mitigation Measures
------------------------------------------------------------------------
       Identified risks to health              Mitigation measures
------------------------------------------------------------------------
False positive test results for the      The FDA document entitled
 presence of MTB-complex may lead to      ``Class II Special Controls
 incorrect treatment of the individual    Guideline: Nucleic Acid-Based
 with possible adverse effects. The       In Vitro Diagnostic Devices
 patient may be subjected to              for the Detection of
 unnecessary isolation. Unnecessary       Mycobacterium tuberculosis
 contact investigations may also occur.   Complex and Genetic Mutations
                                          Associated with Mycobacterium
                                          tuberculosis Antibiotic
                                          Resistance in Respiratory
                                          Specimens,'' which addresses
                                          this risk through:
                                         Device Description Containing
                                          the Information Specified in
                                          the Special Control Guideline.
                                         Performance Studies.
                                         Labeling.
False negative test results for the      The FDA document entitled
 presence of MTB-complex could            ``Class II Special Controls
 contribute to disease progression and    Guideline: Nucleic Acid-Based
 increase the risk of transmitting        In Vitro Diagnostic Devices
 infection to others.                     for the Detection of
                                          Mycobacterium tuberculosis
                                          Complex and Genetic Mutations
                                          Associated with Mycobacterium
                                          tuberculosis Antibiotic
                                          Resistance in Respiratory
                                          Specimens,'' which addresses
                                          this risk through:
                                         Device Description Containing
                                          the Information Specified in
                                          the Special Control Guideline.
                                         Performance Studies.
                                         Labeling.
False positive test results for the      Sec.   866.3373(b)(2) (21 CFR
 presence of genetic mutations            866.3373(b)(2)), which
 associated with MTB-complex antibiotic   addresses the mitigation of
 resistance may lead to incorrect         risks specific to the
 treatment of the individual with         detection of the genetic
 possible adverse effects. The patient    mutations associated with
 may be subjected to unnecessary          antibiotic resistance of M.
 isolation. Unnecessary contact           tuberculosis complex.
 investigations may also occur.
False negative test results for the      Sec.   866.3373(b)(2), which
 presence of genetic mutations            addresses the mitigation of
 associated with MTB-complex antibiotic   risks specific to the
 resistance could contribute to disease   detection of the genetic
 progression and increase the risk of     mutations associated with
 transmitting antibiotic resistant        antibiotic resistance of M.
 tuberculosis to others.                  tuberculosis complex.
Biosafety risks to health care workers   The FDA document entitled
 handling specimens and control           ``Class II Special Controls
 materials with the possibility of        Guideline: Nucleic Acid-Based
 transmission of tuberculosis infection   In Vitro Diagnostic Devices
 to health care workers.                  for the Detection of
                                          Mycobacterium tuberculosis
                                          Complex and Genetic Mutations
                                          Associated with Mycobacterium
                                          tuberculosis Antibiotic
                                          Resistance in Respiratory
                                          Specimens,'' which addresses
                                          this risk through:
                                         Labeling.
------------------------------------------------------------------------

    FDA believes that the measures set forth in the special controls
guideline entitled ``Class II Special Controls Guideline: Nucleic Acid-
Based In Vitro Diagnostic Devices for the Detection of Mycobacterium
tuberculosis Complex and Genetic Mutations Associated with Antibiotic
Resistance in Respiratory Specimens'' and the special controls
identified in Sec.  866.3373(b)(2) of this order are necessary, in
addition to general controls, to mitigate the risks to health described
in table 1.
    Therefore, on July 25, 2013, FDA issued an order to the petitioner
classifying nucleic acid-based in vitro diagnostic devices for the
detection of MTB-complex and the genetic mutations associated with MTB-
complex antibiotic resistance in respiratory specimens devices into
class II. FDA is codifying this device type by adding Sec.  866.3373.

II. 510(k) Premarket Notification

    Following the effective date of this final classification order,
any firm submitting a 510(k) premarket notification for this device
type will need to comply with the special controls.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the device. For this type of device, FDA has
determined that premarket notification is necessary to provide
reasonable assurance of the safety and effectiveness of the device.
Therefore, this type of device is not exempt from premarket
notification requirements. Persons who intend to market this type of
device must submit to FDA a premarket notification, prior to marketing
the device, which contains information about the nucleic acid-based in
vitro diagnostic devices for the detection of MTB-complex and the
genetic mutations associated with MTB-complex antibiotic resistance in
respiratory specimens they intend to market.

III. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of 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.

IV. Paperwork Reduction Act of 1995

    This final administrative order establishes special controls that
refer to previously approved collections of information found in other
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 parts 50 and 56 are approved under OMB control
number 0910-0755; the collections of information in part 807, subpart
E, regarding premarket notification submissions have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR part 812 are 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.

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, 21 CFR part
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for 21 CFR part 866 continues to read as
follows:

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

0
2. Section 866.3373 is added to subpart D to read as follows:

Sec.  866.3373  Nucleic acid-based in vitro diagnostic devices for the
detection of Mycobacterium tuberculosis complex (MTB-complex) and the
genetic mutations associated with MTB-complex antibiotic resistance in
respiratory specimens.

    (a) Identification. Nucleic acid-based in vitro diagnostic devices
for the detection of Mycobacterium tuberculosis complex (MTB-complex)
and the genetic mutations associated with MTB-complex antibiotic
resistance in respiratory specimens are qualitative nucleic acid-based
devices that detect the presence of MTB-complex-associated nucleic acid
sequences in respiratory samples. These devices are intended to aid in
the diagnosis of pulmonary tuberculosis and the selection of an initial
treatment regimen when used in conjunction with clinical findings and
other laboratory results. These devices do not provide confirmation of
antibiotic susceptibility since other mechanisms of resistance may
exist that may be associated with a lack of clinical response to
treatment other than those detected by the device.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) The FDA document entitled ``Class II Special Controls
Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the
Detection of Mycobacterium tuberculosis Complex and Genetic Mutations
Associated with Antibiotic Resistance in Respiratory Specimens,'' which
addresses the mitigation of risks specific to the detection of MTB-
complex. For availability of the document, see Sec.  866.1(e).
    (2) The following items, which address the mitigation of risks
specific to the detection of the genetic mutations associated with
antibiotic resistance of MTB-complex:
    (i) The device must include an external positive assay control as
appropriate. Acceptable positive assay controls include MTB-complex
isolates containing one or more antibiotic-resistance associated target
sequences detected by the device.
    (ii) The device must include internal controls as appropriate. An
acceptable internal control may include human nucleic acid co-extracted
with MTB-complex containing nucleic acid sequences associated with
antibiotic resistance and primers amplifying human housekeeping genes
(e.g., RNaseP, [beta]-actin).
    (iii) The device's intended use must include a description of the
scope of antibiotic resistance targeted by the assay, i.e., the
specific drugs and/or drug classes.
    (iv) The specific performance characteristics section of the
device's labeling must include information regarding the specificity of
the assay oligonucleotides for detecting mutations associated with
antibiotic resistance of MTB-complex, and any information indicating
the potential for non-specific binding (e.g., BLAST search).
    (v) In demonstrating device performance you must perform:
    (A) Pre-analytical studies that evaluate:
    (1) Frozen samples. If there is use of any frozen samples in the
device performance studies, or if there is a device claim for the use
of frozen samples for testing, the effect of freezing samples prior to
testing and the effect of multiple freeze/thaw cycles on both
antibiotic susceptible and antibiotic resistant strains of MTB-complex.
    (2) Nucleic acid extraction methods. Extraction methods must
parallel those used in devices for the detection of MTB-complex nucleic
acid and confirm that the detection of the genetic mutations associated
with antibiotic resistance is not affected.
    (B) Analytical studies that analyze:
    (1) Limit of Detection. Limit of Detection must be determined in
the most challenging matrix (e.g., sputum) claimed for use with the
device. The Limit of Detection must be determined using both antibiotic
susceptible and antibiotic resistant strains of MTB-complex. The
antibiotic resistant strains must be those with well characterized
genetic mutations associated with antibiotic resistance.
    (2) Analytical Reactivity (Inclusivity). Testing must be conducted
to evaluate the ability of the device to detect genetic mutations
associated with antibiotic resistance in a diversity of MTB-complex
strains. Isolates used in testing must be well characterized. Isolate
strain characterization must be determined using standardized reference
methods recognized by a reputable scientific body and appropriate to
the strain lineage.
    (3) Within-Laboratory (Repeatability) Precision Testing. Within-
laboratory precision studies, if appropriate, must include at least one
antibiotic resistant and one antibiotic susceptible strain of MTB-
complex.
    (4) Between Laboratory Reproducibility Testing. The protocol for
the reproducibility study may vary slightly depending on the assay
format; however, the panel must include at least one antibiotic
resistant and one antibiotic susceptible strain of MTB-complex.
    (C) Clinical Studies. Clinical performance of the device must be
established by conducting prospective clinical studies that include
subjects with culture confirmed active tuberculosis. Studies must
attempt to enroll subjects at risk for antibiotic-resistant MTB-
complex; however, it may be necessary to include supplemental
antibiotic resistant retrospective and contrived samples. Clinical
studies must compare device results to both phenotypic drug
susceptibility testing and genotypic reference methods. The genotypic
reference method must be a polymerase chain reaction based method that
uses primers different from those in the experimental device and
confirmed by bidirectional sequencing.

    Dated: October 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25049 Filed 10-21-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: May 12, 2008 (Volume 73, Number 92)]
[Notices]
[Page 27020]
[DOCID:fr12my08-66]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System or Relief From the
Requirements of Title 49 Code of Federal Regulations Part 236

    Pursuant to Title 49 Code of Federal Regulations (CFR) Part 235 and
49 U.S.C. 20502(a), the following railroad has petitioned the Federal
Railroad Administration (FRA) seeking approval for the discontinuance
or modification of the signal system or relief from the requirements of
49 CFR Part 236, as detailed below.

Docket Number FRA-2008-0031

    Applicant: CSX Transportation, Incorporated, Mr. C. M. King, Chief
Engineer, Communications and Signals, 500 Water Street, SC J-350,
Jacksonville, Florida 32202.
    The CSX Transportation, Incorporated seeks approval of the proposed
conversion of two dispatcher controlled power-operated switches to two
T-21 hand-operated clearing switches, switches 486.15, and 486.12, on
the Huntington Division East, Kanawha Subdivision, at CP Milton,
Milepost CA 486.05.
    The reason given for the proposed changes is pole line elimination
and that the power-operated switches are no longer needed to provide
service to industry in present day operation.
    Any interested party desiring to protest the granting of an
application shall set forth specifically the grounds upon which the
protest is made, and include a concise statement of the interest of the
party in the proceeding. Additionally, one copy of the protest shall be
furnished to the applicant at the address listed above.
    FRA expects to be able to determine these matters without an oral
hearing. However, if a specific request for an oral hearing is
accompanied by a showing that the party is unable to adequately present
his or her position by written statements, an application may be set
for public hearing.
    All communications concerning this proceeding should be identified
by Docket Number FRA-2008-0031 and may be submitted by one of the
following methods:
    Web site: http://www.regulations.gov. Follow the instructions for
submitting comments on the DOT electronic site;
    Fax:<PHONE_NUMBER>;
    Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590; or
    Hand Delivery: Room W12-140 of the U.S. Department of
Transportation West Building Ground Floor, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as practicable. All
written communications concerning these proceedings are available for
examination during regular business hours (9 a.m.-5 p.m.) at the above
facility. All documents in the public docket are also available for
inspection and copying on the Internet at the docket facility's Web
site at http://www.regulations.gov.
    FRA wishes to inform all potential commenters that anyone is able
to search the electronic form of all comments received into any of our
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review DOT's complete Privacy Act
Statement in the Federal Register published on April 11, 2000 (Volume
65, Number 70; Pages 19477-78) or you may visit http://
www.regulations.gov.

    Issued in Washington, DC on May 6, 2008.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
[FR Doc. E8-10477 Filed 5-9-08; 8:45 am]

BILLING CODE 4910-06-P


[Federal Register Volume 85, Number 183 (Monday, September 21, 2020)]
[Notices]
[Pages 59336-59337]
[FR Doc No: 2020-20701]

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

[Release No. 34-89877; File No. SR-LTSE-2020-16]

Self-Regulatory Organizations; Long-Term Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
To Amend Rule 11.410(a).

September 15, 2020.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on September 8, 2020, Long-Term Stock Exchange, Inc. (``LTSE'' or
the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. 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

    LTSE proposes a rule change to amend Rule 11.410(a) to update the
Exchange's source of data feeds for purposes of order handling and
execution, and regulatory compliance, to include data regarding MIAX
PEARL, LLC (``MIAX PEARL'').
    The text of the proposed rule change is available at the Exchange's
website at https://longtermstockexchange.com/, at the principal office
of the Exchange, and at the Commission's Public Reference Room.

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

    In its filing with the Commission, the self-regulatory organization
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 self-regulatory organization
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 on the Purpose of, and the
Statutory Basis for, the Proposed Rule Change \3\
---------------------------------------------------------------------------

    \3\ Unless otherwise defined, capitalized terms are used herein
as defined in the LTSE Rulebook.
---------------------------------------------------------------------------

1. Purpose
    The Exchange proposes to amend the Market Data Sources identified
in LTSE Rule 11.410(a), which sets forth on a market-by-market basis
the data feeds that the Exchange utilizes as its source for quotes,
trades and administrative messages. Currently, LTSE utilizes the
securities information processor (``SIP'') consolidated quotation
(i.e., CQS/UQDF), trade and administrative (i.e., CTS/UTDF) data feeds
for data on all national securities exchanges. The Exchange proposes to
amend the table in Rule 11.410(a) to add a new exchange, MIAX PEARL,
and specify that the Exchange also will utilize the consolidated
quotation (i.e., CQS/UQDF), trade and administrative (i.e., CTS/UTDF)
data feeds for MIAX PEARL.
    The Exchange proposes that this rule change become operative on or
before the day that MIAX PEARL launches operations as an equities
exchange, which is currently expected on September 25, 2020.\4\
---------------------------------------------------------------------------

    \4\ See https://www.miaxoptions.com/sites/default/files/press_release-files/MIAX_Press_Release_08182020.pdf.
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\5\ in general, and
furthers the objectives of Section 6(b)(5) of the Act,\6\ in
particular, in that it is designed to prevent fraudulent and
manipulative acts and practices, promote just and equitable principles
of trade, to foster cooperation and coordination with persons engaged
in facilitating transactions in securities, 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.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78f.
    \6\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The Exchange believes that the proposed rule change is consistent
with the Act because including MIAX PEARL in the list of market data
sources the Exchange will use to determine each away trading center's
Top of Book quotes will facilitate transparency in the Exchange's
operations and support the Exchange's compliance with the applicable
requirements of Regulation NMS.

    The Exchange believes its proposal to amend the table in Rule
11.410(a) to update the data feed source for MIAX PEARL will ensure
that Rule 11.410 correctly identifies and publicly states on a market-
by-market basis all of the specific data feeds that the Exchange
utilizes for the handling and execution of orders, and for regulatory
compliance. The proposed rule change also removes impediments to and
perfects the mechanism of a free and open market and protects investors
and the public interest by providing additional specificity, clarity,
and transparency in the Exchange's rules.

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act. The proposed
change is not designed to address any competitive issue, but rather
would provide the public and market participants with up-to-date
information about the data feeds the Exchange will use for the handling
and execution of orders, as well as for regulatory compliance.

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

    Written comments were neither solicited nor 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) of the Act \7\ and Rule 19b-
4(f)(6) thereunder.\8\
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A).
    \8\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires a self-regulatory organization to give the Commission
written notice of its intent to file the proposed rule change, along
with a brief description and text of 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.
---------------------------------------------------------------------------

    A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the
Act \9\ normally does not become operative for 30 days after the date
of its filing. However, Rule 19b-4(f)(6)(iii) \10\ permits the
Commission to designate a shorter time if such action is consistent
with the protection of investors and the public interest. The Exchange
has asked the Commission to waive the 30-day operative delay so that
the proposed rule change may become operative immediately. According to
the Exchange, the proposed rule change does not significantly affect
the protection of investors or the public interest or impose a
significant burden on competition because it merely provides
specificity regarding the Exchange's use of data feeds by identifying
which data feed would be used for MIAX PEARL and enables market
participants to understand how the Exchange views trade and quote
information from other national securities exchanges and does not
impose any burden on Members or market participants. The Commission
believes that waiving the 30-day operative delay is consistent with the
protection of investors and the public interest, as doing so will
ensure that the rule change becomes operative on or before the day that
MIAX PEARL launches operations as an equities exchange, which is
currently expected on September 25, 2020. Accordingly, the Commission
hereby waives the operative delay and designates the proposed rule
change operative upon filing.\11\
---------------------------------------------------------------------------

    \9\ 17 CFR 240.19b-4(f)(6).
    \10\ 17 CFR 240.19b-4(f)(6)(iii).
    \11\ For purposes only of waiving the 30-day operative delay,
the Commission also has considered the proposed rule's impact on
efficiency, competition, and capital formation. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    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 change 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_ADDRESS>Please include
File Number SR-LTSE-2020-16 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-LTSE-2020-16. 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-LTSE-2020-16 and should be submitted on
or before October 13, 2020.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

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

J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-20701 Filed 9-18-20; 8:45 am]
BILLING CODE 8011-01-P


The Motor Vehicle Manufacturing Industry Applying Aluminum Parts --

Leachable 1,2-Dichloroethane Data

Facility Name	City	State	Sample Date	Sample ID	Duplicate Indicator Constituent Name	Leachable Actual or Calculated	Analytical Method Leachable Result	Units	Leachable Non-Detect Indicator	Leachable Detection Limit mg/L	Leachable Detection Limit Data Qualifier Description

GM Orion Assembly Center	LAKE ORION	MI	2/20/1995	UPCU 4108183/255-003 - RB-1	N	dichloroethane, 1,2-	actual

0.013	mg/L

	J	Estimate

GM Orion Assembly Center	LAKE ORION	MI	2/20/1995	UPCU 4117098/255-004 - RB-2	N	dichloroethane, 1,2-	actual

0.007	mg/L

	J	Estimate


 ADVANCE \y63

	UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

	REGION III

1650 Arch Street

	Philadelphia, Pennsylvania  19103-2029

            July 22, 2009

Mr. David K. Paylor, Director

Virginia Department of Environmental Quality

629 East Main Street

P.O Box 1105

Richmond, Virginia 23218

Dear Mr. Paylor:

On February 24, 2009, U.S. Environmental Protection Agency (EPA)
received a revision to the Commonwealth of Virginia’s State
Implementation Plan (SIP) from the Department of Environmental
Protection pertaining to the opacity variance for a rocket testing
facility located in Orange County.  EPA has determined that the
submittal is administratively and technically complete, and is reviewing
it to prepare a Notice of Proposed Rulemaking/Final Rulemaking Notice.

If members of your staff have any questions, they may direct them to Mr.
Timothy Leon-Guerrero, Air-Quality Analysis Branch at<PHONE_NUMBER>.
Mr. Leon Guerrero is the principal contact for this rulemaking.

	Sincerely,

  /s/

           Diana Esher, Acting Director

                          			           Air Protection Division  (3AP00)

	Customer Service Hotline: 1-800-438-2474


[Federal Register Volume 84, Number 140 (Monday, July 22, 2019)]
[Proposed Rules]
[Pages 35052-35054]
[FR Doc No: 2019-15418]

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

40 CFR Part 52

[EPA-R04-OAR-2019-0278; FRL-9996-91-Region 4]

Air Plan Approval; KY; Existing Indirect Heat Exchangers for
Jefferson County

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA or Agency) is
proposing to approve revisions to the Jefferson County portion of the
Kentucky State Implementation Plan (SIP), submitted by the Commonwealth
of Kentucky, through the Energy and Environment Cabinet (Cabinet),
through a letter dated March 15, 2018. The revisions were submitted by
the Cabinet on behalf of the Louisville Metro Air Pollution Control
District (District, also referred to herein as Jefferson County). The
SIP revision includes changes to Jefferson County Regulations regarding
existing indirect heat exchangers.

DATES: Comments must be received on or before August 21, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R04-
OAR-2019-0278 at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e., on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: D. Brad Akers, Air Regulatory
Management Section, Air Planning and Implementation Branch, Air and
Radiation Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street SW, Atlanta, Georgia 30303-8960. Mr. Akers can be
reached via electronic mail at<EMAIL_ADDRESS>or via telephone at
(404) 562-9089.

SUPPLEMENTARY INFORMATION:

I. What action is EPA proposing?

    EPA is proposing to approve changes to the Jefferson County portion
of the Kentucky SIP that were provided to EPA through KDAQ via a letter
dated March 15, 2018.1 2 EPA is proposing to approve the
portions of this SIP revision that make changes to the District's
Regulation 6.07, Standards of Performance for Existing Indirect Heat
Exchangers.\3\ The March 15, 2018, SIP revision makes minor and
ministerial changes to Regulation 6.07 that do not alter the meaning of
the regulation or the emissions levels for sources regulated under the
Jefferson County Regulations, such as clarifying changes to its
applicability. In addition, the changes strengthen the SIP by adding
specific test methods and procedures applicable to existing indirect
heat exchangers. The SIP revision updates the current SIP-approved
version of Regulation 6.07 (version 3) to version 4. The changes to
this rule and EPA's rationale for proposing approval are described in
more detail in Section II.
---------------------------------------------------------------------------

    \1\ EPA notes that the Agency received the SIP revision on March
23, 2018.
    \2\ In 2003, the City of Louisville and Jefferson County
governments merged and the ``Jefferson County Air Pollution Control
District'' was renamed the ``Louisville Metro Air Pollution Control
District.'' See The History of Air Pollution Control in Louisville,
available at https://louisvilleky.gov/government/air-pollution-control-district/history-air-pollution-control-louisville. However,
each of the regulations in the Jefferson County portion of the
Kentucky SIP still has the subheading ``Air Pollution Control
District of Jefferson County.'' Thus, to be consistent with the
terminology used in the SIP, we refer throughout this notice to
regulations contained in the Jefferson County portion of the
Kentucky SIP as the ``Jefferson County'' regulations.
    \3\ EPA notes that the Agency received several submittals
revising the Jefferson County portion of the Kentucky SIP
transmitted with the same March 15, 2018, cover letter. EPA will be
considering action for these other SIP revisions in separate
rulemakings.
---------------------------------------------------------------------------

II. EPA's Analysis of the State Submittal

    As mentioned in Section I of this proposed action, the portion of
Jefferson County's March 15, 2018, SIP revision that EPA is proposing
to approve makes changes to Jefferson County Air Quality Regulations at
Regulation 6.07, Standards of Performance for Existing Indirect Heat
Exchangers.
    The changes to Section 1, Applicability, and Section 2,
Definitions, are intended to provide consistency with other Jefferson
County Air Quality Regulations by defining the affected facility within
the Definitions section and relying on that definition in the
Applicability section. Specifically, Section 1 of the current SIP-
approved version of Regulation 6.07 (version 3) provides that this
regulation apply to indirect heat exchangers at or above 1 million
British thermal units per hour (MMBtu/hr) that ``was in being or under
construction before April 19, 1972.'' The amendments included in the
March 15, 2018, SIP revision simplify Section 1, Applicability, to
refer to affected facilities ``in being or commenced construction,
modification, or reconstruction on or before the applicable
classification date defined [in Section 2].''

    Section 2 then defines ``Affected facility'' as those indirect heat
exchangers with a capacity of 1 MMBtu/hr heat input. Therefore, the
size of such facilities subject to the Regulation is not changed. Next,
the classification date is defined in Section 2 as August 17, 1971 for
facilities with a capacity greater than 250 MMBtu/hr heat input, and
April 9, 1972 for those with a capacity of 250 MMBtu/hr or less, which
correspond to applicability dates for these sizes of sources in
Regulation 7.06, Standards of Performance for New Indirect Heat
Exchangers. EPA notes that the revised dates are earlier than the
current-SIP approved date, however, as Regulation 6.07 regulates
sources that would not otherwise be covered under regulations requiring
greater emissions reductions (for example, Regulation 7.06 or a
relevant NSPS), EPA expects no emissions increases associated with this
revision. EPA has preliminarily concluded that the changes to Sections
1 and 2 serve to correct and clarify the existing SIP.
    Section 3, Standard for Particulate Matter, specifies the
applicable emissions standards for particulate matter and opacity, and
Section 4, Standard for Sulfur Dioxide, specifies the applicable
standards for sulfur dioxide. The changes made to both of these
Sections in the March 15, 2018, SIP submittal are minor and ministerial
(for example, moving the term particulate matter from subsections to
the prefatory text of the corresponding section and moving the
allowable sulfur dioxide emissions descriptor from before the equation
and including it as a defined term in the equation), and no changes are
made to the applicable emissions standards, nor the calculations for
determining the standards. Minor and ministerial changes are also made
to Table 1, Allowable Particulate Matter Emission Rates, and Table 2,
Allowable Sulfur Dioxide Emissions Based on Heat Input Capacity,
appended to Regulation 6.07 and corresponding to Sections 3 and 4,
respectively. EPA has preliminarily concluded that these changes do not
modify the scope or meaning of the provisions.
    Finally, the March 15, 2018, SIP revision adds Section 5, Test
Methods and Procedures, to provide specific instruction on how to
determine compliance with the applicable emissions limits for the
affected facilities. This section requires compliance with standards
for particulate matter and sulfur dioxide be demonstrated using EPA
reference methods included in 40 CFR part 60, Appendix A, except as
provided in Regulation 1.04, Performance Tests. Regulation 1.04
stipulates that if a facility is subject to 40 CFR parts 60, 61, or 63,
then specified procedures for test requirements are to be used unless
EPA and LMAPCD have agreed upon an alternative or have agreed to a
waiver from the applicable test procedures. The addition of section 5
provides specificity in testing requirements for the set of affected
facilities under Regulation 6.07 that would not otherwise be subject to
40 CFR part 60 or part 63 (for example, for a source that commenced
construction or modification prior to the applicability date for 40 CFR
part 60). EPA proposes that the use of federal reference methods is
appropriate and sufficient to determine compliance with the applicable
standards in Regulation 6.07, and that the inclusion of Section 5 in
the SIP is clarifying and SIP-strengthening.
    As noted above, these rule changes do not relax the emissions
reductions to applicable sources, nor do they change any applicable
emissions limitations. With respect to the changes related to test
methods and procedures, EPA proposes that the changes serve to
strengthen the SIP. Therefore, EPA has made the preliminary
determination that the aforementioned changes will not have a negative
impact on air quality in the area and is therefore proposing to approve
version 4 of Regulation 6.07 into the Jefferson County portion of the
Kentucky SIP.

III. Incorporation by Reference

    In this document, EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, EPA is proposing to incorporate by
reference Jefferson County's Regulation 6.07, Standards of Performance
for Existing Indirect Heat Exchangers, version 4, state effective
January 17, 2018. EPA has made, and will continue to make, these
materials generally available through www.regulations.gov and at the
EPA Region 4 office (please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section of this preamble for more
information).

IV. Proposed Action

    EPA is proposing to approve changes to the Jefferson County portion
of the Kentucky SIP included in a March 15, 2018, submittal.
Specifically, EPA is proposing to approve the District's Regulation
6.07 version 4 into the SIP. The March 15, 2018, SIP revision makes
minor and ministerial changes such as clarifying the applicability of
the regulation, and includes more specific requirements for test
methods and procedures for affected facilities. EPA believes these
changes are consistent with the CAA and EPA policy, and these rule
adoptions will not impact the NAAQS or interfere with any other
applicable requirement of the Act.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. See 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. This action merely
proposes to approve state law as meeting Federal requirements and does
not impose additional requirements beyond those imposed by state law.
For that reason, this proposed action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human

health or environmental effects, using practicable and legally
permissible methods, under Executive Order 12898 (59 FR 7629, February
16, 1994).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications as specified by Executive Order 13175 (65
FR 67249, November 9, 2000), nor will it impose substantial direct
costs on tribal governments or preempt tribal law.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

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

    Dated: July 11, 2019.
Mary S. Walker,
Regional Administrator, Region 4.
[FR Doc. 2019-15418 Filed 7-19-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: December 10, 2008 (Volume 73, Number 238)]
[Rules and Regulations]
[Page 74966]
[DOCID:fr10de08-7]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[USCG-2008-1124]

Drawbridge Operation Regulation; Long Island, New York Inland
Waterway From East Rockaway Inlet to Shinnecock Canal, Hempstead, NY,
Maintenance

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Wantagh State Parkway Bridge across Sloop Channel at mile 15.4, at
Jones Beach, New York. Under this temporary deviation the bridge may
operate on a limited operating schedule for four months to facilitate
the completion of bridge construction.

DATES: This deviation is effective from December 1, 2008 through April
1, 2009.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2008-1124 and are available online
at www.regulations.gov. They are also available for inspection or
copying two locations: The Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays, and the First
Coast Guard District, Bridge Branch Office, 408 Atlantic Avenue,
Boston, Massachusetts 02110, between 7 a.m. and 3 p.m., Monday through
Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Judy Leung-Yee, Project Officer, First
Coast Guard District, at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Wantagh State Parkway Bridge has a
vertical clearance in the closed position of 16 feet at mean high
water. The existing drawbridge operation regulations are listed at 33
CFR 117.5.
    The New York State Department of Transportation requested a
temporary deviation to facilitate the completion of bridge construction
and to accommodate holiday work schedule.
    The waterway has seasonal recreational vessels and fishing vessels
of various sizes.
    We contacted the New York Marine Trades Association and Station
Jones Beach. No objection to the proposed temporary deviation schedule
was received.
    Under this temporary deviation, in effect from December 1, 2008
through April 1, 2009, the Wantagh State Parkway Bridge at mile 15.4,
across Sloop Channel, shall operate as follows:
    From Monday through Friday the bridge shall open on signal at 6:30
a.m. and 4 p.m. after at least a 30-minute advance notice is given.
From 4 p.m. to 6:30 a.m. the bridge shall open on signal after at least
a two-hour advance notice is given.
    From Friday, 4 p.m. through Monday, 6:30 a.m. the bridge shall open
on signal after at least a two-hour advance notice is given.
    At all other times including 24, 25, 31 December 2008 and 1 January
2009, the bridge need not open for marine traffic.
    Advance notice may be given by calling<PHONE_NUMBER>.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: December 1, 2008.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. E8-29237 Filed 12-9-08; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 88, Number 52 (Friday, March 17, 2023)]
[Notices]
[Page 16516]
[FR Doc No: 2023-05454]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Research, Engineering, and Development Advisory Committee; Notice
of Public Meeting

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

ACTION: Notice of public meeting.

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SUMMARY: This notice announces a meeting of the Research, Engineering,
and Development Advisory Committee (REDAC).

DATES: The meeting will be held on April 12, 2023, from 9:30 a.m.-4
p.m. EST.
    Requests for accommodations for a disability must be received by
March 28, 2023. Individuals requesting to speak during the meeting must
submit a written copy of their remarks to DOT by March 28, 2023.
Requests to submit written materials to be reviewed during the meeting
must be received no later than March 28, 2023.

ADDRESSES: The meeting will be held in a hybrid setting to permit
virtual participation. Virtual attendance information will be provided
upon registration. The meeting will be held at the Federal Aviation
Administration, 800 Independence Avenue SW, Washington, DC 20591. A
detailed agenda will be available on the REDAC internet website at
http://www.faa.gov/go/redac at least one week before the meeting, along
with copies of the meeting minutes after the meeting.

FOR FURTHER INFORMATION CONTACT: Chinita Roundtree-Coleman, REDAC PM/
Lead, FAA/U.S. Department of Transportation, at [email protected] or<PHONE_NUMBER> or<PHONE_NUMBER>. Any committee-
related request should be sent to the person listed in this section.

SUPPLEMENTARY INFORMATION:

I. Background

    The REDAC was created under the Federal Advisory Committee Act, in
accordance with Public Law (Pub. L.) 100-591 (1988) and Public Law 101-
508 (1990), to provide advice and recommendations to the FAA
Administrator in support of the Agency's Research and Development (R&D)
portfolio.

II. Agenda

    At the meeting, the agenda will cover the following topics:

 FAA R&D Strategies, Initiatives, and Planning
 Impacts of emerging technologies, new entrant vehicles, and
dynamic operations within the National Airspace System

III. Public Participation

    DOT is committed to providing equal access to this meeting for all
participants. If you need alternative formats or services because of a
disability, such as sign language, interpretation, or other ancillary
aids, please contact the person listed in the FOR FURTHER INFORMATION
CONTACT section.
    There will be 45 minutes allotted for oral comments from members of
the public joining the meeting. To accommodate as many speakers as
possible, the time for each commenter may be limited. Individuals
wishing to reserve speaking time during the meeting must submit a
request at the time of registration, as well as the name, address, and
organizational affiliation of the proposed speaker. If the number of
registrants requesting to make statements is greater than can be
reasonably accommodated during the meeting, the FAA may conduct a
lottery to determine the speakers. Speakers are asked to submit a
written copy of their prepared remarks for inclusion in the meeting
records and for circulation to REDAC members before the deadline listed
in the DATE section. All prepared remarks submitted on time will be
accepted and considered as part of the meeting's record. Any member of
the public may present a written statement to the committee at any
time.

    Issued in Washington, DC, this 13th day of March, 2023.
Chinita Roundtree-Coleman,
REDAC PM/Lead, Federal Aviation Administration.
[FR Doc. 2023-05454 Filed 3-16-23; 8:45 am]
BILLING CODE 4910-13-P