[Federal Register: July 6, 2010 (Volume 75, Number 128)]
[Notices]
[Page 38798-38799]
[DOCID:fr06jy10-54]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13722-000]

Douglas County, OR; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

June 24, 2010.
    On May 5, 2010, Douglas County, Oregon, filed an application for a
preliminary permit, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of the Douglas County Wave and Tidal
Energy Power Project, in the Pacific Ocean, off the coast of Douglas
County, Oregon. The sole purpose of a preliminary permit, if issued, is
to grant the permit holder priority to file a license application
during the permit term. A preliminary permit does not authorize the
permit holder to perform any land-disturbing activities or otherwise
enter upon lands or waters owned by others without the owners' express
permission.
    The proposed project would consist of: (1) An approximately 600-
foot-long, 30-foot-wide, 46-foot-high cassion to house the oscillating
water column collecting system (OWCCS); (2) an OWCCS consisting of 15
oscillating water column chambers, each containing two, 110-kilowatt
turbine/generator units; and (3) a 1.9- to 2.3-mile-long transmission
line, depending on the final location and selection of the transmission
line. The project would have a total installed capacity of 1 megawatt
(MW) to 3 MW, and an estimated annual generation of 3.4 gigawatt-hours
(GWh) to 10.2 GWh. The OWCSS is operated by external wave action, which
causes water to oscillate up and down within an underwater chamber. As
the air in the chamber above the water is compressed and decompressed,
air is forced through a turbine/generator unit. There are four
locations under evaluation for the proposed project installation.
    Applicant Contacts: Ronald S. Yockim, 430 SE. Main Street, P.O. Box
2456, Roseburg, OR 97470; phone:<PHONE_NUMBER>. Paul Meyer, County
Counsel, Douglas County Board of Commissioners, 1036 SE. Douglas,
Roseburg, OR 97470; phone:<PHONE_NUMBER>.
    FERC Contact: Jennifer Harper, phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site (http://www.ferc.gov/docs-filing/ferconline.asp) under the
``eFiling'' link. For a simpler method of submitting text only
comments, click on ``Quick Comment.'' For assistance, please contact
FERC Online Support at<EMAIL_ADDRESS>call toll-free at
(866) 208-3676; or, for TTY, contact<PHONE_NUMBER>. Although the
Commission strongly encourages

electronic filing, documents may also be paper-filed. To paper-file,
mail an original and eight copies to: Kimberly D. Bose, Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13722) in the docket number field to access
the document. For assistance, contact FERC Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-16276 Filed 7-2-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: June 14, 2010 (Volume 75, Number 113)]
[Proposed Rules]
[Page 33561-33562]
[DOCID:fr14jn10-18]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2010-0325; Airspace Docket No. 10-AWP-2]

Proposed Modification of Class E Airspace; Willcox, AZ

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 at Willcox,
AZ, to accommodate aircraft using a new Area Navigation (RNAV) Global
Positioning System (GPS) Standard Instrument Approach Procedure (SIAP)
at Cochise County Airport. The FAA is proposing this action to enhance
the safety and management of aircraft operations at the airport.

DATES: Comments must be received on or before July 29, 2010.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590;
telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2010-
0325; Airspace Docket No. 10-AWP-2, at the beginning of your comments.
You may also submit comments through the Internet at http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue, SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

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 (FAA Docket No.
FAA 2010-0325 and Airspace Docket No. 10-AWP-2) and be submitted in
triplicate to the Docket Management System (see ``ADDRESSES'' section
for address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2010-0325 and Airspace Docket No. 10-AWP-2''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. 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/airports_airtraffic/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 a.m. and 5 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, 1601 Lind Avenue, SW., Renton, WA
98057.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory

Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System,
which describes the application procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 to modify Class E airspace at Cochise
County Airport, Willcox, AZ. Controlled airspace extending upward from
700 feet above the surface is necessary to accommodate aircraft using
the new RNAV (GPS) SIAPs at Cochise County Airport. This action would
enhance the safety and management of aircraft operations at the
airport.
    Class E airspace designations are published in paragraph 6005, of
FAA Order 7400.9T, signed August 27, 2009, and effective September 15,
2009, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in this Order.
    The FAA has determined this proposed regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation; (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 this proposed 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.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, section 106 describes
the authority for 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 the
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 establishes additional controlled airspace at Cochise County
Airport, Willcox, AZ.

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

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of the FAA Order
7400.9T, Airspace Designations and Reporting Points, signed August 27,
2009, and effective September 15, 2009 is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700 feet
or more above the surface of the earth.
* * * * *

AWP AZ E5 Willcox, AZ [Modified]

Cochise County Airport, AZ
    (Lat. 32[deg]14'44'' N., long. 109[deg]53'41'' W.)

    That airspace extending upward from 700 feet above the surface
within 6.5-mile radius of the Cochise County Airport and within 5
miles each side of the 225[deg] bearing from the Cochise County
Airport extending from the 6.5-mile radius to 14.5 miles southwest
of the Cochise County Airport, and within 5.5 miles southeast and
4.5 miles northwest of the 055[deg] bearing from the Cochise County
Airport extending from the 6.5-mile radius to 14.5 miles northeast
of the Cochise County Airport; that airspace extending upward from
1,200 feet above the surface bounded on the north by lat.
32[deg]22'40'' N., long. 109[deg]25'00'' W.; to lat. 32[deg]14'30''
N., long. 109[deg]28'00'' W.; to lat. 32[deg]21'20'' N., long.
109[deg]58'00'' W.; to lat. 32[deg]30'00'' N., long. 109[deg]54'00''
W.; thence to point of beginning.

    Issued in Seattle, Washington, on May 26, 2010.
Kevin Nolan,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. 2010-14210 Filed 6-11-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 66 (Wednesday, April 6, 2022)]
[Rules and Regulations]
[Pages 19797-19799]
[FR Doc No: 2022-07203]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31421; Amdt. No. 4002]

Standard Instrument Approach Procedures, and Takeoff Minimums and
Obstacle Departure Procedures; Miscellaneous Amendments

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This rule amends, suspends, or removes Standard Instrument
Approach Procedures (SIAPs) and associated Takeoff Minimums and
Obstacle Departure Procedures for operations at certain airports. These
regulatory actions are needed because of the adoption of new or revised
criteria, or because of changes occurring in the National Airspace
System, such as the commissioning of new navigational facilities,
adding new obstacles, or changing air traffic requirements. These
changes are designed to provide for the safe and efficient use of the
navigable airspace and to promote safe flight operations under
instrument flight rules at the affected airports.

DATES: This rule is effective April 6, 2022. The compliance date for
each SIAP, associated Takeoff Minimums, and ODP is specified in the
amendatory provisions.
    The incorporation by reference of certain publications listed in
the regulations is approved by the Director of the Federal Register as
of April 6, 2022.

ADDRESSES: Availability of matter incorporated by reference in the
amendment is as follows:

For Examination

    1. U.S. Department of Transportation, Docket Ops-M30, 1200 New
Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001;
    2. The FAA Air Traffic Organization Service Area in which the
affected airport is located;
    3. The office of Aeronautical Information Services, 6500 South
MacArthur Blvd., Oklahoma City, OK 73169 or,
    4. The National Archives and Records Administration (NARA).
    For information on the availability of this material at NARA, email
[email protected] or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

Availability

    All SIAPs and Takeoff Minimums and ODPs are available online free
of charge. Visit the National Flight Data Center online at nfdc.faa.gov
to register. Additionally, individual SIAP and Takeoff Minimums and ODP
copies may be obtained from the FAA Air Traffic Organization Service
Area in which the affected airport is located.

FOR FURTHER INFORMATION CONTACT: Thomas J. Nichols, Flight Procedures
and Airspace Group, Flight Technologies and Procedures Division, Flight
Standards Service, Federal Aviation Administration. Mailing Address:
FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace
Group, 6500 South MacArthur Blvd., Registry Bldg. 29, Room 104,
Oklahoma City, OK 73169. Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends 14 CFR part 97 by amending
the referenced SIAPs. The complete regulatory description of each SIAP
is listed on the appropriate FAA Form 8260, as modified by the National
Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is
incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14
CFR 97.20. The large number of SIAPs, their complex nature, and the
need for a special format make their verbatim publication in the
Federal Register

expensive and impractical. Further, airmen do not use the regulatory
text of the SIAPs, but refer to their graphic depiction on charts
printed by publishers of aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP contained on FAA form documents is
unnecessary. This amendment provides the affected CFR sections, and
specifies the SIAPs and Takeoff Minimums and ODPs with their applicable
effective dates. This amendment also identifies the airport and its
location, the procedure and the amendment number.

Availability and Summary of Material Incorporated by Reference

    The material incorporated by reference is publicly available as
listed in the ADDRESSES section.
    The material incorporated by reference describes SIAPs, Takeoff
Minimums and ODPs as identified in the amendatory language for part 97
of this final rule.

The Rule

    This amendment to 14 CFR part 97 is effective upon publication of
each separate SIAP and Takeoff Minimums and ODP as amended in the
transmittal. For safety and timeliness of change considerations, this
amendment incorporates only specific changes contained for each SIAP
and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
    The SIAPs and Takeoff Minimums and ODPs, as modified by FDC
permanent NOTAM, and contained in this amendment are based on criteria
contained in the U.S. Standard for Terminal Instrument Procedures
(TERPS). In developing these changes to SIAPs and Takeoff Minimums and
ODPs, the TERPS criteria were applied only to specific conditions
existing at the affected airports. All SIAP amendments in this rule
have been previously issued by the FAA in a FDC NOTAM as an emergency
action of immediate flight safety relating directly to published
aeronautical charts.
    The circumstances that created the need for these SIAP and Takeoff
Minimums and ODP amendments require making them effective in less than
30 days.
    Because of the close and immediate relationship between these
SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find
that notice and public procedure under 5 U.S.C. 553(b) are
impracticable and contrary to the public interest and, where
applicable, under 5 U.S.C. 553(d), good cause exists for making these
SIAPs effective in less than 30 days.
    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.
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. For the same reason, the FAA
certifies that this amendment will not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 97

    Air Traffic Control, Airports, Incorporation by reference,
Navigation (Air).

    Issued in Washington, DC, on March 18, 2022.
Thomas J Nichols,
Aviation Safety, Flight Standards Service, Manager, Standards Section,
Flight Procedures & Airspace Group, Flight Technologies & Procedures
Division.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
CFR part 97, (is amended by amending Standard Instrument Approach
Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the
dates specified, as follows:

PART 97--STANDARD INSTRUMENT APPROACH PROCEDURES

0
1. The authority citation for part 97 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114,
40120, 44502, 44514, 44701, 44719, 44721-44722.

0
2. Part 97 is amended to read as follows:
    By amending: Sec.  97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or
TACAN; Sec.  97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; Sec.
97.27 NDB, NDB/DME; Sec.  97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Sec.  97.31 RADAR SIAPs; Sec.  97.33 RNAV SIAPs; and Sec.  97.35 COPTER
SIAPs, Identified as follows:

* * * Effective Upon Publication

--------------------------------------------------------------------------------------------------------------------------------------------------------
      AIRAC date          State             City                 Airport          FDC No.      FDC date                       Subject
--------------------------------------------------------------------------------------------------------------------------------------------------------
21-Apr-22............  MN           Luverne.............  Quentin Aanenson Fld       2/3056       3/1/22  RNAV (GPS) RWY 36, Orig-A.
21-Apr-22............  AZ           Payson..............  Payson..............       2/4544       3/1/22  RNAV (GPS)-A, Amdt 1.
21-Apr-22............  AZ           Willcox.............  Cochise County......       2/5159       3/1/22  RNAV (GPS) RWY 3, Amdt 1B.
21-Apr-22............  AZ           Willcox.............  Cochise County......       2/5161       3/1/22  RNAV (GPS) RWY 21, Amdt 1A.
21-Apr-22............  GA           Camilla.............  Camilla-Mitchell           2/6074       3/7/22  RNAV (GPS) RWY 26, Amdt 1C.
                                                           County.
21-Apr-22............  GA           Camilla.............  Camilla-Mitchell           2/6075       3/7/22  RNAV (GPS) RWY 8, Amdt 1B.
                                                           County.
21-Apr-22............  WI           Prairie Du Chien....  Prairie Du Chien           2/6166       3/3/22  RNAV (GPS) RWY 32, Orig-C.
                                                           Muni.
21-Apr-22............  WI           Prairie Du Chien....  Prairie Du Chien           2/6167       3/3/22  RNAV (GPS) RWY 29, Orig-C.
                                                           Muni.
21-Apr-22............  WI           Prairie Du Chien....  Prairie Du Chien           2/6168       3/3/22  RNAV (GPS) RWY 14, Orig-C.
                                                           Muni.
21-Apr-22............  AR           Siloam Springs......  Smith Fld...........       2/6587       3/7/22  RNAV (GPS) RWY 36, Orig.
21-Apr-22............  TN           Sparta..............  Upper Cumberland           2/7124       3/7/22  NDB RWY 4, Amdt 4C.
                                                           Rgnl.
21-Apr-22............  TN           Sparta..............  Upper Cumberland           2/7126       3/7/22  RNAV (GPS) RWY 22, Orig-C.
                                                           Rgnl.
21-Apr-22............  AZ           Safford.............  Safford Rgnl........       2/7525       3/1/22  RNAV (GPS) RWY 12, Orig-D.
21-Apr-22............  TN           Sparta..............  Upper Cumberland           2/7631       3/7/22  ILS OR LOC RWY 4, Amdt 1B.
                                                           Rgnl.
21-Apr-22............  ID           Twin Falls..........  Joslin Fld/Magic           2/8506       3/2/22  RNAV (GPS) RWY 8, Amdt 1A.
                                                           Valley Rgnl.
21-Apr-22............  ID           Twin Falls..........  Joslin Fld/Magic           2/8507       3/2/22  VOR RWY 8, Amdt 5A.
                                                           Valley Rgnl.
21-Apr-22............  ID           Twin Falls..........  Joslin Fld/Magic           2/8508       3/2/22  VOR/DME RWY 8, Amdt 1A.
                                                           Valley Rgnl.
21-Apr-22............  WI           Tomahawk............  Tomahawk Rgnl.......       2/8517       3/3/22  RNAV (GPS) RWY 27, Amdt 2B.
21-Apr-22............  WI           Tomahawk............  Tomahawk Rgnl.......       2/8518       3/3/22  RNAV (GPS) RWY 9, Amdt 2D.
21-Apr-22............  IA           Waterloo............  Waterloo Rgnl.......       2/8563       3/2/22  RNAV (GPS) RWY 36, Amdt 1.
21-Apr-22............  TX           Eastland............  Eastland Muni.......       2/8731       3/1/22  RNAV (GPS) RWY 17, Orig-C.
21-Apr-22............  TX           Hamilton............  Hamilton Muni.......       2/8759       3/1/22  RNAV (GPS) RWY 18, Amdt 1C.
21-Apr-22............  TX           Hamilton............  Hamilton Muni.......       2/8761       3/1/22  RNAV (GPS) RWY 36, Amdt 1C.

21-Apr-22............  TX           Eastland............  Eastland Muni.......       2/8764       3/1/22  RNAV (GPS) RWY 35, Amdt 2B.
21-Apr-22............  TX           Seminole............  Gaines County.......       2/8784       3/1/22  RNAV (GPS) RWY 35, Amdt 1.
21-Apr-22............  WA           Port Townsend.......  Jefferson County           2/8791       3/1/22  RNAV (GPS)-A, Orig-A.
                                                           Intl.
21-Apr-22............  IA           Creston.............  Creston Muni........       2/8865       3/1/22  RNAV (GPS) RWY 34, Amdt 1B.
21-Apr-22............  TX           Pearsall............  Mc Kinley Fld.......       2/8871       3/1/22  VOR/DME OR GPS-A, Amdt 2B.
21-Apr-22............  MO           Marshall............  Marshall Meml Muni..       2/8873       3/1/22  RNAV (GPS) RWY 36, Amdt 3B.
21-Apr-22............  TX           Greenville..........  Majors..............       2/8888       3/1/22  RNAV (GPS) RWY 35, Amdt 1.
21-Apr-22............  TX           Greenville..........  Majors..............       2/8889       3/1/22  TACAN RWY 17, Orig-A.
21-Apr-22............  WI           Chetek..............  Chetek Muni/               2/8904       3/1/22  RNAV (GPS) RWY 35, Orig-D.
                                                           Southworth.
21-Apr-22............  WI           Chetek..............  Chetek Muni/               2/8905       3/1/22  RNAV (GPS) RWY 17, Orig-F.
                                                           Southworth.
21-Apr-22............  WI           Eau Claire..........  Chippewa Valley Rgnl       2/8915       3/1/22  VOR-A, Amdt 22.
21-Apr-22............  PA           Lancaster...........  Lancaster...........       2/8916       3/7/22  VOR/DME RWY 8, Amdt 6C.
21-Apr-22............  MN           Pipestone...........  Pipestone Muni......       2/8927       3/1/22  RNAV (GPS) RWY 18, Amdt 1B.
21-Apr-22............  WI           Black River Falls...  Black River Falls          2/9095       3/1/22  RNAV (GPS) RWY 26, Orig-B.
                                                           Area.
21-Apr-22............  WI           Black River Falls...  Black River Falls          2/9096       3/1/22  RNAV (GPS) RWY 8, Amdt 1A.
                                                           Area.
21-Apr-22............  WI           Shell Lake..........  Shell Lake Muni.....       2/9098       3/1/22  RNAV (GPS) RWY 14, Orig-B.
21-Apr-22............  WI           Shell Lake..........  Shell Lake Muni.....       2/9099       3/1/22  RNAV (GPS) RWY 32, Orig-B.
21-Apr-22............  WI           Phillips............  Price County........       2/9100       3/1/22  RNAV (GPS) RWY 24, Orig-B.
21-Apr-22............  WI           Phillips............  Price County........       2/9102       3/1/22  RNAV (GPS) RWY 19, Orig-C.
21-Apr-22............  NJ           Teterboro...........  Teterboro...........       2/9131       3/7/22  RNAV (GPS) Y RWY 6, Amdt 2D.
21-Apr-22............  CA           Imperial............  Imperial County.....       2/9141       3/2/22  VOR OR GPS-A, Amdt 4B.
21-Apr-22............  IA           Muscatine...........  Muscatine Muni......       2/9253       3/3/22  RNAV (GPS) RWY 6, Orig.
21-Apr-22............  TX           Ingleside...........  Mccampbell-Porter...       2/9880       3/3/22  RNAV (GPS) RWY 31, Amdt 1.
21-Apr-22............  TX           Ingleside...........  Mccampbell-Porter...       2/9881       3/3/22  RNAV (GPS) RWY 13, Amdt 1.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2022-07203 Filed 4-5-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)]
[Notices]
[Pages 8885-8886]
[FR Doc No: 2018-04167]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0627]

Clinical Chemistry and Clinical Toxicology Devices Panel of the
Medical Devices Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Clinical Chemistry and
Clinical Toxicology Devices Panel of the Medical Devices Advisory
Committee. The general function of the committee is to provide advice
and recommendations to the Agency on FDA's regulatory issues. The
meeting will be open to the public.

DATES: The meeting will be held on March 29 and 30, 2018, from 8 a.m.
to 6 p.m.

ADDRESSES: Hilton Washington DC North/Gaithersburg; Salons A, B, C, and
D; 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone
number is<PHONE_NUMBER>. Answers to commonly asked questions including
information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993,
[email protected];<PHONE_NUMBER>, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: On March 29, 2018, the committee will discuss, make
recommendations, and vote on information regarding a premarket approval
application to market a novel continuous glucose monitoring (CGM)
device system, the Senseonics, Inc. Eversense CGM System. This device
requires minor surgery to implant and remove, and if approved, would
provide 90 days of sensor glucose values from each implanted sensor.
    The Eversense CGM System measures patients' glucose concentrations
from subcutaneous interstitial fluid similar to approved CGM systems.
All CGM devices currently or previously marketed used electrochemistry
to measure glucose in interstitial fluids, last for 3 to 11 days and
are inserted via a small-gauge needle by the end user. The proposed CGM
system uses a fluorescence-based measurement technique, requires minor
surgery for subcutaneous implantation, and will have a 90-day sensor
wear period. The proposed CGM sensor also includes a drug component
(dexamethasone acetate) intended to mitigate negative effects on sensor
accuracy and sensor life from the foreign body response at the sensor
insertion site. The proposed intended use, as stated by the sponsor, is
as follows:
    The Eversense CGM System continually measures glucose levels in
adults (age 18 and older) with diabetes for the operating life of the
sensor.
    The system is intended to:
     Aid in the management of diabetes.
     Provide real-time glucose readings.
     Provide glucose trend information.
     Provide alerts for the detection and prediction of
episodes of low blood glucose (hypoglycemia) and high blood glucose
(hyperglycemia).
    The system is a prescription device. Historical data from the
system can be interpreted to aid in providing therapy adjustments.
These adjustments should be based on patterns seen over time.
    On March 30, 2018, the committee will discuss and make
recommendations regarding measuring blood glucose using capillary blood
with blood glucose meters in all hospital patients, including those
receiving intensive medical intervention/therapy and patients with
decreased peripheral blood flow, such as with severe hypotension,
shock, hyperosmolar-hyperglycemia and severe dehydration (e.g.,
patients in intensive care settings). Currently, FDA has cleared one
glucose meter for use all over the hospital using venous and arterial
blood. FDA understands that being able to make capillary blood
measurements in all hospitalized patients using FDA cleared and
Clinical Laboratory Improvement Amendments (CLIA) waived (i.e.,
designated as waived per the standards in the CLIA) glucose meters
would be more convenient and timely for hospital staff. FDA would like
to present new data from capillary blood measurements on glucose meters
in patients receiving intensive medical intervention/therapy to the
Clinical Chemistry and Clinical Toxicology Devices Panel. FDA would
like to receive feedback from the advisory panel on the benefits and
risks of measuring capillary blood using blood glucose meters in this
intended use population, and the considerations for CLIA waiver for
this use.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its website prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's website after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
March 22, 2018. Oral presentations from the public will be scheduled on
March 29 and 30, 2018, between approximately 1 p.m. and 2 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
March 14, 2018. Time allotted for each presentation may be limited. If
the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled

open public hearing session, FDA may conduct a lottery to determine the
speakers for the scheduled open public hearing session. The contact
person will notify interested persons regarding their request to speak
by March 15, 2018.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact AnnMarie Williams, at [email protected], 301-796-
5966 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: February 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04167 Filed 2-28-18; 8:45 am]
BILLING CODE 4164-01-P