[Federal Register Volume 81, Number 57 (Thursday, March 24, 2016)]
[Rules and Regulations]
[Pages 15627-15630]
[FR Doc No: 2016-06327]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31065; Amdt. No. 3686]

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 March 24, 2016. 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 March 24, 2016.

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 Navigation Products, 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, call 202-741-
6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/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 Procedure
Standards Branch (AFS-420) Flight Technologies and Procedures Division,
Flight Standards Service, Federal Aviation Administration, Mike
Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma
City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125)
telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This rule amends Title 14, Code of Federal
Regulations, Part 97 (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 the
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 February 26, 2016.
John S. Duncan,
Director, Flight Standards Service.

Adoption of the Amendment

    Accordingly, pursuant to the authority delegated to me, Title 14,
Code of Federal regulations, Part 97, (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.

Sec. Sec.  97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35  [Amended]

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

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      AIRAC date           State              City                 Airport          FDC No.      FDC date                      Subject
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31-Mar-16............  CA             San Diego...........  Brown Field Muni....       5/7981     01/27/16  This NOTAM, published in TL. 16-07, is
                                                                                hereby rescinded in its entirety.
31-Mar-16............  AL             Auburn..............  Auburn University          5/0011     02/11/16  RNAV (GPS) RWY 36, Amdt 2A.
                                                             Rgnl.
31-Mar-16............  AL             Auburn..............  Auburn University          5/0018     02/11/16  ILS OR LOC RWY 36, Amdt 2A.
                                                             Rgnl.
31-Mar-16............  AL             Auburn..............  Auburn University          5/0020     02/11/16  VOR/DME-A, Amdt 8.
                                                             Rgnl.
31-Mar-16............  WI             Ladysmith...........  Rusk County.........       5/0022     02/10/16  RNAV (GPS) RWY 32, Orig-A.
31-Mar-16............  AL             Auburn..............  Auburn University          5/0026     02/11/16  RNAV (GPS) RWY 29, Amdt 1A.
                                                             Rgnl.
31-Mar-16............  AL             Auburn..............  Auburn University          5/0028     02/11/16  RNAV (GPS) RWY 18, Amdt 1A.
                                                             Rgnl.
31-Mar-16............  AL             Auburn..............  Auburn University          5/0036     02/11/16  RNAV (GPS) RWY 11, Amdt 1A.
                                                             Rgnl.
31-Mar-16............  NC             Morganton...........  Foothills Regional..       5/0803     02/11/16  RNAV (GPS) RWY 3, Amdt 1.
31-Mar-16............  GA             Jasper..............  Pickens County......       5/1499     02/11/16  RNAV (GPS) RWY 16, Amdt 1A.
31-Mar-16............  CO             La Junta............  La Junta Muni.......       5/1868     02/16/16  Takeoff Minimums and (Obstacle) DP, Amdt 3.
31-Mar-16............  MD             Baltimore...........  Martin State........       5/2207     02/16/16  VOR/DME OR TACAN Z RWY 15, Orig-A.
31-Mar-16............  DE             Wilmington..........  New Castle..........       5/2426     02/11/16  RNAV (GPS) RWY 27, Orig-A.
31-Mar-16............  IL             Freeport............  Albertus............       5/2785     02/10/16  ILS OR LOC RWY 24, Orig.
31-Mar-16............  IL             Freeport............  Albertus............       5/2786     02/10/16  RNAV (GPS) RWY 6, Orig.
31-Mar-16............  IL             Freeport............  Albertus............       5/2787     02/10/16  RNAV (GPS) RWY 24, Amdt 1.
31-Mar-16............  IL             Freeport............  Albertus............       5/2788     02/10/16  VOR RWY 24, Amdt 7.
31-Mar-16............  AL             Montgomery..........  Montgomery Rgnl            5/2875     02/11/16  VOR-A, Amdt 4.
                                                             (Dannelly Field).
31-Mar-16............  AL             Montgomery..........  Montgomery Rgnl            5/2876     02/11/16  RADAR 1, Amdt 9.
                                                             (Dannelly Field).
31-Mar-16............  WI             Milwaukee...........  General Mitchell           5/4924     02/17/16  RNAV (GPS) RWY 7L, Orig.
                                                             Intl.
31-Mar-16............  WI             Milwaukee...........  General Mitchell           5/4929     02/17/16  RNAV (GPS) RWY 19L, Orig.
                                                             Intl.
31-Mar-16............  WI             Milwaukee...........  General Mitchell           5/4931     02/17/16  RNAV (GPS) RWY 25R, Orig-A.
                                                             Intl.
31-Mar-16............  WI             Milwaukee...........  General Mitchell           5/4934     02/17/16  RNAV (GPS) RWY 31, Orig.
                                                             Intl.
31-Mar-16............  NC             Wilmington..........  Wilmington Intl.....       5/5567     02/16/16  RNAV (GPS) RWY 24, Amdt 2A.
31-Mar-16............  TN             Jackson.............  Mc Kellar-Sipes Rgnl       5/6906     02/11/16  RNAV (GPS) RWY 20, Orig.
31-Mar-16............  TN             Jackson.............  Mc Kellar-Sipes Rgnl       5/6907     02/11/16  RNAV (GPS) RWY 2, Orig.
31-Mar-16............  TN             Jackson.............  Mc Kellar-Sipes Rgnl       5/6908     02/11/16  ILS OR LOC RWY 2, Amdt 8A.
31-Mar-16............  NC             Reidsville..........  Rockingham County NC       5/9488     02/16/16  NDB RWY 31, Amdt 5.
                                                             Shiloh.............
31-Mar-16............  NC             Reidsville..........  Rockingham County NC       5/9489     02/16/16  RNAV (GPS) RWY 31, Orig.
                                                             Shiloh.............
31-Mar-16............  OH             Marysville..........  Union County........       5/9514     02/17/16  RNAV (GPS) RWY 27, Orig-A.
31-Mar-16............  TN             Athens..............  McMinn County.......       5/9954     02/11/16  RNAV (GPS) RWY 2, Orig-A.
31-Mar-16............  TN             Athens..............  McMinn County.......       5/9955     02/11/16  NDB RWY 2, Amdt 6A.
31-Mar-16............  ND             Devils Lake.........  Devils Lake Rgnl....       6/0293     02/17/16  ILS OR LOC/DME RWY 31, Amdt 3A.
31-Mar-16............  MI             Pellston............  Pellston Rgnl              6/2211     02/17/16  RNAV (GPS) RWY 32, Orig-B.
                                                             Airport Of Emmet
                                                             County.
31-Mar-16............  MI             Pellston............  Pellston Rgnl              6/2212     02/17/16  RNAV (GPS) RWY 23, Orig-A.
                                                             Airport Of Emmet
                                                             County.
31-Mar-16............  MI             Pellston............  Pellston Rgnl              6/2214     02/17/16  ILS OR LOC RWY 32, Amdt 11A.
                                                             Airport Of Emmet
                                                             County.
31-Mar-16............  CT             Groton (New London).  Groton-New London...       6/3087     02/16/16  VOR RWY 5, Amdt 8A.
31-Mar-16............  CT             Groton (New London).  Groton-New London...       6/3088     02/16/16  VOR RWY 23, Amdt 10A.
31-Mar-16............  CT             Groton (New London).  Groton-New London...       6/3089     02/16/16  RNAV (GPS) RWY 23, Orig-B.
31-Mar-16............  CT             Groton (New London).  Groton-New London...       6/3090     02/16/16  RNAV (GPS) RWY 33, Orig-A.
31-Mar-16............  TX             Burnet..............  Burnet Muni Kate           6/3503     02/17/16  RNAV (GPS) RWY 1, Orig-A.
                                                             Craddock Field.
31-Mar-16............  TX             Burnet..............  Burnet Muni Kate           6/3504     02/17/16  RNAV (GPS) RWY 19, Orig.
                                                             Craddock Field.
31-Mar-16............  MN             Olivia..............  Olivia Rgnl.........       6/3505     02/16/16  VOR/DME OR GPS-A, Amdt 2.
31-Mar-16............  MN             Olivia..............  Olivia Rgnl.........       6/3506     02/16/16  RNAV (GPS) RWY 29, Orig.
31-Mar-16............  NE             Imperial............  Imperial Muni.......       6/3507     02/16/16  RNAV (GPS) RWY 13, Orig.
31-Mar-16............  NE             Imperial............  Imperial Muni.......       6/3508     02/16/16  RNAV (GPS) RWY 31, Amdt 1A.
31-Mar-16............  IA             Marshalltown........  Marshalltown Muni...       6/3772     02/17/16  RNAV (GPS) RWY 13, Amdt 1.
31-Mar-16............  IA             Marshalltown........  Marshalltown Muni...       6/3773     02/17/16  RNAV (GPS) RWY 31, Amdt 1.
31-Mar-16............  MI             Grand Ledge.........  Abrams Muni.........       6/4558     02/17/16  VOR OR GPS-A, Amdt 5.
31-Mar-16............  NJ             Toms River..........  Ocean County........       6/4595     02/16/16  ILS OR LOC RWY 6, Amdt 2A.
31-Mar-16............  NJ             Toms River..........  Ocean County........       6/4596     02/16/16  RNAV (GPS) RWY 24, Orig-A.
31-Mar-16............  NJ             Toms River..........  Ocean County........       6/4597     02/16/16  RNAV (GPS) RWY 6, Orig-A.
31-Mar-16............  NJ             Toms River..........  Ocean County........       6/4598     02/16/16  VOR RWY 6, Amdt 7A.
31-Mar-16............  NJ             Toms River..........  Ocean County........       6/4599     02/16/16  VOR/DME RWY 24, Amdt 4A.
31-Mar-16............  TN             Sparta..............  Upper Cumberland           6/4644     02/17/16  RNAV (GPS) RWY 22, Orig-B.
                                                             Rgnl.
31-Mar-16............  CO             Meeker..............  Meeker Coulter Fld..       6/5329     02/11/16  RNAV (GPS)-B, Orig-A.

31-Mar-16............  CO             Meeker..............  Meeker Coulter Fld..       6/5330     02/11/16  RNAV (GPS) RWY 3, Amdt 3A.
31-Mar-16............  CO             Meeker..............  Meeker Coulter Fld..       6/5331     02/11/16  VOR-A, Amdt 1.
31-Mar-16............  NC             Wilmington..........  Wilmington Intl.....       6/5562     02/16/16  RNAV (GPS) 35, Amdt 3A.
31-Mar-16............  VA             Marion/Wytheville...  Mountain Empire.....       6/6183     02/16/16  LOC RWY 26, Amdt 2A.
31-Mar-16............  VA             Marion/Wytheville...  Mountain Empire.....       6/6184     02/16/16  RNAV (GPS) RWY 26, Orig-A.
31-Mar-16............  ME             Rockland............  Knox County Rgnl....       6/6882     02/16/16  NDB RWY 31, Orig-C.
31-Mar-16............  GA             Carrollton..........  West Georgia Rgnl--O       6/7059     02/16/16  RNAV (GPS) RWY 17, Orig-A.
                                                             V Gray Field.
31-Mar-16............  GA             Carrollton..........  West Georgia Rgnl--O       6/7060     02/16/16  RNAV (GPS) RWY 35, Orig.
                                                             V Gray Field.
31-Mar-16............  VA             Crewe...............  Crewe Muni..........       6/7076     02/16/16  RNAV (GPS) RWY 15, Orig.
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[FR Doc. 2016-06327 Filed 3-23-16; 8:45 am]
 BILLING CODE 4910-13-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on May 11, 2004

   NOTICE OF ACTION TAKEN -- DOCKET OST-2004-17279

________________________________________________________________________
______________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Background

By Order 2004-3-3 we instituted the 2004 Hong Kong Fifth-Freedom
All-Cargo Frequency Proceeding to select carriers to operate 18
fifth-freedom frequencies available for U.S. carrier services in the
Hong Kong fifth-freedom market.  Four carriers  (Federal Express
(FedEx), Northwest Airlines (Northwest), Polar Air Cargo (Polar), and
United Parcel Service (UPS)) filed initial applications on March 23,
2004.   FedEx, Northwest, and Polar requested frequencies for services
in the Hong Kong-Seoul market, and those requests exceeded the number
available for service to that city.   UPS requested frequencies for Hong
Kong service via Singapore to Macapagal.

Joint Motion of   Federal Express Corporation, Northwest Airlines, and
Polar Air Cargo filed  4/2/04, for:

XX Allocation of Hong Kong Fifth-Freedom Cargo Frequencies and
Suspension of Procedural Timetable:

The joint carriers propose to allocate the five remaining available
Seoul frequencies among them as follows:  3 frequencies to FedEx, 1
frequency to Northwest, and 1 frequency to Polar.  They state that the
proposed distribution of frequencies will preserve the valuable
resources of the

(See Reverse Side)

2

Department, will avoid any unnecessary and protracted proceeding, will
promote competition in the Hong Kong all-cargo market, and will provide
the Department with a mutually agreed upon proposal that will best serve
the public interest.

We received no answers to the joint motion.

Applicant reps:  Nancy S. Sparks (FedEx)<PHONE_NUMBER>;  Megan Rosia
(Northwest)<PHONE_NUMBER>; Kevin Montgomery (Polar)<PHONE_NUMBER>    DOT
Analyst:   Linda Senese<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (Allocation of Hong Kong-Seoul all-cargo frequencies: 3 to
FedEx, 1 to Northwest, 1 to Polar, subject to conditions, see below)

The above action was effective when taken: May 11, 2004, and will remain
in effect indefinitely, subject to conditions.

By:      Susan McDermott

            Deputy Assistant Secretary for

	   Aviation and International Affairs

XX  The authority granted is consistent with the October 19, 2002,
Memorandum of Understanding between the Government of the United States
and the Government of the Hong Kong Special Administrative Region of the
People’s Republic of China and with the aviation agreement between the
United States and the Republic of Korea.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:  XX Holders’
certificates of public convenience and necessity

________________________________________________________________________
______

Conditions:  Consistent with our standard practice, the frequency
allocation granted is subject to the condition that if any of the
frequencies are not used for a period of 90 days, the allocation as to
each of those frequencies will expire automatically and the frequencies
will revert to the Department for reallocation.  The 90-day dormancy
period for Northwest and Polar will begin immediately, and the 90-day
dormancy period for FedEx will begin on October 26, 2004.

Remarks:  The Department’s instituting order in the 2004 Hong Kong
Fifth-Freedom All-Cargo Frequency Proceeding called for applications on
March 23, 2004, and made no provision for supplemental applications.
While we view the joint motion filed by FedEx, Northwest, and Polar as a
supplement to their originally filed applications, we will nevertheless
entertain it in the public interest in the circumstances presented.
This supplement modifies the three carriers’ original requests so that
FedEx now only seeks three Seoul frequencies; and Northwest and Polar

3

only seek one frequency each for Seoul-Hong Kong service.  We have
reviewed the carriers’ joint request and find that grant of this
request will provide public interest benefits and will provide U.S.
carrier service with all of the Seoul-Hong Kong frequencies permitted
under the MOU.  It is our policy to seek to maximize use of valuable
route rights, and we have determined that the allocations we are making
here promise to promote that objective and will enhance the service
options available to the shipping public. The three frequencies for
FedEx will enable the carrier to use local traffic rights between Seoul
and Hong Kong as part of its U.S.-Hong Kong services, as will the one
frequency for Northwest and the one frequency for Polar.  Thus, the
carriers will enhance the diversity of service in the area. We note that
no party has shown any reason why we should not grant the joint request
of FedEx, Northwest, and Polar and award these carriers the Seoul
frequencies they seek.  In these circumstances, we will award these
carriers frequencies for Hong Kong-Seoul service.  We may amend, modify,
or revoke the authority granted in this Notice at any time without
hearing at our discretion.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

 Sixteen of these frequencies become available under the MOU on October
26, 2004.  Two frequencies were frequencies that remained available from
an earlier proceeding.  These frequencies were awarded one each to
Northwest and Polar on a pendente lite basis for Seoul-Hong Kong
services.  See Order 2004-3-3,

at 6.

 Certain cities have city-pair caps, and services via those cities are
limited.  The MOU only permits 12 weekly fifth-freedom frequencies in
the Seoul-Hong Kong market.  The Department has allocated 7 of those 12
frequencies on a permanent basis, and thus, only 5 frequencies are
available for Seoul-Hong Kong services.

 On March 24 (and supplemented March 29) UPS filed a motion for
immediate allocation of frequencies for the Singapore-Macapagal service
and also for UPS’ dismissal from the balance of the proceeding.  In
its motion, it also withdrew the backup authority requested for Seoul
that had been in its original application.  There was no objection to
the UPS request.  Thus, on March 31, 2004, the Department allocated UPS
6 Hong Kong frequencies for its proposed Hong Kong-Singapore-Macapagal
service and also dismissed UPS from the balance of the 2004 Hong Kong
Fifth-Freedom All-Cargo Frequency Proceeding.

 In view of the circumstances presented and pending our resolution of
the joint motion for allocation, by Notice dated April 6, 2004, the
Department suspended the remaining procedural schedule established in
Order 2004-3-3 until further notice.  Answers to the motion regarding
the allocation of frequencies for Seoul service were due April 13, 2004.

 Northwest and Polar are currently operating one Seoul-Hong Kong
frequency each by virtue of pendente lite exemption authority.  (see
Order 2004-3-3 and note 1, supra.)  By this action we are awarding them
the two long-term frequencies (one to each) that had been awarded to
another carrier in a previous proceeding but that subsequently reverted
to the Department.  These frequencies are available for immediate use.
Our action here terminates the pendente lite awards to Northwest and
Polar but in no way alters their ability to continue these services.  We
are awarding FedEx three frequencies from the pool of frequencies that
become available October 26, 2004.

 We note that UPS filed an application in the above-captioned docket on
April 15, 2004, for three frequencies to other points.   We will act on
the UPS application separately.


[Federal Register Volume 78, Number 166 (Tuesday, August 27, 2013)]
[Notices]
[Pages 52932-52933]
[FR Doc No: 2013-20822]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0847]

Guidance for Institutional Review Boards, Clinical Investigators,
and Sponsors: Institutional Review Board Responsibilities for Reviewing
the Qualifications of Investigators, Adequacy of Research Sites, and
the Determination of Whether an Investigational New Drug/
Investigational Device Exemption is Needed; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Guidance for IRBs, Clinical
Investigators, and Sponsors: IRB Responsibilities for Reviewing the
Qualifications of Investigators, Adequacy of Research Sites, and the
Determination of Whether an IND/IDE is Needed.'' The guidance announced
in this notice is intended to assist institutional review boards
(IRBs), clinical investigators, and sponsors involved in clinical
investigations of FDA-regulated products in fulfilling responsibilities
related to reviewing the qualifications of investigators and adequacy
of research sites, and determining whether an investigational new drug
(IND) application or investigational device exemption (IDE) is
required, to protect the rights and welfare of human subjects involved
in biomedical research.

DATES: Submit written or electronic comments on Agency guidances at any
time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 2201, Silver Spring, MD 20993-0002, 1-888-463-6332 or 301-796-
3400; or the Office of Communication, Outreach and Development (HFM-
40), Center for Biologics Evaluation and Research, Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 1-800-835-4709 or<PHONE_NUMBER>; or the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave. Bldg. 66, Rm. 4621, Silver Spring, MD 20993, 1-800-
638-2041 or<PHONE_NUMBER>. Send one self-addressed adhesive label to
assist the office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments on the guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Doreen Kezer, Office of Good Clinical
Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 5170, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled
``Guidance for IRBs, Clinical Investigators, and Sponsors: IRB
Responsibilities for Reviewing the Qualifications of Investigators,
Adequacy of Research Sites, and the

Determination of Whether an IND/IDE is Needed.'' This guidance is
intended to assist IRBs, clinical investigators, and sponsors involved
in clinical investigations of FDA-regulated products in determining
that the proposed research satisfies the criteria for approval
contained in 21 CFR 56.111, that ``[r]isks to subjects are minimized .
. . [and] reasonable in relation to anticipated benefits, if any, to
subjects . . .'' In particular, the guidance addresses the IRB's role
in reviewing: (1) The qualifications of clinical investigators, (2) the
adequacy of the research site, and (3) the determination of whether an
IND/IDE is required.
    Many of the recommendations in this guidance have appeared in other
FDA guidance documents. FDA has compiled the recommendations from these
various sources into this guidance to ensure that all IRBs have access
to it. The guidance also explains how IRBs may efficiently fulfill
these important responsibilities.
    To enhance protection of human subjects and reduce regulatory
burden, the Department of Health and Human Services, Office for Human
Research Protections (OHRP), and FDA have been actively working to
harmonize the Agencies' regulatory requirements and guidance for human
subject research. This guidance document was developed as a part of
these efforts and in consultation with OHRP.
    In the Federal Register of November 20, 2012 (77 FR 69631), FDA
announced the availability of the draft guidance of the same title. FDA
received several comments on the draft guidance, and considered them in
preparing the final guidance. In the final guidance, FDA clarified that
IRBs, sponsors, and clinical investigators all have responsibility for
ensuring that the research complies with applicable laws and
regulations and that risks to subjects are minimized. FDA also made
changes to confirm that the recommendations in the guidance may be
fulfilled by any IRB, whether independent or affiliated with an
institution, and whether serving as a local IRB or as the central IRB,
and made editorial changes to improve clarity. The guidance announced
in this notice finalizes the draft guidance dated November 2012, and
replaces Question 56 in FDA's guidance entitled ``Institutional Review
Boards Frequently Asked Questions--Information Sheet--Guidance for
Institutional Review Boards and Clinical Investigators.'' \1\
---------------------------------------------------------------------------

    \1\ See http://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm#GeneralQuestions.
---------------------------------------------------------------------------

    The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). None of the collections of information
referenced in this guidance are new or represent material modifications
to previously approved collections of information. The collections of
information under 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information under 21 CFR part 812
have been approved under OMB control number 0910-0078; and the
collections of information under 21 CFR part 56 have been approved
under OMB control number 0910-0130.

III. Comments

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

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm.

    Dated: August 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20822 Filed 8-26-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 15 (Tuesday, January 23, 2018)]
[Notices]
[Pages 3133-3134]
[FR Doc No: 2018-01110]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. OR18-10-000]

Powder River Crude Services, LLC; Notice of Petition for
Declaratory Order

    Take notice that on January 10, 2018, pursuant to Rule 207(a)(2) of
the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.207(a)(2) (2017), Powder River Crude
Services, LLC (Petitioner), filed a petition for a declaratory order
seeking Commission approval of the rate framework, gathering
agreements, and open season process that support a new crude and

gathering system in the Powder River Basin of Wyoming, all as more
fully explained in the petition.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Petitioner.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE, Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
eLibrary link and is available for review in the Commission's Public
Reference Room in Washington, DC. There is an eSubscription link on the
website that enables subscribers to receive email notification when a
document is added to a subscribed docket(s). For assistance with any
FERC Online service, please email [email protected], or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern time on February 9, 2018.

    Dated: January 17, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-01110 Filed 1-22-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: November 29, 2010 (Volume 75, Number 228)]
[Notices]
[Page 73076]
[DOCID:fr29no10-79]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. RP11-1538-000]

National Gas Supply Association, American Forest and Paper
Association, Inc., American Public Gas Association, Independent
Petroleum Association of America, Process Gas Consumers Group; Notice
of Petition

November 19, 2010.
    Take notice that on November 17, 2010, the Natural Gas Supply
Association, American Forest and Paper Association, Inc., American
Public Gas Association, Independent Petroleum Association of America,
and Process Gas Consumers Group (collectively, the Associations), filed
in Docket No. RP11-1538-000, a petition pursuant to Rule 207(a)(5) of
the Commission's Rules of Practice and Procedure, requesting that the
Commission exercise its authority under section 5 of the Natural Gas
Act to enforce its policy regarding pipeline reservation charge
crediting during outages and order pipelines to amend their tariffs in
accordance with Commission policy.
    Specifically, the Associations ask the Commission to ensure that:
(1) All pipelines incorporate into their tariffs an acceptable sharing
mechanism that allows for partial reservation charge credits during
outages that are due to unexpected and uncontrollable force majeure
events, and (2) all pipeline tariffs require full reservation charge
credits to shippers during outages that are not due to unexpected and
uncontrollable force majeure events.
    Any person desiring to intervene or to protest in this proceeding
must file in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or
before 5 p.m. Eastern time on the specified comment date. Protests will
be considered by the Commission in determining the appropriate action
to be taken, but will not serve to make protestants parties to the
proceeding. Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant. In reference to filings
initiating a new proceeding, interventions or protests submitted on or
before the comment deadline need not be served on persons other than
the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above proceedings are accessible in the
Commission's eLibrary system by clicking on the appropriate link in the
above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 8, 2010.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-29859 Filed 11-26-10; 8:45 am]
BILLING CODE 6717-01-P