[Federal Register Volume 83, Number 90 (Wednesday, May 9, 2018)]
[Notices]
[Pages 21291-21293]
[FR Doc No: 2018-09858]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP18-102-000 & CP18-103-000]

Notice of Intent to Prepare an Environmental Assessment for the
Proposed Cheyenne Connector Pipeline and Cheyenne Hub Enhancement
Projects and Request for Comments On Environmental Issues: Cheyenne
Connector, LLC; Rockies Express Pipeline LLC

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the construction and operation of
facilities by Cheyenne Connector, LLC and Rockies Express Pipeline LLC
(``applicants'') in Weld County, Colorado. The Commission will use this
EA in its decision-making process to determine whether the applicants'
projects are in the public convenience and necessity. According to the
applicants, the proposed projects are being developed to work in tandem
to deliver natural gas produced in Weld County to the Cheyenne Hub;
therefore, the Commission is evaluating these two projects within a
single EA.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies on the projects. You can make a difference by providing us
with your specific comments or concerns about the projects. Your
comments should focus on the potential environmental effects,
reasonable alternatives, and measures to avoid or lessen environmental
impacts. Your input will help the Commission staff determine what
issues they need to evaluate in the EA. To ensure that your comments
are timely and properly recorded, please send your comments so that the
Commission receives them in Washington, DC on or before June 4, 2018.
    If you sent comments on either of these projects to the Commission
before the opening of this docket on March 5, 2018, you will need to
file those comments in the appropriate docket number (i.e., CP18-102-
000 and/or CP18-103-000) to ensure they are considered as part of this
proceeding.
    This notice is being sent to the Commission's current environmental
mailing list for the projects. State and local government
representatives should notify their constituents of these proposed
projects and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable agreement. However, if
the Commission approves these projects, that approval conveys with it
the right of eminent domain. Therefore, if easement negotiations fail
to produce an agreement, the pipeline company could initiate
condemnation proceedings where compensation would be determined in
accordance with state law.
    The applicants provided landowners with a fact sheet prepared by
the FERC entitled ``An Interstate Natural Gas Facility On My Land? What
Do I Need To Know?'' This fact sheet addresses a number of typically
asked questions, including the use of eminent domain and how to
participate in the Commission's proceedings. It is also available for
viewing on the FERC website (www.ferc.gov).

Public Participation

    For your convenience, there are three methods you can use to submit
your comments to the Commission. The Commission encourages electronic
filing of comments and has expert staff available to assist you at
(202) 502-8258 or [email protected]. Please carefully follow
these instructions so that your comments are properly recorded.
    (1) You can file your comments electronically using the eComment
feature on the Commission's website (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for submitting brief,
text-only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature on the Commission's website (www.ferc.gov) under the link to
Documents and Filings. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' If you are filing a comment on a particular project,
please select ``Comment on a Filing'' as the filing type; or
    (3) You can file a paper copy of your comments by mailing them to
the following address. Be sure to reference the appropriate docket
number of concern (either CP18-102-000 or CP18-103-000) with your
submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
    Please note this is not your only public input opportunity; refer
to the review process flow chart in appendix 1.\1\
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    \1\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of the appendices were sent to all
those receiving this notice in the mail and are available at
www.ferc.gov using the link called ``eLibrary'' or from the
Commission's Public Reference Room, 888 First Street NE, Washington,
DC 20426, or call<PHONE_NUMBER>. For instructions on connecting to
eLibrary, refer to the last page of this notice.
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Summary of the Proposed Projects

    The applicants propose to construct and operate new natural gas
pipeline, metering, and compression facilities in Weld County,
Colorado. The Cheyenne Connector Pipeline Project (Docket No. CP18-102-
000) would transport northward about 600,000 dekatherms per day of
natural gas from natural gas processing plants to a delivery
interconnect with Rockies Express Pipeline LLC (Rockies Express) at the
Cheyenne Hub. The Cheyenne Hub Enhancement Project (Docket No. CP18-

103-000) would include additional natural gas compression facilities at
the existing Cheyenne Hub to enable deliveries between Rockies Express
and other interconnected pipelines at the Cheyenne Hub. According to
the applicants, their Cheyenne Connector Pipeline and Cheyenne Hub
Enhancement Projects are needed to transport and move growing natural
gas production originating in Weld County to national markets.
    The Cheyenne Connector Pipeline Project would consist of the
following facilities:
     Approximately 70 miles of 36-inch-diameter pipeline,
including three associated mainline valves and other ancillary
facilities; and
     Five meter and regulating stations.
    The Cheyenne Hub Enhancement Project would consist of the following
facilities:
     One new approximately 32,100 horsepower ``Cheyenne Hub
Booster Compressor Station''; and
     Enhancements to modify the existing Cheyenne Hub
interconnect facilities, including installation of pipe, valves,
fittings, filters, and ancillary equipment.
    The general locations of the projects' facilities are shown in
appendix 2.

Land Requirements for Construction

    Construction of the proposed aboveground and pipeline facilities
would disturb about 1,720.3 acres of land. Following construction, the
applicants would maintain about 470.5 acres for permanent operation of
the projects' facilities; the remaining acreage would be restored and
revert to former uses. About 46 percent of the proposed pipeline route
parallels existing pipeline rights-of-way.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
\2\ to discover and address concerns the public may have about
proposals. This process is referred to as ``scoping.'' The main goal of
the scoping process is to focus the analysis in the EA on the important
environmental issues. By this notice, the Commission requests public
comments on the scope of the issues to be addressed in the EA. We will
consider all filed comments during the preparation of the EA.
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    \2\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
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    In the EA we will discuss impacts that could occur as a result of
the construction and operation of the proposed projects under these
general headings:
     Geology and soils;
     land use;
     water resources, fisheries, and wetlands;
     cultural resources;
     vegetation and wildlife;
     air quality and noise;
     endangered and threatened species;
     socioeconomics;
     public safety; and
     cumulative impacts.
    We will also evaluate reasonable alternatives to the proposed
projects or portions of the projects, and make recommendations on how
to lessen or avoid impacts on the various resource areas.
    The EA will present our independent analysis of the issues. The EA
will be available in the public record through eLibrary. We will
publish and distribute the EA to the public for an allotted comment
period. We will consider all comments on the EA before making our
recommendations to the Commission. To ensure we have the opportunity to
consider and address your comments, please carefully follow the
instructions in the Public Participation section, beginning on page 2.
    With this notice, we are asking agencies with jurisdiction by law
and/or special expertise with respect to the environmental issues of
these projects to formally cooperate with us in the preparation of the
EA.\3\ Agencies that would like to request cooperating agency status
should follow the instructions for filing comments provided under the
Public Participation section of this notice.
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    \3\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Part 1501.6.
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Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we are using this notice to initiate consultation
with the Colorado State Historic Preservation Office (SHPO), and to
solicit their views and those of other government agencies, interested
Indian tribes, and the public on the projects' potential effects on
historic properties.\4\ We will define the project-specific Area of
Potential Effects (APE) in consultation with the SHPO as the projects
develop. On natural gas facility projects, the APE at a minimum
encompasses all areas subject to ground disturbance (examples include
construction right-of-way, contractor/pipe storage yards, compressor
stations, and access roads). Our EA for these projects will document
our findings on the impacts on historic properties and summarize the
status of consultations under section 106.
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    \4\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
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Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on a project. We will update the environmental mailing list as
the analysis proceeds to ensure that we send the information related to
this environmental review to all individuals, organizations, and
government entities interested in and/or potentially affected by the
proposed projects.
    Copies of the EA will be sent to the environmental mailing list for
public review and comment. If you would prefer to receive a paper copy
of the document instead of the CD version or would like to remove your
name from the mailing list, please return the attached Information
Request (appendix 3).

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Instructions for becoming an intervenor are in
the ``Document-less Intervention Guide'' under the ``e-filing'' link on
the Commission's website.

Motions to intervene are more fully described at http://www.ferc.gov/resources/guides/how-to/intervene.asp.

Additional Information

    Additional information about the projects is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website at www.ferc.gov using the ``eLibrary'' link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number,
excluding the last three digits in the Docket Number field (i.e., CP18-
102 or CP18-103). Be sure you have selected an appropriate date range.
For assistance, please contact FERC Online Support at
[email protected] or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.
    Finally, public sessions or site visits will be posted on the
Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: May 3, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-09858 Filed 5-8-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 66 (Wednesday, April 6, 2016)]
[Notices]
[Pages 20047-20048]
[FR Doc No: 2016-07915]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Thirty-First Meeting: RTCA Special Committee (213) Enhanced
Flight Visions Systems/Synthetic Vision Systems (EFVS/SVS)(Joint With
EUROCAE WG-79)

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

ACTION: Notice of Thirty-First RTCA Special Committee 213 Meeting.

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SUMMARY: The FAA is issuing this notice to advise the public of the
Thirty-First RTCA Special Committee 213 meeting.

DATES: The meeting will be held May 10-12, 2016 from 8:30 a.m.-5:00
p.m.

ADDRESS: The meeting will be held at Thales, 3 Rue Toussaint Catros,
33185 Le Haillan, Bordeaux, France, Tel:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-
9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org or
Karan Hofmann, Program Director, RTCA, Inc<EMAIL_ADDRESS>(202)
330-0680. Additional Points of Contract: Bruno Aymeric,
<EMAIL_ADDRESS>phone +33 5 56 13 66 79, mobile +33 6
31 84 51 96; Tim Etherington<EMAIL_ADDRESS>phone (757)
864-5796, mobile<PHONE_NUMBER>; Patrick Krohn<EMAIL_ADDRESS>phone
(425) 602-1375, mobile<PHONE_NUMBER>. The RTCA SC-213 Web site has
contact information to support the meetings.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of RTCA Special Committee 213. The agenda
will include the following:

Tuesday, May 10, 2016

1. Plenary discussion (sign-in at 08:00 a.m.)
    a. Introductions and administrative items
    b. Review and approve minutes from last full plenary meeting
    c. Review of terms of reference and update work product dates

    d. WG1, WG2, WG3 and WG4 status updates
    e. Industry updates
    f. Working group discussion

Wednesday, May 11, 2016

1. Plenary Discussion
    a. Working Group Discussion

Thursday, May 12, 2016

1. Plenary discussion
    a. Working group discussion
    b. Administrative items (new meeting location/dates, action items
etc.)

Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Plenary information will be
provided upon request. Persons who wish to present statements or obtain
information should contact the person listed in the FOR FURTHER
INFORMATION CONTACT section. Members of the public may present a
written statement to the committee at any time.

    Issued in Washington, DC, on April 1, 2016.
Latasha Robinson,
Management & Program Analyst, NextGen, Enterprise Support Services
Division, Federal Aviation Administration.
[FR Doc. 2016-07915 Filed 4-5-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 174 (Monday, September 13, 2021)]
[Rules and Regulations]
[Pages 50846-50848]
[FR Doc No: 2021-19643]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 97

[Docket No. 31388; Amdt. No. 3973]

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 establishes, amends, suspends, or removes Standard
Instrument Approach Procedures (SIAPS) and associated Takeoff Minimums
and Obstacle Departure procedures (ODPs) 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 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 September 13, 2021. 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 September 13, 2021.

ADDRESSES: Availability of matters 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_ADDRESS>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 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
establishing, amending, suspending, or removes SIAPS, Takeoff Minimums
and/or ODPS. The complete regulatory description of each SIAP and its
associated Takeoff Minimums or ODP for an identified airport is listed
on FAA form documents which are incorporated by reference in this
amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20.
The applicable FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, 8260-15B,
when required by an entry on 8260-15A, and 8260-15C.
    The large number of SIAPs, Takeoff Minimums and ODPs, their complex
nature, and the need for a special format make publication in the
Federal Register expensive and impractical. Further, airmen do not use
the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead
refer to their graphic depiction on charts

printed by publishers or aeronautical materials. Thus, the advantages
of incorporation by reference are realized and publication of the
complete description of each SIAP, Takeoff Minimums and ODP listed on
FAA form documents is unnecessary. This amendment provides the affected
CFR sections and specifies the typed of SIAPS, 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/or 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, Takeoff Minimums and ODP as amended in the
transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments
may have been issued previously by the FAA in a Flight Data Center
(FDC) Notice to Airmen (NOTAM) as an emergency action of immediate
flights safety relating directly to published aeronautical charts.
    The circumstances that created the need for some SIAP and Takeoff
Minimums and ODP amendments may require making them effective in less
than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an
effective date at least 30 days after publication is provided.
    Further, the SIAPs and Takeoff Minimums and ODPs contained in this
amendment are based on the criteria contained in the U.S. Standard for
Terminal Instrument Procedures (TERPS). In developing these SIAPs and
Takeoff Minimums and ODPs, the TERPS criteria were applied to the
conditions existing or anticipated at the affected airports. 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 some 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.

Lists of Subjects in 14 CFR Part 97

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

    Issued in Washington, DC, on September 3, 2021.
Wade E.K. Terrell,
Aviation Safety, Flight Standards Service, Manager (A), Flight
Technologies and Procedures Division.

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
establishing, amending, suspending, or removing Standard Instrument
Approach Procedures and/or Takeoff Minimums and Obstacle Departure
Procedures 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:

Effective 7 October 2021

Brevig Mission, AK, PFKT, RNAV (GPS) RWY 12, Amdt 1A
Fairbanks, AK, PAFA, RNAV (GPS) RWY 20L, Amdt 2
Gustavus, AK, Gustavus, GUSTAVUS TWO Graphic DP
Chatom, AL, 5R1, RNAV (GPS) RWY 12, Orig-B
Blytheville, AR, KBYH, ILS OR LOC RWY 18, Amdt 3
Paragould, AR, KPGR, RNAV (GPS) RWY 4, Orig-C
Paragould, AR, KPGR, RNAV (GPS) RWY 22, Orig-D
Atlanta, GA, PDK, ILS OR LOC RWY 21L, Amdt 9
Atlanta, GA, PDK, RNAV (GPS) Y RWY 21L, Amdt 2
Sterling/Rockfalls, IL, KSQI, ILS OR LOC RWY 25, Amdt 12
Fort Leavenworth, KS, KFLV, RNAV (GPS) RWY 16, Orig-B
Fort Leavenworth, KS, KFLV, RNAV (GPS) RWY 34, Orig-C
Fort Leavenworth, KS, KFLV, VOR-A, Orig-C
Frankfort, MI, KFKS, RNAV (GPS) RWY 15, Amdt 1B
Sturgis, MI, Kirsch Muni, Takeoff Minimums and Obstacle DP, Amdt 4
Keene, NH, KEEN, ILS OR LOC RWY 2, Amdt 5
Keene, NH, KEEN, RNAV (GPS) RWY 2, Amdt 1
Keene, NH, KEEN, VOR RWY 2, Amdt 13A, CANCELLED
New York, NY, John F Kennedy Intl, RNAV (GPS) Z RWY 13R, Orig
Hamilton, OH, KHAO, RNAV (GPS) RWY 11, Amdt 1A
Hamilton, OH, KHAO, RNAV (GPS) RWY 29, Amdt 1A
La Grande, OR, KLGD, RNAV (GPS) RWY 17, Amdt 1
Conway, SC, KHYW, RNAV (GPS) RWY 4, Amdt 1B
Conway, SC, KHYW, RNAV (GPS) RWY 22, Amdt 1B
Williamsburg, VA, KJGG, VOR-B, AMDT 3A
Janesville, WI, KJVL, ILS OR LOC RWY 4, Amdt 13
Janesville, WI, KJVL, ILS OR LOC RWY 32, Amdt 1C
Wheeling, WV, KHLG, RNAV (GPS) RWY 21, Amdt 1A
Wheeling, WV, KHLG, RNAV (GPS) RWY 34, Amdt 1B
    Rescinded: On August 5, 2021 (86 FR 42708), the FAA published an
Amendment in Docket No. 31382 Amdt No. 3967, to Part 97 of the
Federal Aviation Regulations under section 97.37. The following
entry for Koyukuk, AK, effective October 7, 2021, is hereby
rescinded in its entirety:

Koyukuk, AK, Koyukuk, DIBVY THREE Graphic DP

    Rescinded: On August 20, 2021 (86 FR 46774), the FAA published
an Amendment in Docket No. 31384 Amdt No. 3969, to Part 97 of the
Federal Aviation Regulations under section 97.33. The following
entries for Headland, AL, effective October 7, 2021, are hereby
rescinded their entirety:

Headland, AL, 0J6, RNAV (GPS) RWY 9, Amdt 1B
Headland, AL, 0J6, RNAV (GPS) RWY 27, Amdt 1B

    Rescinded: On August 31, 2021 (86 FR 48502), the FAA published
an Amendment in Docket No. 31386 Amdt No. 3971, to Part 97 of the
Federal Aviation Regulations under section 97.37. The following
entries for Gold Beach, OR, and Jackson, WY effective October 7,
2021, are hereby rescinded in their entirety:

Gold Beach, OR, Gold Beach Municipal Airport, NELL ONE Graphic DP
Gold Beach, OR, Gold Beach Municipal Airport, Takeoff Minimums and
Obstacle DP, Orig

Jackson, WY, Jackson Hole, GEYSER SIX Graphic DP

[FR Doc. 2021-19643 Filed 9-10-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Rules and Regulations]
[Page 30551]
[FR Doc No: 2018-14012]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2018-0607]

Safety Zones; Recurring Events in Captain of the Port Duluth
Zone--LaPointe Fireworks

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the safety zone for the LaPointe
Fireworks in LaPointe, WI from 9:30 p.m. through 11:30 p.m. on July 4,
2018, with a rain date of 9:30 p.m. through 11:30 p.m. on July 5, 2018.
This action is necessary to protect participants and spectators during
the LaPointe Fireworks. During the enforcement period, entry into,
transiting, or anchoring within the safety zone is prohibited unless
authorized by the Captain of the Port Duluth or designated on-scene
representative.

DATES: The regulations in 33 CFR 165.943(b) will be enforced from 9:30
p.m. through 11:30 p.m. on July 4, 2018, with a rain date of 9:30 p.m.
through 11:30 p.m. on July 5, 2018, for the LaPointe Fireworks safety
zone, Sec.  165.943(a)(5).

FOR FURTHER INFORMATION CONTACT: If you have questions on this
document, call or email LT John Mack, Chief of Waterways Management,
Coast Guard; telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
for the annual LaPointe Fireworks in 33 CFR 165.943(a)(5) from 9:30
p.m. through 11:30 p.m. on July 4, 2018, with a rain date of 9:30 p.m.
through 11:30 p.m. on July 5, 2018, on all waters of Lake Superior
bounded by the arc of a circle with a 350-foot radius from the
fireworks launch site with its center in position 46[deg]46'40'' N,
090[deg]47'22'' W.
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port Duluth or their
designated on-scene representative. The Captain of the Port's
designated on-scene representative may be contacted via VHF Channel 16.
    This document is issued under authority of 33 CFR 165.943 and 5
U.S.C. 552(a). In addition to this publication in the Federal Register,
the Coast Guard will provide the maritime community with advance
notification of the enforcement of this safety zone via Broadcast
Notice to Mariners.

    Dated: June 18, 2018.
E.E. Williams,
Commander, U.S. Coast Guard, Captain of the Port Duluth.
[FR Doc. 2018-14012 Filed 6-28-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 83, Number 235 (Friday, December 7, 2018)]
[Notices]
[Pages 63178-63179]
[FR Doc No: 2018-26546]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4000]

Framework for a Real-World Evidence Program; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
establishing a public docket to collect comments on a framework created
by the Center for Drug Evaluation and Research and the Center for
Biologic Evaluation and Research for implementing a program to evaluate
the potential use of real-world evidence (RWE) in regulatory decision
making. This framework is entitled ``Framework for the Real-World
Evidence Program.'' The 21st Century Cures Act (Cures Act) was enacted
on December 13, 2016, and requires that FDA establish a framework for
implementing a program to evaluate the potential use of RWE to help
support the approval of a new indication for a drug approved under the
Federal Food, Drug, and Cosmetic Act (FD&C Act) and to help support or
satisfy postapproval study requirements. FDA has created this framework
to satisfy the Cures Act mandate and is establishing a docket to
receive public comments.

DATES: Submit either electronic or written comments on the draft
document by February 5, 2019 to ensure that the Agency considers your
comment before it begins work to implement the program.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:

     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-4000 for ``Framework for a Real-World Evidence Program;
Availability.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Dianne Paraoan, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3326, Silver Spring, MD 20993-0002, 301-
796-2500, [email protected]; or Stephen Ripley, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is establishing a public docket to collect comments on its
``Framework for a Real-World Evidence Program.'' Section 3022 of the
Cures Act amended the FD&C Act to add section 505F, Utilizing real
world evidence (21 U.S.C. 355g). This section requires the
establishment of a program to evaluate the potential use of RWE to help
support the approval of a new indication for a drug approved under
section 505(c) of the FD&C Act (21 U.S.C. 355(c)) and to help to
support or satisfy postapproval study requirements. This section also
requires FDA publish a framework for that program. In addition to drug
and biological products approved under section 505(c) of the FD&C Act,
FDA is also applying this framework to biological products licensed
under section 351 of the Public Health Service Act (42 U.S.C. 262).
    The statute directs that the framework for the RWE program include
information describing sources of RWE, gaps in data collection
activities, standards and methodologies for collecting and analyzing
RWE, and priority areas, remaining challenges, and potential pilot
opportunities to address the overarching Cures Act requirements. To
help meet a requirement in the Cures Act for consultation in developing
the program framework, on September 13, 2017, through its cooperative
agreement with the Duke Margolis Center for Health Policy, FDA convened
a public meeting that explored the use of RWE for regulatory decisions.
Representatives from industry, academia, and patient advocacy groups
discussed, among other things, opportunities and challenges associated
with applying real-world data and RWE, the evidence derived from that
data, to demonstrate product effectiveness, including data acquisition,
study design, and analytic methods necessary to establish causal
inference. The workshop helped to inform FDA's RWE framework. FDA will
continue to consult stakeholders through public-private partnerships,
public workshops, and demonstration projects as it implements its RWE
program.

II. Electronic Access

    Persons with access to the internet may obtain the ``Framework for
the Real-World Evidence Program'' at https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/21stCenturyCuresAct/ucm562475.htm.

    Dated: November 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26546 Filed 12-6-18; 8:45 am]
 BILLING CODE 4164-01-P