[Federal Register Volume 88, Number 212 (Friday, November 3, 2023)]
[Notices]
[Page 75577]
[FR Doc No: 2023-24259]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP23-535-000]

WBI Energy Transmission, Inc.; Notice of Schedule for the
Preparation of an Environmental Assessment for the South Spearfish
Project

    On August 28, 2023, WBI Energy Transmission, Inc. (WBI Energy)
filed an application in Docket No. CP23-535-000 requesting a
Certificate of Public Convenience and Necessity pursuant to section
7(c) and Authorization pursuant to section 7(b) of the Natural Gas Act
to construct, operate, and abandon certain natural gas pipeline
facilities. The proposed project is known as the South Spearfish
Project (Project) and would allow for incremental firm transportation
capacity from WBI Energy's existing Line Section 15 in western South
Dakota to the community of Spearfish, South Dakota for Montana-Dakota
Utilities, Company.
    On September 11, 2023, the Federal Energy Regulatory Commission
(Commission or FERC) issued its Notice of Application for the Project.
Among other things, that notice alerted agencies issuing Federal
authorizations of the requirement to complete all necessary reviews and
to reach a final decision on a request for a Federal authorization
within 90 days of the date of issuance of the Commission staff's
environmental document for the Project.
    This notice identifies Commission staff's intention to prepare an
environmental assessment (EA) for the Project and the planned schedule
for the completion of the environmental review.\1\
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    \1\ 40 CFR 1501.10 (2020)
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Schedule for Environmental Review

Issuance of EA--February 26, 2024
90-day Federal Authorization Decision Deadline \2\--May 26, 2024
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    \2\ The Commission's deadline applies to the decisions of other
Federal agencies, and State agencies acting under federally
delegated authority, that are responsible for Federal
authorizations, permits, and other approvals necessary for proposed
projects under the Natural Gas Act. Per 18 CFR 157.22(a), the
Commission's deadline for other agency's decisions applies unless a
schedule is otherwise established by Federal law.

    If a schedule change becomes necessary, additional notice will be
provided so that the relevant agencies are kept informed of the
Project's progress.

Project Description

    WBI Energy proposes the following in Lawrence County, South Dakota:
     modify the Deadwood-Central City Lateral Takeoff Valve
Setting adjacent to the Deadwood Mainline Transfer Station on WBI
Energy's Line Section 15;
     increase the maximum allowable operating pressure of the
8-inch-diameter Deadwood-Central City Lateral from the Deadwood
Mainline Transfer Station to the proposed South Spearfish Town Border
Station;
     install two pig launcher/receivers,\3\ one at each end of
the uprated Deadwood-Central City Lateral;
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    \3\ A ``pig'' is a tool that the pipeline company inserts into
and pushes through the pipeline for cleaning the pipeline,
conducting internal inspections, or other purposes. A pig launcher/
receiver are facilities where pigs are inserted/retrieved from the
pipeline.
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     construct the new South Spearfish Town Border Station
adjacent to the existing South Spearfish Lateral Takeoff Valve Setting.
The new station would contain the relocated South Spearfish Town Border
Station and the new Deadwood Lateral Transfer Station;
     relocate approximately 500 feet of the South Spearfish
Lateral adjacent to the South Spearfish Town Border Station and the
existing South Spearfish Lateral Takeoff Valve Setting; and
     abandon by sale the existing 5.5-mile-long 4-inch-diameter
South Spearfish Lateral and certain town border station equipment, at
the existing South Spearfish Town Border Station to Montana-Dakota
Utilities, Company upon the commissioning of the new South Spearfish
Town Border Station.

Background

    On October 13, 2023, the Commission issued a Notice of Scoping
Period Requesting Comments on Environmental Issues for the Proposed
South Spearfish Project (Notice of Scoping). The Notice of Scoping was
sent to affected landowners; Federal, State, and local government
agencies; elected officials; environmental and public interest groups;
Native American Tribes; other interested parties; and local libraries.
All substantive comments will be addressed in the EA.

Additional Information

    In order to receive notification of the issuance of the EA and to
keep track of formal issuances and submittals in specific dockets, the
Commission offers a free service called eSubscription. This service
provides automatic notification of filings made to subscribed dockets,
document summaries, and direct links to the documents. Go to https://www.ferc.gov/ferc-online/overview to register for eSubscription.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC website (www.ferc.gov). Using the ``eLibrary'' link, select
``General Search'' from the eLibrary menu, enter the selected date
range and ``Docket Number'' excluding the last three digits (i.e.,
CP23-535), and follow the instructions. For assistance with access to
eLibrary, the helpline can be reached at<PHONE_NUMBER>, TTY (202) 502-
8659, or at [email protected]. The eLibrary link on the FERC
website also provides access to the texts of formal documents issued by
the Commission, such as orders, notices, and rule makings.

    Dated: October 27, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-24259 Filed 11-2-23; 8:45 am]
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[Federal Register Volume 77, Number 47 (Friday, March 9, 2012)]
[Notices]
[Pages 14401-14402]
[FR Doc No: 2012-5775]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2005-D-0339]

Draft Guidance on Drug Safety Information--FDA's Communication to
the Public; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance titled ``Drug Safety Information--
FDA's Communication to the Public.'' This draft guidance updates and
revises the March 2007 guidance entitled ``Drug Safety Information--
FDA's Communication to the Public.'' This draft guidance describes
FDA's current approach to communicating important drug safety
information, including emerging drug safety information, to the public
and the factors that influence when the information is communicated.
The draft guidance was developed in connection with the Center for Drug
Evaluation and Research's (CDER's) Safety First Initiative.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 8, 2012.

ADDRESSES: Submit written requests for single copies of the draft
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; or
Office of Communication, Outreach and Development (HFM-40), Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Edward Staffa, Center for Drug
Evaluation and Research, Food and Drug Administration, 10001 New
Hampshire Ave., Rm. 1152, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled
``Drug Safety Information--FDA's Communication to the Public.'' This
draft guidance updates and revises a March 2007 guidance of the same
name. It describes FDA's current approach to communicating important
drug safety information, including emerging drug safety information, to
the public and the factors that influence when the information is
communicated.
    For many years, FDA has provided information on drug risks and
benefits to health care professionals and patients when that
information has generated a specific concern, usually waiting until
that information has been fully evaluated and has prompted an action,
such as a revision to the drug's prescribing information. In recent
years, FDA has tended to make information on potential drug risks
available to the public earlier, often while the Agency is still
evaluating the data and determining whether any action is warranted.
FDA believes that timely communication of important drug safety
information will give health care professionals, patients, consumers,
and other interested persons access to the most current information
concerning the potential risks and benefits of a marketed drug, helping
them to make more informed individual treatment choices.
    In the Federal Register of March 7, 2007 (72 FR 10224), FDA
announced the availability of a guidance titled ``Drug Safety
Information--FDA's Communication to the Public.'' FDA has revised the
2007 guidance to provide updated information about its approach to
communicating important drug safety information, including FDA's
development of a single, standardized format for electronic drug safety
communications about marketed drugs. In addition, the draft guidance
describes FDA's posting of other safety assessments on its Web site in
accordance with the requirements of the Food and Drug Administration
Amendments Act of 2007 (FDAAA) and to further our transparency
objectives.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will replace the 2007 guidance and represent the Agency'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. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. 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.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget

(OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
The collections of information in 21 CFR 310.305, 314.80, 314.98,
600.80, and in 21 U.S.C. 379aa have been approved under OMB Control
Numbers 0910-0230, 0910-0291, 0910-0308, and 0910-0636.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: March 6, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5775 Filed 3-8-12; 8:45 am]
BILLING CODE 4160-01-P