[Federal Register Volume 84, Number 166 (Tuesday, August 27, 2019)]
[Notices]
[Pages 44891-44893]
[FR Doc No: 2019-18428]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC19-32-000]

Commission Information Collection Activities (FERC-725M); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission, Department of Energy.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995 (PRA), the Federal Energy Regulatory Commission (Commission
or FERC) is soliciting public comment on the currently approved
information collection, FERC-725M (Mandatory Reliability Standards:
Generator Requirements at the Transmission Interface) which will be
submitted to the Office of Management and Budget (OMB) for a review of
the information collection requirements.

DATES: Comments on the collection of information are due October 28,
2019.

ADDRESSES: You may submit comments (identified by Docket No. IC19-32-
000) by either of the following methods:
     eFiling at Commission's website: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance, contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov/docs-filing/docs-filing.asp.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION:
    Title: FERC-725M (Mandatory Reliability Standards: Generator
Requirements at the Transmission Interface).
    OMB Control No.: 1902-0263.
    Type of Request: Three-year extension of the FERC-725M with no
updates to the current reporting requirements.

    Abstract: On September 19, 2013, the Commission issued Order No.
785, Docket No. RM12-16-000, a Final Rule \1\ approving modifications
to four existing Reliability Standards submitted by the North American
Electric Reliability Corporation (NERC), the Commission certified
Electric Reliability Organization. Specifically, the Commission
approved Reliability Standards FAC-001-1 (Facility Connection
Requirements), FAC-003-3 (Transmission Vegetation Management), PRC-004-
2.1a (Analysis and Mitigation of Transmission and Generation Protection
System Misoperations), and PRC-005-1.1b (Transmission and Generation
Protection System Maintenance and Testing).\2\ The modifications
improved reliability either by extending applicability of the
Reliability Standard to certain generator interconnection facilities,
or by clarifying that the existing Reliability Standard is and remains
applicable to generator interconnection facilities.
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    \1\ Generator Requirements at the Transmission Interface, 144
FERC ] 61,221 (2013).
    \2\ The burden is included in information collection FERC-725M.
    The burdens related to previous versions of Reliability
Standards mentioned in the Final Rule: FAC-001-0 (Facility
Connection Requirements); FAC-003-2 (Transmission Vegetation
Management); PRC-004-2a (Analysis and Mitigation of Transmission and
Generation Protection System Misoperations); and PRC-005-1b
(Transmission and Generation Protection System Maintenance and
Testing) are included in FERC-725A (Mandatory Reliability Standards
for the Bulk-Power System, OMB Control No. 1902-0244).
    The Final Rule states the modifications included in PRC-004-2.1a
and PRC-005-1.1b are clarifications of existing requirements, do not
extend those existing requirements to any new entity or to
additional facilities, and do not affect the existing burden related
to those standards.
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    On April 26, 2016, a Delegated Letter Order was issued, Docket No.
RD16-4-000, approving proposed Reliability Standard FAC-003-4
(Transmission Vegetation Management). Reliability Standard FAC-003-4
reflected revisions to the current Minimum Vegetation Clearance
Distances (MVCDs) in Reliability Standard FAC-003-3 based on additional
testing regarding the appropriate gap factor to be used to calculate
clearance distances for vegetation. NERC explained that Reliability
Standard FAC-003-4 includes higher and more conservative MVCD values
and, therefore, maintained that these revisions would ``enhance
reliability and provide additional confidence by applying a more
conservative approach to determining the vegetation clearing
distances.''
    In FERC-725M we are:
    (1) Adjusting the burden in FAC-003-4 to reflect the latest number
of applicable entities based on the NERC Compliance Registry as of July
26, 2019.
    (2) Making a program change to administratively remove all one-time
burden \3\ that is being inadvertently counted in FERC-725M and FERC-
725D.
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    \3\ One-time burden is typically performed in the first year of
implementation. All burden associated with FAC-001-3 in this
collection was removed in 2015. The burden in FAC-001-3 was
transferred in 2015 to FERC-725D (OMB Control Number 1902-0247). See
the November 6, 2014 Delegated Letter Order, Docket No. RD14-12-000,
approving Reliability Standard FAC-001-2 and Order No. 836,
Balancing Authority Control, Inadvertent Interchange, and Facility
Interconnection Reliability Standards, 160 FERC 61,070 (2017),
approving Reliability Standard FAC-001-3.
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    Type of Respondents: Transmission Owner (TO); Generator Owner (GO);
and Regional Entity (RE).
    Estimate of Annual Burden.\4\ The Commission estimates the annual
public reporting burden and cost \5\ for the information collection as:
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    \4\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a federal agency. See 5
CFR 1320 for additional information on the definition of information
collection burden.
    \5\ The estimated hourly cost (salary plus benefits) are based
on the figures for May 2018 posted by the Bureau of Labor Statistics
for the Utilities sector (available at http://www.bls.gov/oes/current/naics2_22.htm) and updated March 2019 for benefits
information (at http://www.bls.gov/news.release/ecec.nr0.htm). The
hourly estimates for salary plus benefits are:
    --Manager (code 11-0000), $95.24
    --Information and Records Clerks (code 43-4199), $40.84
    --Electrical Engineer (code 17-2071), $68.17
    The average hourly burden cost for this collection is $68.08
[($95.24 + $40.84 + $68.17)/3 = $68.08)].and is rounded to $68.00 an
hour.
    \6\ According to the NERC Compliance Registry as of July 26,
2019, there are 946 generator owners and 328 transmission owners
registered in North America. We estimate that approximately 10
percent (or 95) of these generator owners have interconnection
facilities that are applicable to the standard.
    \7\ The estimated number of respondents (101) includes 95
generator owners and 6 Regional Entities.

                            FERC-725M, Mandatory Reliability Standards: Generator Requirements at the Transmission Interface
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               Annual  number
                                  Number of     of  responses   Total  number   Average burden  hours &    Total annual  burden hours &      Cost per
                                 respondents         per        of  responses      cost  per response            total annual cost          respondent
                                     \6\         respondent                                                                                ($)
                                          (1)             (2)     (1) * (2) =  (4)......................  (3) * (4) = (5)...............         (5)/(1)
                                                                          (3)
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                                                     FAC-003-4 (Transmission Vegetation Management)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Generator Owners, Regional            101 \7\               4             404  0.25 hrs.; $17.00........  101 hrs.; 6,868.00............          $68.00
 Entities: Quarterly
 Reporting (Compliance 1.4).
Generator Owners: Annual Veg.              95               1              95  2 hrs.; $136.00..........  190 hrs.; 12,920.00...........          136.00
 inspect. Doc. (M6); Work
 Plan (M7); Evidence of Mgt.
 of Veg. (M1 & M2); Confirmed
 Veg. Condition (M4); &
 Corrective Action (M5).
Generator Owners,                         423               1             423  1 hr.; $68.00............  423 hrs.; 28,764.00...........           68.00
 Transmission Owners: Record
 Retention (Compliance 1.2).
                              --------------------------------------------------------------------------------------------------------------------------
    Total....................  ..............  ..............             922  .........................  714 hrs.: $48,552.00..........         $272.00
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    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimates of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: August 21, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-18428 Filed 8-26-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: April 13, 2009 (Volume 74, Number 69)]
[Rules and Regulations]
[Page 16782]
[DOCID:fr13ap09-9]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[USCG-2009-0230]

Drawbridge Operating Regulations; Gulf Intracoastal Waterway,
Belle Chasse, LA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Eighth Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Louisiana State Route 23 (LA 23) vertical lift span bridge, also known
as the Judge Perez Bridge, across the Gulf Intracoastal Waterway
(Algiers Alternate Route), mile 3.8, at Belle Chasse, Plaquemines
Parish, Louisiana. This deviation provides for the bridge to remain
closed to navigation for six hours a day for 21 consecutive days in
order to perform scheduled maintenance.

DATES: This deviation is effective from 9 a.m. on Monday, May 18, 2009
until 3 p.m. on Sunday, June 7, 2009.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2009-0230 and are available online
at www.regulations.gov. They are also available for inspection or
copying at two locations: The Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays; and the office of
the Eighth Coast Guard District, Bridge Administration Branch, Hale
Boggs Federal Building, Room 1313, 500 Poydras Street, New Orleans,
Louisiana 70130-3310 between 7 a.m. and 3 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: David Frank, Bridge Administration
Branch, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Louisiana Department of Transportation
and Development (LDOTD) has requested a temporary deviation in order to
perform maintenance on the State Route 23 (LA 23) vertical lift span
bridge, also known as the Judge Perez Bridge, across the Gulf
Intracoastal Waterway (Algiers Alternate Route), mile 3.8, at Belle
Chasse, Plaquemines Parish, Louisiana. This maintenance is necessary to
make mechanical repairs to the lift towers of the bridge. This
temporary deviation will allow the bridge to remain closed-to-
navigation position from 7 a.m. until 3 p.m. daily from Monday, May 18,
2009 until Sunday, June 7, 2009. During the closure the draw will not
be able to open for emergencies. Currently, the draw opens on signal;
except that, from 6 a.m. to 8:30 a.m. and from 3:30 p.m. to 5:30 p.m.
Monday through Friday, except Federal holidays, the draw need not be
opened for the passage of vessels.
    The State Route 23 vertical lift span drawbridge across the Gulf
Intracoastal Waterway (Algiers Alternate Route), mile 3.8, at Belle
Chasse, Louisiana has a vertical clearance of 40 feet above mean high
water in the closed-to-navigation position and 100 feet above mean high
water in the open-to-navigation position. Navigation on the waterway
consists primarily of tugs with tows, commercial fishing vessels, and
occasional recreational craft. Mariners may use the Gulf Intracoastal
Waterway (Harvey Canal) to avoid unnecessary delays. The Coast Guard
has coordinated this closure with the Gulf Intracoastal Canal
Association (GICA). The GICA representative indicated that the vessel
operators will be able to schedule transits through the bridge such
that operations will not significantly be hindered. Thus, it has been
determined that this closure will not have a significant effect on
these vessels. This closure is considered necessary for repair of the
bridge.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: March 30, 2009.
David M. Frank,
Bridge Administrator.
[FR Doc. E9-8304 Filed 4-10-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register: February 13, 2009 (Volume 74, Number 29)]
[Proposed Rules]
[Page 7204-7205]
[DOCID:fr13fe09-14]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-1129; Airspace Docket No. 08-ANM-7]

Proposed Establishment of Class E Airspace; Ten Sleep, WY

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

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SUMMARY: This action proposes to establish Class E airspace at Red
Reflet Ranch Airport, Ten Sleep, WY. Additional controlled airspace is
necessary to accommodate aircraft using a new Area Navigation (RNAV)
Global Positioning System (GPS) Standard Instrument Approach Procedure
(SIAP) at Red Reflet Ranch Airport, Ten Sleep, WY. The FAA is proposing
this action to enhance the safety and management of aircraft operations
at Red Reflet Ranch Airport, Ten Sleep, WY.

DATES: Comments must be received on or before March 30, 2009.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W2-140, 1200 New Jersey Avenue, SE., Washington, DC 20590.
Telephone<PHONE_NUMBER>. You must identify FAA Docket No. FAA-2008-
1129; Airspace Docket No. 08-ANM-7, at the beginning of your comments.
You may also submit comments through the Internet at http://
www.regulations.gov.

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

SUPPLEMENTARY INFORMATION:

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA 2008-1129 and Airspace Docket No. 08-ANM-7) and be submitted in
triplicate to the Docket Management System (see ADDRESSES section for
address and phone number). You may also submit comments through the
Internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2008-l129 and Airspace Docket No. 08-ANM-7''. The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the closing date
for comments. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the

Internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's Web page at http://
www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_
amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9 a.m. and 5 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 1601 Lind Avenue, SW., Renton, WA
98057.
    Persons interested in being placed on a mailing list for future
NPRMs should contact the FAA's Office of Rulemaking,<PHONE_NUMBER>,
for a copy of Advisory Circular No. 11-2A, Notice of Proposed
Rulemaking Distribution System, which describes the application
procedure.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by establishing Class E airspace at Red
Reflet Ranch Airport, Ten Sleep, WY. Controlled airspace is necessary
to accommodate aircraft using the new RNAV (GPS) SIAP at Red Reflet
Ranch Airport, Ten Sleep, WY. This action would enhance the safety and
management of aircraft operations at Red Reflet Ranch Airport, Ten
Sleep, WY.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.9S, signed October 3, 2008, and effective October 31,
2008, which is incorporated by reference in 14 CFR 71.1. The Class F
airspace designation listed in this document will be published
subsequently in this Order.
    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this proposed regulation; (1) Is not a ``significant
regulatory action'' under Executive Order 12866; (2) is not a
``significant rule'' under DOT Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3) does not warrant preparation of a
regulatory evaluation as the anticipated impact is so minimal. Since
this is a routine matter that will only affect air traffic procedures
and air navigation, it is certified that this proposed rule, when
promulgated, would not have a significant economic impact on a
substantial number of small entities under the criteria of the
Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority for the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103.
    Under that section, the FAA is charged with prescribing regulations
to assign the use of the airspace necessary to ensure the safety of
aircraft and the efficient use of airspace. This regulation is within
the scope of that authority as it establishes additional controlled
airspace at Red Reflet Ranch Airport, Ten Sleep, WY.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

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

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

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

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

Sec.  71.1  [Amended]

    2. The incorporation by reference in 14 CFR 71.1 of the FAA Order
7400.9S, Airspace Designations and Reporting Points, signed October 3,
2008, and effective October 31, 2008 is amended as follows:

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

* * * * *

ANM WY, E5 Ten Sleep, WY [New]

Ten Sleep, Red Reflet Ranch Airport, WY
    (Lat. 43[deg]58'04'' N., long. 107[deg]22'46'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.6 mile radius of the Red Reflet Ranch Airport, and within
4 miles each side of the Red Reflet Ranch Airport 293[deg] bearing
extending from the 6.6-mile radius to 12 miles northwest of the Red
Reflet Ranch Airport.
* * * * *

    Issued in Seattle, Washington, on January 14, 2009.
H. Steve Karnes,
Acting Manager, Operations Support Group, Western Service Center.
[FR Doc. E9-3076 Filed 2-12-09; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 86, Number 173 (Friday, September 10, 2021)]
[Notices]
[Pages 50712-50713]
[FR Doc No: 2021-19528]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP21-487-000]

Hardy Storage Company, LLC; Notice of Request Under Blanket
Authorization and Establishing Intervention and Protest Deadline

    Take notice that on August 26, 2021, Hardy Storage Company, LLC
(HSC), 700 Louisiana Street, Houston, Texas 77002-2700, filed in the
above referenced docket a prior notice pursuant to sections 157.205 and
157.214 of the Federal Energy Regulatory Commission's regulations under
the Natural Gas Act, seeking authorization to increase the maximum
storage capacity at the Hardy Storage Field, located in Hardy and
Hampshire Counties, West Virginia, from 29.6 billion cubic feet (Bcf)
to 31.07 Bcf. HSC states this increase reflects the quantity of
additional base gas needed to improve late season deliverability in the
Hardy Storage Field. HSC proposes this maximum storage capacity
increase under authorities granted by its blanket certificate issued in
Docket No. CP05-152-000,\1\ all as more fully set forth in the request
which is on file with the Commission and open to public inspection.
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    \1\ 113 FERC ] 61,118 (2005).
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    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Any questions concerning this application should be directed to
David A. Alonzo, Manager, Project Authorizations, Hardy Storage
Company, LLC, 700 Louisiana Street, Suite 1300, Houston, Texas 77002-
2700, phone:<PHONE_NUMBER>, email<EMAIL_ADDRESS>
Public Participation

    There are three ways to become involved in the Commission's review
of this project: You can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on November 2, 2021.
How to file protests, motions to intervene, and comments is explained
below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\2\ any person \3\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
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    \2\ 18 CFR 157.205.
    \3\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
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    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\4\ and must be submitted by
the protest deadline, which is November 2, 2021. A protest may also
serve as a motion to intervene so long as the protestor states it also
seeks to be an intervenor.
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    \4\ 18 CFR 157.205(e).
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Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \5\ and the regulations under the NGA \6\ by the
intervention deadline for the project, which is November 2, 2021. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
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    \5\ 18 CFR 385.214.
    \6\ 18 CFR 157.10.
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    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before November 2, 2021. The filing of a comment alone will not
serve to make the filer a party to the proceeding. To become a party,
you must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please

reference the Project docket number CP21-487-000 in your submission.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing''; or \7\
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    \7\ Additionally, you may file your comments electronically by
using the eComment feature, which is located on the Commission's
website at www.ferc.gov under the link to Documents and Filings.
Using eComment is an easy method for interested persons to submit
brief, text-only comments on a project.
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    (2) You can file a paper copy of your submission by mailing it to
the address below.\8\ Your submission must reference the Project docket
number CP21-487-000.
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    \8\ Hand-delivered submissions in docketed proceedings should be
delivered to Health and Human Services, 12225 Wilkins Avenue,
Rockville, Maryland 20852.

Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
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First Street NE, Washington, DC 20426

    The Commission encourages electronic filing of submissions (option
1 above) and has eFiling staff available to assist you at (202) 502-
8258 or [email protected]
    Protests and motions to intervene must be served on the applicant
either by mail or email (with a link to the document) at: David A.
Alonzo, Manager, Project Authorizations, 700 Louisiana Street, Suite
1300, Houston, Texas 77002-2700 or<EMAIL_ADDRESS>Any
subsequent submissions by an intervenor must be served on the applicant
and all other parties to the proceeding. Contact information for
parties can be downloaded from the service list at the eService link on
FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be 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 as described above. The eLibrary link also provides
access to the texts of all 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. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: September 3, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-19528 Filed 9-9-21; 8:45 am]
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[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Notices]
[Page 70141]
[FR Doc No: 2021-26648]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1194]

Fresenius Kabi Deutschland GmbH; Withdrawal of Approval of New
Drug Application of Hydroxyethyl Starch

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of a new drug application (NDA) BN 070012/0022 for
VOLUVEN (6 Percent Hydroxyethyl Starch 130/0.4 in 0.9 Percent Sodium
Chloride Injection), held by Fresenius Kabi Deutschland GmbH. Fresenius
Kabi Deutschland GmbH requested in writing that the Agency's approval
of the application be withdrawn because the drug is no longer being
marketed and has waived its opportunity for a hearing.

DATES: Approval is withdrawn as of January 10, 2022.

FOR FURTHER INFORMATION CONTACT: Myrna Hanna, 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.

SUPPLEMENTARY INFORMATION: Fresenius Kabi Deutschland GmbH, Bad
Homburg, Germany (Authorized U.S. Agent: Fresenius Kabi USA, LLC, Three
Corporate Dr., Lake Zurich, IL 60047), has requested that FDA withdraw
approval of NDA BN 070012 sequence 0022, pursuant to Sec.  314.150(c)
(21 CFR 314.150(c)), because the drug is no longer being marketed. By
its request, Fresenius Kabi Deutschland GmbH, has also waived its
opportunity for a hearing. Withdrawal of approval of an application
under Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
            Application No.                      Proprietary name
------------------------------------------------------------------------
NDA BN 070012/0022.....................  VOLUVEN (6% Hydroxyethyl Starch
                                          130/0.4 in 0.9% Sodium
                                          Chloride Injection)
------------------------------------------------------------------------

    Therefore, approval of the application listed in the table, and all
amendments and supplements thereto, is hereby withdrawn as of January
10, 2022. Introduction or delivery for introduction into interstate
commerce for products without a new drug application violates section
301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
331(a) and (d)). The drug product that is listed in the table above
that is in inventory on January 10, 2022 may continue to be dispensed
until the inventory has been depleted or the drug product has reached
its expiration date or otherwise becomes violative, whichever occurs
first.

    Dated: December 3, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26648 Filed 12-8-21; 8:45 am]
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[Federal Register Volume 80, Number 27 (Tuesday, February 10, 2015)]
[Notices]
[Pages 7479-7480]
[FR Doc No: 2015-02591]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0973]

Complicated Intra-Abdominal Infections: Developing Drugs for
Treatment; Guidance for Industry; 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 guidance for industry entitled ``Complicated Intra-
Abdominal Infections: Developing Drugs for Treatment.'' The purpose of
this guidance is to assist sponsors in the clinical development of
drugs for the treatment of complicated intra-abdominal infections
(cIAIs). Specifically, this guidance addresses FDA's current thinking
regarding the overall drug development program for the treatment of
cIAIs, including clinical trial designs to support approval of drugs.
This guidance finalizes the draft guidance of the same name issued
October 1, 2012.

DATES: Submit either electronic or written 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, 10001 New Hampshire Ave.,
Hillandale Bldg., 4th Floor, Silver Spring, MD 20993. Send one self-
addressed adhesive label to assist that 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 to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Joseph G. Toerner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993-0002, 301-
796-1300.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Complicated Intra-Abdominal Infections: Developing Drugs for
Treatment.'' The purpose of this guidance is to assist sponsors in the
development of drugs for the treatment of cIAIs.
    Intra-abdominal infections including cIAIs are common in clinical
practice and comprise a wide variety of clinical presentations and
differing sources of infection. Different bacterial pathogens are
responsible for cIAI, including Gram-negative aerobic bacteria, Gram-
positive bacteria, and anaerobic bacteria, including mixed infections.
This guidance describes the efficacy endpoint of clinical success as
resolution of the baseline signs and symptoms attributable to cIAI. The
guidance provides a scientific justification for a noninferiority
margin.
    This guidance finalizes the draft guidance of the same name issued
October 1, 2012. After consideration of comments received in response
to the draft guidance, FDA updated the guidance to include
clarifications about the primary efficacy endpoint and the use of prior
nontrial antibacterial drugs. In addition, issuance of this guidance
fulfills a portion of the requirements of Title VIII, section 804 of
the Food and Drug Safety and Innovation Act of 2012 (Pub. L. 112-144),
which requires FDA to review and, as appropriate, revise not fewer than
three guidance documents per year for the conduct of clinical trials
with respect to antibacterial and antifungal drugs.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents 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. The Paperwork Reduction Act of 1995

    This 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 parts 312 and 314 have
been approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.

III. Comments

    Interested persons may submit either electronic comments regarding
this document 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
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02591 Filed 2-9-15; 8:45 am]
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