[Federal Register: September 8, 2010 (Volume 75, Number 173)]
[Notices]
[Page 54637-54638]
[DOCID:fr08se10-82]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0285]

Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document for Certain Percutaneous
Transluminal Coronary Angioplasty (PTCA) Catheters; 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 the guidance entitled ``Class II Special Controls
Guidance Document for Certain Percutaneous Transluminal Coronary
Angioplasty (PTCA) Catheters.'' The guidance was developed as a special
control to support the reclassification of PTCA catheters, other than
cutting/scoring PTCA catheters, from class III (premarket approval)
into class II (special controls). This guidance describes a means by
which PTCA catheters, other than cutting/scoring PTCA catheters, may
comply with the requirement of special controls for class II devices.
Elsewhere in this issue of the Federal Register, FDA is publishing a
final rule that codifies the reclassification of this device type from
class III (premarket approval) into class II (special controls).

DATES:  Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.

ADDRESSES:  Submit written requests for single copies of the guidance
document entitled ``Class II Special Controls Guidance Document for
Certain Percutaneous Transluminal Coronary Angioplasty (PTCA)
Catheters'' to the Division of Small Manufacturers, International, and
Consumer Assistance (HFZ-220), Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 4613, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request, or fax
your request to<PHONE_NUMBER>. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance.
    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. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Kathryn O'Callaghan, Center for
Devices and Radiological Health (HFZ-450), Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-
796-6349.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance document was developed as a special control guidance
to support the reclassification of PTCA catheters, other than cutting/
scoring PTCA catheters, into class II (special controls). The device is
intended for balloon dilatation of a hemodynamically significant
coronary artery or bypass graft stenosis in patients evidencing
coronary ischemia for the purpose of improving myocardial perfusion,
treatment of acute myocardial infarction, treatment of in-stent
restenosis and/or post-deployment stent expansion. Cutting/scoring PTCA
catheters (Product Code: NWX) remain in class III and are subject to
premarket

approval (PMA) requirements (section 515 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360e)).
    On December 4, 2000, at a public meeting of FDA's Circulatory
System Devices Panel (the Panel), the Panel recommended that PTCA
catheters, other than cutting/scoring PTCA catheters and standard PTCA
catheters for the treatment of in-stent restenosis and/or post-
deployment stent expansion, be reclassified from class III to class II,
when indicated for balloon dilatation of a hemodynamically significant
coronary artery or bypass graft stenosis in patients evidencing
coronary ischemia for the purpose of improving myocardial perfusion, or
for treatment of acute myocardial infarction. The Panel recommended a
guidance document, labeling, and postmarket surveillance as special
controls.
    FDA considered the Panel's recommendations and, on May 30, 2008,
published a proposed rule to reclassify certain PTCA catheters,
including standard PTCA catheters for the treatment of in-stent
restenosis and/or post-deployment stent expansion, but not cutting/
scoring PTCA catheters, into class II. In addition, FDA issued a draft
class II special controls guidance document entitled ``Class II Special
Controls Guidance Document for Certain Percutaneous Transluminal
Coronary Angioplasty (PTCA) Catheters'' to support the proposed
reclassification.
    Following publication of the draft guidance, two sets of comments
on the guidance were submitted to the FDA. The comments received sought
minor clarifications on several pre-clinical testing recommendations,
including biocompatibility, shelf-life and performance testing. We
considered the suggestions and made appropriate revisions. In addition,
the guidance was updated to include more specific recommendations
regarding evaluation of coating integrity. FDA is now identifying the
guidance document entitled ``Class II Special Controls Guidance
Document for Certain Percutaneous Transluminal Coronary Angioplasty
(PTCA) Catheters'' as the guidance document that will serve as the
special control for this device type.
    The guidance document provides a means by which PTCA catheters,
other than cutting/scoring PTCA catheters, may comply with the
requirement of special controls for this class II device. Following the
effective date of the final reclassification rule, any firm submitting
a premarket notification (510(k)) for a PTCA catheter will need to
address the issues covered in the special controls guidance document.
However, the firm need only show that its device meets the
recommendations of the guidance document or in some other way provides
equivalent assurances of safety and effectiveness.

II. Significance of Guidance

    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 standard PTCA catheters. 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 statute and
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
using the Internet. To receive ``Class II Special Controls Guidance
Document for Certain Percutaneous Transluminal Coronary Angioplasty
(PTCA) Catheters'' you may either send an e-mail request to
<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive a hard copy. Please use
the document number (1608) to identify the guidance you are requesting.
    CDRH maintains an entry on the Internet for easy access to
information including text, graphics, and files that may be downloaded
to a personal computer with Internet access. Updated on a regular
basis, the CDRH home page includes device safety alerts, Federal
Register reprints, information on premarket submissions (including
lists of approved applications and manufacturers' addresses), small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at http://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available on the Division of Dockets Management Internet site at http:/
/www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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 part 807, Subpart E, have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 812 have been approved under OMB control
number 0910-0078; the collections of information under CFR parts 50 and
56 have been approved under OMB control number 0910-0130; the
collections of information in 21 CFR part 820 have been approved under
0910-0073; and the collections of information in 21 CFR part 801 have
been approved under OMB control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.

    Dated: August 31, 2010.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2010-22303 Filed 9-7-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 72 (Friday, April 16, 2021)]
[Notices]
[Page 20135]
[FR Doc No: 2021-07834]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC21-75-000.
    Applicants: Waterbury Generation LLC, Hull Street Energy, LLC.
    Description: Joint Application for Authorization Under Section 203
of the Federal Power Act of Waterbury Generation LLC, et al.
    Filed Date: 04/09/2021.
    Accession Number: 20210409-5357.
    Comment Date: 5 p.m. ET 4/30/21.

    Take notice that the Commission received the following exempt
wholesale generator filings:

    Docket Numbers: EG21-120-000.
    Applicants: BMP Wind LLC.
    Description: Notice of Self Certification of Exempt Wholesale
Generator Status of BMP Wind LLC.
    Filed Date: 4/12/21.
    Accession Number: 20210412-5598.
    Comments Due: 5 p.m. ET 5/3/21.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER21-1657-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA No. 6003; Queue
No. AF1-102 to be effective 3/11/2021.
    Filed Date: 4/12/21.
    Accession Number: 20210412-5465.
    Comments Due: 5 p.m. ET 5/3/21.

    Docket Numbers: ER21-1658-000.
    Applicants: Alabama Power Company.
    Description: Sec.  205(d) Rate Filing: Hobnail Solar LGIA Filing to
be effective 3/29/2021.
    Filed Date: 4/12/21.
    Accession Number: 20210412-5625.
    Comments Due: 5 p.m. ET 5/3/21.

    Docket Numbers: ER21-1659-000.
    Applicants: Ohio Power Company, AEP Ohio Transmission Company,
Inc., American Electric Power Service Corporation, PJM Interconnection,
L.L.C.
    Description: Sec.  205(d) Rate Filing: AEP submits the Hardin Solar
FA re: ILDSA SA No. 1336 to be effective 6/12/2021.
    Filed Date: 4/12/21.
    Accession Number: 20210412-5636.
    Comments Due: 5 p.m. ET 5/3/21.

    Docket Numbers: ER21-1660-000.
    Applicants: Arizona Public Service Company.
    Description: Sec.  205(d) Rate Filing: Service Agreement No. 363--
Amendment Nos. 2 & 3 to be effective 5/15/2020.
    Filed Date: 4/12/21.
    Accession Number: 20210412-5681.
    Comments Due: 5 p.m. ET 5/3/21.

    Docket Numbers: ER21-1661-000.
    Applicants: Arizona Public Service Company.
    Description: Tariff Cancellation: Service Agreement No. 363--Notice
of Cancellation to be effective 5/15/2021.
    Filed Date: 4/12/21.
    Accession Number: 20210412-5713.
    Comments Due: 5 p.m. ET 5/3/21.

    Docket Numbers: ER21-1662-000.
    Applicants: Indianapolis Power & Light Company.
    Description: Application to Modify Reactive Power and Voltage
Control Revenue Requirement of Indianapolis Power & Light Company.
    Filed Date: 04/09/2021.
    Accession Number: 20210409-5382.
    Comments Due: 5 p.m. ET 4/30/21.

    Take notice that the Commission received the following electric
securities filings:

    Docket Numbers: ES21-36-000.
    Applicants: El Paso Electric Company.
    Description: Application Under Section 204 of the Federal Power Act
for Authorization to Issue Securities of El Paso Electric Company.
    Filed Date: 04/09/2021.
    Accession Number: 20210409-5356.
    Comments Due: 5 p.m. ET 4/30/21.

    Docket Numbers: ES21-37-000.
    Applicants: DTE Electric Company.
    Description: Application under Section 204 of the Federal Power Act
for Authorization to Issue Securities for DTE Electric Company.
    Filed Date: 4/12/21.
    Accession Number: 20210412-5518.
    Comments Due: 5 p.m. ET 5/3/21.

    Take notice that the Commission received the following PURPA
210(m)(3) filings:

    Docket Numbers: QM21-16-000.
    Applicants: Northern States Power Company, a Minnesota Corporation,
Northern States Power Company, a Wisconsin Corporation.
    Description: Application of Northern States Power Company, a
Minnesota Corporation, et al. to Terminate Its Mandatory Purchase
Obligation under the Public Utility Regulatory Policies Act of 1978.
    Filed Date: 04/09/2021.
    Accession Number: 20210409-5380.
    Comments Due: 5 p.m. ET 5/7/21.

    Docket Numbers: QM21-17-000.
    Applicants: Arkansas Electric Cooperative Corporation.
    Description: Application of Arkansas Electric Cooperative
Corporation to Terminate Its Mandatory Purchase Obligation under the
Public Utility Regulatory Policies Act of 1978.
    Filed Date: 04/12/2021.
    Accession Number: 20210412-5789.
    Comments Due: 5 p.m. ET 5/10/21.

    Docket Numbers: QM21-18-000.
    Applicants: Arkansas Electric Cooperative Corporation.
    Description: Application of Arkansas Electric Cooperative
Corporation to Terminate its Mandatory Purchase Obligation under the
Public Utility Regulatory Policies Act of 1978.
    Filed Date: 04/12/2021.
    Accession Number: 20210412-5796.
    Comments Due: 5 p.m. ET 5/10/21.

    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 12, 2021.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2021-07834 Filed 4-15-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Rules and Regulations]
[Pages 57826-57828]
[FR Doc No: 2017-26462]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2017-1067]
RIN 1625-AA00

Safety Zone; Sector Key West COTP Zone Post Storm Recovery,
Atlantic Ocean, FL

AGENCY: Coast Guard, DHS.

ACTION: Temporary interim rule; request for comments.

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SUMMARY: The Coast Guard has established a temporary safety zone for
certain waters within the Sector Key West Captain of the Port (COTP)
Zone. Vessels are prohibited from entering into, anchoring, loitering,
or movement within a safety zone around salvage or pollution removal
vessels in the Florida Keys. These temporary regulations are necessary
for the safety of persons, vessels, and property due to the large
volume of debris, sunken vessels and salvage operations associated with
Hurricane Irma. We invite your comments on this rulemaking.

DATES: This rule is effective without actual notice from December 8,
2017 through February 1, 2018. For the purposes of enforcement, actual
notice will be used from December 1, 2017 until December 8, 2017.
Comments and related materials must be received by the Coast Guard on
or before January 8, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2017-1067 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
rulemaking, call or email Lieutenant Scott Ledee, Waterways Management
Division Chief, Sector Key West, FL, U.S. Coast Guard; telephone (305)
292-8768, e-mail [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

    CFR Code of Federal Regulations
    DHS Department of Homeland Security
    FR Federal Register
    NPRM Notice of proposed rulemaking
    Sec.  Section
    U.S.C. United States Code
    COTP Captain of the Port

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because insufficient time remains to publish
an NPRM and to receive public comments, as Hurricane Irma has already
caused significant damage to vessels and property in the Sector Key
West COTP Zone leaving underwater debris and sunken vessels around the
Florida Keys. The safety zone is necessary to provide for the safety of
persons, vessels, and property from the hazards posed by sunken vessels
and debris. For those reasons, it would be impracticable and contrary
to the public interest to publish an NPRM.
    On October 12, 2017, the Coast Guard published a temporary interim
final rule, entitled ``Safety Zone; Sector Key West COTP Zone Post
Storm Recovery, Atlantic Ocean, FL'' in the Federal Register (82 FR
473474) establishing a temporary safety zone around salvage or
pollution removal vessels in the Florida Keys. The Coast Guard
solicited for comments for this interim final rule, the comment period
for this rule ended on November 13, 2017, no comments were received.
The safety zone expires on December 1, 2017, but additional time is
needed to complete the salvage and pollution recovery operations. This
rule establishes a safety zone from December 1, 2017 to February 1,
2018 to ensure, to the extent practicable, that there continues to be
protections for the safety of persons, vessels, and property due to the
large volume of debris, sunken vessels and salvage operations
associated with Hurricane Irma, which was unable to be completed during
the original time frame. It would be impracticable and contrary to the
public interest for the existing safety zone to lapse when the salvage
and pollution recovery operations need to continue past the expiration
date of the existing safety zone.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making it effective less than 30 days after publication in
the Federal Register. Any delay in the effective date of this rule
would be contrary to the public interest because immediate action is
needed to respond to the potential hazards associated with hurricane
debris.
    The Coast Guard is soliciting public comments on this temporary
interim rule. Although we need to make this interim rule effective
immediately, we will consider public comments and may issue a temporary
final rule that will supersede this interim rule based on comments
received.

III. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, visit http://www.regulations.gov/privacyNotice. Documents
mentioned in this rule as being available in the docket, and all public
comments, will be in our online docket at http://www.regulations.gov
and can be viewed by following that Web site's instructions.
Additionally, if you go to the online docket and sign up for email
alerts, you will be notified when comments are posted or a final rule
is published.

IV. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231 The COTP Key West has determined that potential hazards associated
with salvage operations and hurricane debris will be a safety concern
for persons, vessels, and property within the waters of the ports
mentioned above. The COTP Key West has determined it is necessary
establish a safety zone from December 1, 2017 until February 1,

2018, to protect persons, vessels, and property on the navigable waters
within the safety zone while cleanup efforts are underway.

V. Discussion of the Rule

    This rule establishes a temporary safety zone for certain waters
within the Sector Key West Captain of the Port (COTP) Zone as salvage
and pollution recovery cleanup efforts continue. Vessels are prohibited
from entering into, anchoring, loitering, or movement within a safety
zone around salvage or pollution removal vessels in the Florida Keys.
These temporary regulations are necessary for the safety of persons,
vessels, and property due to the large volume of debris, sunken vessels
and salvage operations associated with Hurricane Irma.
    The COTP Key West will continue to evaluate conditions in the
waters in the vicinity of the Florida Keys and may stop enforcing this
rule earlier if the conditions permit. The Coast Guard will provide
notification of the safety zone to the local maritime community by
Marine Safety Information Bulletins, Broadcast Notice to Mariners, and
on-scene designated representatives.

VI. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the following
reasons: The safety zone is of a small diameter around salvage and
pollution recovery vessels and wreckage, and the Coast Guard will
provide notice of the safety zones to the local maritime community by
Marine Safety Information Bulletins, Broadcast Notice to Mariners, and
designated on-scene representatives.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
VI.A above, this rule will not have a significant economic impact on
any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves a safety zone from which vessels are excluded. This rule
is categorically excluded from further review under paragraph 34(g) of
Figure 2-1 of the Commandant Instruction. A Record of Environmental
Consideration supporting this determination is available in the docket
where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your

message can be received without jeopardizing the safety or security of
people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191, 33 CFR 1.05-1, 6.04-
1, 6.04-6, 160.5; and Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T07-1067 to read as follows:

Sec.  165.T07-1067  Safety Zone; Sector Key West COTP Zone Post Storm
Recovery, Atlantic Ocean, FL.

    (a) Location. The following area is a safety zone: All waters
within 100 yards of all salvage vessels and pollution recovery vessels
operating within 1 nautical mile of land in the Captain of the Port
(COTP) Key West.
    (b) Definition. As used in this section, the term ``designated
representative'' includes Coast Guard coxswains, petty officers, and
other officers operating Coast Guard vessels, and Federal, state, and
local officers designated by or assisting the COTP Key West in the
enforcement of the safety zone.
    (c) Regulations. (1) All persons and vessels are prohibited from
entering, transiting through, anchoring in, or remaining within the
safety zone unless authorized by the COTP Key West or a designated
representative.
    (2) Persons and vessels desiring to enter, transit through, anchor
in, or remain within the safety zone may contact the COTP Key West by
telephone at<PHONE_NUMBER>, or a designated representative via VHF-FM
radio on channel 16 to request authorization. If authorization is
granted, all persons and vessels receiving such authorization must
comply with the instructions of the COTP Key West or a designated
representative.
    (d) Enforcement period. This rule will be enforced from 8 a.m. on
December 1, 2017, through 8 a.m. on February 1, 2018, unless sooner
terminated by the COTP Key West.

    Dated: December 1, 2017.
Jeffrey. A. Janszen,
Captain, U.S. Coast Guard, Captain of the Port Key West.
[FR Doc. 2017-26462 Filed 12-7-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 129 (Friday, July 7, 2023)]
[Notices]
[Pages 43334-43335]
[FR Doc No: 2023-14345]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1121-140]

Pacific Gas and Electric Company; Notice of Application Accepted
for Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Request for license amendment.
    b. Project No.: 1121-140.
    c. Date Filed: June 8, 2023.
    d. Applicant: Pacific Gas and Electric Company.
    e. Name of Project: Battle Creek Project.
    f. Location: The project is located on Battle Creek, and the North
and South Forks of Battle Creek, in Shasta and Tehama counties,
California, and occupies Federal lands administered by the U.S. Forest
Service.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Ms. Shelby McArthur, Pacific Gas and Electric
Company, Mail Code: N11D P.O. Box 770000, San Francisco, CA 94177,
(530) 215-7825.
    i. FERC Contact: Mr. John Aedo,<PHONE_NUMBER>, [email protected].
    j. Deadline for filing comments, motions to intervene, and
protests: July 31, 2023.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/doc-sfiling/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, MD 20852. The first page of any filing should
include docket number P-1121-140. Comments emailed to Commission staff
are not considered part of the Commission record.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person on the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Request: The applicant requests a long-term
variance of the ramping rate requirements below North Battle Creek Dam
between the months of November and March when there is no minimum flow
requirement in place. During this time, the applicant would perform a
required annual test of low-level outlet functionality by opening the
outlet and releasing approximately 40 cubic feet per second and then
closing the outlet, all within the span of about 10 minutes. The
applicant's proposal would exceed the 0.1 feet per hour ramping rate
depth requirement on a reoccurring annual basis during the outlet
tests. The applicant is requesting the variance of the ramping rate
requirement until such

a time the project is surrendered. Due to the continuing nature of the
applicant's request without a definitive end date, the Commission is
considering the request as an application to amend the ramping rate
requirement set forth in Article 33(d) of the project license.
    l. Locations of the Application: This filing may be viewed on the
Commission's website at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
[email protected], for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Motions to Intervene, or Protests: Anyone may submit
comments, a motion to intervene, or a protest in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, motions to
intervene, or protests must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS'', ``MOTION TO
INTERVENE'', or ``PROTEST'' as applicable; (2) set forth in the heading
the name of the applicant and the project number(s) of the application
to which the filing responds; (3) furnish the name, address, and
telephone number of the person intervening or protesting; and (4)
otherwise comply with the requirements of 18 CFR 385.2001 through
385.2005. All comments, motions to intervene, or protests must set
forth their evidentiary basis. A copy of all other filings in reference
to this application must be accompanied by proof of service on all
persons listed in the service list prepared by the Commission in this
proceeding, in accordance with 18 CFR 385.2010.
    p. 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].

    Dated: June 30, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-14345 Filed 7-6-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 232 (Tuesday, December 5, 2017)]
[Rules and Regulations]
[Pages 57353-57354]
[FR Doc No: 2017-26094]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2017-1038]

Drawbridge Operation Regulation; Rigolets Pass, Slidell, LA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the CSX Railroad Bridge across the
Rigolets Pass, mile 0.0, St. Tammany Parish, Louisiana. This deviation
is necessary to perform maintenance for the continued safe operation of
the bridge. This deviation allows for the bridge to remain in the
closed-to-navigation position on December 12, 2017, through December
15, 2017. It further requires a one-hour advance notice for openings to
facilitate passage of vessel traffic from 7 a.m. to 5 p.m. on certain
dates from December 18, 2017 through January 12, 2018.

DATES: This deviation is effective from 4 a.m. on December 12, 2017,
through 5 p.m. on January 12, 2018.

ADDRESSES: The docket for this deviation, [USCG-2017-1038] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Giselle T. MacDonald, Bridge
Administration Branch, Coast Guard, telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION: The CSX Transportation requested a temporary
deviation from the operating schedule of the CSX Railroad Swing Bridge
across Rigolets Pass, mile 0.0, near Slidell, St. Tammany Parish,
Louisiana. This deviation is necessary to replace the center pivot
bearing and the wedge machinery on the south center and southwest end
of the swing span.
    For the purposes of this deviation, the bridge will be allowed to
remain in the closed-to-navigation position from 4 a.m. on Tuesday,
December 12, 2017, through 4 a.m. on Friday, December 15, 2017, and a
one-hour advance notice for openings to facilitate passage of vessel
traffic from 7 a.m. to 5 p.m., each day, on December 18, 2017, through
December 22, 2017, and from January 2, 2018 through January 12, 2018.
At all other times the bridge will operate in accordance with 33 CFR
117.5.
    The vertical clearance of the bridge is 14.5 feet above mean low
water (MLW), elevation 11.9 feet above mean high water (MHW) in the
closed-to-navigation position. Navigation on the waterway consists of
tugs with tows, commercial fishing vessels and some recreational
crafts.
    For the duration of the repair work, vessels will not be allowed to
pass through the bridge in the closed-to-navigation position and will
not be able to open for emergencies. The alternate route for vessels to
pass is the Pearl

River. The Coast Guard will also inform the users of the waterways
through our Local and Broadcast Notices to Mariners of the change in
operating schedule for the bridge so that vessel operators can arrange
their transits to minimize any impact caused by the temporary
deviation.
    In accordance with 33 CFR 117.35, the drawbridge must return to its
regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: November 29, 2017.
Douglas A. Blakemore,
Bridge Administrator, Eighth Coast Guard District.
[FR Doc. 2017-26094 Filed 12-4-17; 8:45 am]
BILLING CODE 9110-04-P