[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Rules and Regulations]
[Pages 38657-38660]
[FR Doc No: 2018-15978]

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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

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Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0688; Product Identifier 2018-CE-026-AD; Amendment
39-19338; AD 2018-15-06]
RIN 2120-AA64

Airworthiness Directives; Honda Aircraft Company LLC Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Honda Aircraft Company LLC Model HA-420 airplanes. This AD requires
incorporating new and revised airworthiness limitations into the
airplane's maintenance program. This AD was prompted by a report that
several maintenance tasks were omitted from the airworthiness
limitations section of the Honda Aircraft Company, Inc. Model HA-420
Airworthiness Limitation and Inspection Manual (ALIM). We are issuing
this AD to address the unsafe condition on these products.

DATES: This AD is effective August 13, 2018.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 13,
2018.
    We must receive comments on this AD by September 21, 2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, 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.
    For service information identified in this final rule, contact
Honda Aircraft Company LLC, 6430 Ballinger Road, Greensboro, North
Carolina 27410; telephone<PHONE_NUMBER>; internet: http://www.hondajet.com. You may view this service information at the FAA,
Policy and Innovation Division, 901 Locust, Kansas City, Missouri
64106. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0688.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0688; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, the regulatory evaluation, any comments received, and
other information. The street address for the Docket Operations (phone:
800-647-5527) is listed above. Comments will be available in the AD
docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Samuel Kovitch, Aerospace Engineer,
Atlanta ACO Branch, FAA, 1701 Columbia Avenue, College Park, Georgia
30337; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    Honda Aircraft Company LLC has informed us that several required
maintenance tasks driven by system safety assessment requirements were
inadvertently omitted from or listed incorrectly in the airworthiness
limitations section of the Honda Aircraft Company, Inc. Model HA-420
ALIM with a revision level prior to Revision C1 and dated earlier than
May 1, 2018. Additional airworthiness limitations, additional
maintenance tasks for various systems, and reduced compliance times for
existing maintenance tasks are necessary to maintain all airplanes in a
condition for safe operation.
    In addition, we determined that some airplanes may have exceeded
the new maintenance intervals once the ALIM was revised, including but
not limited to:
    1. Latent failure mode of the Wing Anti-Ice Crossflow Valve
(WAIXV): This condition would prevent the opening of the WAIXV when
commanded and could result in loss of control of the airplane if one
bleed air source becomes unavailable while operating in icing
conditions. An existing ice protection system check would identify this
condition; however, the system check was not located in the
airworthiness limitations section of the ALIM. The revised ALIM
relocates the system check to the airworthiness limitations section and
reduces the system check intervals from 600 hours time-in-service (TIS)
to 300 hours TIS.
    2. Latent failures in the brake and emergency accumulators: The
hydraulic power system check for identifying and correcting potential
latent failures in the brake and emergency accumulators contained
incorrect procedures and was not located in the airworthiness
limitations section of the ALIM. Honda corrected these procedures and
superseded the current procedures (-801) with the new procedures (-
802). The revised ALIM lists the correct procedures for the hydraulic
power system check and relocates this check to the airworthiness
limitations section.
    These conditions, if not addressed, could result in failures in
various airplane systems, including but not limited to the hydraulic
and ice protection systems, which could result in loss of control of
the airplane.

Related Service Information Under 1 CFR Part 51

    We reviewed Honda Aircraft Company HA-420 Airworthiness Limitation
and Inspection Manual ``Airworthiness Limitations--Inspection/Check''
(Airworthiness Limitations section 05-60-00), dated May 1, 2018. The
service information contains airworthiness limitations, additional
maintenance tasks for various

systems, and reduced compliance times for existing maintenance tasks,
including but not limited to the hydraulic and ice protection systems.
This service information is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination

    We are issuing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

AD Requirements

    This AD requires revising the airworthiness limitations section of
the maintenance program by replacing Airworthiness Limitations section
05-60-00 with an issue date earlier than May 1, 2018, with the revised
Airworthiness Limitations section 05-60-00, dated May 1, 2018.
Incorporating these airworthiness limitations makes them mandatory
(reference 14 CFR 43.16 and 14 CFR 91.403(c)). For airplanes that have
exceeded the new maintenance intervals, compliance with replacement
times or inspection intervals is required before further flight once
the limitations are incorporated. Operators have the compliance time
period of the AD to plan for any immediate maintenance action required
by the new limitations. This includes, but is not limited to the
following:
     The 600-hour TIS ice protection system check, AMM Task
Reference 30-10-01-700-801, previously located in the Scheduled
Inspections section 05-20-00, has been relocated to the Airworthiness
Limitations section 05-60-00, and reduced to a 300-hour TIS interval.
Airplanes that have exceeded 300 hours TIS since the ice protection
system check was last performed must have the ice protection system
check within the compliance time specified in paragraph (f) of the AD.
This AD allows a credit for airplanes that had the system check at the
previous 600-hour TIS interval but have not exceeded 300 hours TIS
since the last check and the WAIXV passed the functionality check
contained in the procedure.
     The 600-hour TIS hydraulic power system check, AMM Task
Reference 29-00-01-700-801, previously located in the Scheduled
Inspections section 05-20-00, has been relocated to the Airworthiness
Limitations section 05-60-00, and revised to AMM Task Reference 29-00-
01-700-802. Airplanes that had the system check per the previous
incorrect version of the maintenance task (29-00-01-700-801) at 600
hours TIS must have the inspection done before further flight after
incorporating the airworthiness limitations.

FAA's Justification and Determination of the Effective Date

    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies waiving notice and comment prior to adoption of this rule
because exceeding certain maintenance intervals and/or limitations
could cause failures in various airplane systems, including but not
limited to the hydraulic and ice protection systems, which could result
in loss of control. Therefore, we find good cause that notice and
opportunity for prior public comment are impracticable. In addition,
for the reasons stated above, we find that good cause exists for making
this amendment effective in less than 30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, we invite you to send any written data, views, or
arguments about this final rule. Send your comments to an address
listed under the ADDRESSES section. Include the docket number FAA-2018-
0688 and Product Identifier 2018-CE-026-AD at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this final rule. We will
consider all comments received by the closing date and may amend this
final rule because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this final rule.

Costs of Compliance

    We estimate that this AD affects 96 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
              Action                      Labor cost              Parts cost          product        operators
----------------------------------------------------------------------------------------------------------------
Incorporate the revised            1 work-hour x $85 per     Not applicable.....             $85          $8,160
 Airworthiness Limitations          hour = $85.
 section 05-60-00 into the ALIM.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation Programs''
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to small airplanes, gliders,
balloons, airships, domestic business jet transport airplanes, and
associated appliances to the Director of the Policy and Innovation
Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have 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.
    For the reasons discussed above, I certify that this AD:
    (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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2018-15-06 Honda Aircraft Company LLC: Amendment 39-19338; Docket
No. FAA-2018-0688; Product Identifier 2018-CE-026-AD.

(a) Effective Date

    This AD is effective August 13, 2018.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Honda Aircraft Company LLC Model HA-420
airplanes with a serial number in the range of 42000011 through
42000112, certificated in any category.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 05, Time Limits.

(e) Unsafe Condition

    This AD was prompted by a report that several required
maintenance tasks were omitted from ``Airworthiness Limitations--
Inspection/Check'' (Airworthiness Limitations section 05-60-00), of
the Honda Aircraft Company HA-420 Airworthiness Limitation and
Inspection Manual (ALIM), with a revision level prior to C1 and
dated earlier than May 1, 2018. We are issuing this AD to prevent
failures in various airplane systems, including but not limited to
the hydraulic and ice protection systems, which could result in loss
of control of the airplane.

(f) Compliance

    Comply with the action of this AD within 30 days after August
13, 2018 (the effective date of this AD) or within 15 hours time-in-
service (TIS) after August 13, 2018 (the effective date of this AD),
whichever occurs first, unless already done. The airworthiness
limitations section revision required in paragraph (g) of this AD
contains new and reduced inspection intervals. Once you comply with
paragraph (g) of this AD, if the hours TIS of your airplane exceed
the threshold of any new limitation, you are required to comply with
the replacement times or inspection intervals before further flight.
This includes, but is not limited to, the following revised
inspections:
    (1) The 600-hour TIS interval ice protection system check, AMM
Task Reference 30-10-01-700-801, previously located in the Scheduled
Inspections section 05-20-00, has been relocated to the
Airworthiness Limitations section 05-60-00, and reduced to a 300-
hour TIS interval.
    (2) The 600-hour TIS interval hydraulic power system check (AMM
Task Reference 29-00-01-700-801), previously located in the
Scheduled Inspections section 05-20-00, has been relocated to the
Airworthiness Limitations section 05-60-00 and revised to AMM Task
Reference 29-00-01-700-802.

(g) Airworthiness Limitations Revision

    Revise the airworthiness limitations section of the maintenance
program by replacing Airworthiness Limitations section 05-60-00 with
an issue date earlier than May 1, 2018, with Airworthiness
Limitations section 05-60-00, ``Airworthiness Limitation--
Inspection/Check,'' dated May 1, 2018. Incorporating these
airworthiness limitations makes them mandatory (reference 14 CFR
43.16 and 14 CFR 91.403(c)).

    Note 1 to paragraph (g) of this AD: Airworthiness Limitations
section 05-60-00 is contained in the Honda Aircraft Company, Inc.
Model HA-420 ALIM.

(h) No Alternative Actions or Intervals

    After revising the airworthiness limitations section as required
by paragraph (g) of this AD, no alternative replacement times or
inspection intervals may be approved unless the actions and/or
intervals are approved as an alternative method of compliance in
accordance with the procedures specified in paragraph (k)(1) of this
AD.

(i) Credit for Previous Actions

    Actions accomplished before the effective date of this AD in
accordance with the 600-hour TIS ice protection system check, AMM
Task Reference 30-10-01-700-801 located in the Scheduled Inspections
section 05-20-00, is considered acceptable for compliance with the
300-hour TIS interval ice protection system check, AMM Task
Reference 30-10-01-700-801 located in the Airworthiness Limitations
section 05-60-00, dated May 1, 2018, if:
    (1) The wing anti-ice crossflow valve (WAIXV) passed the
functionality check contained in the procedure; and
    (2) The airplane has not exceeded 300 hours TIS since the ice
protection check was last performed.

(j) Special Flight Permit

    Special flight permits are prohibited.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Atlanta ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (l) of this AD.
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(l) Related Information

    For more information about this AD, contact Samuel Kovitch,
Aerospace Engineer, Atlanta ACO Branch, FAA, 1701 Columbia Avenue,
College Park, Georgia 30337; phone:<PHONE_NUMBER>; fax: (404) 474-
5605; email: [email protected].

(m) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Honda Aircraft Company, Inc. Model HA-420 Airworthiness
Limitation and Inspection Manual ``Airworthiness Limitations--
Inspection/Check,'' (Airworthiness Limitations section (05-60-00)),
dated May 1, 2018.
    (ii) Reserved.
    (3) For Honda Aircraft Company LLC service information
identified in this AD, contact Honda Aircraft Company LLC, 6430
Ballinger Road, Greensboro, North Carolina 27410; telephone (336)
662-0246; internet: http://www.hondajet.com.
    (4) You may view this service information at the FAA, Policy and
Innovation Division, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148.
    (5) You may view the service information that is incorporated by
reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Kansas City, Missouri, on July 19, 2018.
Pat Mullen,
Aircraft Certification Service, Acting Deputy Director, Policy and
Innovation Division, AIR-601.
[FR Doc. 2018-15978 Filed 8-6-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: April 6, 2009 (Volume 74, Number 64)]
[Notices]
[Page 15477]
[DOCID:fr06ap09-64]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP09-85-000]

El Paso Natural Gas Company; Notice of Request Under Blanket
Authorization

March 30, 2009.
    Take notice that on March 24, 2009, El Paso Natural Gas Company (El
Paso) filed a prior notice request pursuant to sections 157.205 and
157.208 of the Federal Energy Regulatory Commission's regulations under
the Natural Gas Act for authorization to decrease the Maximum Allowable
Operating Pressure (MAOP), under El Paso's blanket certificate issued
in Docket No. CP82-435-000. The filing may also be viewed on the Web 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. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Specifically, El Paso requests authorization to decrease the
certificated MAOP of a 111-mile segment of its 12\3/4\'' O.D. El Paso-
Douglas line (also referred as ``Line No. 1004) located in Cochise
County, Arizona and Dona Ana, Luna, Grant, and Hidalgo Counties, New
Mexico and to thereafter operate the segment of Line No. 1004 at the
lower MAOP. The MAOP decrease will be from 850 psig to 803 psig. This
change will not result in any abandonment of service to its customers.
    Any questions regarding the application should be directed to
Richard Derryberry, Director, Regulatory Affairs Department, El Paso
Natural Gas Company, P.O. Box 1087, Colorado Springs, CO 80944, phone:
(719) 520-3782, fax:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>    Any person may, within 60 days after the issuance of the instant
notice by the Commission, file pursuant to Rule 214 of the Commission's
Procedural Rules (18 CFR 385.214) a motion to intervene or notice of
intervention. Any person filing to intervene or the Commission's staff
may, pursuant to section 157.205 of the Commission's Regulations under
the Natural Gas Act (NGA) (18 CFR 157.205) file a protest to the
request. If no protest is filed within the time allowed therefore, 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 shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions via the Internet in lieu of paper. See 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site (http://www.ferc.gov) under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-7572 Filed 4-3-09; 8:45 am]

BILLING CODE 6717-01-P


MEMORANDUM

DATE:		October 8, 2014

TO:		Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	Gavin Lau, EPA Region 2/CASD-APB

SUBJECT:	October 7, 2014 Meeting Regarding Proposed Clean Power Plan for Existing Power Plants
--------------------------------------------------------------------------------

SUMMARY

      A meeting was held between EPA and the attendees listed below on October 7, 2014 to discuss the proposed Clean Power Plan for Existing Power Plants.  The Clean Power Plan for Existing Power Plants was proposed on June 2, 2014.

ATTENDEES

350NYC.org:
Patrick Almonrode

Advocate for Justice and Peace
Tiger Paul Schubert

Assemblymember Kavanogh's Office
Tara Pistilli

Bronx Health Link
Barbara Hart

Brooklyn for Peace  -  AMC Safe Energy Coalition
Bob Alpern

Ingram Financial Group
Sonia Ingram

Ironbound Community Corporation
Molly Greenberg

Neighbors Allied for Good Growth
Jenny Romer
Yim Lin

New York City Council
Jerrel Burney

New York City Law Department
Kathleen Schmid
Avery Grant
Joe Turpin

New York Committee for Occupational Safety and Health
Charlene Obernauer

New York Lawyers for the Public Interest
Mark Ladov
Rachel Spector

New Yorkers Against Fracking
Jessica Roff

NJ EJ Alliance
Nicky Sheats

Nos Quedamos
Jessica Clemente
Anthony Winn

NYC Mayor's Office
Michael Delaney

NYC Council
Samana Swamston

NYS Department of Environmental Conservation
Jared Snyder, Asst. Commissioner

NYS Office of the Attorney General
Peter Washburn

NYS Public Service Commission
Tony Belisto, Advisor to the Chair

Ocean Bay Community Development Corporation
Keith Kinch

THE NEW SCHOOL, Milano School of International Affairs, Management and Urban Policy
Ana I. Baptista, PhD
Laura Marincloa

UN Rep for the Anglican Communion Office in N.Y./ IMAC - Interfaith Moral Action on Climate
Catherine Skopic

United for Action
Bruce Rosen

WE ACT
Jonathan Hernandez

Youth Ministries
David Shuffler
Anthony Thomas


[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Rules and Regulations]
[Pages 47965-47967]
[FR Doc No: 2017-22287]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2017-N-5296]

Medical Devices; Immunology and Microbiology Devices;
Classification of the Nucleic Acid-Based Device for the Amplification,
Detection, and Identification of Microbial Pathogens Directly From
Whole Blood Specimens

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the nucleic acid-based device for the amplification, detection, and
identification of microbial pathogens directly from whole blood
specimens into class II (special controls). The special controls that
apply to the device type are identified in this order and will be part
of the codified language for the nucleic acid-based device for the
amplification, detection, and identification of microbial pathogens
directly from whole blood specimens' classification. We are taking this
action because we have determined that classifying the device into
class II (special controls) will provide a reasonable assurance of
safety and effectiveness of the device. We believe this action will
also enhance patients' access to beneficial innovative devices, in part
by reducing regulatory burdens.

DATES: This order is effective October 16, 2017. The classification was
applicable on September 22, 2014.

FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the nucleic acid-based device for
the amplification, detection, and identification of microbial pathogens

directly from whole blood specimens as class II (special controls),
which we have determined will provide a reasonable assurance of safety
and effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (the FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act to a predicate device that does not require
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new
device is substantially equivalent to a predicate by means of the
procedures for premarket notification under section 510(k) of the FD&C
Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act. Although the device was automatically within
class III, the De Novo classification is considered to be the initial
classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or PMA in order to market a substantially equivalent device (see 21
U.S.C. 360c(i), defining ``substantial equivalence''). Instead,
sponsors can use the less-burdensome 510(k) process, when necessary, to
market their device.

II. De Novo Classification

    On May 27, 2014, T2 Biosystems, Inc., submitted a request for
classification of the T2Candida Panel and T2Dx[supreg] Instrument. FDA
reviewed the request in order to classify the device under the criteria
for classification set forth in section 513(a)(1) of the FD&C Act. We
classify devices into class II if general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to general
controls, will provide reasonable assurance of the safety and
effectiveness of the device.
    Therefore, on September 22, 2014, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 866.3960. We have named
the generic type of device nucleic acid-based device for the
amplification, detection, and identification of microbial pathogens
directly from whole blood specimens, and it is identified as a
qualitative in vitro device intended for the amplification, detection,
and identification of microbial-associated nucleic acid sequences from
patients with suspected bloodstream infections. This device is intended
to aid in the diagnosis of bloodstream infection when used in
conjunction with clinical signs and symptoms and other laboratory
findings.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

Table 1--Nucleic Acid-Based Device for the Amplification, Detection, and
     Identification of Microbial Pathogens Directly From Whole Blood
                 Specimens Risks and Mitigation Measures
------------------------------------------------------------------------
            Identified risks                   Mitigations measures
------------------------------------------------------------------------
Incorrect identification of a            Special Controls (1), (2), (3),
 pathogenic microorganism by the device   (4), and (5).
 can lead to improper patient
 management.
Failure to correctly interpret test      Special Control (6).
 results.
Failure to correctly operate the         Special Controls (7) and (8).
 instrument.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is

subject to premarket notification requirements under section 510(k) of
the FD&C Act.

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other 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
part 807, subpart E, regarding premarket notification submissions have
been approved under OMB control number 0910-0120, the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073, and the collections of information in 21 CFR parts
801 and 809, regarding labeling have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  866.3960 to subpart D to read as follows:

Sec.  866.3960  Nucleic acid-based device for the amplification,
detection, and identification of microbial pathogens directly from
whole blood specimens.

    (a) Identification. A nucleic acid-based device for the
amplification, detection, and identification of microbial pathogens
directly from whole blood specimens is a qualitative in vitro device
intended for the amplification, detection, and identification of
microbial-associated nucleic acid sequences from patients with
suspected bloodstream infections. This device is intended to aid in the
diagnosis of bloodstream infection when used in conjunction with
clinical signs and symptoms and other laboratory findings.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Premarket notification submissions must include detailed device
description documentation, including the device components, ancillary
reagents required but not provided, and a detailed explanation of the
methodology, including primer/probe sequence, design, and rationale for
sequence selection.
    (2) Premarket notification submissions must include detailed
documentation from the following analytical and clinical performance
studies: Analytical sensitivity (limit of detection), reactivity,
inclusivity, precision, reproducibility, interference, cross
reactivity, carryover, and cross contamination.
    (3) Premarket notification submissions must include detailed
documentation from a clinical study. The study, performed on a study
population consistent with the intended use population, must compare
the device performance to results obtained from well-accepted reference
methods.
    (4) Premarket notification submissions must include detailed
documentation for device software, including, but not limited to,
software applications and hardware-based devices that incorporate
software.
    (5) The device labeling must include limitations regarding the need
for culture confirmation of negative specimens, as appropriate.
    (6) A detailed explanation of the interpretation of results and
acceptance criteria must be included in the device's 21 CFR
809.10(b)(9) compliant labeling.
    (7) Premarket notification submissions must include details on an
end user device training program that will be offered while marketing
the device, as appropriate.
    (8) As part of the risk management activities performed as part of
your 21 CFR 820.30 design controls, you must document an appropriate
end user device training program that will be offered as part of your
efforts to mitigate the risk of failure to correctly operate the
instrument.

    Dated: October 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22287 Filed 10-13-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 77 (Monday, April 22, 2019)]
[Notices]
[Page 16666]
[FR Doc No: 2019-08016]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Staff Attendance at the Southwest Power Pool, Regional
State Committee, Members' Committee and Board of Directors' Meetings

    The Federal Energy Regulatory Commission (Commission) hereby gives
notice that members of its staff may attend the meetings of the
Southwest Power Pool, Inc. Regional State Committee (RSC), Human
Resource Committee (HR), Finance Committee (FC), Members' Committee and
Board of Directors as noted below. Their attendance is part of the
Commission's ongoing outreach efforts.
    The meetings will be held at the Doubletree Warren Place, 6110
South Yale Place, Tulsa, OK 74136. The phone number is<PHONE_NUMBER>.
All meetings are Central Time.

SPP RSC

April 29, 2019 (8:00 a.m.-4:30 p.m. CDT)

SPP HR

April 29, 2019 (8:00 a.m.-1:00 p.m. CDT)

SPP FC

April 29, 2019 (8:00 a.m.-11:30 p.m. CDT)

SPP Members/Board of Directors

April 30, 2019 (8:00 a.m.-2:00 p.m. CDT)

    The discussions may address matters at issue in the following
proceedings:

Docket No. ER09-548, Kansas Corporation Commission
Docket No. ER14-2850, Southwest Power Pool, Inc.
Docket No. ER14-2851, Southwest Power Pool, Inc.
Docket No. ER15-2028, Southwest Power Pool, Inc.
Docket No. ER15-2115, Southwest Power Pool, Inc.
Docket No. ER15-2594, South Central MCN LLC
Docket No. EL16-91, Southwest Power Pool, Inc.
Docket No. EL16-108, Tilton Energy v. Midcontinent Independent System
Operator, Inc.
Docket No. ER16-204, Southwest Power Pool, Inc.
Docket No. ER16-505, GridLiance High Plains LLC
Docket No. ER16-1341, Southwest Power Pool, Inc.
Docket No. RM17-8, Reform of Generator Interconnection Procedures and
Agreements
Docket No. EL17-21, Kansas Electric Co. v. Southwest Power Pool, Inc.
Docket No. EL17-89, American Electric Power Service Corporation v.
Midcontinent Independent System Operator, Inc., et al.
Docket No. EL17-92, East Texas Electric Cooperative
Docket No. ER17-953, South Central MCN LLC
Docket No. ER17-1568, Southwest Power Pool, Inc.
Docket No. AD18-8, Reform of Affected System Coordination in the
Generator Interconnection Process
Docket No. EL18-9, Xcel Energy Services, Inc. v. Southwest Power Pool,
Inc.
Docket No. EL18-19, Southwest Power Pool, Inc.
Docket No. EL18-26, EDF Renewable Energy, Inc. v. Midcontinent
Independent System Operator, Inc., Southwest Power Pool, Inc., and PJM
Interconnection, L.L.C.
Docket No. EL18-35, Southwest Power Pool, Inc.
Docket No. EL18-58, Oklahoma Municipal Power Authority v. Oklahoma Gas
and Electric Co.
Docket No. EL18-194, Nebraska Public Power District v. Tri-State
Generation and Transmission Association, Inc. and Southwest Power Pool,
Inc.
Docket No. EL19-62-000, City Utilities of Springfield, Missouri v.
Southwest Power Pool, Inc.
Docket No. ER18-99, Southwest Power Pool, Inc.
Docket No. ER18-194, Southwest Power Pool, Inc.
Docket No. ER18-195, Southwest Power Pool, Inc.
Docket No. ER18-939, Southwest Power Pool, Inc.
Docket No. ER18-1267, South Central MCN LLC
Docket No. ER18-1702, Southwest Power Pool, Inc.
Docket No. ER18-1854, Southwest Power Pool, Inc.
Docket No. ER18-2030, Southwest Power Pool, Inc.
Docket No. ER18-2058, Southwest Power Pool, Inc.
Docket No. ER18-2318, Southwest Power Pool, Inc.
Docket No. ER18-2358, Southwest Power Pool, Inc.
Docket No. ER18-2404, Southwest Power Pool, Inc.
Docket No. ER19-261, Southwest Power Pool, Inc.
Docket No. ER19-356, Southwest Power Pool, Inc.
Docket No. ER19-456, Southwest Power Pool, Inc.
Docket No. ER19-460, Southwest Power Pool, Inc.
Docket No. ER19-477, Southwest Power Pool, Inc.
Docket No. ER19-1039, Southwest Power Pool, Inc.
Docket No. ER19-1111, Southwest Power Pool, Inc.
Docket No. ER19-1114, Southwest Power Pool, Inc.
Docket No. ER19-1135, Southwest Power Pool, Inc.
Docket No. ER19-1137, Southwest Power Pool, Inc.
Docket No. ER19-1159, Southwest Power Pool, Inc.
Docket No. ER19-1177, Southwest Power Pool, Inc.
Docket No. ER19-1178, Southwest Power Pool, Inc.
Docket No. ER19-1214, Southwestern Electric Power Company
Docket No. ER19-1297, Southwest Power Pool, Inc.
Docket No. ER19-1303, Westar Energy, Inc.
Docket No. ER19-1396, American Electric Power Service Corporation
Docket No. ER19-1446, Southwest Power Pool, Inc.
Docket No. ER19-1460, Southwest Power Pool, Inc.
Docket No. ER19-1497, Southwest Power Pool, Inc.
Docket No. ER19-1520, Sunflower Electric Power Corporation
Docket No. ES19-19, Southwest Power Pool, Inc.

    This meeting is open to the public.
    For more information, contact Patrick Clarey, Office of Energy
Market Regulation, Federal Energy Regulatory Commission at (317) 249-
5937 or [email protected].

    Dated: April 16, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-08016 Filed 4-19-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 230 (Thursday, December 1, 2022)]
[Rules and Regulations]
[Pages 73650-73652]
[FR Doc No: 2022-26260]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2022-0954]
RIN 1625-AA00

Safety Zone; Maumee River, Toledo, OH

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters directly surrounding the northern half of the I-75
Bridge over the Maumee River. The safety zone is needed to protect
personnel, vessels, and the marine environment from potential hazards
created by demolition of the bridge. Entry of vessels or persons into
this zone is prohibited unless specifically authorized by the Captain
of the Port Detroit.

DATES: This rule is effective from 1 p.m. on December 1, 2022, through
3 p.m. on December 3, 2022. This rule will be enforced from 1 p.m.
through 3 p.m. daily.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2022-0954 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 rule,
call or email MST1 Karl Dirksmeyer, Waterways Management, Marine Safety
Unit Toledo, Coast Guard; telephone<PHONE_NUMBER>, email
[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

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 the party conducting the work
notified the Coast Guard with insufficient time to accommodate a
comment period. It is impracticable to publish an NPRM because we must
establish this safety zone by December 1, 2022 in order to protect the
public with the hazards associated with this demolition project.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because immediate action is needed in
order to protect the public with the hazards associated with this
demolition project.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The Captain of the Port Detroit
(COTP) has determined that potential hazards associated with the bridge
demolition occurring between December 1, 2022-December 3, 2022, will be
a safety concern for anyone transiting near the I-75 bridge on the
Maumee River. This rule is needed to protect personnel, vessels, and
the marine environment in the navigable waters within the safety zone
while the bridge is being demolished.

IV. Discussion of the Rule

    This rule establishes a safety zone from 1 p.m. through 3 p.m. on
December 1, 2022 and December 2, 2022. In the case of inclement
weather, this safety zone will be enforced from 1 p.m.

through 3 p.m. on December 3, 2022. The safety zone will cover all
navigable waters 800 feet up and down river from surface to bottom,
below the old Michael V. DiSalle Memorial (I-75) Bridge located at
41[deg]37'36.026'' N 83[deg]32'30.552'' W. The duration of the safety
zone is intended to protect personnel, vessels, and the marine
environment in these navigable waters while the bridge is being
demolished. No vessel or person will be permitted to enter the safety
zone without obtaining permission from the COTP or a designated
representative.

V. 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. 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).
    This regulatory action determination is based on size, location,
duration, and time-of-day of the safety zone.

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
V.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
call or email 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.

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
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), 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 that will prohibit entry into the waters 800 feet up and
down river of the Michael V. DiSalle Memorial (I-75) Bridge while it is
demolished. It is categorically excluded from further review under
paragraph L[60(a)] of Appendix A, Table 1 of DHS Instruction Manual
023-01-001-01, Rev. 1. A Record of Environmental Consideration
supporting this determination is available in the docket. For
instructions on locating the docket, see the ADDRESSES section of this
preamble.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email 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 record
keeping 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: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T09-0954 to read as follows:

Sec.  165.T09-0954  Safety Zone; Maumee River, Toledo, OH.

    (a) Location. The following area is a safety zone: The safety zone
will cover all navigable waters 800 feet up and down river from surface
to bottom, underneath the old Michael V. DiSalle Memorial (I-75) Bridge
located at 41[deg]37'36.026'' N 83[deg]32'30.552'' W. All geographic
coordinates are North American Datum of 1983 (NAD 83).
    (b) Regulations. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into, transiting or anchoring within
this safety zone is prohibited unless authorized by the Captain of the
Port Detroit, or his or her designated representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Detroit or his designated
representative.
    (3) The ``designated representative'' of the Captain of the Port
Detroit is any Coast Guard commissioned, warrant, or petty officer who
has been designated by the Captain of the Port Detroit to act on his
behalf. The designated representative of the Captain of the Port
Detroit will be aboard either a Coast Guard or Coast Guard Auxiliary
vessel. The Captain of the Port Detroit or his designated
representative may be contacted via VHF Channel 16.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port Detroit or his designated
representative to obtain permission to do so at least 30 minutes prior
to transit. Vessel operators given permission to enter or operate in
the safety zone must comply with all directions given to them by the
Captain of the Port Detroit or his designated representative.
    (c) Enforcement periods. This section will be enforced from
December 1, 2022, through December 3, 2022, from 1 p.m. through 3 p.m.
daily.

    Dated: November 28, 2022.
Brad W. Kelly,
Captain, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2022-26260 Filed 11-30-22; 8:45 am]
BILLING CODE 9110-04-P