[Federal Register Volume 87, Number 30 (Monday, February 14, 2022)]
[Notices]
[Pages 8337-8338]
[FR Doc No: 2022-03087]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Actions on Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice of actions on special permit applications.

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SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations, notice is hereby given
that the Office of Hazardous Materials Safety has received the
application described herein.

DATES: Comments must be received on or before March 16, 2022.

ADDRESSES: Record Center, Pipeline and Hazardous Materials Safety
Administration, U.S. Department of Transportation, Washington, DC
20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Donald Burger, Chief, Office of
Hazardous Materials Safety General Approvals and Permits Branch,
Pipeline and Hazardous Materials Safety Administration, U.S. Department
of Transportation, East Building, PHH-13, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Copies of the applications are available for
inspection in the Records Center, East Building, PHH-13, 1200 New
Jersey Avenue Southeast, Washington DC.
    This notice of receipt of applications for special permit is
published in accordance with part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on February 4, 2022.
Donald P. Burger,
Chief, General Approvals and Permits Branch.

----------------------------------------------------------------------------------------------------------------
                                                                                Nature of the special permits
       Application No.                 Applicant          Regulation(s) affected              thereof
----------------------------------------------------------------------------------------------------------------
                                          Special Permits Data--Granted
----------------------------------------------------------------------------------------------------------------
11993-M......................  Key Safety Systems, Inc.  173.301(a)(1),            To modify the special permit
                                                          173.302(a)(1).            to authorize a different
                                                                                pressure test and
                                                                                alternative safety control
                                                                                measures.
12135-M......................  Daicel Safety Systems     173.301(a)(1),            To modify the special permit
                                Inc.                      173.302a(a),              to remove the flattening
                                                          178.65(c)(3).             test requirement and
                                                                                authorize alternative
                                                                                markings.
14799-M......................  Joyson Safety Systems     173.301(a),               To modify the special permit
                                Sachsen Gmbh.             173.302(a)(1).            to authorize a different
                                                                                pressure test and
                                                                                alternative safety control
                                                                                measures.
14833-M......................  Joyson Safety Systems     178.65(f)(2),             To modify the special permit
                                Aschaffenburg Gmbh.       173.301(a),               to authorize a different
                                                          173.302(a)(2).            pressure test and
                                                                                alternative safety control
                                                                                measures.
15372-M......................  Equipo Automotriz         173.301(a)(1),            To modify the special permit
                                Americana, S.a. De C.v.   173.302(a).               to authorize a different
                                                                                pressure test and
                                                                                alternative safety control
                                                                                measures.
15713-M......................  Bulk Tank International,  178.345-2, 178.346-2,     To modify the special permit
                                S. De R.l. De C.v.        178.347-2, 178.348-2.     to authorize the use of the
                                                                                2017 Edition of the ASME
                                                                                Code.
16318-M......................  Technical Chemical        173.304(d), 173.167(a)..  To modify the special permit
                                Company.                                            to authorize an additional
                                                                                hazardous material.

20646-M......................  Omni Tanker Pty. Ltd....  107.503(b), 107.503(c),   To modify the special permit
                                                          172.102(c)(3),            to authorize additional
                                                          172.102(c)(7)(ii),        hazardous materials and rail
                                                          178.274(b), 178.274(c),   freight.
                                                          178.274(d).
21231-N......................  Patrick J. Kelly Drums,   173.28(b)...............  To authorize the recondition
                                Inc.                                                of UN specification metal
                                                                                drums that have minimum
                                                                                steel thicknesses below
                                                                                those now authorized in 49
                                                                                CFR Sec.   173.28(b)(4).
21257-N......................  The Procter & Gamble      173.306(a)(5)(v),         To authorize the
                                Company.                  173.306(a)(5)(vi).        transportation in commerce
                                                                                of non-flammable, non-toxic
                                                                                compressed gases (Division
                                                                                2.2) in DOT Specification 2S
                                                                                and non-DOT specification
                                                                                plastic aerosols not
                                                                                exceeding a capacity of one
                                                                                liter, designed and tested
                                                                                through an in-line pressure
                                                                                testing approach under a
                                                                                quality management system.
21274-N......................  Cf Industries Sales, LLC  172.401, 172.502........  To authorize the
                                                                                transportation in commerce
                                                                                of nitric acid mixtures with
                                                                                nitric acid concentrations
                                                                                of equal to or greater than
                                                                                64.5% and less than 65.0% as
                                                                                having a Division 5.1
                                                                                subsidiary hazard.
21289-N......................  Chemtrade Refinery        173.35(e)...............  To authorize the
                                Services Inc.                                       transportation in commerce
                                                                                of IBCs containing the
                                                                                residue of certain hazardous
                                                                                materials where the closure
                                                                                nearest to the hazardous
                                                                                materials is open.
21293-N......................  Harnyss, LLC............  173.311.................  To authorize the manufacture,
                                                                                mark, sale and use of a
                                                                                specially designed storage
                                                                                device consisting of a non-
                                                                                DOT specification cylinder
                                                                                similar to a DOT 3AL
                                                                                cylinder for use in
                                                                                transporting hydrogen
                                                                                absorbed in metal hydride,
                                                                                Division 2.1.
21296-N......................  Lockheed Martin           173.185(a)(1)...........  To authorize the
                                Corporation.                                        transportation in commerce
                                                                                of low production lithium
                                                                                batteries in alternative
                                                                                packaging via motor vehicle.
21303-N......................  Korean Air Lines Co.,     172.101(j),               Authorizes the transportation
                                Ltd.                      173.27(b)(2),             in commerce of certain
                                                          173.27(b)(3), 175.30(a).  explosives that are
                                                                                forbidden for transportation
                                                                                by aircraft.
21305-N......................  Cyanco International,     180.605(e)..............  To authorize the use of
                                LLC.                                                ultrasonic thickness testing
                                                                                as an alternative to
                                                                                internal inspection for U.N.
                                                                                portable tanks containing
                                                                                sodium cyanide.
----------------------------------------------------------------------------------------------------------------
                                          Special Permits Data--Denied
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                         Special Permits Data--Withdrawn
----------------------------------------------------------------------------------------------------------------
21309-N......................  Construction              172.101(j), 173.27(b)(2)  To authorize the
                                Helicopters, Inc.                                   transportation in commerce
                                                                                of Division 1.1, 1.2, 1.3
                                                                                and 1.4 explosives that are
                                                                                not permitted for
                                                                                transportation aboard cargo-
                                                                                only aircraft or are in
                                                                                quantities greater than
                                                                                those prescribed for
                                                                                transportation aboard cargo-
                                                                                only aircraft.
21319-N......................  Kavok Eir, Tov..........  172.101(j),               To authorize the
                                                          172.204(c)(3), 173.27,    transportation in commerce
                                                          175.30(a)(1).             of forbidden explosives by
                                                                                cargo aircraft.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2022-03087 Filed 2-11-22; 8:45 am]
BILLING CODE P


[Federal Register Volume 76, Number 95 (Tuesday, May 17, 2011)]
[Rules and Regulations]
[Pages 28308-28309]
[FR Doc No: 2011-12037]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 800

[Docket No. FDA-2011-D-0258]

Compliance Policy Guide: Surgeons' Gloves and Patient Examination
Gloves; Defects--Criteria for Direct Reference Seizure

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of Compliance Policy Guide Sec. 335.700, Surgeons' Gloves
and Patient Examination Gloves; Defects--Criteria for Direct Reference
Seizure (the CPG). The CPG, which was originally issued in 1991,
provides guidance to FDA staff on the submission of seizure
recommendations for medical gloves that exceed the defect levels in FDA
regulations. The CPG has been revised to remove an appendix that became
obsolete when the regulations were amended, and to make other minor
changes for clarity and consistency with the amended regulation.

DATES: Submit either electronic or written comments on the CPG at any
time.

ADDRESSES: Submit written requests for single copies of the CPG to the
Division of Compliance Policy (HFC-230), Office of Enforcement, Food
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send
one self-addressed adhesive label to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for electronic
access to the CPG.
    Submit electronic comments on the CPG to http://www.regulations.gov. Submit written comments on the CPG to the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: David R. Kalins, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance document entitled
``Compliance Policy Guide Sec. 335.700, Surgeons' Gloves and Patient
Examination Gloves; Defects--Criteria for Direct Reference Seizure.''
The CPG provides guidance to FDA staff on the submission of seizure
recommendations for medical gloves that exceed the defect levels in 21
CFR 800.20. The CPG was originally issued on May 31, 1991, and was
previously revised in July 2005. It is currently being revised to
remove an appendix that became obsolete when an amendment to 21 CFR
800.20 became effective December 19, 2008. The amended rule includes
changes intended to improve the barrier quality of medical gloves
marketed in the United States by reducing the acceptable quality levels
(AQLs) for leaks and visual defects observed during FDA testing of
medical gloves. The CPG was revised for consistency with the AQLs in
the amended regulation. The text of the CPG also includes a number of
minor edits made for clarity. This document supersedes Compliance
Policy Guide Sec. 335.700, Surgeons' Gloves and Patient Examination
Gloves; Defects--Criteria for Direct Reference Seizure dated July 2005.
    FDA is issuing the CPG as Level 2 guidance consistent with FDA's
good guidance practices regulation (21 CFR 10.115). The CPG represents
FDA's current thinking on the criteria for direct reference seizure of
defective medical gloves. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Comments

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

III. Electronic Access

    Persons with access to the Internet may obtain the CPG at either
http://www.fda.gov/ora/compliance_ref/cpg/default.htm or at http://www.regulations.gov.

    Dated: May 5, 2011.
Dara A. Corrigan,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 2011-12037 Filed 5-16-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)]
[Rules and Regulations]
[Pages 66790-66792]
[FR Doc No: 2015-27440]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-3300; Directorate Identifier 2015-CE-024-AD;
Amendment 38-18309; AD 2015-22-04]
RIN 2120-AA64

Airworthiness Directives; Fiberglas-Technik Rudolf Lindner GmbH &
Co. KG Gliders

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

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for all
Fiberglas-Technik Rudolf Lindner GmbH & Co. KG Models G103 TWIN ASTIR,
G103 TWIN II, and G103A TWIN II ACRO gliders. This AD results from
mandatory continuing airworthiness information (MCAI) issued by an
aviation authority of another country to identify and correct an unsafe
condition on an aviation product. The MCAI describes the unsafe
condition as a broken bell-crank installed in the air brake control
system. We are issuing this AD to require actions to address the unsafe
condition on these products.

DATES: This AD is effective December 4, 2015.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in the AD as of December 4,
2015.

ADDRESSES: You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-
3300; or in person at Document Management Facility, U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
    For service information identified in this AD, contact Fiberglas-
Technik Rudolf Lindner GmbH & Co.KG, Steige 3, D-88487 Walpertshofen,
Germany; phone: ++49 (0) 7353/22 43; fax: ++49 (0) 7353/30 96; email:
<EMAIL_ADDRESS>Internet: www.ltb-lindner.com. You may view this
referenced service information at the FAA, Small Airplane Directorate,
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 Docket No. FAA-2015-3300.

FOR FURTHER INFORMATION CONTACT: Jim Rutherford, Aerospace Engineer,
FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City,
Missouri 64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to add an AD that would apply to all Fiberglas-Technik Rudolf
Lindner GmbH & Co. KG Models G103 TWIN ASTIR, G103 TWIN II, and G103A
TWIN II ACRO gliders. The NPRM was published in the Federal Register on
August 10, 2015 (80 FR 47871). The NPRM proposed to correct an unsafe
condition for the specified products and was based on mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country. The MCAI states:

    A report was received concerning a broken bell-crank, installed
in the air brake control circuit approximately 1.4 m outside the
wing root rib of a GROB G 103 Twin II sailplane. Preliminary
investigation results revealed additional cases of cracks on the
same part, installed in the air brake control systems of the early
Twin II type design.
    The same bell-cranks are also installed at the same location in
the control systems of other models belonging to the same type
design (see list of affected models under Applicability).
    This condition, if not detected and corrected, could lead to
failure of the air brake system, possibly resulting in reduced
control of the sailplane.
    To address this potential unsafe condition, Fiberglas-Technik
issued Technische Mitteilung (TM)/Service Bulletin (SB) TM-G08/SB-
G08 (one document) and Anweisung (A)/Instructions (I) A/I-G08 (one
document) to provide instructions for a check of the air brake
locking forces, the inspection of the bell-crank and, if cracks are
found, replacement of the bell-crank.
    Additionally, TM-G07/SB-G07 (one document) and A/I-G07 (one
document) provide instructions for the installation of inspection
openings in the wing of GROB G 103 TWIN II and G 103 A TWIN II ACRO
sailplanes to facilitate the inspection of the bell-crank. (For the
TWIN ASTIR and TWIN ASTIR TRAINER sailplanes, such an opening is
required by LBA AD 92-190/2 (GROB SB 315-45/2.) This installation is
optional for sailplanes not exceeding the original intended life
limit.
    For the reason described above, this AD requires a check of the
air brake locking forces, an inspection for cracks in the air brake
control unit and, if cracks are found, replacement of the affected
flight control system parts. This AD is a temporary measure and
further AD action may follow.

    The MCAI can be found in the AD docket on the Internet at http://www.regulations.gov/#!documentDetail;D=FAA-2015-3300-0003.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the proposal
and the FAA's response to each comment.

Request Credit for Certain Inspections Done Before AD Was Issued

    William Tisdale requested that the AD give credit for inspections
that were done following Fiberglas-Technik Rudolf Lindner Service
Bulletin (SB-G08), Edition April 24, 2015; and Fiberglas-Technik Rudolf
Lindner Anweisung (English translation: Instructions), (A/I-G08),
Ausgabe (English translation: Edition) April 24, 2015, within the year
before the AD being issued as meeting the initial inspection
requirement for both the tension and crack inspection.
    We infer that the commenter made this request in order to prevent
duplication of work already done.
    We agree with the commenter. In paragraph (f) of this AD, the first
sentence reads, ``Unless already done, do the following actions:.''
This sentence gives compliance credit to owners/operators of the
affected gliders for actions required by this AD that have already been
done before the effective date of this AD, if done following the
service information required by this AD.
    Because the requested change is already part of this AD, we have
not changed the final rule AD action based on this comment.

Request to Use Lighted Borescope To Inspect the Bell-Crank

    William Tisdale requested the use of a lighted borescope from
either the wing rib root or access through the spoiler box push rod
opening to inspect the bell-crank.
    We infer that the commenter wants us to incorporate into the AD an
allowance to use a lighted borescope to do the inspection of the bell-
crank installed in the air brake control system.
    We agree with the commenter about using a lighted borescope for the
inspection from the wing rib root as it is already allowed in
Fiberglas-Technik Rudolf Lindner Service Bulletin (SB-G08), Edition
April 24, 2015; and Fiberglas-Technik Rudolf Lindner Anweisung (English
translation: Instructions), (A/I-G08), Ausgabe (English translation:
Edition) April 24, 2015. In the service information it states, ``This
inspection is done using an endoscope or small camera working

through the wing root rib or using a mirror when working through an
inspecting opening.'' An endoscope consists of an optical system with a
high intensity light source and is sometimes referred to as a
borescope.
    We disagree with the commenter with using a lighted borescope to do
the inspection by accessing the area through the spoiler box push rod
opening since this procedure is not specified in the required service
information. The commenter may request an alternative method of
compliance (AMOC) for this process. The request, including all
substantiating data, may be submitted following 14 CFR 39.19 as
specified in paragraph (g)(1) of this AD.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD as proposed except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM (80 FR 47871, August 10, 2015) for correcting the unsafe
condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM (80 FR 47871, August 10, 2015).

Related Service Information Under 1 CFR Part 51

    We reviewed Fiberglas-Technik Rudolf Lindner Service Bulletin (SB-
G08), Edition April 24, 2015; and Fiberglas-Technik Rudolf Lindner
Anweisung/(English translation: Instructions), (A/I-G08), Ausgabe
(English translation: Edition) April 24, 2015. The service information
describes procedures for inspecting the air brake locking forces;
inspecting the bell-crank; and, if cracks are found during the
inspections, replacing the bell-crank. 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 of the AD.

Interim Action

    We consider this AD interim action. The design approval holder is
working toward a terminating action for the repetitive inspections. We
may take further AD action in the future.

Costs of Compliance

    We estimate that this AD will affect 106 products of U.S. registry.
We also estimate that it will take about 2 work-hours per product to
comply with the basic requirements of this AD. The average labor rate
is $85 per work-hour.
    Based on these figures, we estimate the cost of this AD on U.S.
operators to be $18,020, or $170 per product.
    In addition, we estimate that any necessary follow-on actions will
be as follows:
     Replacement of bell-crank will take about 5 work-hours per
product. Required parts will cost about $566 for a total of $991 per
product.
     Installation of optional inspection openings will take
about 15 work-hours per product. Required parts will cost about $1,004
for a total of $2,279 per product.
    We have no way of determining the number of products that may need
these actions.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to the FAA
at 800 Independence Ave. SW., Washington, DC 20591. ATTN: Information
Collection Clearance Officer, AES-200.

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.

Regulatory Findings

    We determined that 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 this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the 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.

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-2015-
3300; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains the NPRM, the regulatory evaluation, any comments received,
and other information. The street address for the Docket Office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

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 AD:

2015-22-04 Fiberglas-Technik Rudolf Lindner GmbH & Co. KG: Amendment
38-18309; Docket No. FAA-2015-3300; Directorate Identifier 2015-CE-
024-AD.

(a) Effective Date

    This airworthiness directive (AD) becomes effective December 4,
2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Fiberglas-Technik Rudolf Lindner GmbH & Co.
KG Models G103 TWIN ASTIR, G103 TWIN II, and G103A TWIN II ACRO
gliders, all manufacturer serial numbers, certificated in any
category.

(d) Subject

    Air Transport Association of America (ATA) Code 27: Flight
Controls.

(e) Reason

    This AD was prompted by mandatory continuing airworthiness
information (MCAI) originated by an aviation authority of another
country to identify and correct an unsafe condition on an aviation
product. The MCAI describes the unsafe condition as a broken bell-
crank installed in the air brake control system. We are issuing this
AD to detect and correct a broken bell-crank which could lead to
failure of the air brake system, possibly resulting in reduced
control.

(f) Actions and Compliance

    Unless already done, do the following actions:
    (1) Within 30 days after December 4, 2015 (the effective date of
this AD) and repetitively thereafter at intervals not to exceed 12
months, inspect the locking forces of the air brake control unit,
and, if any discrepancy is found, before further flight, correct the
locking forces. Do the inspection and correction of any discrepancy
following the instructions of Fiberglas-Technik Rudolf Lindner
Service Bulletin (SB-G08), Edition April 24, 2015; and Fiberglas-
Technik Rudolf Lindner Anweisung (English translation:
Instructions), (A/I-G08), Ausgabe (English translation: Edition)
April 24, 2015.

    Note 1 to paragraph (f)(1) of this AD:  This service information
contains German to English translation. The European Aviation Safety
Agency (EASA) used the English translation in referencing the
document. For enforceability purposes, we will refer to the
Fiberglas-Technik Rudolf Lindner service information as it appears
on the document.

    (2) Within 60 days after December 4, 2015 (the effective date of
this AD), inspect the bell-crank installed in the air brake control
system, and, if any cracks are found, before further flight, replace
the bell-crank with a serviceable part. Do the inspection and
replacement following the instructions of Fiberglas-Technik Rudolf
Lindner Service Bulletin (SB-G08), Edition April 24, 2015; and
Fiberglas-Technik Rudolf Lindner Anweisung (English translation:
Instructions), (A/I-G08), Ausgabe (English translation: Edition)
April 24, 2015.

    Note 2 to paragraph (f)(2) of this AD:  In the lower wing
surface inspection, openings near the bell-crank may be installed to
simplify the inspection and make a possible replacement of the bell-
crank possible. This optional installation is described in GROB Luft
Und Raumfahrt Service Bulletin 315-45/2, dated December 21, 1995;
and Fiberglas-Technik Rudolf Lindner Service Bulletin (SB-G07),
Edition April 24, 2015.

    (3) Within 30 days after replacing a bell-crank as required by
paragraph (f)(2) of this AD or within the next 30 days after
December 4, 2015 (the effective date of this AD), whichever occurs
later, report the inspection results of the removed bell-crank to
Fiberglas-Technik Rudolf Lindner GmbH & Co. KG. You may find contact
information for Fiberglas-Technik Rudolf Lindner GmbH & Co. KG in
paragraph (h) of this AD.

(g) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Jim Rutherford, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>Before using any approved AMOC on any glider
to which the AMOC applies, notify your appropriate principal
inspector (PI) in the FAA Flight Standards District Office (FSDO),
or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, a federal agency may not conduct or sponsor, and a person
is not required to respond to, nor shall a person be subject to a
penalty for failure to comply with a collection of information
subject to the requirements of the Paperwork Reduction Act unless
that collection of information displays a current valid OMB Control
Number. The OMB Control Number for this information collection is
2120-0056. Public reporting for this collection of information is
estimated to be approximately 5 minutes per response, including the
time for reviewing instructions, completing and reviewing the
collection of information. All responses to this collection of
information are mandatory. Comments concerning the accuracy of this
burden and suggestions for reducing the burden should be directed to
the FAA at: 800 Independence Ave. SW., Washington, DC 20591, Attn:
Information Collection Clearance Officer, AES-200.

(h) Related Information

    Refer to MCAI European Aviation Safety Agency (EASA) AD No.:
2015-0116, dated June 24, 2015; GROB Luft Und Raumfahrt Service
Bulletin 315-45/2, dated December 21, 1995; and Fiberglas-Technik
Rudolf Lindner Service Bulletin (SB-G07), Edition April 24, 2015,
for related information. You may examine the MCAI on the Internet at
http://www.regulations.gov/#!documentDetail;D=FAA-2015-3300-0003.

(i) 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) Fiberglas-Technik Rudolf Lindner Service Bulletin (SB-G08),
Edition April 24, 2015; and
    (ii) Fiberglas-Technik Rudolf Lindner Anweisung (English
translation: Instructions), (A/I-G08), Ausgabe (English translation:
Edition) April 24, 2015.
    (3) For Fiberglas-Technik Rudolf Lindner GmbH & Co. KG service
information identified in this AD, contact Fiberglas-Technik Rudolf
Lindner GmbH & Co. KG, Steige 3, D-88487 Walpertshofen, Germany;
phone: ++49 (0) 7353/22 43; fax: ++49 (0) 7353/30 96; email:
<EMAIL_ADDRESS>Internet: http://www.ltb-lindner.com.
    (4) You may view this service information at the FAA, Small
Airplane Directorate, 901 Locust, Kansas City, Missouri 64106. For
information on the availability of this material at the FAA, call
(816) 329-4148. In addition, you can access this service information
on the Internet at http://www.regulations.gov by searching for and
locating Docket No. FAA-2015-3300.
    (5) You may view this 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 October 22, 2015.
Melvin Johnson,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2015-27440 Filed 10-29-15; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63584-63586]
[FR Doc No: 2023-20016]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0109]

Fostering Medical Device Improvement: Food and Drug
Administration Activities and Engagement With the Voluntary Improvement
Program; Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Fostering Medical
Device Improvement: Food and Drug Administration Activities and
Engagement with the Voluntary Improvement Program.'' FDA is issuing
this guidance to describe its policy regarding FDA's participation in
the Voluntary Improvement Program (VIP). The VIP is a voluntary program
facilitated through the Medical Device Innovation Consortium (MDIC)
that evaluates the capability and performance of a medical device
manufacturer's practices using third-party appraisals, and is intended
to guide improvement to enhance the quality of devices. The VIP builds
on the framework piloted through FDA's 2018 Case for Quality Voluntary
Medical Device Manufacturing and Product Quality Pilot Program (CfQ
Pilot Program) and incorporates some of the successes and learnings
from the pilot.

DATES: The announcement of the guidance is published in the Federal
Register on September 15, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-0109 for ``Fostering Medical Device Improvement: Food and
Drug Administration Activities and Engagement with the Voluntary
Improvement Program.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Fostering Medical Device Improvement: Food and Drug Administration
Activities and Engagement with the Voluntary Improvement Program'' to
the Office of Policy, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Francisco Vicenty, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1534, Silver Spring, MD 20993-0002, 301-
796-5577.

SUPPLEMENTARY INFORMATION:

I. Background

    As part of the Center for Devices and Radiological Health's
(CDRH's) 2016-2017 strategic priority to ``Promote a Culture of Quality
and Organizational Excellence,'' CDRH envisions a future where the
medical device ecosystem is

inherently focused on device features and manufacturing practices that
have the greatest impact on product quality and patient safety. Among
its other regulatory activities, FDA evaluates manufacturers'
compliance with regulations governing the design and production of
devices. Compliance with the ``Quality System Regulation,'' 21 CFR part
820, is a baseline requirement for medical device manufacturing
firms.\1\
---------------------------------------------------------------------------

    \1\ On February 23, 2022, FDA proposed to amend the device QS
regulation, 21 CFR part 820, to align more closely with
international consensus standards for devices (87 FR 10119;
available at https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-amendments).
Specifically, FDA proposed to withdraw the majority of the current
requirements in part 820 and instead incorporate by reference the
2016 edition of the International Organization for Standardization
(ISO) 13485, Medical devices--Quality management systems for
regulatory purposes, in part 820. As stated in that proposed rule,
the requirements in ISO 13485 are, when taken in totality,
substantially similar to the requirements of the current part 820,
providing a similar level of assurance in a firm's quality
management system and ability to consistently manufacture devices
that are safe and effective and otherwise in compliance with the
FD&C Act. FDA intends to finalize this proposed rule expeditiously.
When the final rule takes effect, FDA will also update the
references to provisions in 21 CFR part 820 in this guidance to be
consistent with that rule.
---------------------------------------------------------------------------

    In an effort to elevate and enhance manufacturing practices and
behaviors through which quality and safety of medical devices can be
improved, FDA has collaborated with various stakeholders, brought
together through the MDIC public-private partnership, to develop the
CfQ Pilot Program. FDA announced the voluntary CfQ Pilot Program in the
Federal Register on December 28, 2017 (82 FR 61575).
    As in the CfQ Pilot Program, the VIP oversees third-party
appraisers who evaluate voluntary industry participants, and the VIP
assesses the capability and performance of key business processes using
a series of integrated best practices. Those practices are detailed in
the Information Systems Audit and Control Association Capability
Maturity Model Integration (CMMI) system. CMMI provides a roadmap that
guides improvement toward disciplined and consistent processes for
achieving key business objectives, including quality and performance.
The VIP uses a version of the CMMI appraisal appropriate for the
medical device industry. This appraisal tool is referred to as the
Medical Device Discovery Appraisal Program (MDDAP) model. The baseline
appraisal using the MDDAP model covers 11 practices areas, such as
Governance, Implementation Infrastructure, and Managing Performance and
Measurement. Subsequent appraisals may include an alternate list of
practice areas compared to the baseline set. As part of the VIP, and as
in the CfQ Pilot Program, the program provides firms and FDA with
information about the firm's capability and performance for activities
covered in the third-party appraisal.
    Details and results from the 2018 CfQ Pilot Program are outlined in
MDIC's Case for Quality Pilot Report, available at https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/voluntary-medical-device-manufacturing-and-product-quality-pilot-program.
    This voluntary program is currently only available to eligible
manufacturers of medical devices regulated by CDRH and whose marketing
applications are reviewed under the applicable provisions of the
Federal Food, Drug, and Cosmetic Act (including under sections 510(k),
513, 515, and 520) (21 U.S.C. 360(k), 360c, 360e, and 360j).
    A notice of availability of the draft guidance appeared in the
Federal Register of May 6, 2022 (87 FR 27165). FDA considered comments
received and revised the guidance as appropriate in response to the
comments, including clarifying what participants must demonstrate to
benefit from the opportunities offered by VIP, explaining that program
participation is not a substitute for an FDA inspection, and providing
further detail regarding the role of FDA in VIP.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on Fostering Medical Device Improvement: Food
and Drug Administration Activities and Engagement with the Voluntary
Improvement Program. It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Fostering Medical Device Improvement:
Food and Drug Administration Activities and Engagement with the
Voluntary Improvement Program'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number GUI00020039 and complete title to
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The
guidance also refers to previously approved FDA collections of
information which are also subject to review by OMB under the PRA. The
collections of information in the following FDA regulations, guidance,
and forms have been approved by OMB as listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
21 CFR part; Guidance; or FDA form          Topic               No.
------------------------------------------------------------------------
``Fostering Medical Device          Voluntary                  0910-0922
 Improvement: Food and Drug          Improvement Program
 Administration Activities and       (VIP).
 Engagement with the Voluntary
 Improvement Program''.
807, subpart E....................  Premarket                  0910-0120
                                     notification.
7.................................  Recalls.............       0910-0432
814, subparts A through E.........  Premarket approval..       0910-0231
814, subpart H....................  Humanitarian Device        0910-0332
                                     Exemption.
860, subpart D....................  De Novo                    0910-0844
                                     classification
                                     process.
803...............................  Medical Device             0910-0437
                                     Reporting.

806...............................  Medical Devices;           0910-0359
                                     Reports of
                                     Corrections and
                                     Removals.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
807, subparts A through D.........  Medical Device             0910-0625
                                     Registration and
                                     Listing.
------------------------------------------------------------------------

    Dated: September 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20016 Filed 9-14-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 75, Number 212 (Wednesday, November 3, 2010)]
[Rules and Regulations]
[Pages 67620-67623]
[FR Doc No: 2010-27704]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0721]
RIN 1625-AA87

Temporary Security Zones; San Francisco Bay, Delta Ports,
Monterey Bay and Humboldt Bay, CA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing temporary security zones on
the navigable waters of San Francisco Bay, Delta Ports, Monterey Bay
and Humboldt Bay, CA, in support of increasing the size of security
zones currently provided by 33 CFR 165.1183 from 100 yards to 500
yards. These temporary security zones are necessary to effectively
protect cruise ships, high interest vessels (HIVs), or tankers, as
defined under 33 CFR 165.1183. Persons and vessels are prohibited from
entering into, transiting through, or anchoring within the temporary
security zones unless authorized by the Captain of the Port or her
designated representative.

DATES: This rule is effective in the CFR from November 3, 2010 through
April 15, 2011. This rule is effective with actual notice for purposes
of enforcement from October 5, 2010, through April 15, 2011.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2010-0721 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-0721 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail Ensign Liezl Nicholas, Waterways
Management, U.S. Coast Guard Sector San Francisco, Coast Guard;
telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>If you
have questions on viewing the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final 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)
at this time with respect to this temporary rule because it was
contrary to the public interest to wait. The COTP has deemed this
temporary rule as necessary because it allows the Coast Guard to better
protect HIVs. As noted in the Discussion of the Rule section below, the
Coast Guard has initiated a separate, notice-and-comment rulemaking
while this temporary rule is in effect.
    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. It would be contrary to the public
interest not to publish this rule, as it is necessary to put the Coast
Guard in better position to afford protection to HIVs.

Basis and Purpose

    Based on experience with actual security zone enforcement
operations, observations during boat tactics training, and discussions
with Coast Guard experts, Sector San Francisco has concluded that the
current 100-yard security zones are not large enough to sufficiently
protect cruise ships, HIVs, or tankers from sabotage, other subversive
acts, criminal actions or other causes of a similar nature. The
increase of the security zones to 500 yards would allow reaction time
to a vessel closing in at 20 knots to increase from 9 seconds (for 100
yards) to 36 seconds (for 500 yards). In addition, 500 yards would
establish a consistent standard for all escort operations in the San
Francisco Bay area that would benefit tactical coxswains and minimize
the potential for confusion on the part of the boating public.

Discussion of Rule

    This rule establishes temporary security zones that will be
enforced from October 5, 2010, through April 5, 2011. This rule also
temporarily suspends 33 CFR 165.1183. The Coast Guard has initiated a
separate rulemaking that proposes to revise Sec.  165.1183 so that it
contains security zones the same size as the zones established by this
temporary final rule. The Coast Guard expects to complete that separate
notice-and-comment rulemaking during the effective period of this
temporary final rule. To comment on that rulemaking [Docket No. USCG-
2010-1004] for a permanent revision of Sec.  165.1183, please find our
notice of proposed rulemaking entitled, ``Security Zone; Increase of
Security Zones under 33 CFR 165.1183 from 100 to 500 yards; San
Francisco Bay, Delta Ports, Monterey Bay, and Humboldt Bay, CA,''
published elsewhere in today's issue of the Federal Register.
    The limits of these temporary security zones include all waters in
San Francisco Bay, extending from the surface to the sea floor, within
500 yards ahead, astern and extending 500 yards along either side of
any cruise ship, tanker or HIV that is underway, anchored, or moored
within the San Francisco Bay and Delta port areas shoreward of the line
drawn between San Francisco Main Ship Channel Buoys 7 and 8 (LLNR 4190
and 4195, positions 37[deg]46.9' N, 122[deg]35.4' W and 37[deg]46.5' N,
122[deg]35.2' W, respectively).
    In Monterey Bay, the limits of the security zones include all
waters, extending from the surface to the sea floor, within 500 yards
ahead, astern and extending 500 yards along either side of any cruise
ship, tanker or HIV that is underway, anchored or moored within the
Monterey Bay area shoreward of a line drawn between Santa Cruz Light
(LLNR 305) to the north in position 36[deg]57.10' N, 122[deg]01.60' W,
and Cypress Point, Monterey to the south, in position 36[deg]34.90' N,
121[deg]58.70' W.
    In Humboldt Bay the limits of these temporary security zones apply
to all waters, extending from the surface to the sea floor, within 500
yards ahead, astern and extending 500 yards along either side of any
cruise ship, tanker or HIV that is underway, anchored, or moored within
Humboldt Bay area shoreward of a 4 nautical mile radius line drawn to
the west of the Humboldt Bay Entrance Lighted Whistle Buoy HB (LLNR
8230), in position 40[deg]46.25' N, 124[deg]16.13' W.
    The temporary security zones are necessary to effectively protect
cruise ships, high interest vessels (HIV), and tankers as defined under
33 CFR 165.1183 from sabotage or other subversive acts, criminal
actions, or other causes of a similar nature. Persons and vessels will
be prohibited from entering into, transiting through, or anchoring
within the temporary safety zones unless authorized by the Captain of
the Port, or her designated representative.
    The temporary security zones will be enforced by Coast Guard patrol
craft and San Francisco Harbor Police as authorized by the Captain of
the Port. See 33 CFR 6.04-11, Assistance of other agencies.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    It is not ``significant'' under the regulatory policies and
procedures of the Department of Homeland Security (DHS). We expect the
economic impact of this rule to be so minimal that full Regulatory
Evaluation is unnecessary. Most of the entities likely to be affected
are pleasure craft engaged in recreational activities and sightseeing.
In addition, due to National Security interests, the implementation of
these temporary security zones is necessary for the protection of the
United States

and its people. The size of the zones is the minimum necessary to
provide adequate protection for cruise ships, HIVs, and tankers as
defined under 33 CFR 165.1183 assets.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. 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.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of vessels intending to transit
or anchor in a portion of the San Francisco Bay, Delta Ports, Monterey
Bay and Humboldt Bay from October 5, 2010 through April 5, 2011.
    The security zones will not have a significant economic impact on a
substantial number of small entities for the following reasons. Vessel
traffic can pass safely around the zone. Before the effective period,
the Coast Guard will issue local notice to mariners (LNM) and broadcast
notice to mariners (BNM) alerts via VHF-FM marine channel 16 before the
security zone is enforced.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    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.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for Federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
Federalism.

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 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.

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    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.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

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 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. This rule involves the establishment of a
security zone.
    An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

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

0
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. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. From November 3, 2010, through April 5, 2011, temporarily suspend
Sec.  165.1183 and temporarily add Sec.  165.T11-362 to read as
follows:

Sec.  165.T11-362  Temporary Security Zones; San Francisco Bay, Delta
Ports, Monterey Bay and Humboldt Bay, CA.

    (a) Location. (1) San Francisco Bay. The limits of these security
zones include all waters in San Francisco Bay, extending from the
surface to the sea floor, within 500 yards ahead, astern and extending
500 yards along either side of any cruise ship, tanker or HIV that is
underway, anchored, or moored within the San Francisco Bay and Delta
port areas shoreward of the line drawn between San Francisco Main Ship
Channel Buoys 7 and 8 (LLNR 4190 and 4195, positions 37[deg]46.9' N,
122[deg]35.4' W and 37[deg]46.5' N, 122[deg]35.2' W, respectively).
    (2) Monterey Bay. In Monterey Bay, the limits of the security zones
include all waters, extending from the surface to the sea floor, within
500 yards ahead, astern and extending 500 yards along either side of
any cruise ship, tanker or HIV that is underway, anchored or moored
within Monterey Bay area shoreward of a line drawn between Santa Cruz
Light (LLNR 305) to the north in position 36[deg]57.10' N,
122[deg]01.60' W and Cypress Point, Monterey to the south in position
36[deg]34.90' N, 121[deg]58.70' W.
    (3) Humboldt Bay. In Humboldt Bay the limits of the security zones
apply to all waters, extending from the surface to the sea floor,
within 500 yards ahead, astern and extending 500 yards along either
side of any cruise ship, tanker or HIV that is underway, anchored, or
moored within Humboldt Bay area shoreward of a 4 nautical mile radius
line drawn to the west of the Humboldt Bay Entrance Lighted Whistle
Buoy HB (LLNR 8230), in position 40[deg]46.25' N, 124[deg]16.13' W.
    (b) Definitions. As used in this section--
    Cruise ship means any vessel over 100 gross register tons, carrying
more than 12 passengers for hire which makes voyages lasting more than
24 hours, of which any part is on the high seas. Passengers from cruise
ships are embarked or disembarked in the U.S. or its territories.
Cruise ships do not include ferries that hold Coast Guard Certificates
of Inspection endorsed for ``Lakes, Bays and Sounds'' that transit
international waters for only short periods of time on frequent
schedules.
    Designated representative means any commissioned, warrant, and
petty officers of the Coast Guard on board Coast Guard, Coast Guard
Auxiliary, and local, State and Federal law enforcement vessels who
have been authorized to act on the behalf of the Captain of the Port.
    High Interest Vessel or HIV means any vessel deemed by the Captain
of the Port, or higher authority, as a vessel requiring protection
based upon risk assessment analysis of the vessel and is therefore
escorted by a Coast Guard or other law enforcement vessel with an
embarked Coast Guard commissioned, warrant, or petty officer.
    Tanker means any self-propelled tank vessel constructed or adapted
primarily to carry oil or hazardous materials in bulk in the cargo
spaces.
    (c) Enforcement period. This section will be enforced from October
5, 2010, through April 5, 2011. If the need to enforce the security
zones in paragraph (a) of this section terminates before this rule
expires, the Captain of the Port will cease enforcement of the security
zones and will announce that fact via Broadcast Notice to Mariners.
    (d) Regulations. (1) Entry into, transit through or anchoring
within the security zones described in paragraph (a) of this section is
prohibited unless authorized by the Captain of the Port of San
Francisco or her designated representative.
    (2) Mariners requesting permission to transit through the security
zone may request authorization to do so from the Patrol Commander
(PATCOM), a designated representative. The PATCOM may be contacted on
VHF-FM Channel 16.
    (3) All persons and vessels shall comply with the instructions of
the Coast Guard Captain of the Port or the designated representative.
    (4) Upon being hailed by U.S. Coast Guard patrol personnel by
siren, radio, flashing light, or other means, the operator of a vessel
shall proceed as directed.
    (5) The Coast Guard may be assisted by other Federal, State, or
local agencies.

    Dated: October 4, 2010.
C.L. Stowe,
Captain, U.S. Coast Guard, Captain of the Port San Francisco.
[FR Doc. 2010-27704 Filed 11-2-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 75, Number 1 (Monday, January 4, 2010)]
[Notices]
[Pages 158-159]
[FR Doc No: E9-31125]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1866-DR; Docket ID FEMA-2008-0018]

Alabama; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Alabama (FEMA-1866-DR), dated December 22,
2009, and related determinations.

DATES: Effective Date: December 22, 2009.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated December 22, 2009, the President issued a major disaster
declaration under the authority of the Robert T. Stafford Disaster
Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the
``Stafford Act''), as follows:

    I have determined that the damage in certain areas of the State
of Alabama resulting from Tropical Storm Ida during the period of
November 9-10, 2009, is of sufficient severity and magnitude to
warrant a major disaster declaration under the Robert T. Stafford
Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq.
(the ``Stafford Act''). Therefore, I declare that such a major
disaster exists in the State of Alabama.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State.
Consistent with the requirement that Federal assistance is
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Michael Bolch, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of Alabama have been designated as
adversely affected by this major disaster:

    Baldwin and Mobile Counties for Public Assistance.
    All counties within the State of Alabama are eligible to apply
for assistance under the Hazard Mitigation Grant Program.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially

Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. E9-31125 Filed 12-31-09; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 84, Number 58 (Tuesday, March 26, 2019)]
[Notices]
[Pages 11314-11319]
[FR Doc No: 2019-05730]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2019-0131]

Port Access Route Study: The Areas Offshore of Massachusetts and
Rhode Island

AGENCY: Coast Guard, DHS.

ACTION: Notice of study and public meetings; request for comments.

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SUMMARY: In order to provide safe access routes for the movement of
vessel traffic offshore of the Massachusetts and Rhode Island area of
the United States for vessels proceeding to or from ports or places of
the United States and transiting within the United States Exclusive
Economic Zone (EEZ), the Coast Guard is conducting a Massachusetts and
Rhode Island Port Access Route Study (MARIPARS) to evaluate the need
for establishing vessel routing measures. The information gathered
during this MARIPARS may result in the establishment of one or more
vessel routing measures. The goal of the MARIPARS is to enhance
navigational safety by examining existing shipping routes and waterway
uses. The recommendations of the study may lead to future rulemaking
action or appropriate international agreements.

DATES: Comments and related material must be received by the Coast
Guard on or before May 28, 2019. Two public meetings will be held to
provide an opportunity for comments about the MARIPARS on Tuesday,
April 23, 2019, from 6 p.m. to 9 p.m. and on Thursday, April 25, 2019,
from 6 p.m. to 9 p.m. Written comments and related material may also be
submitted to Coast Guard personnel at the meetings. All comments and
related material submitted after the meetings must be received by the
Coast Guard on or before May 28, 2019. Commenters should be aware that
the electronic Federal Docket Management System will not accept
comments after midnight Eastern Daylight Time on the last day of the
comment period.

ADDRESSES: You may submit comments identified by docket number USCG-
2019-0131 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.
    The public meeting on Tuesday, April 23, 2019, from 6 p.m. to 9
p.m., will be

held at Corless Auditorium (Watkins Laboratory Building), University of
Rhode Island, Graduate School of Oceanography at 215 South Ferry Road,
Narragansett, RI 02882-1197.
    The public meeting on Thursday, April 25, 2019, from 6 p.m. to 9
p.m., will be held at Flanagan Hall, Massachusetts Maritime Academy at
101 Academy Drive, Buzzards Bay, MA 02532.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice or study call or email the Project Officer, Mr. Edward G.
LeBlanc, Chief of Coast Guard Sector Southeastern New England Waterways
Management Division, telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Public Participation and Request for Comments

    We encourage you to participate in this study by submitting
comments and related materials to the online public docket or orally at
the public meetings. All comments received will be posted, without
change, to http://www.regulations.gov and will include any personal
information you have provided.
    A. Submitting Comments: If you submit comments to the online public
docket, please include the docket number for this rulemaking (USCG-
2019-0131), indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. We accept anonymous comments.
    To submit your comment online, go to http://www.regulations.gov,
and insert ``USCG-2019-0131'' in the ``search box.'' Click ``Search''.
Then click ``Comment Now.'' We will consider all comments and material
received during the comment period.
    B. Public Meetings: We plan to hold two public meetings to receive
oral comments on this notice. If you bring written comments to the
public meeting, you may submit them to Mr. Edward G. LeBlanc. These
comments will be added to our online public docket. We recommend that
you include your name and a mailing address, an email address, or a
telephone number in the body of your document so that we can contact
you if we have questions regarding your submission. Attendance at the
public meeting is not required. We will provide a written summary of
the oral comments received and will place that summary in the docket.
    The first public meeting on Tuesday, April 23, 2019, from 6 p.m. to
9 p.m., will be held at Corless Auditorium (Watkins Laboratory
Building), University of Rhode Island, Graduate School of Oceanography,
215 South Ferry Road, Narragansett, RI 02882-1197.
    The second public meeting on Thursday, April 25, 2019, from 6 p.m.
to 9 p.m., will be held at Flanagan Hall, Massachusetts Maritime
Academy, 101 Academy Drive, Buzzards Bay, MA 02532.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the public meeting,
contact Mr. Edward Leblanc at the telephone number or email address
indicated under the FOR FURTHER INFORMATION CONTACT section of this
notice.
    C. Viewing the comments and documents: To view the comments and
documents mentioned in this preamble as being available in the docket,
go to http://www.regulations.gov, click on the ``read comments'' box,
which will then become highlighted in blue. In the ``Keyword'' box
insert ``USCG-2019-0131'' and click ``Search.'' Click the ``Open Docket
Folder'' in the ``Actions'' column.
    D. Privacy Act: Anyone can search the electronic form of comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review a
Privacy Act, system of records notice regarding our public dockets in
the January 17, 2008, issue of the Federal Register (73 FR 3316)
https://www.federalregister.gov/documents/2008/01/17/E8-785/privacy-act-of-1974-system-of-records.

II. Purpose and Background

    A. Requirement for Port Access Route Studies: Under 46 U.S.C. 70003
the Commandant of the Coast Guard may designate necessary fairways and
traffic separation schemes (TSSs) to provide safe access routes for
vessels proceeding to and from U.S. ports. The designation of fairways
and TSSs recognizes the paramount right of navigation over all other
uses in the designated areas.
    Before establishing or adjusting fairways or TSSs, 46 U.S.C. 70003
requires the Coast Guard to conduct a port access route study (PARS),
i.e. a study of potential traffic density and the need for safe access
routes for vessels. Through the study process, we must coordinate with
Federal, State, and foreign state agencies (as appropriate) and
consider the views of maritime community representatives, environmental
groups, and other interested stakeholders. A primary purpose of this
coordination is, to the extent practicable, to reconcile the need for
safe access routes with other reasonable waterway uses such as
construction and operation of renewable energy facilities and other
uses of the Atlantic Ocean in the study area.
    B. Previous port access route studies: In 2011, the Coast Guard
conducted a PARS which focused on the entire Atlantic Coast from Maine
to Florida to analyze all vessel traffic proceeding to and from all
Atlantic Coast ports and transiting through the United States Exclusive
Economic Zone (EEZ). The Atlantic Coast Port Access Route Study Final
Report is available at the Coast Guard Navigation Center website
https://navcen.uscg.gov/pdf/PARS/ACPARS_Final_Report_08Jul2015_Combined_Appendix_Enclosures_Final_After_LMI_Review.pdf.
    C. Necessity for a new port access route study: The Bureau of Ocean
Energy Management (BOEM) has leased seven adjacent areas of the outer
continental shelf (OCS) south of Martha's Vineyard and east of Rhode
Island that together constitute the MA/RI Wind Energy Area (WEA).
Potentially seven distinct offshore renewable energy installations
(``wind farms'') could be constructed, each with its own number, size,
type of wind turbines, and distinct turbine layout. The topic of safe
navigation routes to facilitate vessel transit through the MA/RI WEA
has been discussed at various forums throughout southeastern New
England. The forums have included participation by the Coast Guard,
other federal, state, and local agencies, fishing industry
representatives, and a myriad of stakeholders. Various different
transit plans have been proposed through these different forums.
    In September 2018, the Massachusetts Coastal Zone Management
Fisheries Working Group offered a vessel transit layout as depicted at
https://www.mass.gov/service-details/fisheries-working-group-on-offshore-wind-energy and below:

[GRAPHIC] [TIFF OMITTED] TN26MR19.002

    In December 2018, the Responsible Offshore Development Alliance
(RODA), https://www.rodafisheries.org/, offered an alternative layout
for consideration by stakeholders:

[GRAPHIC] [TIFF OMITTED] TN26MR19.003

    Though neither of these alternatives achieved consensus of all
stakeholders, they serve as a basis for further discussion of the issue
and are provided here for that purpose. Comments on these alternative
proposals are welcome, but comments need not be limited to them.

III. This PARS: Timeline, Study Area, and Process

    The First Coast Guard District Waterways Management Division and
Coast Guard Sector Southeastern New England Waterways Management
Division will conduct this PARS. The study will begin upon publication
of this notice and should take approximately six months to complete.
    The study area is described as an area bounded by a line connecting
the following geographic positions:
     41[deg]20' N, 070[deg]00' W;
     40[deg]35' N, 070[deg]00' W;
     40[deg]35' N, 071[deg]15' W;
     41[deg]20' N, 071[deg]15' W.
    Below is an illustration showing the study area.

[GRAPHIC] [TIFF OMITTED] TN26MR19.004

    The Coast Guard will use the PARS process described in Appendix D
to Commandant Instruction 16003.2A, Marine Planning to Operate and
Maintain the National Marine Transportation System (MTS) and Implement
National Policy, which is available in the docket or see https://
media.defense.gov/2017/Mar/15/

2001716995/-1/-1/0/CI_16003_2A.PDF, as a guide.

IV. Possible Scope of the Recommendations

    We are attempting to determine what, if any, navigational safety
concerns exist with vessel transits in the study area. We expect that
information gathered during the study will help us identify anticipated
impacts to navigation that may be experienced by mariners intending to
transit in, around and through the study area which includes the MA/RI
Wind Energy Area (MA/RI WEA) which is an area of wind farm leases south
of Martha's Vineyard. All leases are currently being studied for
development including the construction of wind energy generating
turbines affixed to the sea floor. These installations could impact
routes used to access ports (e.g., transiting from Georges Bank through
the MA/RI WEA to New Bedford; or from the vicinity of Montauk, NY/Point
Judith, RI, to Georges Bank, etc.). Impacts could result from factors
such as number, size, type, and layout of wind farm turbines and
electric service platform(s), subsea cabling, increased vessel traffic,
changing vessel traffic patterns, weather conditions, or navigational
difficulty. Comments should include or reference data (both empirical
and anecdotal) where available, published studies (academic,
government, or industry), and other supporting documentation.
    As part of this study, we may collect and analyze data and other
information on vessel traffic characteristics and trends in an attempt
to balance the needs of all waterway users.
    This MARIPARS includes the following objectives:
    1. Determine present vessel traffic types, patterns, and density;
    2. Determine potential vessel traffic types, patterns, and density;
    3. Determine if existing vessel routing measures are adequate;
    4. Determine if existing vessel routing measures require
modifications;
    5. Determine the type of modifications;
    6. Define and justify the needs for new vessel routing measures;
    7. Determine the type of new vessel routing measures; and
    8. Determine if the usage of the vessel routing measures must be
mandatory for specific classes of vessels.
    We will publish the results of the PARS in the Federal Register. It
is possible the study may validate the status quo (no routing measures)
and conclude that no changes are necessary. It is also possible the
study may recommend one or more changes to enhance navigational safety
and the efficiency of vessel traffic management. The recommendations
may lead to future rulemakings or appropriate international agreements.
    This notice is published under the authority of 46 U.S.C. 70004 and
5 U.S.C. 552(a).

    Dated: March 21, 2019.
G. D. Case,
Captain, U.S. Coast Guard, Acting Commander, First Coast Guard
District.
[FR Doc. 2019-05730 Filed 3-25-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 77 (Tuesday, April 22, 2014)]
[Rules and Regulations]
[Page 22398]
[FR Doc No: 2014-09054]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2013-0928]

Drawbridge Operation Regulation; Delaware River, NJ

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 bascule span of the Tacony-Palmyra
Bridge (Route 73), across the Delaware River, mile 107.2, between the
townships of Tacony, PA and Palmyra, NJ. The deviation is necessary to
facilitate the replacement of the bridge deck. This deviation allows
the bridge to remain in the closed to navigation position during the
rehabilitation project.

DATES: This deviation is effective from 9 p.m. on Friday, June 13, 2014
until 9 p.m. on Saturday, June 21, 2014.

ADDRESSES: The docket for this deviation [USCG-2013-0928] 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. You may also visit the Docket
Management Facility in Room W12-140 on the ground floor of the
Department of Transportation West Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Terrance Knowles, Environmental
Protection Specialist, Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Cheryl Collins, Program Manager, Docket Operations, at
202-366-9826.

SUPPLEMENTARY INFORMATION: The Burlington County Bridge Commission, who
owns and operates this bascule drawbridge, has requested a temporary
deviation from the current operating regulations to facilitate the
resurfacing of the bridge roadway. The Tacony-Palmyra Bridge (Route 73)
at mile 107.2, across the Delaware River, between PA and NJ, has a
vertical clearance in the closed position of 50 feet above mean high
water.
    Under the current operating schedule set out in 33 CFR 117.5 and
117.716(b): The regulation requires that the drawbridge must open
promptly and fully for the passage of vessels when a request or signal
to open is given, and that the opening not be delayed more than five
minutes.
    Under this temporary deviation, the bridge will be closed-to-
navigation from 9 p.m., on June 13, 2014 until 9 p.m., on June 21,
2014. Vessels able to pass through the bridge in the closed position
may do so at anytime. The bridge will not be able to open for
emergencies and there is no alternate route for vessels to pass this
section of the Delaware River.
    The Coast Guard has coordinated this with the Pilots Association
for the Bay and Delaware River, and will inform the users of the
waterway through our Local and Broadcast Notices to Mariners of the
change in operating schedule for the bridge so that vessels can arrange
their transits to minimize any impact caused by the temporary
deviation. Waterway traffic consists of freighters, recreational boats,
tugs, and barges.
    In accordance with 33 CFR 117.35(e), 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: April 9, 2014.
Waverly W. Gregory, Jr.,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2014-09054 Filed 4-21-14; 8:45 am]
BILLING CODE 9110-04-P