[Federal Register Volume 80, Number 206 (Monday, October 26, 2015)]
[Rules and Regulations]
[Pages 65165-65168]
[FR Doc No: 2015-27062]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

46 CFR Part 15

[Docket No. USCG-2015-0758]
RIN 1625-AC25

Offshore Supply Vessels, Towing Vessel, and Barge Engine Rating
Watches

AGENCY: Coast Guard, DHS.

ACTION: Direct final rule.

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SUMMARY: This direct final rule amends the Coast Guard's merchant
mariner manning regulations to align them with statutory changes made
by the Howard Coble Coast Guard and Maritime Transportation Act of
2014. The Act allows oilers serving on certain offshore support
vessels, towing vessels, and barges to be divided into at least two
watches. This change increases the sea service credit affected mariners
are permitted to earn for each 12-hour period of work from one day to
one and a half days.

DATES: This direct final rule will be effective January 25, 2016 unless
the Coast Guard receives adverse comment by December 28, 2015. If an
adverse comment is received, the Coast Guard will publish a timely
withdrawal of the direct final rule in the Federal Register informing
the public the rule will not take effect.

ADDRESSES: You may submit comments identified by docket number USCG-
2015-0758 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Comments'' portion of the SUPPLEMENTARY
INFORMATION section for further instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
email or call Mr. Davis Breyer, Marine Personnel Qualifications
Division (CG-OES-1), Coast Guard; email<EMAIL_ADDRESS>
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Comments

    If you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION
CONTACT section of this document for alternate instructions. Documents
mentioned in this notice, and all public comments, are in our online
docket at http://www.regulations.gov and can be viewed by following
that Web site's instructions. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).

II. Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
OMB Office of Management and Budget
QMED Qualified Member of the Engine Department
RFA Regulatory Flexibility Act
The Secretary The Secretary of Homeland Security
Sec. 316 Section 316 of the Howard Coble Coast Guard and Maritime
Transportation Act of 2014
U.S.C. United States Code

III. Basis and Purpose

A. Basis

    The changes to 46 CFR 15.705 made by this rule are required by 46
U.S.C. 8104 as amended by Sec. 316 of the Howard Coble Coast Guard and
Maritime Transportation Act of 2014 (Pub. L. 113-281, December 18,
2014). Under Title 46 of the United States Code, Sec. 2103, the
Secretary of Homeland Security (the Secretary) has general authority
over the merchant marine of the United States and merchant marine
personnel. The Secretary delegated the authority for determining
minimum manning standards to the Commandant of the Coast Guard in
Department of Homeland Security Delegation No. 0170.1, paragraph 92.

B. Purpose

    The purpose of this rule is to conform regulations to the amended
statute and clarify that oilers on covered vessels are entitled to
receive an equitable amount of sea service credit.

IV. Discussion of the Rule

    The Howard Coble Coast Guard and Maritime Transportation Act of
2014, sec. 316, amended 46 U.S.C. 8104(g)(1) by allowing coal passers,
firemen, oilers, and water tenders serving on offshore supply vessels,
towing vessels, and barges engaged in seagoing voyages of less than 600
miles to be divided into at least two watches. Previously, only
officers and other deck crew members on those vessels were divided into
two watches.
    46 CFR 10.107 and 10.232(h)(2) provide in the definition of ``Day''
that ``[o]n vessels authorized by 46 U.S.C. 8104 and 46 CFR 15.705 to
operate a two-watch system, a 12-hour working day may be creditable as
1\1/2\ days of service.'' Regulations at 46 CFR 15.705(c)(1), however,
still do not authorize mariners affected by sec. 316 to be divided into
two watches. In order to align the regulations with the amended
statute, this direct final rule revises 46 CFR 15.705(c)(1) by deleting
the clause ``(except the coal passers, firemen, oilers, and water
tenders)''.
    Similarly, sec. 316 also updated 46 U.S.C. 8104(d) by deleting the
words ``coal passers, firemen, . . . and watertenders.'' The changes
related to those terms simplify the statute. To update the
corresponding regulations and align them with the revised statute, this
rule also makes similar changes to 46 CFR 15.705(b).
    This rule makes existing regulations consistent with the statute
and clarifies the sea service credit of maritime personnel on affected
vessels, which have for many years operated on a two-watch system, both
on deck and in the engine room. Specifically, the revised regulations
make clear that typical sea service credit for upgrades toward
engineering licenses for oilers is 1\1/2\ days for each 12-hour period
worked, as it is for personnel aboard the same vessels working toward
deck licenses and upgrades. The effect of these changes is that all
qualified members of the engine department on covered vessels are
permitted to divide into two watches, and will be given proper credit
for 12 hours of work in accordance with the amended statute.
    Revision of our regulations without delay is necessary because
misalignment between the amended statute and the corresponding
regulations causes confusion, and delay could have a negative impact on
the sea service credit and career advancement of oilers on affected
vessels. Additionally, the Coast Guard must conform its regulations to
the revised statute, and is exercising no discretion in doing so
because this rule will only mirror amended statutory language. For
these reasons, the rule is expected to be uncontroversial, and adverse
comment is unlikely.

V. Direct Final Rule

    A direct final rule is appropriate when a rule is noncontroversial
and

unlikely to result in adverse public comment. The Coast Guard
considered publishing a notice of proposed rulemaking, but is pursuing
a direct final rule because it will better serve the regulated mariners
and industry by correcting the misalignment between the regulations and
statue more quickly. If no adverse comment is received by December 28,
2015, this rule will become effective as stated in the DATES
section.\1\ In that case, we will publish a document in the Federal
Register stating that no adverse comment was received and confirming
that this rule will become effective as scheduled. However, if we
receive an adverse comment, we will publish a document in the Federal
Register announcing the withdrawal of all or part of this direct final
rule. If an adverse comment applies only to part of this rule (e.g., to
an amendment, a paragraph, or a section) and it is possible to remove
that part without defeating the purpose of this rule, we may adopt, as
final, those parts of this rule on which no adverse comment was
received. We will withdraw the part of this rule that was the subject
of an adverse comment. If we decide to proceed with a rulemaking
following receipt of an adverse comment, we will publish a separate
notice of proposed rulemaking (NPRM) and provide a new opportunity for
comment. A comment is considered ``adverse'' if the comment explains
why this rule or a part of this rule would be inappropriate, including
a challenge to its underlying premise or approach, or would be
ineffective or unacceptable without a change.
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    \1\ 33 CFR 1.05-55 provides that a direct final rule effective
date is ``generally at least 90 days after the date of publication''
and ``[t]he public will usually be given at least 60 days'' to
submit comments.
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VI. Regulatory Analyses

    The Coast Guard developed this direct final rule after considering
numerous statutes and executive orders related to this rulemaking.
Below, the Coast Guard summarizes its analyses based on these statutes
or executive orders.

A. Regulatory Planning and Review

    Executive Orders 12866 (``Regulatory Planning and Review'') and
13563 (``Improving Regulation and Regulatory Review'') direct agencies
to assess the costs and benefits of available regulatory alternatives
and, if regulation is necessary, to select regulatory approaches that
maximize net benefits (including potential economic, environmental,
public health and safety effects, distributive impacts, and equity).
Executive Order 13563 emphasizes the importance of quantifying both
costs and benefits, of reducing costs, of harmonizing rules, and of
promoting flexibility. This direct final rule has not been designated a
``significant regulatory action'', under section 3(f) of Executive
Order 12866. Accordingly, the direct final rule has not been reviewed
by the Office of Management and Budget (OMB). A regulatory assessment
of the direct final rule follows.
    This direct final rule conforms Coast Guard regulations to sec.
316, which eliminated the exception of engine ratings originally found
within 46 U.S.C. 8104(g)(1). Sec. 316 amended 46 U.S.C. 8104(g)(1) to
allow coal passers, firemen, oilers, and water tenders serving on
certain offshore support vessels, towing vessels, and barges to be
divided into at least two watches. In order to align the regulations
with the amended statute, this rule will revise 46 CFR 15.705(b) by
deleting the words ``coal passers, firemen, . . . and water tenders,''
and 46 CFR 15.705(c)(1) by deleting the words ``except the coal
passers, firemen, oilers, and water tenders.''
Affected Population
    The changes in 46 CFR 15.705(c)(1) clarify that the sea service
credit afforded to all qualified members of the engine department, on
certain offshore support vessels, towing vessels and barges is
consistent with revised 46 U.S.C. 8104(g)(1). The National Maritime
Center of the Coast Guard identified approximately 18,721 such mariners
holding valid licenses as of the end of 2014. This figure constitutes
the total number of mariners that this rule could affect and includes
valid licenses for Unlicensed Engine Ratings and QMED with a variety of
job descriptions. Before the statute was amended, these unlicensed
mariners could not be divided into two watches to work 12-hour shifts
and, therefore, could not receive 1\1/2\-day sea service credit for 12
hours of work that licensed mariners both on deck and in the engine
room are allowed. The changes in 46 CFR 15.705(b) align with revised 46
U.S.C. 8104(d) by removing the coal passer, fireman, and watertender
exceptions to simplify the statute and regulations.
Costs
    This direct final rule will result in no adverse impacts or costs
to the industry and affected mariners. On the contrary, the industry is
urging speedy revision of our regulations because delaying this rule
would have a negative impact on the sea service credit and career
advancement of affected mariners due to confusion caused by conflicting
statutory and regulatory provisions. This rule will not result in a
change to the Coast Guard's budget and it will not increase federal
spending.
Benefits
    The direct final rule aligns Coast Guard regulations with the
amended statute and clarifies that affected mariners are entitled to
benefits allowed by 46 CFR 10.107 and 10.232(h)(2). The primary benefit
of this rule is to reduce confusion and clarify that affected mariners
are allowed to receive 1\1/2\ days sea service credit for working 12-
hour shifts on a two watch schedule that can be utilized for career
advancement and renewal. Additionally, by making the accrual of sea
service credit comparable to other mariners serving on the same
vessels, vessel owners will have greater assurance of having a steady
supply of mariners with higher ratings that are required to operate
offshore supply vessels.
Alternatives
    The Coast Guard considered four alternatives for this direct final
rule:

 Alternative 1: No action
 Alternative 2: Delayed Action
 Alternative 3: Develop Policy

    The no-action alternative (Alternative 1) would cause confusion
because it would leave regulations in place that contradict the new
statute. Therefore, the Coast Guard rejected this alternative.
    The Coast Guard rejected the delayed-action alternative
(Alternative 2) for the same reason. The misalignment between 46 U.S.C.
8104 and the corresponding regulations is causing confusion among
mariners, and there is no discernible advantage in delay.
    The develop policy alternative (Alternative 3) could grant the
affected engine ratings the same sea service credit as the officers and
deck ratings aboard the affected vessels. The Coast Guard rejected this
alternative, however, because policy properly provides either: guidance
about accepted methods for meeting regulations; or short term
solutions, within the limits of existing regulations, to provide relief
until amended regulations can be promulgated.
    In this case, the time and effort required by the Coast Guard to
develop and publish relevant policy would equal or exceed that expected
to amend the regulation with a direct final rule. In addition, after
publishing the policy, the regulation would still require amendment to
be consistent with the statute. Therefore, the Coast Guard rejected
this alternative.

B. Small Entities

    In accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C.
601-612), the Coast Guard prepared this Regulatory Flexibility Analysis
(RFA) that examines the impacts of this direct final rule on small
entities (5 U.S.C. 601 et seq.). Under the RFA, we have considered
whether this rule will have a significant economic impact on a
substantial number of small entities. The term of ``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 fewer than 50,000.
    The direct final rule will regulate mariners who are individually
responsible for obtaining their appropriate sea service credit for
career advancement. In addition, current and future mariners will not
incur any costs to comply with this rule. Finally, individuals, such as
the mariners regulated by this rule, are not small entities under the
definition of a small entity in the RFA. Therefore, we certify that
this direct final rule will not have a significant economic impact on a
substantial number of small entities under section 605(b) of the
Regulatory Flexibility Act.
    The Coast Guard is interested in the potential impacts from this
direct final rule on small businesses and we request public comment on
these potential impacts. If you think that your business, organization,
or governmental jurisdiction qualifies as a small entity and that this
rulemaking would have a significant economic impact on it, please
submit a comment to the address under ADDRESSES. In your comment,
explain why you think it qualifies and how, and to what degree this
rule would economically affect it.

C. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), the Coast Guard wants to assist
small entities in understanding this rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
rule would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please consult Mr. Davis Breyer, Maritime
Personnel Qualifications Division (CG-OES-1), Coast Guard; email
<EMAIL_ADDRESS>telephone<PHONE_NUMBER>. 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.
    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).

D. 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).

E. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. The Coast Guard has analyzed this rule under that Order and
has determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132. It is well settled that States may not regulate in categories
reserved for regulation by the Coast Guard. It is also well settled
that all of the categories covered in 46 U.S.C. 3306, 3703, 7101, and
8101 (design, construction, alteration, repair, maintenance, operation,
equipping, personnel qualification, and manning of covered vessels), as
well as the reporting of casualties and any other category in which
Congress intended the Coast Guard to be the sole source of a vessel's
obligations, are within the field foreclosed from regulation by the
States. (See the decision of the Supreme Court in the consolidated
cases of United States v. Locke and Intertanko v. Locke, 529 U.S. 89,
120 S.Ct. 1135 (2000)). Since this rule involves the documentation of
merchant mariners manning covered U.S. vessels, it is a matter of
personnel qualifications, which is a field reserved for regulation by
the Coast Guard. Because States may not promulgate rules within this
category, the rule is consistent with the principles of federalism and
preemption requirements in Executive Order 13132.

F. Unfunded Mandates Reform Act

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

G. 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.

H. 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.

I. Protection of Children

    The Coast Guard has 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.

J. 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.

K. Energy Effects

    The Coast Guard has analyzed this rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. The Coast Guard has determined that it is not a
``significant energy action'' under that order because it is not a
``significant regulatory action'' under E.O. 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.

L. 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 OMB, 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, the Coast
Guard did not consider the use of voluntary consensus standards.

M. Environment

    The Coast Guard has analyzed this rule under DHS 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 has concluded that this action
is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded under section 2.B.2, figure 2-1,
paragraph (34) (a) and (c) of the Instruction. This rule involves
procedural changes and the licensing of mariners under sec. 316. An
environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 46 CFR Part 15

    Reporting and recordkeeping requirements, Seamen, Vessels.

    For the reasons discussed in the preamble, the Coast Guard amends
46 CFR part 15 as follows:

PART 15--MANNING REQUIREMENTS

0
1. The authority citation for part 15 continues to read as follows:

    Authority: 46 U.S.C. 2101, 2103, 3306, 3703, 8101, 8102, 8104,
8105, 8301, 8304, 8502, 8503, 8701, 8702, 8901, 8902, 8903, 8904,
8905(b), 8906, 9102, and 8103; sec. 617, Pub. L. 111-281, 124 Stat.
2905; and Department of Homeland Security Delegation No. 0170.1.

Sec.  15.705  Watches.

0
2. Amend Sec.  15.705 as follows:
0
a. In paragraph (b), remove the words ``, coal passers, firemen,
oilers, and watertenders'' and add in their place the words ``, and
oilers''; and
0
b. In paragraph (c)(1) introductory text, remove the words ``(except
the coal passers, firemen, oilers, and watertenders)''.

J.G. Lantz,
Director, Commercial Regulations and Standards, U.S. Coast Guard.
[FR Doc. 2015-27062 Filed 10-23-15; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 35 (Wednesday, February 24, 2021)]
[Notices]
[Pages 11301-11303]
[FR Doc No: 2021-03727]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0031]

Best Practices for Development and Application of Disease
Progression Models; Public Workshop; Establishment of a Public Docket;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

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SUMMARY: One of the goals of the Prescription Drug User Fee Act of 2017
(PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA), is
advancing model-informed drug development (MIDD). The ``Best Practices
for Development and Application of Disease Progression Models''
workshop fulfills FDA's performance commitment under PDUFA VI to hold a
workshop. The Food and Drug Administration (FDA or Agency) is opening a
docket to solicit public input on topics areas for an upcoming disease
progression modeling workshop. The purpose of this public workshop is
to discuss the best practices for developing disease progression models
and their application to support drug development decisions; share

experiences and case studies that highlight the opportunities and
limitations in the development and application of disease progression
models including models for natural history of disease and clinical
trial simulations; and discuss the knowledge gaps and research needed
to advance the development and use of disease progression models.

DATES: To ensure that the Agency considers your input, submit either
electronic or written comments by March 26, 2021.

ADDRESSES: FDA is establishing a docket for public comment on this
workshop. The docket number is FDA-2021-N-0031. The docket will close
on March 26, 2021. Submit either electronic or written comments on this
public workshop by March 26, 2021. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before March 26, 2021. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of March 26, 2021. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.
    You may submit comments 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-2021-N-0031 for ``Best Practices for Development and Application of
Disease Progression Models; Public Workshop; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), 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,<PHONE_NUMBER>.
     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>.

FOR FURTHER INFORMATION CONTACT: Maryanne Dingman, Office of Clinical
Pharmacology, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002,
301-796-8777, or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Under FDARA, FDA agreed, in accordance with section I of the PDUFA
VI Performance Goals, ``Ensuring the Effectiveness of the Human Drug
Review, part J, Enhancing Regulatory Decision Tools to Support Drug
Development and Review,'' to hold several workshops to identify best
practices for MIDD. The workshop entitled ``Best Practices for
Development and Application of Disease Progression Models,'' to be held
in 2021, fulfills FDA's performance commitment under PDUFA VI. FDA is
requesting comments from the public to help identify areas of interest
to be discussed during the workshop given the wide range of approaches
to data collection, aggregation modeling, model development,
verification and validation, and potential applications in drug
development and regulatory review. The outcome will help the Agency
inform the public on current experience, emerging techniques, and
limitations to streamline the drug model development and facilitate the
decision-making process.

II. Request for Information and Comments

    Interested persons are invited to provide detailed information and
comments on areas of interest to discuss during the upcoming ``Best
Practices for Development and Application of Disease Progression Models
'' workshop. FDA is interested in responses about best practice
considerations including, but not limited to, the following:
    1. The development and application of different types of disease
progression models (e.g., empirical, semi-mechanistic, and fully
mechanistic or systems modeling).

    2. Modeling natural history of disease, specifically methodological
considerations and challenges in characterizing the natural
relationship between pharmacodynamic markers and clinical outcomes.
    3. Clinical trial simulations based on disease progression/natural
history models to support drug development and regulatory decisions.

    Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03727 Filed 2-23-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 168 (Wednesday, August 29, 2018)]
[Notices]
[Page 44120]
[FR Doc No: 2018-18764]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Request To Release Airport Property
at the Dallas/Fort Worth International Airport, DFW, Texas

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of request to release airport property.

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SUMMARY: The FAA proposes to rule and invite public comment on the
release of land at the Dallas/Fort Worth International Airport under
the provisions of Section 125 of the Wendell H. Ford Aviation
Investment Reform Act for the 21st Century (AIR 21).

DATES: Comments must be received on or before (from 30 days of the
posting of this Federal Register Notice).

ADDRESSES: Comments on this application may be mailed or delivered to
the FAA at the following address: Mr. Ben Guttery, Manager, Federal
Aviation Administration, Southwest Region, Airports Division, Texas
Airports District Office, ASW-650, 10101 Hillwood Parkway, Fort Worth,
Texas 76177.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to the at the following address: Mr. Sean Donohue,
Chief Executive Officer, Dallas/Fort Worth International Airport,
Executive Office, P.O. Box 619428, DFW Airport, Texas 75261.

FOR FURTHER INFORMATION CONTACT: Mr. Steven Cooks, Program Manager,
Federal Aviation Administration, Texas Airports District Office, ASW-
650, 10101 Hillwood Parkway, Fort Worth, TX 76177, Telephone: (817)
222-5608, email: [email protected], fax:<PHONE_NUMBER>.
    The request to release property may be reviewed in person at this
same location.

SUPPLEMENTARY INFORMATION: The FAA invites public comment on the
request to release property at the Dallas/Fort Worth International
Airport under the provisions of the AIR 21.
    The following is a brief overview of the request:
    The Dallas/Fort Worth International Airport requests the release of
39.737 acres of non-aeronautical airport property for permanent
easement to the Fort Worth Transportation Autority. The permanent and
temporary easements to be released will enable TRA to construct the
Interceptor line which is approximately 9,850 linear feet and continue
to maintain the Interceptor in the future and revuenes shall be used to
further develop, operate and maintain DFW Airport.
    Any person may inspect the request in person at the FAA office
listed above under FOR FURTHER INFORMATION CONTACT.
    In addition, any person may, upon request, inspect the application,
notice and other documents relevant to the application in person at
the: Dallas/Fort Worth International Airport, Telephone Number (972)
973-4646.

    Issued in Fort Worth, Texas, on August 16, 2018.
Ignacio Flores,
Director, Airports Division.
[FR Doc. 2018-18764 Filed 8-28-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register: February 18, 2010 (Volume 75, Number 32)]
[Notices]
[Page 7276-7277]
[DOCID:fr18fe10-36]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0070]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Agreement for Shipment of Devices for Sterilization

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
requirements relating to shipment of nonsterile devices that are to be
sterilized elsewhere or are shipped to other establishments for further
processing, labeling, or repacking.

DATES:  Submit written or electronic comments on the collection of
information by April 19, 2010.

ADDRESSES:  Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Agreement for Shipment of Devices for Sterilization--21 CFR 801.150(e)
(OMB Control Number 0910-0131)--Extension

    Under sections 501(c) and 502(a) of the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 351(c) and 352(a)), nonsterile
devices that are labeled as sterile but are in interstate transit to a
facility to be sterilized are adulterated and misbranded. FDA
regulations in Sec.  801.150(e) (21 CFR 801.150(e)) establish a control
mechanism by which firms may manufacture and label medical devices as
sterile at one establishment and ship the devices in interstate
commerce for sterilization at another establishment, a practice that
facilitates the processing of devices and is economically necessary for
some firms. Under Sec.  801.150(e)(1), manufacturers and sterilizers
may sign an agreement containing the following: (1) Instructions for
maintaining accountability of the number of units in each shipment; (2)
acknowledgment that the devices that are nonsterile are being shipped
for further processing; and (3) specifications for sterilization
processing.
    This agreement allows the manufacturer to ship misbranded products
to be sterilized without initiating regulatory action and provides FDA
with a means to protect consumers from use of nonsterile products.
    During routine plant inspections, FDA normally reviews agreements
that must be kept for 2 years after final shipment or delivery of
devices (Sec.  801.150(a)(2)).
    The respondents to this collection of information are device
manufacturers and contact sterilizers.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
801.150(e)                        90                 20              1,800                  4              7,200
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                           No. of        Annual Frequency     Total Annual      Hours per                             Total Operating &
           21 CFR Section               Recordkeepers    per Recordkeeping      Records           Record           Total Hours        Maintenance Costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.150(a)(2)                                       90                  20            1,800              0.5                   900               $55,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with this collection of information.

    FDA's estimate of the reporting burden is based on actual data
obtained from industry over the past several years where there are
approximately 90 firms subject to this requirement. It is estimated
that each of these firms on the average prepares 20 written agreements
each year. This estimate varies greatly, from 1 to 100, because some
firms provide sterilization services on a part time basis for only one
customer while others are large facilities with many customers. The
average time required to prepare each written agreement is estimated to
be four hours. This estimate varies depending on whether the agreement
is the initial agreement or an annual renewal, on the format each firm
elects to use, and on the length of time required to reach agreement.
The estimate applies only to those portions of the written agreement
that pertain to the requirements imposed by this regulation. The
written agreement generally also includes contractual agreements that
are a customary and usual business practice. On the average, the total
annual recordkeeping burden is 7,200 hours (90 firms x 20 agreements x
4 hours).
    The recordkeeping requirements of Sec.  801.150(a)(2) consist of
making copies and maintaining the actual reporting requests which were
required under the reporting section of this collection. To fulfill
this requirement, FDA estimates it will take about 30 minutes to copy
each package, for a total of 900 recordkeeping hours and includes
$55,800 operating and maintenance costs.

    Dated: February 4, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3027 Filed 2-17-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 81, Number 164 (Wednesday, August 24, 2016)]
[Notices]
[Pages 57960-57963]
[FR Doc No: 2016-20205]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-78611; File No. SR-MSRB-2016-07]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Notice of Filing of Amendment No. 1 and Order Granting
Accelerated Approval of a Proposed Rule Change, as Modified by
Amendment No. 1, Consisting of Proposed Amendments to Rule G-12, on
Uniform Practice, Regarding Close-Out Procedures for Municipal
Securities

August 18, 2016.

I. Introduction

    On May 11, 2016, the Municipal Securities Rulemaking Board (the
``MSRB'' or ``Board'') filed with the Securities and Exchange
Commission (the ``SEC'' or ``Commission''), pursuant to Section
19(b)(1) of the Securities Exchange Act of 1934 (``Act'') \1\ and Rule
19b-4 thereunder,\2\ a proposed rule change consisting of proposed
amendments to Rule G-12, on uniform practice, regarding close-out
procedures for municipal securities. The proposed rule change was
published for comment in the Federal Register on June 1, 2016.\3\
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 77903 (May 25, 2016)
(the ``Proposing Release''), 81 FR 35111 (June 1, 2016).
---------------------------------------------------------------------------

    The Commission received three comment letters on the proposal.\4\
On July 25, 2016, the MSRB responded to the comments \5\ and filed
Amendment No. 1 to the proposed rule change.\6\ The

Commission is publishing this notice to solicit comments on Amendment
No. 1 to the proposed rule change from interested persons and is
approving the proposed rule change, as modified by Amendment No. 1, on
an accelerated basis.
---------------------------------------------------------------------------

    \4\ See Letters to Secretary, Commission, from Leslie M.
Norwood, Managing Director and Associate General Counsel, Securities
Industry and Financial Markets Association (``SIFMA''), dated June
22, 2016 (the ``SIFMA Letter''); Michael Nicholas, Chief Executive
Officer, Bond Dealers of America (``BDA''), dated June 22, 2016 (the
``BDA Letter''); and David T. Bellaire, Esq., Executive Vice
president and General Counsel, Financial Services Institute
(``FSI''), dated June 22, 2016 (the ``FSI Letter'').
    \5\ See Letter to Secretary, Commission, from Michael Cowart,
Deputy Director, Professional Qualifications and Assistant General
Counsel, MSRB, dated July 25, 2016 (the ``MSRB Response and
Amendment Letter''), available at https://www.sec.gov/comments/sr-msrb-2016-07/msrb201607-4.pdf.
    \6\ Id. In Amendment No. 1, the MSRB partially amended the text
of the original proposed rule change to shorten the period in which
firms are required to resolve an inter-dealer fail from 20 calendar
days to 10 calendar days, and to permit the buyer to grant the
seller a one-time 10 calendar day extension.
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    In the Proposing Release, the MSRB stated that a more timely
resolution of inter-dealer fails would ultimately benefit customers by
providing greater certainty that their fully paid for securities are in
fact owned in their account, not allocated to a firm short, and would
benefit dealers by reducing the risk and costs associated with inter-
dealer fails.
    As further described in the Proposing Release and the MSRB Response
and Amendment Letter, the MSRB states that the purpose of the proposed
rule change is to significantly compress the timing to initiate and
complete a close-out by allowing a close-out notice to be issued the
day after the purchaser's original settlement date, with the last day
by which the purchasing dealer must complete a close-out on an open
transaction being reduced to 10 calendar days, with an option for the
buyer to grant the seller a one-time 10 calendar day extension.\7\
---------------------------------------------------------------------------

    \7\ See supra notes 3 and 5. The rule as initially proposed in
the Proposing Release provided for a period of 20 days in which a
close-out must be completed.
---------------------------------------------------------------------------

    With the vast majority of municipal securities in book entry form
and the Depository Trust & Clearing Corporation's (``DTCC'') continued
efforts to promote dematerialization, the MSRB proposed that firms
should no longer have to provide a 10-day delivery window before
implementing an execution period. The MSRB believes a three-day
delivery window would be sufficient as the majority of inter-dealer
fails are resolved within days of the original settlement and/or a fail
situation is known prior to the original settlement date.
    Additionally, the current rule requires that the earliest day that
can be specified as the execution date is 11 days after telephonic
notice. The proposed amendments would amend the current allowable
execution time frame from 11 days to four days after electronic
notification. Accelerating the execution date could improve a firm's
likelihood of finding a security for a buy-in, lower overall counter-
party risk and may further reduce accrual, capital and other expenses.
    Under the proposed rule change, a purchasing dealer notifying the
selling dealer of an intent to close out an inter-dealer fail would
continue to prompt DTCC to ``exit'' the position from DTCC's continuous
net settlement (``CNS'') and the two parties are responsible for
effecting the close-out. Because a municipal security may not be
available for purchase, incorporating the buy-in procedures of a
registered clearing agency will often not solve the inter-dealer fail.
The MSRB expects firms to not solely rely upon the CNS system or the
services of a registered clearing agency to resolve inter-dealer fails
and take prompt action to close out inter-dealer fails in a timely
manner. Under the proposed rule change, regardless of the date the
positions are exited from CNS, the inter-dealer fail must be resolved
within 20 calendar days of the purchasing dealer's original settlement
date. The MSRB is also proposing to retire the Manual on Close-Out
Procedures.\8\
---------------------------------------------------------------------------

    \8\ See Manual on Close-Out Procedures. The Manual on Close-Out
Procedures will be retired because such procedures would be outdated
and, given the proposed rule change's overall simplicity, developing
an updated version of the manual is not warranted.
---------------------------------------------------------------------------

Proposed Amendments to MSRB Rule G-12(h)

    Rule G-12, on uniform practice, establishes uniform industry
practices for processing, clearance and settlement of transactions in
municipal securities between a broker, dealer or municipal securities
dealer and any other broker, dealer or municipal securities dealer. The
proposed amendments would amend Rule G-12(h) by requiring close-outs to
be settled no later than 20 calendar days after the settlement date.
The proposed amendments to G-12(h)(i)(B) would allow for the close-out
process to continue to provide three options to the purchasing dealer.
The three options include: (1) Purchase (``buy-in'') at the current
market all or any part of the securities necessary to complete the
transaction for the account and liability of the seller; (2) accept
from the seller in satisfaction of the seller's obligation under the
original contract (which shall be concurrently cancelled) the delivery
of municipal securities that are comparable to those originally bought
in quantity, quality, yield or price, and maturity, with any additional
expenses or any additional cost of acquiring such substituted
securities being borne by the seller; or (3) require the seller to
repurchase the securities on terms which provide that the seller pay an
amount which includes accrued interest and bear the burden of any
change in market price or yield.
    Firms must coordinate internally to determine which of the three
close-out options are appropriate for any given fail-to-deliver
situation. While a buy-in may be the most preferred method, Rule G-
12(h) provides two other options to a purchaser in the event a buy-in
is not feasible. Firms are reminded that, regardless of the option
agreed upon by the counterparties, including a cancelation of the
original transaction, the close-out transaction is reportable to the
Real-time Transaction Reporting System (``RTRS'') as currently required
pursuant to Rule G-14.
    Additionally, the proposed amendments to Rule G-12(h)(i)(A) would
allow a purchaser to notify the seller of the purchaser's intent to
close-out the transaction the first business day following the
purchaser's original transaction settlement date, instead of waiting
five business days as currently required in Rule G-12(h)(i)(A).
    Currently Rule G-12(h) references use of the telephone and mail as
part of the notification process. The proposed amendments would update
Rule G-12(h) throughout, to reflect modern communication methods and
widely-used industry practices that would facilitate more timely and
efficient close-outs. For example, DTCC's SMART/Track is available for
use by any existing NSCC clearing firm or DTCC settling member,
allowing users to create, retransmit, respond, update, cancel and view
a notice.
    The proposed amendments to Rule G-12(h)(i)(D) would require sellers
to use their best efforts to locate the securities that are subject to
a close-out notice from a purchaser. The proposed amendments to Rule G-
12(h)(i)(E)(1) would also require the seller to bear any burden in the
market price, with any benefit from any change in the market price
remaining with the purchaser.
    The proposed amendments would also require a purchasing dealer that
has multiple counterparties, to utilize the FIFO (first-in-first-out)
method for determining the contract date for the failing quantity.
Amendments to Rule G-12(h)(iv) would require dealers to maintain all
records regarding the close-out transaction as part of the firm's books
and records.

III. Summary of Comments Received and the MSRB's Response

    As noted previously, the Commission received three comment letters
on the proposed rule change and a response

letter from the MSRB.\9\ The commenters generally support the proposed
rule change.\10\ However, some commenters asked for further
clarification and provided suggested amendments to the proposed rule
change.\11\ The MSRB has responded to the commenters, as discussed
below.\12\
---------------------------------------------------------------------------

    \9\ See supra notes 4 and 5.
    \10\ Id.
    \11\ Id.
    \12\ See MSRB Response and Amendment Letter.
---------------------------------------------------------------------------

1. Shorter Close-Out Deadline

    As noted above, the original proposed rule change provided for a
close-out deadline of 20 calendar days. Both BDA and SIFMA commented
that they would support an even shorter close-out period, with both
suggesting a period of 10 calendar days, with an option for the buyer
to consent to a 10-day extension, for a maximum aggregate total of 20
days.\13\
---------------------------------------------------------------------------

    \13\ See BDA Letter and SIFMA Letter.
---------------------------------------------------------------------------

    In response to comments, the MSRB proposed, in Amendment No. 1, to
amend the original proposed rule change to require firms to resolve an
inter-dealer fail from 20 calendar days to 10 calendar days and permit
the buyer to grant the seller a one-time 10 calendar day extension,
which would allow the buyer flexibility, while still ensuring that
inter-dealer fails would be closed-out in a maximum of 20 calendar
days. The MSRB stated in the Proposing Release that ``a more timely
resolution of inter-dealer fails would ultimately benefit customers by
providing greater certainty that their fully paid for securities are in
fact owned in their account and not allocated to a firm short, and
would also benefit dealers by reducing the risk and costs associated
with inter-dealer fails.'' \14\ The MSRB states in the MSRB Response
and Amendment Letter that shortening the close-out period from 20
calendar days, as stated in the original proposed rule change, to 10
calendar days will further reduce the risk and cost associated with
inter-dealer fails.
---------------------------------------------------------------------------

    \14\ See supra note 3.
---------------------------------------------------------------------------

2. Requests for Clarification and Guidance

    BDA commented that its member firms still have outstanding
questions about how the proposed rule change would impact close-out
processes related to accounts transferred to a broker-dealer via the
Automated Customer Account Transfer Service (``ACATS''), and requested
additional guidance from the MSRB regarding close-outs through
ACATS.\15\ SIFMA requested further guidance from the MSRB regarding
close-outs with respect to self-directed customer accounts, in which
broker-dealers are not allowed to use discretion.\16\
---------------------------------------------------------------------------

    \15\ See BDA Letter.
    \16\ See SIFMA Letter.
---------------------------------------------------------------------------

    The MSRB responded that both of these requests for guidance are
beyond the scope of the proposed rule change, both as originally
proposed and as amended by Amendment No. 1.\17\
---------------------------------------------------------------------------

    \17\ See MSRB Response and Amendment Letter.
---------------------------------------------------------------------------

IV. Discussion and Commission Findings

    The Commission has carefully considered the proposed rule change,
as modified by Amendment No. 1, as well as the three comment letters
received and the MSRB's response. The Commission finds that the
proposed rule change, as amended by Amendment No. 1, is consistent with
the requirements of the Act and the rules and regulations thereunder
applicable to the MSRB.
    In particular, the proposed rule change is consistent with Section
15B(b)(2)(C) of the Act. Section 15B(b)(2)(C) of the Act requires that
the MSRB's rules be designed to prevent fraudulent and manipulative
acts and practices, to promote just and equitable principles of trade,
to foster cooperation and coordination with persons engaged in
regulating, clearing, settling, processing information with respect to,
and facilitating transactions in municipal securities and municipal
financial products, to remove impediments to and perfect the mechanism
of a free and open market in municipal securities and municipal
financial products, in general, to protect investors, municipal
entities, obligated persons, and the public interest.\18\
---------------------------------------------------------------------------

    \18\ See 15 U.S.C. 78o-4(b)(2)(C).
---------------------------------------------------------------------------

    The MSRB states that the proposed rule change would benefit
investors, dealers and issuers. Specifically, the MSRB states that
dealers may benefit from clarifications and revisions that more closely
reflect actual market practices. In addition, dealers may be able to
more quickly and efficiently resolve inter-dealer fails, which may
reduce dealer risk, reduce the likelihood and duration that dealers are
required to pay ``substitute interest'' to customers and reduce
systemic risk. The MSRB further states that the proposed rule change
may also reduce the likelihood and duration of firm short positions
that allocate to customer long positions, reduce investor tax exposure
and increase investor confidence in the market. According to the MSRB,
issuers and the market as a whole may benefit from increased investor
confidence.
    In approving the proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition, and
capital formation.\19\ The Commission believes the proposed rule change
will improve efficiency in the municipal securities market. The
Commission notes that all of the commenters stated that the proposed
rule change would have positive effects on municipal market
efficiency.\20\ The Commission does not believe that the proposed rule
change would impose any burden on competition not necessary or
appropriate in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78c(f).
    \20\ See supra note 4.
---------------------------------------------------------------------------

    As noted above, the Commission received three comment letters on
the filing. The Commission believes that the MSRB, through its
responses and through proposed changes in Amendment No. 1, has
addressed commenters' concerns.
    For the reasons noted above, including those discussed in the MSRB
Response and Amendment Letter, the Commission believes that the
proposed rule change, as amended by Amendment No. 1, is consistent with
the Act.

V. Solicitation of Comments on Amendment No. 1

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether Amendment No. 1
to the proposed rule change is consistent with the Act. Comments may be
submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MSRB-2016-07 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street NE., Washington, DC 20549.

All submissions should refer to File Number SR-MSRB-2016-07. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the

submission, all subsequent amendments, all written statements with
respect to the proposed rule change that are filed with the Commission,
and all written communications relating to the proposed rule change
between the Commission and any person, other than those that may be
withheld from the public in accordance with the provisions of 5 U.S.C.
552, will be available for Web site viewing and printing in the
Commission's Public Reference Room, 100 F Street NE., Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the MSRB. All comments received
will be posted without change; the Commission does not edit personal
identifying information from submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-MSRB-2016-07 and should be submitted on
or before September 14, 2016.

VI. Accelerated Approval of Proposed Rule Change as Modified by
Amendment No. 1

    The Commission finds good cause for approving the proposed rule
change, as amended by Amendment No. 1, prior to the 30th day after the
date of publication of notice in the Federal Register. As discussed
above, Amendment No. 1 amends the proposed rule change by shortening
the required time frame for firms to resolve an inter-dealer fail from
20 calendar days to 10 calendar days, and permitting the buyer to grant
the seller a one-time 10 calendar day extension.
    The MSRB has proposed the revisions included in Amendment No. 1 to
further reduce the risk and cost associated with inter-dealer fails. As
noted by the MSRB, the only substantive change to the proposed
amendment, the shortening of the close-out period, was made to address
concerns raised during the comment period. The MSRB has further noted
that, in light of the stated goal of the original proposal to compress
the timing for initiating and completing a close-out, the revisions are
consistent with the original proposal and are unlikely to be
controversial.
    For the foregoing reasons, the Commission finds good cause for
approving the proposed rule change, as modified by Amendment No. 1, on
an accelerated basis, pursuant to Section 19(b)(2) of the Act.

VII. Conclusion

    It Is Therefore Ordered, pursuant to Section 19(b)(2) of the
Act,\21\ that the proposed rule change (SR-MSRB-2016-07), as modified
by Amendment No. 1, be, and hereby is, approved on an accelerated
basis.
---------------------------------------------------------------------------

    \21\ 15 U.S.C. 78s(b)(2).

    For the Commission, pursuant to delegated authority.\22\
---------------------------------------------------------------------------

    \22\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-20205 Filed 8-23-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register: April 15, 2010 (Volume 75, Number 72)]
[Notices]
[Page 19644]
[DOCID:fr15ap10-48]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER10-1030-000]

West Oaks Energy NY/NE, LP; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

April 8, 2010.
    This is a supplemental notice in the above-referenced proceeding of
West Oaks Energy NY/NE LP's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is April 28, 2010.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive e-mail notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please e-mail<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-8582 Filed 4-14-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 192 (Thursday, October 3, 2013)]
[Proposed Rules]
[Pages 61223-61226]
[FR Doc No: 2013-24150]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2012-0080]
RIN 1625-AA00

Regulated Navigation Area; Southern Oahu Tsunami Vessel
Evacuation, Honolulu, HI

AGENCY: Coast Guard, DHS.

ACTION: Supplementary notice of proposed rulemaking.

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SUMMARY: The Coast Guard is proposing to establish a permanent
regulated navigation area (RNA) and to enforce this proposed regulation
only when a tsunami warning is issued for the Hawaiian Islands by the
Pacific Tsunami Warning Center. Tsunami warnings require the evacuation
of a large number of vessels from their respective harbors. Following
the evacuation, these vessels must remain offshore until the emergency
situation has passed and the harbors have been deemed safe for reentry.
Past tsunami warnings have created potentially dangerous offshore
traffic congestion between commercial and recreational vessel traffic.
Because of this, designated vessel traffic staging areas are necessary
for a safe and orderly evacuation of Southern Oahu ports.

DATES: Comments and related material must be received by the Coast
Guard on or before November 4, 2013.

ADDRESSES: Documents mentioned in this preamble are part of docket
USCG-2012-0080. To view documents mentioned in this preamble as being
available in the docket, go to 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 rulemaking. The
following link will take you directly to the docket: http://www.regulations.gov/#!docketDetail;D=USCG-2012-0080. 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 proposed
rule, call or email Lieutenant Commander Scott Whaley of the United
States Coast Guard Sector Honolulu at<PHONE_NUMBER> ext. 3352 or
<EMAIL_ADDRESS>respectively. If you have questions on viewing
or submitting material to the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
SNPRM Supplemental Notice of Proposed Rulemaking
RNA Regulated Navigation Area

A. Public Participation and Request for Comments

    We encourage you to respond to this notice by submitting comments
and related materials. All comments received will be posted without
change to http://www.regulations.gov and will include any personal
information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online at
http://www.regulations.gov, or by fax, mail, or hand delivery, but
please use only one of these means. If you submit a comment online, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as having been received by the Coast Guard when
it is received at the Docket Management Facility. 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. To submit your
comment online, go to http://www.regulations.gov, type the docket
number USCG-2012-0080 in the ``SEARCH'' box, and then click ``SEARCH.''
Click on ``Submit a Comment'' on the line associated with this
supplementary notice of proposed rulemaking (SNPRM).
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8[frac12] by 11 inches, suitable
for copying and electronic filing. If you submit comments by mail and
would like to know that they reached the Facility, please enclose a
stamped, self-addressed postcard or envelope. We will consider all
comments and material received during the comment period and may change
the proposed rule based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
inserting USCG-2012-0080 in the ``SEARCH'' box, and then click
``SEARCH.'' 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. We
have an agreement with the Department of Transportation to use the
Docket Management Facility.

3. 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 notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We do not plan to hold a public meeting. But you may submit a
request for one using one of the four methods specified under
ADDRESSES. Please explain in detail why you believe a public meeting
would be beneficial. If

we determine that one would aid in solving this problem, we will hold
one at a time and place announced by a later notice in the Federal
Register.

B. Regulatory History and Information

    The Coast Guard collaborated with the Hawaii Ocean Safety Team, the
Industry Advisory Board and other industry partners in the initial
development of a proposed Southern Oahu Tsunami Vessel Evacuation
regulated navigation area. All recommendations received careful
consideration during the drafting of this rule. On May 14, 2013, the
Coast Guard published a notice of proposed rulemaking (NPRM) in the
Federal Register (78 FR 28170) under the same docket number (USCG-2012-
0080) as this SNPRM. The Coast Guard received a total of five comments;
those comments are posted, without change, at http://www.regulations.gov. To view these comments go to http://www.regulations.gov, insert USCG-2012-0080 in the ``SEARCH'' box, and
then click ``SEARCH.''
    In accordance with 33 CFR 1.05-40, we are issuing this
supplementary notice of proposed rulemaking (SNPRM) because, after
consideration of the comments received, the Coast Guard proposes to
substantially change the rule from that originally published in the
NPRM. This SNPRM advises the public of the revised proposal and
provides an opportunity for comment on the changes.

C. Basis and Purpose

    The statutory basis for this rulemaking is 33 U.S.C. 1231, which
gives the Coast Guard, under a delegation from the Secretary of
Homeland Security, regulatory authority to enforce the Ports and
Waterways Safety Act. A regulated navigation area is a water area
within a defined boundary for which regulations for vessels navigating
within the area have been established to mitigate hazardous conditions
deemed to exist in that area. The purpose of this rulemaking is to
provide greater safety for vessels and maritime commerce in the event
of a tsunami threat.

D. Discussion of Comments, Changes and the New Proposed Rule

    The Coast Guard received a total of five written submissions on the
NPRM published on May 14, 2013 in the Federal Register.
    One commenter voiced his support of the rule proposed in the NPRM,
calling it an ``important safety regulation''.
    One commenter was unable to locate the graphic displaying the
staging areas. An electronic copy of the graphic was emailed to him.
The graphic was also disseminated via press release, advertised on the
local TV news and posted on the Coast Guard Sector Honolulu HOMEPORT
Web page. Further, the graphic associated with the NPRM was filed in
the docket on June 5, 2013.
    One commenter suggested changes to the proposed rule that would
reduce the potential for small recreational vessels operating in the
same staging area as large container vessels and cruise ships. In this
SNPRM, the Coast Guard proposes to segregate the staging areas for
recreational and commercial vessels. The potential for hazardous
situations or even collisions, due to, among other things, limited
maneuverability, would increase if recreational and commercial vessels
were staged in the same area. Therefore, in this SNPRM the Coast Guard
has modified the proposed staging areas to further reduce the potential
for vessel intermingling, congestion and incidents. The current
proposed rule adds a second recreational vessel staging area,
eliminating the need for recreational vessels departing Keehi Lagoon to
transit through the commercial vessel staging area.
    One commenter suggested reconsideration of the potential path of
commercial vessels and recreational vessels transiting from their
berths to their respective staging areas. The staging areas have been
modified so that commercial and recreational vessels can transit to
their respective staging area without crossing each other's path.
    One commenter pointed out a discrepancy with the stated
geographical positions. The latitudes and longitudes have been changed
to more accurately reflect the intended boundary for the regulated
navigation zone.

E. Discussion of the Proposed Rule

    Earthquakes off Chile and Japan in February 2010 and March 2011,
respectively, resulted in tsunami threats to the Main Hawaiian Islands.
These incidents emphasized the need to establish heightened safety
measures, to ensure an orderly and organized evacuation plan, in order
to protect the infrastructure of the southern coast of Oahu, Hawaii,
including Honolulu Harbor. Honolulu Harbor has only one entrance for
large commercial vessels and is the principle harbor of Hawaii's hub
and spoke maritime commerce system. If, in response to a tsunami
warning, a marine incident were to occur off the southern shore of
Oahu, especially near the entrance of Honolulu Harbor, the results
could be devastating to Hawaii's economy and the maritime commerce
system and the constituencies that rely heavily upon the system's
viability.
    In response to this risk, the Coast Guard proposes the
establishment of a regulated navigation area (RNA) designated as the
Southern Oahu Tsunami Evacuation zone.
    In the event of a tsunami warning, the Coast Guard Captain of the
Port for Honolulu (COTP) would notify the public that an enforcement
period is in effect for the duration of the emergency for this RNA. At
the conclusion of the threat, the COTP would notify the public when the
RNA enforcement period is suspended or terminated.
    During the enforcement period, the COTP intends to deploy Coast
Guard vessels and personnel, if feasible, to ensure participating
commercial and recreational vessels move to and stay within separate
staging areas, and seaward of the 50-fathom curve that covers near-
shore waters less than 300 feet deep. Coast Guard plans, which could
vary depending on specific conditions during an actual emergency, call
for those staging areas to be separated by an exclusionary area. This
exclusionary area would measure 4 nautical miles long by one (1)
nautical mile wide, centering lengthwise and along a line running
seaward at 208 degrees southwest of the Honolulu Harbor Range light.
Vessels participating in the staging area would have to stay outside of
the exclusionary area.
    There are two staging areas to the east of the exclusionary area: a
commercial vessel staging area and a recreational vessel staging area.
This eastern recreational staging area is intended for use by
recreational vessels departing from and returning to the Ala Wai Small
Boat harbor and Kewalo Basin. There will also be one recreational
vessel staging area to the west of the exclusionary area. This staging
area is intended for recreational vessels departing from and returning
to the Keehi Lagoon area.
    Although recreational vessels would be able to use either the east
or west staging area, the mariners decision for which staging area to
use should be based on which staging area is the easiest to transit to
so as to avoid crossing the path of other vessels. The commercial
staging area is intended for use by all commercial vessels departing
from and returning to Kewalo Basin and Honolulu Harbor.
    A graphic of the regulated navigation area is posted in the docket
(http://www.regulations.gov/

!docketDetail;D=USCG-2012-0080) and also on the United States
Coast Guard Sector Honolulu Homeport Web page (https://homeport.uscg.mil/mycg/portal/ep/portDirectory.do?tabId=1&cotpId=27)
under the Waterways Management tab. The graphic shows how we expect to
separate commercial and recreational vessels when the RNA is being
enforced, but under actual enforcement conditions local commanders may
vary the plan as conditions warrant.

F. Regulatory Analyses

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

1. Regulatory Planning and Review

    This proposed rule is not a significant regulatory action under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
because it would have an effect on the regulated public only in the
rare circumstances of a tsunami threat, while at other times vessels
will be able to transit the area freely. Further, staging within this
RNA is completely voluntary and vessels are free to evacuate outside of
the RNA if they prefer. Therefore, it 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.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule will not have a significant economic impact on a substantial
number of small entities. This proposed rule would affect the following
entities, some of which might be small entities: the owners or
operators of vessels intending to transit and remain in the
exclusionary zone during a tsunami threat, or owners or operators of
vessels otherwise intending to operate in a fashion not compatible with
this proposed rule. This rule would not have a significant impact on a
substantial number of small entities because the RNA would only be
activated, and thus subject to enforcement, when a tsunami warning has
been issued by the Pacific Tsunami Warning Center.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    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.

4. Collection of Information

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

5. Federalism

    A proposed 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
proposed rule under that Order and have determined that it does not
have implications for federalism.

 6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the For Further
Information Contact section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

7. 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 proposed rule would not result in such
expenditure, we do discuss the effects of this proposed rule elsewhere
in this preamble.

8. Taking of Private Property

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

9. 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.

10. Protection of Children From Environmental Heath Risks

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

11. Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. 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 proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this proposed 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
made a preliminary determination that this action is one of a category
of actions which do not individually or cumulatively have a significant
effect on the human environment. This proposed rule, implementing an
RNA for vessel staging areas in the event of a tsunami threat to the
Main Hawaiian Islands, is categorically excluded from further review
under paragraph (34)(g) of Figure 2-1 of the Commandant Instruction. A
preliminary environmental analysis checklist and a categorical
exclusion determination are available in the docket where indicated
under ADDRESSES, or you may obtain a copy by calling or emailing
Lieutenant Commander Scott Whaley of the United States Coast Guard
Sector Honolulu at<PHONE_NUMBER> ext. 3352 or<EMAIL_ADDRESS>
respectively. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this proposed
rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.
    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1231; 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. Add Sec.  165.14-1413 to read as follows:

Sec.  165.14-1413  Regulated navigation area; Southern Oahu Tsunami
Evacuation; Honolulu, Hawaii.

    (a) Location. The following area is a regulated navigation area
(RNA): All waters of the Pacific Ocean south of the southern shoreline
of Oahu, HI, extending from the surface of the water to the ocean
floor, enclosed by a line connecting the following points:
21[deg]17'14'' N, 157[deg]55'34'' W; 21[deg]13'30'' N, 157[deg]55'34''
W; 21[deg]13'30'' N, 157[deg]48'20'' W; 21[deg]14'14'' N,
157[deg]48'20'' W, thence westward along the 50 fathom curve to the
beginning point. These coordinates are based upon the National Oceanic
and Atmospheric Administration Coast Survey, Pacific Ocean, Oahu,
Hawaii, chart 19357.
    (b) Regulations. You may contact the Coast Guard on VHF Channel 16
(156.800 MHz) or at telephone number<PHONE_NUMBER>, to obtain
clarification on RNA transits and locations. Operations permitting, the
Coast Guard patrol boats plan to enforce the RNA and provide on-scene
direction. During the enforcement period persons and vessels wishing to
remain inside the RNA must abide by the following stipulations:
    (1) No person or vessel may enter into an exclusionary area 4
nautical miles long by one (1) nautical mile wide, centered lengthwise
and along a line running seaward at 208 degrees southwest of Honolulu
Harbor Front Range Light, except to transit to or from the staging
areas or other areas outside the zone. Loitering or lingering in the
exclusionary zone is prohibited.
    (2) The Western Recreational Vessel Staging area is bound by a line
connecting the following points: 21[deg]17'14'' N, 157[deg]55'34'' W;
21[deg]14'36'' N, 157[deg]55'34'' W; 21[deg]16'31'' N, 157[deg]53'54''
W and then along the 50-fathom curve to the beginning point. This
staging area is intended for recreational vessels departing from and
returning to the Keehi Lagoon area.
    (3) The Commercial Vessel Staging Area is bound by a line
connecting the following points: 21[deg]16'09'' N, 157[deg]52'59'' W;
21[deg]13'30'' N, 157[deg]55'34'' W; 21[deg]13'30'' N, 157[deg]51'39''
W; 21[deg]15'22'' N, 157[deg]51'10'' W and then along the 50-fathom
curve to the beginning point. This staging area is intended for use by
all commercial vessels intended to remain in the RNA during a tsunami
treat.
    (4) The Eastern Recreational Vessel Staging Area is bound by the
following points: 21[deg]15'22'' N, 157[deg]51'10'' W; 21[deg]13'30''
N, 157[deg]51'39'' W; 21[deg]13'30'' N, 157[deg]48'20'' W;
21[deg]14'14'' N, 157[deg]48'20'' W and then along the 50-fathom curve
to the beginning point. The Commercial Vessel Staging Area bounds this
staging area's western edge. The dividing line between the Commercial
Vessel Staging Area and the Eastern Recreational Vessel Staging Area
can be determined visually. The private dayboards located in the Ala
Wai Small Boat Harbor and the La Ronde Rotating Restaurant roof top
restaurant form a natural range that mariners can use in daylight hours
to gauge the eastern boundary of the Commercial Vessel Staging Area and
the western boundary of the Eastern Recreational Vessel Staging Area.
This eastern recreational staging area is intended for use by
recreational vessels departing from and returning to the Ala Wai Small
Boat harbor and Kewalo Basin.
    (5) Located between the Western Recreational Vessel Staging Area
and the Commercial Vessel Staging Area is an Exclusion Area. This area
is bound by the following points: 21[deg]16'31'' N, 157[deg]53'54'' W;
21[deg]14'36'' N, 157[deg]55'35'' W; 21[deg]13'30'' N, 157[deg]55'34''
W; 21[deg]13'54'' N, 157[deg]55'08'' W; 21[deg]16'09'' N,
157[deg]52'59'' W.
    (6) All vessels staging in the RNA must be seaward of
    the 50 fathom (300 foot) curve.
    (c) Enforcement period. Paragraph (b) of this section will be
enforced only when a tsunami warning has been issued for the Hawaiian
Islands by the Pacific Tsunami Warning Center. The COTP will notify the
public of any enforcement, suspension of enforcement, or termination of
enforcement through appropriate means to ensure the widest publicity,
including the use of broadcast notice to mariners, notices of
implementation and press releases.
    (d) Penalties. Vessels or persons violating this rule are subject
to the penalties set forth in 33 U.S.C. 1232.

    Dated: September 3, 2013.
C.B. Thomas,
Rear Admiral, U.S. Coast Guard, Commander, Fourteenth Coast Guard
District.
[FR Doc. 2013-24150 Filed 10-2-13; 8:45 am]
BILLING CODE 9110-04-P