[Federal Register Volume 88, Number 166 (Tuesday, August 29, 2023)]
[Rules and Regulations]
[Pages 59453-59455]
[FR Doc No: 2023-18697]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0743]
RIN 1625-AA00

Safety Zone; Lahaina Boat Basin, Maui, HI--Emergency Operations
and Port Recovery

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
the navigable waters in the vicinity of Lahaina Boat Basin, Maui,
Hawaii. The temporary safety zone encompasses all waters extending 200
yards from shore starting from the potential safety hazards associated
with the damage assessment, debris management, vessel salvage and port
recovery of Lahaina Boat Basin and surrounding waters, through
September 27, 2023. Entry of vessels or persons into this zone is
prohibited unless specifically authorized by the Captain of the Port
Sector Honolulu or designated representative.

DATES: This rule is effective without actual notice from August 29,
2023, through September 27, 2023. For the purposes of enforcement,
actual notice will be used from August 24, 2023, until August 29, 2023.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0742 in the search box and click ``Search.'' Next, in the Document
Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Lieutenant Commander Wade Thomson, Waterways Management
Division, U.S. Coast Guard Sector Honolulu at<PHONE_NUMBER> or
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background Information and Regulatory History

    On August 9, 2023, high winds and wildfires struck portions of
Maui, Hawaii, causing damage to coastal infrastructure and prompting
mass rescue operations for area residents.
    On August 9, 2023, the Coast Guard issued a rulemaking creating a
temporary safety zone for all waters extending 1 nautical mile from
shore starting from the northernmost point of Kekaa Point, Maui,
thenceforth to the southernmost point at Hekili Point, Maui, to protect
personnel, vessels, and the marine environment from potential hazards
associated with emergency response and port recovery operations after
wildfires affected the area (88 FR 55373, August 15, 2023). The safety
zone was effective through August 23, 2023. A copy of the rulemaking
that ended on August 23, 2023, is available in Docket USCG-2023-0669,
which can be found using instructions in the ADDRESSES section.
However, additional time is needed to continue to provide protection
against hazards in the area due to emergency response and port recovery
operations. The safety zone encompasses all waters extending 200 yards
from shore starting from the northernmost boundary at Wahikuli Wayside
Park, Maui, thenceforth to the southernmost boundary at Launiupoko
Beach Park, Maui.

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
because it would be impracticable and contrary to the public interest.
The Coast Guard was unable to publish an NPRM and hold a reasonable
comment period for this rulemaking due to the emergent nature of the
continuing damage assessment and salvage operations.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because immediate action to restrict
vessel traffic within the safety zone is needed to protect life,
property and the environment, therefore a 30-day notice period is
impracticable. Delaying the effective date would be contrary to the
safety zone's intended objectives of providing immediate protection to
on-scene emergency personal, creating a working buffer necessary to
mitigate any safety and potential pollution threats caused by the
wildfires and establishing immediate maritime safety in the vicinity of
on-scene damage assessments.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. On August 9, 2023, the Coast Guard was informed of damage,
pollution, and debris in the vicinity of Lahaina Boat Basin, Maui,
Hawaii. The Coast Guard COTP Sector Honolulu has determined that the
potential hazards associated with the emergency response and port
recovery efforts connected to wildfires in the area constitute a safety
concern for anyone within the designated safety zone. This rule is
necessary to protect personnel, vessels, and the marine environment
within the navigable waters of the safety zone during ongoing emergency
response and port recovery operations.

IV. Discussion of the Rule

    This rule is in effect from August 24, 2023, through September 27,
2023, at 11:59 p.m., or until emergency response and port recovery
operations are complete, whichever is earlier. If the safety zone is
terminated prior to 11:59 p.m. on September 27, 2023, the Coast Guard
will provide notice via a broadcast notice to mariners. The temporary
safety zone encompasses all waters extending 200 yards from shore
starting from the northernmost boundary at Wahikuli Wayside Park, Maui,
thenceforth to the southernmost boundary at Launiupoko Beach Park,
Maui. The safety zone is needed to protect personnel, vessels, and the
marine environment from potential hazards associated with ongoing
emergency response and port recovery operations after wildfires
affected the area. No vessel or person will be permitted to enter the
safety zone absent the express authorization of the COTP or his
designated representative.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under Executive Order 12866, as amended by
Executive Order 14094 (Modernizing Regulatory Review). Accordingly,
this rule has not been reviewed by the Office of Management and Budget
(OMB).
    This regulatory action determination is based on the size,
location, and limited duration of the safety zone. This zone impacts a
small, designated area of the Lahaina Harbor and surrounding waters and
operations may suspend early at the discretion of the Captain of the
Port, Sector Honolulu.

B. Impact on Small Entities

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

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting that will prohibit entry within certain navigable
waters of Lahaina Boat Basin. It is categorically excluded from further
review under paragraph L60(d) of Appendix A, Table 1 of DHS Instruction
Manual 023-01-001-01, Rev. 1.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-
1, 6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T14-0743 to read as follows:

Sec.  165.T14-0743  Safety Zone; Pacific Ocean, Lahaina Boat Basin,
Maui, HI--Emergency Operations and Port Recovery.

    (a) Location. The following area is a safety zone: All waters
extending 200 yards from shore starting from the northernmost boundary
at Wahikuli Wayside Park, Maui, thenceforth to the southernmost
boundary at Launiupoko Beach Park, Maui.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, and local officer designated by or assisting the
Captain of the Port Sector Honolulu (COTP) in the enforcement of the
safety zone.
    (c) Regulations. Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by VHF/FM Chanel 16. Those in the safety zone must
comply with all lawful orders or directions given to them by the COTP
or the COTP's designated representative.
    (d) Enforcement period. This section will be enforced August 24,
2023, through September 27, 2023, unless an earlier end is announced by
broadcast notice to mariners.

    Dated: August 24, 2023.
A.L. Kirksey,
Captain, U.S. Coast Guard, Captain of the Port Sector Honolulu.
[FR Doc. 2023-18697 Filed 8-25-23; 4:15 pm]
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[Federal Register Volume 75, Number 218 (Friday, November 12, 2010)]
[Notices]
[Pages 69449-69451]
[FR Doc No: 2010-28440]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0319]

Draft Guidance for Industry and Food and Drug Administration
Staff on Dear Health Care Provider Letters: Improving Communication of
Important Safety Information; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry and FDA staff entitled
``Dear Health Care Provider Letters: Improving Communication of
Important Safety Information.'' Dear Health Care Provider (DHCP)
Letters are correspondence--usually in the form of a mass mailing from
the manufacturer or distributor of a human drug or biologic, or from
FDA--intended to alert physicians and other health care providers to
important new information about a marketed drug or biological product.
This draft guidance provides recommendations on when to use a DHCP
letter, the types of information to include in a DHCP letter, how to
organize that information, and formatting techniques to make the
information more accessible. The draft guidance is intended to improve
the quality of DHCP letters to make them more effective communication
tools for new information about marketed products.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by January 11, 2011.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or
the Office of Communication, Outreach, and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one

self-addressed adhesive label to assist those offices in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sandy Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4206, Silver Spring, MD 20993-0002, 301-
796-2270; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
and FDA staff entitled ``Dear Health Care Provider Letters: Improving
Communication of Important Safety Information.'' Important new
information about prescription drug and biological products emerges
throughout a product's lifecycle. For marketed products, there may be
occasions when it is important to communicate new information promptly
to health care practitioners involved in prescribing or dispensing a
drug, or in caring for patients who receive a drug. The DHCP letter is
an important mechanism (one of a number of different mechanisms) used
to communicate important new information to health care professionals
about a marketed product.
    Formal and informal evaluations of DHCP letters have shown that the
communication quality of DHCP letters--the extent to which the
information is accessible and can be understood--varies widely. A study
reported in 2005 evaluated the quality of a group of DHCP letters sent
during 2000 and 2001 that were intended to communicate important new
drug safety information.\1\ The study found that there is a correlation
between the quality or perceived quality of a DHCP letter and the
extent to which physicians perceive the new information as important.
Letters that were evaluated as clearer, more concise, better organized
and formatted, and focused on the most important aspects of the new
safety information were considered to be more effective in
communicating the new information.
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    \1\ Mazor K, S. Andrade, J. Auger, et al., ``Communicating
Safety Information to Physicians: An Examination of Dear Doctor
Letters,'' Pharmacoepidemiol Drug Safety, 14:869-875, 2005.
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    FDA believes guidance concerning the format and content of the DHCP
letter would be beneficial in improving the effectiveness of DHCP
letters in communicating drug information. Accordingly, this draft
guidance contains recommendations on when to use a DHCP letter, what
types of information to include in a DHCP letter, how to organize that
information, and formatting techniques to make the information in the
letter more accessible.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the format
and content of DHCP letters. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (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 that
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 for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this
draft guidance, FDA invites comments on the following topics: (1)
Whether the proposed information collected is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimated burden of
the proposed information collected, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information collected; and (4) ways to
minimize the burden of information collected on the respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    FDA estimates the burden of this collection of information as
follows:
    Based on a review of MedWatch Safety Alerts for 2008 and 2009, we
identified each Dear Health Care Provider Letter sent and the identity
of each sponsor sending out a Dear Health Care Provider Letter for each
year. We estimate that we will receive approximately 30 Dear Health
Care Provider letters annually from approximately 25 application
holders. FDA professionals familiar with Dear Health Care Provider
Letters and with the recommendations in the draft guidance estimate
that it should take an application holder approximately 100 hours to
prepare and send Dear Health Care Provider Letters in accordance with
the draft guidance. Therefore we estimate the annual reporting burden
as follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
                                     Number of     responses per       Total         Hours per      Total hours
                                    respondents     respondent       responses       response
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Annual Average..................              25            1.20              30             100           3,000
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\1\ There are no capital costs or operating and maintenance costs associated with this information collection.

    In the draft guidance, we refer to an earlier guidance for industry
entitled ``Using Electronic Means to Distribute Certain Product
Information'' (71 FR 26102, May 3, 2006). That guidance referred to
previously approved collections of information found in FDA regulations
that are subject to review by OMB. The collections of information in
that guidance have been approved under OMB control number 0910-0249.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-28440 Filed 11-10-10; 8:45 am]
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