[Federal Register Volume 83, Number 97 (Friday, May 18, 2018)]
[Rules and Regulations]
[Pages 23230-23232]
[FR Doc No: 2018-10647]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2018-0248]
RIN 1625-AA00

Safety Zone; Algonac Fireworks, St. Clair River, Algonac, MI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters within a 700-foot radius of a portion of the St. Clair
River, Algonac, MI. This zone is necessary to protect spectators and
vessels from potential hazards associated with the Algonac Fireworks.

DATES: This temporary final rule is effective from 10 p.m. on June 29,
2018 through 11:30 p.m. on June 30, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-0248 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or email Tracy Girard, Prevention Department,
Sector Detroit, Coast Guard; telephone<PHONE_NUMBER>, or email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

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

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b) (B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)

with respect to this rule because doing so would be impracticable. The
Coast Guard did not receive the final details of this fireworks display
in time to publish an NPRM. As such, it is impracticable to publish an
NPRM because we lack sufficient time to provide a reasonable comment
period and then consider those comments before issuing the rule.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Detroit (COTP) has determined that
potential hazard associated with fireworks from 10 p.m. on June 29,
2018 through 11:30 p.m. on June 30, 2018 will be a safety concern to
anyone within a 700-foot radius of the launch site. This rule is needed
to protect personnel, vessels, and the marine environment in the
navigable waters within the safety zone while the fireworks are being
displayed.

IV. Discussion of the Rule

    This rule establishes a safety zone from 10 p.m. on June 29, 2018
through 11:30 p.m. on June 30, 2018. The safety zone will encompass all
U.S. navigable waters of the St. Clair River, Algonac, MI, within a
700-foot radius of position 42[deg]37.1' N, 082[deg]31.36' W (NAD 83).
No vessel or person will be permitted to enter the safety zone without
obtaining permission from the COTP or a designated representative.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-year of the safety zone. Vessel traffic
will be able to safely transit around this safety zone which will
impact a small designated area of the St. Clair River during enforced
times from 10 p.m. on June 29 through 11:30 p.m. on June 30, 2018.
Moreover, the Coast Guard will issue Broadcast Notice to Mariners (BNM)
via VHF-FM marine channel 16 about the zone and the rule allows vessels
to seek permission to enter the zone.

B. Impact on Small Entities

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

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Commandant Instruction M16475.1D, 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
two enforced times during the duration of the safety zone lasting one
and a half hours each that will prohibit entry into a designated area.
It is categorically excluded from further review under paragraph L60(a)
of Appendix A, Table

1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of
Environmental Consideration supporting this determination is available
in the docket where indicated under ADDRESSES.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

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

0
2. Add Sec.  165.T09-0248 to read as follows:

Sec.  165.T09-0248  Safety Zone; Algonac Fireworks, St. Clair River,
Algonac, MI.

    (a) Location. A safety zone is established to include all U.S.
navigable waters of the St. Clair River, Algonac, MI, within a 700-foot
radius of position 42[deg]37.1' N, 082[deg]31.36' W (NAD 83).
    (b) Enforcement period. The regulated area described in paragraph
(a) will be enforced from 10 p.m. through 11:30 p.m. on June 29, 2018
and June 30, 2018.
    (c) Regulations. (1) No vessel or person may enter, transit
through, or anchor within the safety zone unless authorized by the
Captain of the Port Detroit (COTP), or his on-scene representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the COTP or his on-scene representative.
    (3) The ``on-scene representative'' of COTP is any Coast Guard
commissioned, warrant or petty officer or a Federal, State, or local
law enforcement officer designated by or assisting the Captain of the
Port Detroit to act on his behalf.
    (4) Vessel operators shall contact the COTP or his on-scene
representative to obtain permission to enter or operate within the
safety zone. The COTP or his on-scene representative may be contacted
via VHF Channel 16 or at<PHONE_NUMBER>. Vessel operators given
permission to enter or operate in the regulated area must comply with
all directions given to them by the COTP or his on-scene
representative.

    Dated: May 3, 2018.
Jeffrey W. Novak,
Captain, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2018-10647 Filed 5-17-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: October 20, 2008 (Volume 73, Number 203)]
[Notices]
[Page 62298-62299]
[DOCID:fr20oc08-64]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0530]

Draft Guidance for Industry on Tropical Disease Priority Review
Vouchers; 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 entitled ``Tropical
Disease Priority Review Vouchers.'' There has been significant outside
interest in FDA's interpretation of section 1102 of the Food and Drug
Administration Amendments Act (FDAAA), which adds a new section 524 to
the Federal Food, Drug, and Cosmetic Act (the act). Section 524 makes
provisions for awarding priority review vouchers for future
applications to sponsors of tropical disease product applications that
meet the criteria specified by the act. This draft guidance explains to
internal and external stakeholders how FDA intends to implement the
provisions of section 524.

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 written or electronic comments on the draft guidance
by December 19, 2008. Submit written comments on the proposed
collection of information by December 19, 2008.

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, Training, and Manufacturers Assistance
(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 that
office in processing your requests. The draft guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>.
Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:
    David Roeder, Office of Antimicrobial Products, Center for Drug
Evaluation and Research, Food and Drug Administration (WO-22), rm.
6410, 0903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-
0799,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
entitled ``Tropical Disease Priority Review Vouchers.'' Section 1102 of
FDAAA adds new section 524 to the act. Section 524 is designed to
encourage development of new drug or biological products for prevention
and treatment of certain tropical diseases affecting millions of people
throughout the world. By enacting section 524, Congress intends to
stimulate new drug development for drugs to treat certain tropical
diseases for which there are no or few available treatments by offering
additional incentives for obtaining FDA approval for pharmaceutical
treatments for these diseases. Under section 524, a sponsor of a human
drug application for a qualified tropical disease may be eligible for a
voucher that can be used to obtain a priority review for any
application submitted under section 505(b)(1) of the act or section 351
of the Public Health Service (PHS) Act. The draft guidance also
provides information on using the priority review vouchers and on
transferring priority review vouchers to other sponsors.
    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 obtaining
tropical disease priority review vouchers. 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.
    Under the draft guidance, sponsors of certain tropical disease drug
product applications submitted under section 505(b)(1) of the act and
section 351 of the PHS Act may request a priority review voucher. Based
on the inquiries FDA has received on section 524 and related
discussions with sponsors, we estimate that we will receive annually
approximately five requests from five sponsors, and that each request
will take approximately 8 hours to prepare and submit to FDA.
    The draft guidance also states that sponsors should notify FDA of
their intent to use a priority review voucher, including the date on
which the sponsor intends to submit the application, at least 1 year
before use. We estimate that we will receive annually approximately
five notifications of intent to use a voucher from five sponsors, and
that

each notification will take approximately 8 hours to prepare and submit
to FDA.
    The draft guidance also permits the transfer of a priority review
voucher from one sponsor to another, and states that each transfer
should be documented with a letter of transfer. We estimate that we
will receive approximately two letters indicating the transfer of a
voucher from two application holders, and two letters from two new
voucher owners acknowledging the transfer, and that it will take
approximately 8 hours to prepare and submit each letter to FDA.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of        No. responses  per                          Hours Per
         Reporting Under Section 1102 of FDAAA             Respondents          Respondent        Total  Responses       Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Priority review voucher request                                         5                     1                  5                  8                 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notifications of intent to use a voucher                                5                     1                  5                  8                 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letters indicating the transfer of a voucher                            2                     1                  2                  8                 16
--------------------------------------------------------------------------------------------------------------------------------------------------------
Letters acknowledging the receipt of a transferred                      2                     1                  2                  8                 16
 voucher.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                112
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified 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.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: October 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-24932 Filed 10-17-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Rules and Regulations]
[Pages 51409-51411]
[FR Doc No: 2019-20735]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0758]
RIN 1625-AA00

Safety Zone; Mackinaw City Fall Colors Fireworks, Mackinaw City,
MI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone in the
Straits of Mackinac near Mackinac City, MI. The temporary safety zone
is needed to protect vessels and spectators from the hazards associated
with a fireworks show during the Mackinaw City Fall Colors Fireworks.
Entry of vessels or persons into this zone is prohibited unless
specifically authorized by the Captain of the Port Sector Sault Sainte
Marie or a designated representative.

DATES: This rule is effective from 8:00 p.m. on October 4, 2019 through
10:00 p.m. on October 12, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2019-0758 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email MST2 Onnalee A. Blackledge, Waterways Management, Coast
Guard Sector Sault Sainte Marie, U.S. Coast Guard; telephone 906-253-
2443, email<EMAIL_ADDRESS>
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, Purpose, and Legal Basis

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency, for good cause, finds that
those procedures are ``impracticable, unnecessary, or contrary to the
public interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that
good cause exists for not publishing a notice of proposed rulemaking
(NPRM) with respect to this rule because doing so would be
impracticable. The Coast Guard did not receive the final details of the
requested safety zone with sufficient time for a comment period to run
before the start of the fireworks display. Thus, delaying this rule to
wait for a notice and comment period to run would be impracticable
because it would inhibit the Coast Guard's ability to protect the
public from the potential hazards associated with the fireworks
display.
    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. For the same reasons discussed in
the preceding paragraph, a 30-day notice period would be impracticable.

III. Legal Authority and Need for Rule

    The legal basis for this final rulemaking is found at 46 U.S.C
70034; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland
Security Delegation No. 0170.1.
    On October 4, 2019 and October 11, 2019 from 8:00 p.m. through
10:00 p.m., Mackinaw City will have a fireworks display at position
45[deg]46'28.5'' N, 084[deg]43'12.0'' W (NAD 83). Alternative rain
dates will be October 5, 2019 and October 12, 2019 and enforced from
8:00 p.m. to 10:00 p.m. on those days. The maximum sized shell to be
used is six inches and requires a temporary safety zone of at least 420
feet. The State of Michigan regulates fireworks displays. This action
is only for the temporary safety zone.
    The Captain of the Port Sault Sainte Marie has determined that
potential hazard associated with these fireworks will be a safety
concern to anyone within a 420-foot radius of the launch site. Such
hazards include premature and accidental detonations, falling and
burning debris, and collisions among spectator vessels. This rule is
needed to protect personnel, vessels, and the marine environment in the
navigable waters within the temporary safety zone while the fireworks
are being displayed.

IV. Discussion of the Rule

    This rule establishes a temporary safety zone from 8:00 p.m.
through 10:00 p.m. on October 4, 2019 and October 11, 2019. Alternative
rain dates will be October 5, 2019 and October 12, 2019 and enforced
from 8:00 p.m. to

10:00 p.m. on those days. This rule is necessary to protect the safety
of spectators and vessels during the aforementioned display. The
temporary safety zone will encompass all U.S. waters of Lake Huron
within a 420 feet radius from 45[deg]46'28.5'' N, 084[deg]43'12.0'' W
(NAD83). The rule will be enforced to mitigate risks associated with
the display.
    The duration of the zone is intended to protect the safety of life
and property in these navigable waters during the scheduled fireworks
display. No vessel or person will be permitted to enter the temporary
safety zone without obtaining permission from the Captain of the Port
or a designated representative. The Captain of the Port or a designated
representative may be contacted via VHF Channel 16 or at<PHONE_NUMBER>.

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. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance, it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-day for this temporary safety zone.
Vessel traffic will be able to safely transit around this safety zone
which will impact a small-designated area of Lake Huron near Mackinac
City for two hours on two days. Moreover, the Coast Guard will issue
Broadcast Notice to Mariners via VHF-FM marine channel 16 about the
zone and the rule allows vessels to seek permission to enter the zone.

B. Impact on Small Entities

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

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and 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 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 temporary safety zone lasting two
hours that will prohibit entry into a designated area. Normally such
actions are categorically excluded from further review under paragraph
L60(a) in Table 3-1 of U.S. Coast Guard Environmental Planning
Implementing Procedures 5090.1. A Record of Environmental Consideration
supporting this determination is available in the docket where
indicated under ADDRESSES.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T09-0758 to read as follows:

Sec.  165.T09-0758  Safety Zone; Mackinaw City Fall Colors Fireworks,
Mackinaw City, MI.

    (a) Location. The temporary safety zone will encompass all U.S.
navigable waters of Lake Huron within a 420-foot radius of
45[deg]46'28.5'' N, 084[deg]43'12.0'' W (NAD 83).
    (b) Enforcement period. This section will be enforced on October 4,
2019 and October 11, 2019 from 8:00 p.m. through 10:00 p.m. Alternative
rain dates will be October 5, 2019 and October 12, 2019 and enforced
from 8:00 p.m. to 10:00 p.m. on those dates.
    (c) Regulations. (1) In accordance with the general regulations in
Sec.  165.23, entry into, transiting, or anchoring within this
temporary safety zone is prohibited unless authorized by the Captain of
the Port Sault Sainte Marie or an on-scene representative.
    (2) This temporary safety zone is closed to all vessel traffic,
except as may be permitted by the Captain of the Port Sault Sainte
Marie or an on-scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port
Sault Sainte Marie is any Coast Guard commissioned, warrant or petty
officer who has been designated by the Captain of the Port Sault Sainte
Marie to act on his or her behalf. The on-scene representative of the
Captain of the Port Sault Sainte Marie will be aboard a Coast Guard
vessel.
    (4) Vessel Operators desiring to enter or operate within the
temporary safety zone shall contact the Captain of the Port Sault
Sainte Marie, or an on-scene representative to obtain permission to do
so. The Captain of the Port Sault Sainte Marie or his on-scene
representative may be contacted via VHF Channel 16 or at (906) 635-
3237. Vessel operators given permission to enter or operate in the
temporary safety zone must comply with all directions given to them by
the Captain of the Port, Sault Sainte Marie or his on-scene
representative.

    Dated: September 17, 2019.
P.S. Nelson,
Captain, U.S. Coast Guard, Captain of the Port Sault Sainte Marie.
[FR Doc. 2019-20735 Filed 9-27-19; 8:45 am]
 BILLING CODE 9110-04-P