Anchorage Regulations; Passagassawakeag River, Belfast, ME, 32269-32271 [2019-14428]
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Federal Register / Vol. 84, No. 130 / Monday, July 8, 2019 / Rules and Regulations
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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Office of
Communications, Division of Drug
Information, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10001 New Hampshire
Ave., Hillandale Bldg., 4th Floor, Silver
Spring, MD 20993–0002, 855–543–3784
or 301–796–3400; Fax: 301–431–6353,
email: druginfo@fda.hhs.gov. Send two
self-addressed adhesive labels to assist
that office in processing your requests.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
guidance document.
FOR FURTHER INFORMATION CONTACT:
Tracy Rupp, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 5171, Silver Spring,
MD 20993, 240–402–0260.
SUPPLEMENTARY INFORMATION:
jbell on DSK3GLQ082PROD with RULES
I. Background
FDA is announcing the availability of
an immediately in effect guidance for
industry entitled ‘‘Compliance Policy
for Certain Compounding of Oral
Oxitriptan (5-HTP) Drug Products for
Patients With Tetrahydrobiopterin
(BH4) Deficiency.’’ This guidance
describes FDA’s policy concerning the
conditions under which the Agency
does not generally intend to take
regulatory action against a licensed
pharmacist in a State-licensed pharmacy
or Federal facility or a licensed
physician using the bulk drug substance
oxitriptan to compound oral drug
products for patients with BH4
deficiency.
Section 503A of the FD&C Act (21
U.S.C. 353a) describes the conditions
that must be satisfied for human drug
products compounded by a licensed
pharmacist in a State-licensed pharmacy
or Federal facility, or by a licensed
physician to qualify for exemptions
from certain requirements of the FD&C
Act related to FDA approval prior to
marketing, current good manufacturing
practice requirements, and labeling with
adequate directions for use (see sections
505, 501(a)(2)(B), and 502(f)(1) of the
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Jkt 247001
FD&C Act (21 U.S.C. 355, 351(a)(2)(B),
and 352(f)(1))). One of the conditions
that must be met for a compounded
drug product to qualify for these
exemptions is that a licensed
pharmacist or licensed physician
compounds the drug product using bulk
drug substances that: (1) Comply with
the standards of an applicable United
States Pharmacopoeia (USP) or National
Formulary (NF) monograph, if a
monograph exists, and the USP chapter
on pharmacy compounding; (2) if such
a monograph does not exist, are drug
substances that are components of drugs
approved by FDA; or (3) if such a
monograph does not exist and the drug
substance is not a component of a drug
approved by FDA, appear on a list of
bulk drug substances developed by FDA
through regulation. (See section
503A(b)(1)(A)(i) of the FD&C Act.)
On February 19, 2019, FDA issued a
final rule (84 FR 4696) (‘‘February 19,
2019, final rule’’), which established the
list of bulk drug substances that can be
used to compound drug products under
section 503A of the FD&C Act even
though they are not the subject of an
applicable USP or NF monograph or a
component of an FDA approved drug
product (the 503A Bulks List). (See
section 503A(b)(1)(A) of the FD&C Act.)
The final rule, codified at § 216.23 (21
CFR 216.23), placed six bulk drug
substances on the 503A Bulks List
(§ 216.23(a)), and identified four others,
including oxitriptan, that cannot be
used to compound drug products under
section 503A of the FD&C Act
(§ 216.23(b)). Additional bulk drug
substances nominated by the public for
inclusion on this list are currently under
consideration and will be the subject of
future rulemaking.
FDA developed this guidance in
response to communications from
pharmacists and caregivers regarding
the use of oxitriptan to treat patients
with BH4 deficiency following issuance
of the February 19, 2019, final rule,
which placed oxitriptan on the list of
bulk drug substances that cannot be
used to compound drug products under
section 503A of the FD&C Act.
According to those communications and
other information available to the
Agency, oxitriptan is the standard of
care for the treatment of BH4 deficiency,
which is caused by several different rare
enzyme defects that result from gene
mutations. BH4 deficiency is also
known as: Primary tetrahydrobiopterin
deficiency, atypical phenylketonuria
(PKU), GTP cyclohydrolase (GTPCH)
deficiency, 6-pyruvoyl-tetrahydropterin
synthase (6-PTPS) deficiency, and
dihydropteridine reductase (DHPR)
deficiency. FDA did not consider BH4
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32269
deficiency during its initial review of
this substance for the 503A Bulks List.
Thus, this guidance addresses the
conditions under which FDA does not
intend to take regulatory action against
a licensed pharmacist in a Statelicensed pharmacy or Federal facility or
a licensed physician for the use of bulk
oxitriptan to compound oral drug
products for the treatment of identified
individual patients with BH4 deficiency
provided certain conditions are met. In
light of the new information regarding
use of oral oxitriptan to treat BH4
deficiency, FDA is considering whether
to reevaluate the exclusion of oxitriptan
from the 503A Bulks List.
FDA is issuing this guidance
consistent with our good guidance
practices (GGP) regulation (21 CFR
10.115). We are implementing this
guidance without prior public comment
because we have determined that prior
public participation is not feasible or
appropriate due to the public health
need for patients with BH4 deficiency to
access compounded oxitriptan oral drug
products (21 CFR 10.115(g)(2)). This
guidance does not establish any rights
for any person and is not binding on
FDA or the public. Although this
guidance is immediately in effect, it
remains subject to comment in
accordance with FDA’s GGP regulation.
This guidance is not subject to
Executive Order 12866.
II. Electronic Access
Persons with access to the internet
may obtain the document at either
https://www.fda.gov/Regulatory
Information/Guidances/default.htm or
https://www.regulations.gov. Use the
FDA website listed in the previous
sentence to find the most current
version of the guidance.
Dated: July 1, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–14355 Filed 7–5–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 110
[Docket Number USCG–2016–0989]
RIN 1625–AA01
Anchorage Regulations;
Passagassawakeag River, Belfast, ME
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
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32270
Federal Register / Vol. 84, No. 130 / Monday, July 8, 2019 / Rules and Regulations
The Coast Guard is
establishing two special anchorage areas
in the Passagassawakeag River in the
vicinity of Belfast, ME. This proposed
action is necessary to facilitate safe
navigation in that area and provide safe
and secure anchorages for vessels less
than 65 feet in length. This action is
intended to increase the safety of life
and property in the Passagassawakeag
River in the vicinity of Belfast, improve
the safety of anchored vessels, and
provide for the overall safe and efficient
flow of vessel traffic and commerce.
DATES: This rule is effective August 7,
2019.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2016–
0989 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 about this proposed
rulemaking, contact Mr. Craig Lapiejko,
Waterways Management at First Coast
Guard District, telephone (617) 223–
8351, email craig.d.lapiejko@uscg.mil.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Table of Abbreviations
jbell on DSK3GLQ082PROD with RULES
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NOAA National Oceanic and Atmospheric
Administration
NPRM Notice of proposed rulemaking
§ Section
U.S.C. United States Code
II. Background Information and
Regulatory History
In March 2016, the harbormaster
submitted a draft proposal to the Belfast
City Council and subsequently the town
began talks with Coast Guard Sector
Northern New England regarding
establishment of a special anchorage
area in Belfast. Subsequently, the Town
of Belfast, ME Harbor Committee and
the Belfast harbormaster petitioned
Coast Guard Sector Northern New
England to designate a special
anchorage area in the Passagassawakeag
River, in the vicinity of Belfast, ME. In
response, on October 3, 2017, the Coast
Guard published a NPRM titled
‘‘Special Anchorage Areas;
Passagassawakeag River, Belfast Bay,
Belfast, Maine’’ (82 FR 46004). There,
we stated why we issued the NPRM,
and invited comments on our proposed
regulatory action related to establishing
two special anchorages in the
Passagassawakeag River. During the
comment period that ended December 4,
2017, we received one comment. For the
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Jkt 247001
reasons discussed below, the Coast
Guard is making no changes to this rule
from the proposed rule.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule
under authority in 33 U.S.C. 471, 2071;
46 U.S.C. 70034 (previously 33 U.S.C.
1231). Commander, First Coast Guard
District has determined that this rule
will reduce the risk of vessel collisions
by creating two special anchorage areas
in the Passagassawakeag River in the
vicinity of the northeastern portion of
Belfast, ME. The purpose of this rule is
to increase the safety of life and
property in the Passagassawakeag River
in the vicinity of Belfast, improve the
safety of anchored vessels, and provide
for the overall safe and efficient flow of
vessel traffic and commerce.
IV. Discussion of Comments, Changes,
and the Rule
This rule establishes two special
anchorage areas, referred to as special
anchorage areas A and B, in the
Passagassawakeag River in the vicinity
of Belfast, ME. Special anchorage area A
is approximately 554,800 sq. yards and
is on the north side of the river located
between the mouth of the Goose River
and Patterson Pt, downstream of the US
RT 1 Bridge. Special anchorage area B
is approximately 693,889 sq. yards and
located along the southern shores of the
river located between the Belfast Town
docks to Belfast City Park.
Vessels less than 65 feet in length,
when at anchor in these special
anchorage areas, will not be required to
sound signals or display anchorage
lights or shapes when at anchor.
Additionally, mariners using these
anchorage areas are encouraged to
contact local and state authorities, such
as the local harbormaster, to ensure
compliance with any additional
applicable state and local laws. Such
laws may involve, for example,
compliance with direction from the
local harbormaster when placing or
using moorings within the anchorage.
The Coast Guard received one
comment on our NPRM published on
October 3, 2017. There are no changes
in the regulatory text of this rule from
the proposed rule in the NPRM.
The one comment was authored by a
NOAA cartographer who wanted to
make the Coast Guard aware of charted
features within the proposed special
anchorage areas. Specifically, a charted
obstruction (Obstn) feature within
special anchorage area A and a charted
pier (jetty) in ruins within special
anchorage area B.
The Coast Guard and Belfast
harbormaster are aware of the charted
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Fmt 4700
Sfmt 4700
obstructions. The town of Belfast has
operated these areas as managed
mooring fields for decades and places
the moorings around the charted
obstructions. The regulatory text
appears at the end of this document. In
our note to § 110.4(d), we state that all
coordinates referenced use datum NAD
83 and that all anchoring in the areas is
under the supervision of the town of
Belfast harbormaster or other such
authority as may be designated by the
authorities of the Town of Belfast,
Maine. Mariners using these special
anchorage areas are encouraged to
contact local and state authorities, such
as the local harbormaster, to ensure
compliance with any additional
applicable state and local laws.
Additionally during the
environmental review process the Coast
Guard received comments from the
NOAA Habitat Conservation Division.
The comments, authored by a NOAA
Marine Habitat Resource Specialist,
recommended an eelgrass survey be
conducted to determine the presence of
eelgrass beds. Additionally, the Marine
Habitat Resource Specialist
recommended the moorings be
converted to conservation moorings that
use a floating pendant in lieu of chains
to prevent damage to eelgrass beds.
An eelgrass study was conducted by
the City of Belfast in October, 2018. The
study concluded there was no eelgrass
within the proposed area. The City of
Belfast expressed their intention to
continuously monitor the area for
potential eelgrass growth.
V. Regulatory Analyses
We developed this rule after
considering numerous statutes and
Executive Orders related to rulemaking.
Below we summarize our analysis based
on those 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.
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08JYR1
Federal Register / Vol. 84, No. 130 / Monday, July 8, 2019 / Rules and Regulations
This regulatory action determination
is based on the fact that vessel
movement in the area will not be
affected. Additionally, those using the
waterway will see no adverse changes to
how the waterway presently operates.
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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 received no comments
from the Small Business Administration
on this rulemaking. 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
Passagassawakeag River in Belfast, ME
may be small entities, for the reasons
stated above 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
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15:55 Jul 05, 2019
Jkt 247001
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.
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 Environmental
Planning COMDTINST 5090.1 (series),
which guides 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 the
establishment of two special anchorage
areas in the Passagassawakeag River in
the vicinity of northeastern Belfast, ME.
It is categorically excluded from further
review under paragraph L59 (a) in Table
3–1 of U.S. Coast Guard Environmental
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Frm 00017
Fmt 4700
Sfmt 9990
32271
Planning Implementing Procedures
5090.1. A Record of Environmental
Consideration supporting this
determination is available in the docket
where indicated under ADDRESSES.
PART 110—ANCHORAGE
REGULATIONS
1. The authority citation for part 110
continues to read as follows:
■
Authority: 33 U.S.C. 471, 2071; 46 U.S.C.
70034; 33 CFR 1.05–1; Department of
Homeland Security Delegation No. 0170.1.
2. Amend § 110.4 by adding paragraph
(d) to read as follows:
■
§ 110.4
Penobscot Bay, Maine.
*
*
*
*
*
(d) Passagassawakeag River, Belfast
Bay, Belfast, Maine—(1) Special
anchorage area A. All of the waters
enclosed by a line beginning at latitude
44°25′23″ N, longitude 068°58′55″ W;
thence to latitude 44°25′30″ N,
longitude 068°58′48″ W; thence to
latitude 44°25′33″ N, longitude
068°59′15″ W; thence to latitude
44°25′39″ N, longitude 068°59′17″ W;
thence to latitude 44°25′48″ N,
longitude 068°59′57″ W; thence to
latitude 44°25′46″ N, longitude
069°00′08″ W; thence to the point of
beginning.
(2) Special anchorage area B. All of
the waters enclosed by a line beginning
at latitude 44°25′17″ N, longitude
068°59′00″ W; thence to latitude
44°24′56″ N, longitude 068°59′23″ W;
thence to latitude 44°25′20″ N,
longitude 068°59′38″ W; thence to
latitude 44°25′44″ N, longitude
069°00′09″ W; thence to the point of
beginning.
Note to § 110.4(d): All coordinates
referenced use datum: NAD 83. All anchoring
in the areas is under the supervision of the
town of Belfast harbormaster or other such
authority as may be designated by the
authorities of the Town of Belfast, Maine.
Mariners using these special anchorage areas
are encouraged to contact local and state
authorities, such as the local harbormaster, to
ensure compliance with any additional
applicable state and local laws.
Dated: June 28, 2019.
A.J. Tiongson,
Rear Admiral, U.S. Coast Guard, Commander,
First Coast Guard District.
[FR Doc. 2019–14428 Filed 7–5–19; 8:45 am]
BILLING CODE 9110–04–P
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]]>Agencies
[Federal Register Volume 84, Number 130 (Monday, July 8, 2019)]
[Rules and Regulations]
[Pages 32269-32271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14428]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Coast Guard
33 CFR Part 110
[Docket Number USCG-2016-0989]
RIN 1625-AA01
Anchorage Regulations; Passagassawakeag River, Belfast, ME
AGENCY: Coast Guard, DHS.
ACTION: Final rule.
-----------------------------------------------------------------------
[[Page 32270]]
SUMMARY: The Coast Guard is establishing two special anchorage areas in
the Passagassawakeag River in the vicinity of Belfast, ME. This
proposed action is necessary to facilitate safe navigation in that area
and provide safe and secure anchorages for vessels less than 65 feet in
length. This action is intended to increase the safety of life and
property in the Passagassawakeag River in the vicinity of Belfast,
improve the safety of anchored vessels, and provide for the overall
safe and efficient flow of vessel traffic and commerce.
DATES: This rule is effective August 7, 2019.
ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2016-0989 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 about this
proposed rulemaking, contact Mr. Craig Lapiejko, Waterways Management
at First Coast Guard District, telephone (617) 223-8351, email
[email protected].
SUPPLEMENTARY INFORMATION:
I. Table of Abbreviations
CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NOAA National Oceanic and Atmospheric Administration
NPRM Notice of proposed rulemaking
Sec. Section
U.S.C. United States Code
II. Background Information and Regulatory History
In March 2016, the harbormaster submitted a draft proposal to the
Belfast City Council and subsequently the town began talks with Coast
Guard Sector Northern New England regarding establishment of a special
anchorage area in Belfast. Subsequently, the Town of Belfast, ME Harbor
Committee and the Belfast harbormaster petitioned Coast Guard Sector
Northern New England to designate a special anchorage area in the
Passagassawakeag River, in the vicinity of Belfast, ME. In response, on
October 3, 2017, the Coast Guard published a NPRM titled ``Special
Anchorage Areas; Passagassawakeag River, Belfast Bay, Belfast, Maine''
(82 FR 46004). There, we stated why we issued the NPRM, and invited
comments on our proposed regulatory action related to establishing two
special anchorages in the Passagassawakeag River. During the comment
period that ended December 4, 2017, we received one comment. For the
reasons discussed below, the Coast Guard is making no changes to this
rule from the proposed rule.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule under authority in 33 U.S.C.
471, 2071; 46 U.S.C. 70034 (previously 33 U.S.C. 1231). Commander,
First Coast Guard District has determined that this rule will reduce
the risk of vessel collisions by creating two special anchorage areas
in the Passagassawakeag River in the vicinity of the northeastern
portion of Belfast, ME. The purpose of this rule is to increase the
safety of life and property in the Passagassawakeag River in the
vicinity of Belfast, improve the safety of anchored vessels, and
provide for the overall safe and efficient flow of vessel traffic and
commerce.
IV. Discussion of Comments, Changes, and the Rule
This rule establishes two special anchorage areas, referred to as
special anchorage areas A and B, in the Passagassawakeag River in the
vicinity of Belfast, ME. Special anchorage area A is approximately
554,800 sq. yards and is on the north side of the river located between
the mouth of the Goose River and Patterson Pt, downstream of the US RT
1 Bridge. Special anchorage area B is approximately 693,889 sq. yards
and located along the southern shores of the river located between the
Belfast Town docks to Belfast City Park.
Vessels less than 65 feet in length, when at anchor in these
special anchorage areas, will not be required to sound signals or
display anchorage lights or shapes when at anchor. Additionally,
mariners using these anchorage areas are encouraged to contact local
and state authorities, such as the local harbormaster, to ensure
compliance with any additional applicable state and local laws. Such
laws may involve, for example, compliance with direction from the local
harbormaster when placing or using moorings within the anchorage.
The Coast Guard received one comment on our NPRM published on
October 3, 2017. There are no changes in the regulatory text of this
rule from the proposed rule in the NPRM.
The one comment was authored by a NOAA cartographer who wanted to
make the Coast Guard aware of charted features within the proposed
special anchorage areas. Specifically, a charted obstruction (Obstn)
feature within special anchorage area A and a charted pier (jetty) in
ruins within special anchorage area B.
The Coast Guard and Belfast harbormaster are aware of the charted
obstructions. The town of Belfast has operated these areas as managed
mooring fields for decades and places the moorings around the charted
obstructions. The regulatory text appears at the end of this document.
In our note to Sec. 110.4(d), we state that all coordinates referenced
use datum NAD 83 and that all anchoring in the areas is under the
supervision of the town of Belfast harbormaster or other such authority
as may be designated by the authorities of the Town of Belfast, Maine.
Mariners using these special anchorage areas are encouraged to contact
local and state authorities, such as the local harbormaster, to ensure
compliance with any additional applicable state and local laws.
Additionally during the environmental review process the Coast
Guard received comments from the NOAA Habitat Conservation Division.
The comments, authored by a NOAA Marine Habitat Resource Specialist,
recommended an eelgrass survey be conducted to determine the presence
of eelgrass beds. Additionally, the Marine Habitat Resource Specialist
recommended the moorings be converted to conservation moorings that use
a floating pendant in lieu of chains to prevent damage to eelgrass
beds.
An eelgrass study was conducted by the City of Belfast in October,
2018. The study concluded there was no eelgrass within the proposed
area. The City of Belfast expressed their intention to continuously
monitor the area for potential eelgrass growth.
V. Regulatory Analyses
We developed this rule after considering numerous statutes and
Executive Orders related to rulemaking. Below we summarize our analysis
based on those 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.
[[Page 32271]]
This regulatory action determination is based on the fact that
vessel movement in the area will not be affected. Additionally, those
using the waterway will see no adverse changes to how the waterway
presently operates.
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 received no comments from the Small Business
Administration on this rulemaking. 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
Passagassawakeag River in Belfast, ME may be small entities, for the
reasons stated above 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.
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 Environmental Planning COMDTINST 5090.1 (series),
which guides 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 the establishment of two special
anchorage areas in the Passagassawakeag River in the vicinity of
northeastern Belfast, ME. It is categorically excluded from further
review under paragraph L59 (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.
PART 110--ANCHORAGE REGULATIONS
0
1. The authority citation for part 110 continues to read as follows:
Authority: 33 U.S.C. 471, 2071; 46 U.S.C. 70034; 33 CFR 1.05-1;
Department of Homeland Security Delegation No. 0170.1.
0
2. Amend Sec. 110.4 by adding paragraph (d) to read as follows:
Sec. 110.4 Penobscot Bay, Maine.
* * * * *
(d) Passagassawakeag River, Belfast Bay, Belfast, Maine--(1)
Special anchorage area A. All of the waters enclosed by a line
beginning at latitude 44[deg]25'23'' N, longitude 068[deg]58'55'' W;
thence to latitude 44[deg]25'30'' N, longitude 068[deg]58'48'' W;
thence to latitude 44[deg]25'33'' N, longitude 068[deg]59'15'' W;
thence to latitude 44[deg]25'39'' N, longitude 068[deg]59'17'' W;
thence to latitude 44[deg]25'48'' N, longitude 068[deg]59'57'' W;
thence to latitude 44[deg]25'46'' N, longitude 069[deg]00'08'' W;
thence to the point of beginning.
(2) Special anchorage area B. All of the waters enclosed by a line
beginning at latitude 44[deg]25'17'' N, longitude 068[deg]59'00'' W;
thence to latitude 44[deg]24'56'' N, longitude 068[deg]59'23'' W;
thence to latitude 44[deg]25'20'' N, longitude 068[deg]59'38'' W;
thence to latitude 44[deg]25'44'' N, longitude 069[deg]00'09'' W;
thence to the point of beginning.
Note to Sec. 110.4(d): All coordinates referenced use datum:
NAD 83. All anchoring in the areas is under the supervision of the
town of Belfast harbormaster or other such authority as may be
designated by the authorities of the Town of Belfast, Maine.
Mariners using these special anchorage areas are encouraged to
contact local and state authorities, such as the local harbormaster,
to ensure compliance with any additional applicable state and local
laws.
Dated: June 28, 2019.
A.J. Tiongson,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2019-14428 Filed 7-5-19; 8:45 am]
BILLING CODE 9110-04-P
