[Federal Register: August 7, 2006 (Volume 71, Number 151)]
[Rules and Regulations]
[Page 44587-44590]
[DOCID:fr07au06-8]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2006-0322; FRL-8190-2]

Approval and Promulgation of Implementation Plans; Las Vegas
Valley Carbon Monoxide Attainment Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is taking final action to approve a revised attainment
plan, as modified to withdraw the motor vehicle emissions budget for
2030, for the Las Vegas Valley carbon monoxide nonattainment area as a
revision to the Nevada state implementation plan. The revised
attainment plan, as modified, includes revised base year and future
year emissions inventories and a revised demonstration of continued
attainment of the carbon monoxide national ambient air quality standard
in Las Vegas Valley through 2020 based on the most recent emissions
models and planning assumptions and establishes new motor vehicle
emissions budgets. EPA is acting under section 110(k) of the Clean Air
Act, which obligates the Agency to take action on State submittals of
revisions to state implementation plans. The intended effect of this
approval action is to update the carbon monoxide motor vehicle
emissions budgets in the Las Vegas area and thereby make them available
for the purposes of transportation conformity.

DATES: This rule is effective on September 6, 2006.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R09-OAR-2006-0322. All documents in the docket are listed on
the http://www.regulations.gov Web site. Although listed in the index,

some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
information, such as copyrighted material, will be publicly available
only in hard copy. Publicly available docket materials are available
either electronically in http://www.regulations.gov or in hard copy at

EPA Region IX, 75 Hawthorne Street, San Francisco, California. To
inspect the hard copy materials, please schedule an appointment during
normal business hours with the contact listed in the FOR FURTHER
INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Karina O'Connor, EPA Region IX,
telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-mail
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. What Action Did EPA Propose?
II. Is the Background for This Rule?
III. What Comments Did We Receive on the Proposed Action?
IV. What Is Our Final Action?
V. Statutory and Executive Order Reviews

I. What Action Did EPA Propose?

    On May 9, 2006 (71 FR 26910), under section 110(k) of the Clean Air
Act (CAA or ``Act''), we proposed to approve the Carbon Monoxide State
Implementation Plan Revision, Las Vegas Valley Nonattainment Area,
Clark County, Nevada (October 2005), which was adopted by the Clark
County Board of Commissioners on October 4, 2005 and submitted to EPA
by NDEP on February 14, 2006, as a revision to the Nevada SIP on the
condition that Clark County and the State of Nevada withdraw the 2030
motor vehicle emission budget, or, in the alternative, we propose to
disapprove the plan. Specifically, we proposed to approve the plan's
revised base year and projected emission inventories and modeling
demonstration of continued attainment of the CO standard through 2020.
Our proposed disapproval was based on our finding that the plan does
not demonstrate continued attainment in year 2030 because it lacks
micro-scale modeling analysis for the environs of the County's airports
in that year.
    Furthermore, we found that, with the exception of the 2030 budget,
the new motor vehicle emissions budgets established in the plan are
also consistent with continued attainment of the CO NAAQS in Las Vegas
Valley. Thus, we proposed to approve the motor vehicle emissions
budgets from the 2005 CO plan for 2006, 2010, 2015, and 2020 as meeting
the purposes of section 176(c)(1) and the transportation conformity
rule at 40 CFR 93, subpart A contingent upon the withdrawal of the 2030
budget by Clark County and the State of Nevada, and to disapprove the
submitted budgets in the 2005 CO plan, in the alternative, if no such
withdrawal was made.
    As discussed below, the State of Nevada has submitted a second SIP
revision that withdraws the 2030 budget, and we received no comments on
our proposal, and thus, we are taking final action to approve the 2005
CO plan, as amended, and to approve the related motor vehicle emissions
budgets for 2006, 2010, 2015, and 2020.

II. What Is the Background for This Rule?

    Based on monitoring data from the mid-1970's, EPA designated Las
Vegas Valley \1\ as a carbon monoxide (CO) nonattainment area under the
Clean Air Act (CAA or ``Act''), as amended in 1977. See 43 FR 8962,
9012 (March 3, 1978). In response, Clark County and the State of Nevada
adopted and implemented various air quality plans and programs,
including a vehicle inspection and maintenance (I/M) program, to reduce
CO levels in Las Vegas Valley, but the CO national ambient air quality
standards (NAAQS) were not attained by the then-applicable 1987
attainment date. [EPA approved these plans and programs at various
times as revisions to the Nevada state implementation plan (SIP).]
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    \1\ The boundaries of the Las Vegas Valley CO nonattainment area
are defined by reference to State hydrographic area 212,
which covers the central portion of Clark County. See 40 CFR 81.329.
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    The CAA was significantly amended by Congress in 1990 to establish
new attainment dates and planning and control requirements for areas
that had failed to attain the NAAQS under the 1977 Amendments. Under
the 1990 Amended Act, Las Vegas Valley was initially classified as a
``moderate'' nonattainment area for CO but was later reclassified as a
``serious'' CO nonattainment area after having missed the attainment
date for moderate areas.
    In response to the ``moderate'', and then ``serious,''
nonattainment classification and related CAA requirements, Clark County
and the State of Nevada adopted and implemented new air quality plans
and programs, including a ``serious'' area attainment plan, the Carbon
Monoxide State Implementation Plan, Las Vegas Valley Nonattainment
Area, Clark County, Nevada (August 2000) (``2000 CO plan''). In 2004,
we approved the 2000 CO plan and related motor vehicle emissions
budgets for years 2000, 2010 and 2020. See 69 FR 56351, September 21,
2004.
    In response to changes in the EPA-approved motor vehicle emission
factor model and higher-than-forecast increases in population growth in
Las Vegas Valley, the Clark County Department of Air Quality and
Environmental Management (DAQEM), in consultation with the Regional
Transportation Commission of Southern Nevada (RTC), undertook a
comprehensive air quality planning effort to review and update the 2000
CO plan and the associated motor vehicle emission budgets to maintain
consistency for future transportation conformity findings. The planning
efforts culminated in the preparation of the Carbon Monoxide State
Implementation Plan Revision, Las Vegas Valley Nonattainment Area,
Clark County, Nevada (October 2005) (``2005 CO plan''). The Clark
County Board of Commissioners adopted the 2005 CO plan on October 4,
2005, and the Nevada Division of Environmental Protection (NDEP)
submitted the plan to EPA as a revision to the Nevada SIP on February
14, 2006.
    The 2005 CO plan, as adopted on October 4, 2005 and submitted on
February 14, 2006, includes revised base year and future year emissions
inventories and a revised demonstration of continued attainment of the
CO NAAQS in Las Vegas Valley through 2030 based on the most recent
emissions models and planning assumptions and establishes new motor
vehicle emissions budgets. The inventories and modeling demonstration
included in the 2005 CO plan relate to analysis years 1996, 2006, 2010,
2015, 2020 and 2030. The plan allocates almost all of the estimated
safety margins \2\ in years 2006, 2010, 2015, 2020, and 2030 to the on-
road motor vehicle emissions category. Based on our review and
evaluation of NDEP's February 14, 2006 SIP revision submittal, we
proposed to approve the 2005 CO plan on the condition that

Clark County and the State of Nevada withdraw the 2030 motor vehicle
emission budget, or, in the alternative, to disapprove the plan. See 71
FR 26910 (May 9, 2006).
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    \2\ The term ``safety margin'' refers to the amount by which the
total projected emissions from all sources of a given pollutant are
less than the total emissions that would satisfy the applicable
requirement for reasonable further progress, attainment or
maintenance. See 40 CFR 93.101. The 2005 CO plan also allocates a
small portion of the safety margins to certain point sources.
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    As stated in our proposed rule published on May 9, 2006, our
objection to the 2030 budget was premised on our finding that the plan
lacks micro-scale modeling analysis for the environs of the County's
airports in that year. In response, on May 2, 2006, Clark County
adopted a revision to the 2005 CO plan that involved withdrawal of the
2030 budget and revision and replacement of the specific section of the
plan (section 7.3, page 7-2, ``Mobile Source Emissions Budget'') that
identifies the emissions budgets. On May 12, 2006, NDEP submitted the
amended page of the plan to EPA as a SIP revision together with
evidence of adoption of this amendment by the Clark County Board of
Commissioners. We have reviewed the May 12, 2006 submittal, and find
that it meets the condition we placed on the proposed approval of the
2005 CO plan, and thus we are taking final action today to approve the
plan, as amended.
    Please see the proposed rule at 71 FR 26910 (May 9, 2006) for more
information about the background leading up to the submittal of the
2005 CO plan and our review and evaluation of the plan.

III. What Comments Did We Receive on the Proposed Action?

    EPA provided a 30-day review and comment period on the proposal
published in the Federal Register on May 9, 2006 (71 FR 26910). We
received no comments on our proposed rulemaking.

IV. What Is Our Final Action?

    Pursuant to section 110(k) of the Act and for the reasons set forth
above and in the proposed rule, we are approving the Carbon Monoxide
State Implementation Plan Revision, Las Vegas Valley Nonattainment
Area, Clark County, Nevada (October 2005), as adopted on October 4,
2005 by the Clark County Board of Commissioners and submitted by NDEP
on February 14, 2006, and as amended by the board on May 2, 2006 and
submitted by NDEP on May 12, 2006, as a revision to the Nevada SIP.
    Our approval is based on our evaluation of the plan submittals and
determination that the plan's revised base year and projected emission
inventories and modeling demonstration of continued attainment of the
CO standard through 2020 reflect acceptable methods and the most recent
models and planning assumptions.
    Furthermore, we find that the new motor vehicle emissions budgets
established in the plan and reflecting scaled inventories are also
consistent with continued attainment of the CO NAAQS in Las Vegas
Valley. Thus, we are approving the following motor vehicle emissions
budgets from the 2005 CO plan, as modified by the withdrawal of the
2030 budget as set forth in NDEP's February 12, 2006 submittal, as
meeting the purposes of section 176(c)(1) and the transportation
conformity rule at 40 CFR part 93, subpart A:

                    CO Motor Vehicle Emissions Budget
                           [December weekday]
------------------------------------------------------------------------
                                                                Tons per
                             Year                                 day
------------------------------------------------------------------------
2006.........................................................        623
2010.........................................................        690
2015.........................................................        768
2020.........................................................        817
------------------------------------------------------------------------

    Our action today in approving the above budgets has the effect of
replacing the previously-approved CO motor vehicle emissions budgets
from the Las Vegas Valley 2000 CO plan for the purposes of
transportation conformity.

V. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves an air quality plan as meeting Federal requirements and
imposes no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4).
    This rule also does not have tribal implications because it will
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, as specified by Executive Order 13175 (65
FR 67249, November 9, 2000). This action also does not have Federalism
implications because it does not have substantial direct effects 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, as specified in Executive Order 13132 (64
FR 43255, August 10, 1999). This action merely approves a state plan
implementing a Federal standard and does not alter the relationship or
the distribution of power and responsibilities established in the Clean
Air Act. This rule also is not subject to Executive Order 13045,
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997), because it is not economically
significant.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule

cannot take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by October 6, 2006. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
This action may not be challenged later in proceedings to enforce its
requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Reporting and
recordkeeping requirements.

    Dated: June 20, 2006.
Wayne Nastri,
Regional Administrator, Region IX.

0
Part 52, chapter I, title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart DD--Nevada

0
2. Section 52.1470 is amended by adding paragraphs (c)(57) and (c)(58)
to read as follows:

Sec.  52.1470  Identification of plan.

* * * * *
    (c) * * *
    (57) The following plan revision was submitted on February 14,
2006, by the Governor's designee.
    (i) Incorporation by reference.
    (A) Clark County Department of Air Quality and Environmental
Management.
    (1) Carbon Monoxide State Implementation Plan Revision, Las Vegas
Valley Nonattainment Area, Clark County, Nevada, adopted on October 4,
2005 by the Clark County Board of Commissioners (with the exception of
section 7.3 (page 7-2), ``Mobile Source Emissions Budget'').
    (58) The following plan revision was submitted on May 12, 2006, by
the Governor's designee.
    (i) Incorporation by reference.
    (A) Clark County Department of Air Quality and Environmental
Management.
    (1) Section 7.3 (page 7-2), ``Mobile Source Emissions Budget'' of
the Carbon Monoxide State Implementation Plan Revision, Las Vegas
Valley Nonattainment Area, Clark County, Nevada, adopted on May 2, 2006
by the Clark County Board of Commissioners.

[FR Doc. E6-12761 Filed 8-4-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 185 (Tuesday, September 24, 2019)]
[Notices]
[Pages 50045-50047]
[FR Doc No: 2019-20629]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0035]

Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled
``Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment.'' The
guidance provides FDA's current thinking on the clinical development
program and clinical trial designs for drugs to support an indication
for the treatment of amyotrophic lateral

sclerosis (ALS). The guidance addresses the clinical development of
drugs intended to treat the main motor aspects of ALS, i.e., muscle
weakness and its direct consequences, including shortened life
expectancy. It does not address in detail the development of drugs to
treat other symptoms that may arise in ALS, such as muscle cramps,
spasticity, sialorrhea, pseudobulbar affect, and others. This guidance
finalizes the draft guidance of the same name issued on February 16,
2018.

DATES: The announcement of the guidance is published in the Federal
Register on September 24, 2019.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0035 for ``Amyotrophic Lateral Sclerosis: Developing Drugs
for Treatment.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Billy Dunn, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 4332, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry
entitled ``Amyotrophic Lateral Sclerosis: Developing Drugs for
Treatment.'' ALS is a progressive neurodegenerative disease that
primarily affects motor neurons in the cerebral motor cortex,
brainstem, and spinal cord, leading to loss of voluntary movement and
the development of difficulty in swallowing, speaking, and breathing.
The purpose of this guidance is to assist sponsors in the clinical
development of drugs for the treatment of ALS.
    The guidance addresses the clinical development of drugs intended
to treat the main motor aspects of ALS (i.e., muscle weakness and its
direct consequences, including shortened survival). It does not address
in detail the development of drugs to treat other symptoms that may
arise in ALS, such as muscle cramps, spasticity, sialorrhea, and
pseudobulbar affect.
    The guidance covers considerations for early phase clinical
development, drug development population, clinical efficacy study
design and endpoints, and risk-benefit, as well as other factors, such
as relevant nonclinical safety and pharmacokinetic/pharmacodynamic
considerations. This guidance finalizes the draft guidance of the same
name issued on February 16, 2018 (83 FR 7047). Changes made to the
guidance took into consideration written and verbal comments received.
Information was added about strategies to expedite clinical trials in
ALS and minimize exposure to placebo, about the importance of broad
inclusion criteria in ALS clinical trials, encouraging the use

of patient input and experience in the development of new outcome
measures that are capable of measuring clinically meaningful effects in
patients, and encouraging the incorporation of exploratory biomarkers
in ALS development programs. Language was also added to provide greater
context on the use of historical control data in ALS clinical trials,
to suggest approaches to minimize patient burden during clinical
trials, and to clarify safety data expectations for new ALS treatments.
Finally, additions emphasize FDA's willingness to exercise flexibility
in applying the statutory standards for approval of drugs for the
treatment of serious diseases with unmet medical needs, while
preserving appropriate assurances for safety and effectiveness.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Amyotrophic Lateral Sclerosis: Developing
Drugs for Treatment.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 312 have been
approved under OMB control number 0910-0014, the collections of
information in 21 CFR part 314 have been approved under OMB control
number 0910-0001, and the collections of information referred to in the
guidance for industry entitled ``Establishment and Operation of
Clinical Trial Data Monitoring Committees'' (available at https://www.fda.gov/media/75398/download) have been approved under OMB control
number 0910-0581.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, or https://www.regulations.gov.

    Dated: September 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20629 Filed 9-23-19; 8:45 am]
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[Federal Register Volume 84, Number 108 (Wednesday, June 5, 2019)]
[Notices]
[Page 26137]
[FR Doc No: 2019-11673]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2019-0002; Internal Agency Docket No. FEMA-B-1912]

 Proposed Flood Hazard Determinations for Frederick County,
Maryland and Incorporated Areas

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice; withdrawal.

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SUMMARY: The Federal Emergency Management Agency (FEMA) is withdrawing
its proposed notice concerning proposed flood hazard determinations,
which may include the addition or modification of any Base Flood
Elevation, base flood depth, Special Flood Hazard Area boundary or zone
designation, or regulatory floodway (herein after referred to as
proposed flood hazard determinations) on the Flood Insurance Rate Maps
and, where applicable, in the supporting Flood Insurance Study reports
for Frederick County, Maryland and Incorporated Areas.

DATES: This withdrawal is effective June 5, 2019.

ADDRESSES: You may submit comments, identified by Docket No. FEMA-B-
1912, to Rick Sacbibit, Chief, Engineering Services Branch, Federal
Insurance and Mitigation Administration, FEMA, 400 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On March 18, 2019, FEMA published a proposed
notice at 84 FR 9806, proposing flood hazard determinations for
Frederick County, Maryland and Incorporated Areas. FEMA is withdrawing
the proposed notice.

    Authority: 42 U.S.C. 4104; 44 CFR 67.4.

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2019-11673 Filed 6-4-19; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register Volume 78, Number 112 (Tuesday, June 11, 2013)]
[Rules and Regulations]
[Pages 34887-34892]
[FR Doc No: 2013-13757]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 100 and 165

[Docket No. USCG-2012-1057]
RIN 1625-AA08; 1625-AA00

Special Local Regulations and Safety Zones; Marine Events in
Northern New England

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing three temporary special local
regulations for marine regattas and fifteen temporary safety zones for
fireworks displays and swim events within the Captain of the Port
(COTP) Northern New England (NNE) Zone. This action is necessary to
provide for the safety of life on navigable waters during these events.
Entry into, transit through, mooring or anchoring within these zones is
prohibited unless authorized by the COTP Sector Northern New England.

DATES: This rule will be enforced with actual notice from May 24, 2013,
until June 11, 2013. This rule is effective in the Code of Federal
Regulations from June 11, 2013 until July 5, 2013. This rule will be
enforced during the specific dates and times listed in Table to Sec.
100.T01-1057 and Table to Sec.  165.T01-1057.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2013-1057]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rulemaking. You may also
visit the Docket Management Facility in Room W12-140 on the ground
floor of the Department of Transportation West Building, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Ensign Elizabeth Morris, Waterways Management Division at
Coast Guard Sector Northern New England, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Barbara Hairston, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
LIS Long Island Sound
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    On March 22, 2013, the Coast Guard provided the public with notice
and an opportunity to comment when it published a notice of proposed
rulemaking (NPRM) titled, ``Special Local Regulations and Safety Zones;
Recurring Events in Northern New England,'' in the Federal Register.
(78 FR 17613). The comment period ended on May 21, 2013, with no
comments.
    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. There is insufficient time to
undergo a 30 day delayed effective date and thus it is impracticable.
Any delay encountered in this regulation's effective date would also be
contrary to public interest since immediate action is needed to provide
for the safety of life and property on navigable waters from the
hazardous nature of fireworks, high speed power boat races, and large
gatherings of swimmers in the waterway.

B. Basis and Purpose

    The legal basis for this temporary rule is 33 U.S.C. 1231, 1233; 46
U.S.C. chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1,
6.04-1, 6.04-6, and 160.5; Public Law 107-295, 116 Stat. 2064; and
Department of Homeland Security Delegation No. 0170.1, which
collectively authorize the Coast Guard to define regulatory safety
zones and regulated areas.
    This rulemaking establishes special local regulations for power
boat races and marine parades and safety zones for marine events
involving fireworks displays and swim events on the navigable waters of
the COTP Sector NNE Zone. This rule is necessary to protect waterway
users from the dangers inherent to these activities.

C. Discussion of the Final Rule

    This temporary rule establishes special local regulations and
safety zones for eighteen events in the COTP Sector NNE Zone. Specific
event names, locations, dates and times are listed below in the
regulation text.
    Because large numbers of spectator vessels are expected to
congregate around the location of these events, these regulated areas
are needed to protect both spectators and participants from the safety
hazards created by them including vessels operating at high speeds and
unexpected pyrotechnics detonation and burning debris.
    This rule prevents vessels from entering, transiting, mooring or
anchoring within areas specifically designated as regulated areas
during the periods of enforcement unless authorized by the COTP or
designated representative.
    The Coast Guard has determined that these regulated areas will not
have a significant impact on vessel traffic due to their temporary
nature, limited size, and the fact that vessels are allowed to transit
the navigable waters outside of the regulated areas. The COTP will
cause public notifications to be made by all appropriate means
including but not limited to the Local Notice to Mariners and Broadcast
Notice to Mariners.

D. Regulatory Analyses

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

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866 or
under section 1 of Executive Order 13563. The Office of Management and
Budget has not reviewed it under those Orders.
    The Coast Guard determined that this rule is not a significant
regulatory action for the following reasons: The regulated areas will
be of limited duration and cover only a small portion of the navigable
waterways. Furthermore, vessels may transit the navigable

waterways outside of the regulated areas. Vessels requiring entry into
the regulated areas may be authorized to do so by the COTP or
designated representative.
    Advanced public notifications will also be made to the local
maritime community by the Local Notice to Mariners as well as Broadcast
Notice to Mariners.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    The owners or operators of vessels intending to transit or anchor
in the designated regulated areas during the enforcement periods stated
for each event listed below in the List of Subjects.
    The temporary special local regulations and safety zones will not
have a significant economic impact on a substantial number of small
entities for the following reasons: the regulated areas will be of
limited size and of short duration, and vessels that can safely do so
may navigate in all other portions of the waterways except for the
areas designated as regulated areas. Additionally, notifications will
be made before the effective period by all appropriate means, including
but not limited to the Local Notice to Mariners and Broadcast Notice to
Mariners well in advance of the events.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

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

5. Federalism

    A 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 determined
that this rule does not have implications for federalism.

6. Protest Activities

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

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (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.

8. Taking of Private Property

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

9. Civil Justice Reform

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

10. Protection of Children

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

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

12. Energy Effects

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

13. Technical Standards

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

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have 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 safety zones. This
rule is categorically excluded from further review under paragraph
34(g) of Figure 2-1 of the Commandant Instruction. An environmental
analysis checklist supporting this determination and a Categorical
Exclusion Determination are available in the docket where indicated
under ADDRESSES.

List of Subjects

33 CFR Part 100

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

33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR Parts 100 and 165 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for Part 100 continues to read as follows:

    Authority: 33 U.S.C. 1233.

0
2. Add Sec.  100.T01-1057 to read as follows:

Sec.  100.T01-1057  Special Local Regulations; Marine Events in
Northern New England.

    (a) Regulations. The general regulations contained in 33 CFR
100.120 as well as the following regulations apply to the events listed
in the TABLE to Sec.  100.T01-1057. These regulations will be enforced
for the duration of each event.
    (b) Enforcement Period. This rule will be enforced on the dates and
times listed for each event in TABLE to Sec.  100.T01-1057.
    (c) Definitions. The following definitions apply to this section:
    (1) Designated Representative. A ``designated representative'' is
any Coast Guard commissioned, warrant or petty officer of the U.S.
Coast Guard who has been designated by the Captain of the Port (COTP),
Sector Long Island Sound, to act on his or her behalf. The designated
representative may be on an official patrol vessel or may be on shore
and will communicate with vessels via VHF-FM radio or loudhailer. In
addition, members of the Coast Guard Auxiliary may be present to inform
vessel operators of this regulation.
    (2) Official Patrol Vessels. Official patrol vessels may consist of
any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement
vessels assigned or approved by the COTP.
    (3) Spectators. All persons and vessels not registered with the
event sponsor as participants or official patrol vessels.
    (d) Spectators desiring to enter or operate within the regulated
areas should contact the COTP or the designated representative via VHF
channel 16 or by telephone at<PHONE_NUMBER> to obtain permission to do
so. Spectators given permission to enter or operate in the regulated
area must comply with all directions given to them by the COTP Sector
Northern New England or the designated on-scene representative.
    (e) Upon being hailed by an official patrol vessel or the
designated representative, by siren, radio, flashing light or other
means, the operator of the vessel shall proceed as directed. Failure to
comply with a lawful direction may result in expulsion from the area,
citation for failure to comply, or both.
    (f) For all power boat races listed, vessels operating within the
regulated area must be at anchor within a designated spectator area or
moored to a waterfront facility in a way that will not interfere with
the progress of the event.
    (g) For all regattas and boat parades listed, spectator vessels
operating within the regulated area shall maintain a separation of at
least 50 yards from the participants.
    (h) For all rowing and paddling boat races listed, vessels not
associated with the event shall maintain a separation of at least 50
yards from the participants.

                      Table to Sec.   100.T01-1057
------------------------------------------------------------------------

------------------------------------------------------------------------
                                  JUNE
------------------------------------------------------------------------
Charlie Begin Memorial Lobster Boat     Event Type: Power Boat
 Races.                                 Race.
                                        Sponsor: Boothbay Harbor
                                        Lobster Boat Race Committee.
                                        Date: June 15, 2013.
                                        Time: 9:00 am to 3:00
                                        pm.
                                        Location: The regulated
                                        area includes all waters of
                                        Boothbay Harbor, Maine in the
                                        vicinity of John's Island within
                                        the following points (NAD 83):
                                         43[deg]50'04'' N
                                       069[deg]38'37'' W.
                                         43[deg]50'54'' N
                                       069[deg]38'06'' W.
                                         43[deg]50'49'' N
                                       069[deg]37'50'' W.
                                         43[deg]50'00'' N
                                       069[deg]38'20'' W.
------------------------------------------------------------------------
Rockland Harbor Lobster Boat Races...   Event Type: Power Boat
                                        Race.
                                        Sponsor: Rockland Harbor
                                        Lobster Boat Race Committee.
                                        Date: June 16, 2013.
                                        Time: 9:00 am to 4:00
                                        pm.
                                        Location: The regulated
                                        area includes all waters of
                                        Rockland Harbor, Maine in the
                                        vicinity of the Rockland
                                        Breakwater Light within the
                                        following points (NAD 83):
                                         44[deg]05'59'' N
                                       069[deg]04'53'' W.
                                         44[deg]06'43'' N
                                       069[deg]05'25'' W.
                                         44[deg]06'50'' N
                                       069[deg]05'05'' W.
                                         44[deg]06'05'' N
                                       069[deg]04'34'' W.
------------------------------------------------------------------------
Windjammer Days Parade of Ships......   Event Type: Tall Ship
                                        Parade.
                                        Sponsor: Boothbay Region
                                        Chamber of Commerce.
                                        Date: June 26, 2013.
                                        Time: 1:00 pm to 5:00
                                        pm.
                                        Location: The regulated
                                        area includes all waters of
                                        Boothbay Harbor, Maine in the
                                        vicinity of Tumbler's Island
                                        within the following points (NAD
                                        83):
                                         43[deg]51'02'' N
                                       069[deg]37'33'' W.
                                         43[deg]50'47'' N
                                       069[deg]37'31'' W.
                                         43[deg]50'23'' N
                                       069[deg]37'57'' W.
                                         43[deg]50'01'' N
                                       069[deg]37'45'' W.
                                         43[deg]50'01'' N
                                       069[deg]38'31'' W.
                                         43[deg]50'25'' N
                                       069[deg]38'25'' W.
                                         43[deg]50'49'' N
                                       069[deg]37'45'' W.
------------------------------------------------------------------------

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
3. The authority citation for Part 165 continues to read as follows:

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

0
4. Add Sec.  165.T01-1057 to read as follows:

Sec.  165.T01-1057  Safety Zones; Marine Events in Northern New
England.

    (a) Regulations. The general regulations contained in 33 CFR 165.23
as well as the following regulations apply to the events listed in the
TABLE of Sec.  165.T01-1057. These regulations will be enforced for the
duration of each event.
    (b) Enforcement Period. This rule will be enforced from on the
dates and times listed for each event in TABLE of Sec.  165.T01-1057.
    (c) Definitions. The following definitions apply to this section:
    (1) Designated Representative. A ``designated representative'' is
any Coast Guard commissioned, warrant or petty officer of the U.S.
Coast Guard who has been designated by the Captain of the Port (COTP),
Sector Long Island Sound, to act on his or her behalf. The designated
representative may be on an official patrol vessel or may be on shore
and will communicate with vessels via VHF-FM radio or loudhailer. In
addition, members of the Coast Guard Auxiliary may be present to inform
vessel operators of this regulation.
    (2) Official Patrol Vessels. Official patrol vessels may consist of
any Coast Guard, Coast Guard Auxiliary, state, or local law enforcement
vessels assigned or approved by the COTP.
    (3) Spectators. All persons and vessels not registered with the
event sponsor as participants or official patrol vessels.
    (d) Spectators desiring to enter or operate within the regulated
areas should contact the COTP or the designated representative via VHF
channel 16 or by telephone at<PHONE_NUMBER> to obtain permission to do
so. Spectators given permission to enter or operate in the regulated
area must comply with all directions given to them by the COTP Sector
Northern New England or the designated on-scene representative.
    (e) Upon being hailed by an official patrol vessel or the
designated representative, by siren, radio, flashing light or other
means, the operator of the vessel shall proceed as directed. Failure to
comply with a lawful direction may result in expulsion from the area,
citation for failure to comply, or both.
    (f) For all swim events listed, vessels not associated with the
event shall maintain a separation zone of 200 feet from participating
swimmers.
    (g) For all fireworks displays listed below, the regulated area is
that area of navigable waters within a 350 yard radius of the launch
platform or launch site for each fireworks display.

                      Table to Sec.   165.T01-1057
------------------------------------------------------------------------

------------------------------------------------------------------------
                                   MAY
------------------------------------------------------------------------
Ride Into Summer (formerly known as       Event Type: Fireworks
 Hawgs, Pies, & Fireworks).               Display.
                                          Sponsor: Gardiner
                                          Maine Street.
                                          Date: May 25, 2013.
                                          Time: 8:00 p.m. to
                                          10:30 p.m.
                                          Location: In the
                                          vicinity of the Gardiner
                                          Waterfront, Gardiner, Maine in
                                          approximate position:
                                          44[deg]13'43'' N,
                                          069[deg]46'04'' W (NAD 83).
------------------------------------------------------------------------
                                  JUNE
------------------------------------------------------------------------
Tri for a Cure Swim Clinics and           Event Type: Swim
 Triathlon.                               Event.
                                          Sponsor: Maine Cancer
                                          Foundation.
                                          Dates and Times:
                                           June 19, 2013 4:30 p.m. to
                                         8:30 p.m.
                                           June 22, 2013 7:30 a.m. to
                                         11:30 a.m.
                                           July 1, 2013 4:00 p.m. to
                                         8:00 p.m.
                                           July 13, 2013 11:30 a.m. to
                                         3:30 p.m.
                                           July 21, 2013 7:00 a.m. to
                                         11:00 a.m.
                                          Location: The
                                          regulated area includes all
                                          waters of Portland Harbor,
                                          Maine in the vicinity of
                                          Spring Point Light within the
                                          following points (NAD 83):
                                           43[deg]39'01'' N
                                         070[deg]13'32'' W.
                                           43[deg]39'07'' N
                                         070[deg]13'29'' W.
                                           43[deg]39'06'' N
                                         070[deg]13'41'' W.
                                           43[deg]39'01'' N
                                         070[deg]13'36'' W.
------------------------------------------------------------------------
Rotary Waterfront Days Fireworks.......   Event Type: Fireworks
                                          Display.
                                          Sponsor: Gardiner
                                          Rotary.
                                          Date: June 22, 2013.
                                          Time: 8:00 p.m. to
                                          10:00 p.m.
                                          Location: In the
                                          vicinity of the Gardiner
                                          Waterfront, Gardiner, Maine in
                                          approximate position:
                                          44[deg]13'52'' N,
                                          069[deg]46'08'' W (NAD 83).
------------------------------------------------------------------------
Windjammer Days Fireworks..............   Event Type: Fireworks
                                          Display.
                                          Sponsor: Boothbay
                                          Harbor Region Chamber of
                                          Commerce.
                                          Date: June 26, 2013.
                                          Time: 8:00 p.m. to
                                          10:30 p.m.
                                          Location: In the
                                          vicinity of McFarland Island,
                                          Boothbay Harbor, Maine in
                                          approximate position:
                                          43[deg]50'38'' N,
                                          069[deg]37'57'' W (NAD 83).
------------------------------------------------------------------------
Jonesport 4th of July Fireworks........   Event Type: Fireworks
                                          Display.
                                          Sponsor: Jonesport 4th
                                          of July Committee.

                                          Date: June 29, 2013.
                                          Time: 8:30 p.m. to
                                          11:00 p.m.
                                          Location: In the
                                          vicinity of Beals Island,
                                          Jonesport, Maine in
                                          approximate position:
                                          44[deg]31'18'' N,
                                          067[deg]36'43'' W (NAD 83).
------------------------------------------------------------------------
                                  JULY
------------------------------------------------------------------------
Burlington Independence Day Fireworks     Event Type: Firework
 Complete.                                Display.
                                          Sponsor: City of
                                          Burlington, Vermont.
                                          Date: July 3, 2013.
                                          Time: 8:00 p.m. to
                                          10:30 p.m.
                                          Location: From a barge
                                          in the vicinity of Burlington
                                          Harbor, Burlington, Vermont in
                                          approximate position:
                                          44[deg]28'31'' N,
                                          073[deg]13'31'' W (NAD 83).
------------------------------------------------------------------------
Camden 4th of July Fireworks (Formerly    Event Type: Fireworks
 Camden 3rd of July Fireworks).           Display.
                                          Sponsor: Penobscot Bay
                                          Regional Chamber of Commerce
                                          (Formerly Camden, Rockport,
                                          Lincolnville Chamber of
                                          Commerce).
                                          Date: July 4, 2013.
                                          Time: 8:15 p.m. to
                                          10:45 p.m.
                                          Location: In the
                                          vicinity of Camden Harbor,
                                          Maine in approximate position:
                                          44[deg]12'32'' N,
                                          069[deg]02'58'' W (NAD 83).
------------------------------------------------------------------------
Bangor 4th of July Fireworks...........   Event Type: Fireworks
                                          Display.
                                          Sponsor: Bangor 4th of
                                          July Fireworks.
                                          Date: July 4, 2013.
                                          Time: 8:30 p.m. to
                                          11:00 p.m.
                                          Location: In the
                                          vicinity of the Bangor
                                          Waterfront, Bangor, Maine in
                                          approximate position:
                                          44[deg]47'27'' N,
                                          068[deg]46'31'' W (NAD 83).
------------------------------------------------------------------------
Bar Harbor 4th of July Fireworks.......   Event Type: Fireworks
                                          Display.
                                          Sponsor: Bar Harbor
                                          Chamber of Commerce.
                                          Date: July 4, 2013.
                                          Rain date: July 5,
                                          2013.
                                          Time: 8:00 p.m. to
                                          10:30 p.m.
                                          Location: In the
                                          vicinity of Bar Harbor Town.
                                          Pier, Bar Harbor, Maine in
                                          approximate position:
                                          44[deg]23'31'' N,
                                          068[deg]12'15'' W (NAD 83).
------------------------------------------------------------------------
Boothbay Harbor 4th of July Fireworks..   Event Type: Fireworks
                                          Display.
                                          Sponsor: Town of
                                          Boothbay Harbor.
                                          Date: July 4, 2013.
                                          Time: 8:00 p.m. to
                                          10:30 p.m.
                                          Location: In the
                                          vicinity of McFarland Island,
                                          Boothbay Harbor, Maine in
                                          approximate position:
                                          43[deg]50'38'' N,
                                          069[deg]37'57'' W (NAD 83).
------------------------------------------------------------------------
Colchester 4th of July Fireworks.......   Event Type: Fireworks
                                          Display.
                                          Sponsor: Town of
                                          Colchester, Recreation
                                          Department.
                                          Date: July 4, 2013.
                                          Rain Date: July 5,
                                          2013.
                                          Time: 8:00 p.m. to
                                          10:30 p.m.
                                          Location: In the
                                          vicinity of Bayside Beach and
                                          Mallets Bay in Colchester,
                                          Vermont in approximate
                                          position: 44[deg]32'44'' N,
                                          073[deg]13'10'' W (NAD 83).
------------------------------------------------------------------------
Eastport 4th of July Fireworks.........   Event Type: Fireworks
                                          Display.
                                          Sponsor: Eastport 4th
                                          of July Committee.
                                          Date: July 4, 2013.
                                          Time: 8:00 p.m. to
                                          10:30 p.m.
                                          Location: From the
                                          Waterfront Public Pier in
                                          Eastport, Maine in approximate
                                          position: 44[deg]54'25'' N,
                                          066[deg]58'55'' W (NAD 83).
------------------------------------------------------------------------
Portland Harbor 4th of July Fireworks..   Event Type: Fireworks
                                          Display.
                                          Sponsor: Department of
                                          Parks and Recreation,
                                          Portland, Maine.
                                          Date: July 4, 2013.
                                          Rain date: July 5,
                                          2013.
                                          Time: 8:30 p.m. to
                                          10:30 p.m.
                                          Location: In the
                                          vicinity of East End Beach,
                                          Portland, Maine in approximate
                                          position: 43[deg]40'16'' N,
                                          070[deg]14'44'' W (NAD 83).
------------------------------------------------------------------------
Stonington 4th of July Fireworks.......   Event Type: Fireworks
                                          Display.
                                          Sponsor: Deer Isle--
                                          Stonington Chamber of
                                          Commerce.
                                          Date: July 4, 2013.
                                          Rain Date: July 5,
                                          2013.
                                          Time: 8:00 p.m. to
                                          10:30 p.m.

                                          Location: In the
                                          vicinity of Two Bush Island,
                                          Stonington, Maine in
                                          approximate position:
                                          44[deg]08'57'' N,
                                          068[deg]39'54'' W (NAD 83).
------------------------------------------------------------------------
Ellis Short Sand Park Trustee Fireworks   Event Type: Fireworks
                                          Display.
                                          Sponsor: William.
                                          Burnham.
                                          Date: July 5, 2013.
                                          Time: 8:30 p.m. to
                                          11:30 p.m.
                                          Location: In the
                                          vicinity of York Beach, Maine
                                          in approximate position:
                                          43[deg]10'27'' N,
                                          070[deg]36'25'' W (NAD 83).
------------------------------------------------------------------------

    Dated: May 24, 2013.
B.S. Gilda,
Captain, U.S. Coast Guard, Acting Captain of the Port Sector Northern
New England.
[FR Doc. 2013-13757 Filed 6-10-13; 8:45 a.m.]
BILLING CODE 9110-04-P