[Federal Register: June 27, 2008 (Volume 73, Number 125)]
[Rules and Regulations]
[Page 36429-36431]
[DOCID:fr27jn08-10]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2008-0490]
RIN 1625-AA00

Safety Zone; Erie Summer Festival of the Arts, Presque Isle Bay,
Erie, PA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on
Lake Erie, Presque Isle Bay, Erie, PA. This zone is intended to
restrict vessels from a portion of Presque Isle Bay during the June 28,
2008, Erie Summer Festival of the Arts fireworks event. This temporary
safety zone is necessary to protect spectators and vessels from the
hazards associated with fireworks displays.

DATES: This rule is effective from 10 p.m. to 11 p.m. on June 28, 2008.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2008-0490 and are available for
inspection or copying at two locations: the Docket Management Facility
(M-30), U.S. Department of Transportation, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays, and the U.S. Coast Guard Sector Buffalo, 1 Fuhrmann
Boulevard, Buffalo, NY 14203 between 9:30 a.m. and 2 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call Commander Joseph Boudrow, Prevention Division,
U.S. Coast Guard Sector Buffalo, at<PHONE_NUMBER>. If you have questions
on viewing the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    We did not publish a notice of proposed rulemaking (NPRM) for this
regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing an NPRM. The permit application was not
received in time to publish an NPRM followed by a final rule before the
effective date. Under 5 U.S.C. 553(d)(3), good cause exists for making
this rule effective fewer than 30 days after publication in the Federal
Register. Delaying this rule would be contrary to the public interest
of ensuring the safety of spectators and vessels during this event and
immediate action is necessary to prevent possible loss of life or
property.

Background and Purpose

    This temporary safety zone is necessary to ensure the safety of
vessels and spectators from hazards associated with a fireworks
display. Based on accidents that have occurred in other Captain of the
Port zones, and the explosive hazards of fireworks, the Captain of the
Port Buffalo has determined that fireworks launches proximate to
watercraft pose a significant risk to public safety and property. The
likely combination of large numbers of recreation vessels, congested
waterways, darkness punctuated by bright flashes of light, alcohol use,
and debris falling into the water could easily result in serious
injuries or fatalities. Establishing a safety zone to control vessel
movement around the location of the launch platform will help ensure
the safety of persons and property at these events and help minimize
the associated risks.

Discussion of Rule

    A temporary safety zone is necessary to ensure the safety of
spectators and vessels during the setup, loading and launching of a
fireworks display in conjunction with the Erie Summer festival of the
Arts fireworks display. The fireworks display will occur between 10
p.m. and 11 p.m. on June 28, 2008.
    The safety zone for the fireworks will encompass all waters of Lake
Erie, Presque Isle Bay, Erie, PA, within a 420 ft radius of position
42[deg]07'45'' N, 080[deg]06'20'' W.
    All persons and vessels shall comply with the instructions of the
Coast Guard Captain of the Port or the on-scene representative. Entry
into, transiting, or anchoring within the safety zone is prohibited
unless authorized by the Captain of the Port Buffalo or his on-scene
representative. The Captain of the Port or his on-scene representative
may be contacted via VHF Channel 16.

Regulatory Evaluation

    This rule is not a ``significant regulatory action'' under section
3(f) of Executive Order 12866, Regulatory Planning and Review, and does
not require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    This determination is based on the minimal time that vessels will
be restricted from the zone and the zone is an area where the Coast
Guard expects insignificant adverse impact to mariners from the zones'
activation.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. 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.
    This rule will affect the following entities, some of which may be
small entities: The owners and operators of vessels intending to
transit or anchor in a portion of Lake Erie, Presque Isle Bay, Erie,
PA, between 10 p.m. and 11 p.m. on June 28, 2008.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: This
rule will be in effect for only one hour for one event. Vessel traffic
can safely pass outside the safety zone during the event. In the event
that this temporary safety zone affects shipping, commercial vessels
may request permission from the Captain of the Port Buffalo to transit
through the safety zone. The Coast

Guard will give notice to the public via a Broadcast to Mariners that
the regulation is in effect.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offered to assist small
entities in understanding the rule so that they could better evaluate
its effects on them and participate in the rulemaking process. 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.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

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

Taking of Private Property

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

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.

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 concern an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    The Coast Guard recognizes the treaty rights of Native American
Tribes. Moreover, the Coast Guard is committed to working with Tribal
Governments to implement local policies and to mitigate tribal
concerns. We have determined that these regulations and fishing rights
protection need not be incompatible. We have also determined that 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. Nevertheless, Indian Tribes
that have questions concerning the provisions of this Rule or options
for compliance are encouraged to contact the point of contact listed
under FOR FURTHER INFORMATION CONTACT.

Energy Effects

    We have analyzed this rule under Executive order 13211, Actions
Concerning Regulations that Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedure; and related management
system practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Commandant Instruction M16475.lD
which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have
concluded that there are no factors in this case that would limit the
use of a categorical exclusion under section 2.B.2 of the Instruction.
Therefore, this rule is categorically excluded, under figure 2-1,
paragraph (34)(g), of the Instruction, from further environmental
documentation. This event establishes a safety zone therefore paragraph
(34)(g) of the Instruction applies.
    A final ``Environmental Analysis Check List'' and a final
``Categorical Exclusion Determination'' are available in the docket
where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

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

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. A new temporary Sec.  165.T09-0490 is added as follows:

Sec.  165.T09-0490  Safety zone; Erie Summer Festival of the Arts, Lake
Erie, Presque Isle Bay, Erie, PA.

    (a) Location. The following area is a temporary safety zone: all
waters of Lake Erie, Presque Isle Bay, Erie, PA, within a 420 ft radius
of position (42[deg]07'45'' N, 080[deg]06'20'' W). (DATUM: NAD 83).
    (b) Effective period. This regulation is effective from 10 p.m. to
11 p.m. on June 28, 2008.
    (c) Regulations.
    (1) In accordance with the general regulations in Sec.  165.23 of
this part, entry into, transiting, or anchoring within this safety zone
is prohibited unless authorized by the Captain of the Port Buffalo, or
his on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Buffalo or his on-scene
representative.
    (3) The ``on-scene representative'' of the Captain of the Port is
any Coast Guard commissioned, warrant or petty officer who has been
designated by the Captain of the Port to act on his behalf. The on-
scene representative of the Captain of the Port will be aboard either a
Coast Guard or Coast Guard Auxiliary vessel.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port Buffalo or his on-scene
representative to obtain permission to do so. The Captain of the Port
or his on-scene representative may be contacted via VHF Channel 16.
Vessel operators given permission to enter or operate in the safety
zone must comply with all directions given to them by the Captain of
the Port Buffalo or his on-scene representative.

    Dated: June 13, 2008.
S.J. Ferguson,
Captain, U.S. Coast Guard, Captain of the Port Buffalo.
 [FR Doc. E8-14615 Filed 6-26-08; 8:45 am]

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[Federal Register: February 11, 2009 (Volume 74, Number 27)]
[Notices]
[Page 6903]
[DOCID:fr11fe09-62]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Improving Endpoints, Improving Care: Alpha-1 Antitrypsin
Augmentation Therapy and Clinical Trials; Public Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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    The Food and Drug Administration (FDA) is announcing a public
workshop entitled: Improving Endpoints, Improving Care: Alpha-1
Antitrypsin Augmentation Therapy and Clinical Trials. The purpose of
the public workshop is to identify the most useful clinical trial
endpoints and surrogate markers for Alpha-1 antitrypsin (AAT)
augmentation therapy. FDA, Alpha-1 Foundation, and the Department of
Health and Human Services, Office of Public Health and Science are
convening this workshop to facilitate the design of future clinical
trials intended to establish clinical efficacy of AAT products. The
public workshop will feature presentations and panel discussions led by
experts from academic institutions, government, and industry.
    Date and Time: The public workshop will be held on March 23, 2009,
from 8:30 a.m. to 5:30 p.m. and March 24, 2009, from 8:30 a.m. to 5
p.m.
    Location: The public workshop will be held at the Lister Hill
Center Auditorium, Bldg. 38A, National Institutes of Health, 8800
Rockville Pike, Bethesda, MD 20894.
    Contact Person: Rhonda Dawson, Center for Biologics Evaluation and
Research (HFM-302), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>,
e-mail<EMAIL_ADDRESS>    Registration: Mail, fax, or e-mail your registration information
(including name, title, firm name, address, telephone, and fax numbers)
to the contact person by March 6, 2009. There is no registration fee
for the public workshop. Early registration is recommended because
seating is limited to 175 attendees. Registration on the day of the
public workshop will be provided on a space available basis beginning
at 7:30 a.m.
    If you need special accommodations due to a disability, please
contact Rhonda Dawson (see Contact Person) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: AAT deficiency is a genetic condition that
leads to decreased levels of alpha-1 antitrypsin in the blood and
significantly increases the risk of serious lung disease in adults and
liver disease in infants, children, and adults. Intravenous
augmentation therapy with FDA-licensed, plasma-derived AAT products has
become the standard of care for treatment in the subset of patients
with AAT deficiency who have moderate pulmonary disease. Since the
original product approvals, additional data collection and advances in
understanding of AAT deficiency suggest the need to revisit and improve
clinical trial efficacy endpoints.
    The public workshop will facilitate scientific discussions to
identify the most relevant and feasible, currently available and future
clinical trial efficacy endpoints for AAT augmentation therapy and
further evaluate its usefulness to a broader patient population. Topics
to be discussed include: (1) AAT deficiency disease characteristics,
progression and pulmonary pathophysiology; (2) patient selection for
clinical trials; (3) current challenges to the development of endpoints
for clinical trials; and (4) currently available and future clinical
trial endpoints, including functional markers of disease progression,
and radiological and biochemical endpoints.
    Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the public workshop at a cost of 10
cents per page. A transcript of the public workshop will be available
on the Internet at http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: February 6, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-2905 Filed 2-10-09; 8:45 am]

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