[Federal Register Volume 78, Number 113 (Wednesday, June 12, 2013)]
[Notices]
[Pages 35277-35279]
[FR Doc No: 2013-13858]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0653]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Orphan Drugs; Common European Medicines Agency/Food
and Drug Administration Application Form for Orphan Medicinal Product
Designation (Form FDA 3671)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on

the procedures by which sponsors of orphan drugs may request
eligibility for the incentives by implementing a program as outlined in
the Orphan Drug Act and the joint adoption by FDA and the European
Medicines Agency (EMA) of the Common EMA/FDA Application Form for
Orphan Medicinal Product Designation (Form FDA 3671).

DATES: Submit either electronic or written comments on the collection
of information by August 12, 2013.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Orphan Drugs; Common EMA/FDA Application Form for Orphan Medicinal
Product Designation (Form FDA 3671)--21 CFR Part 316 (OMB Control
Number 0910-0167)--Extension

    Sections 525 through 528 of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360aa through 360dd) give FDA statutory
authority to do the following: (1) Provide recommendations on
investigations required for approval of marketing applications for
orphan drugs; (2) designate eligible drugs as orphan drugs; (3) set
forth conditions under which a sponsor of an approved orphan drug
obtains exclusive approval; and (4) encourage sponsors to make orphan
drugs available for treatment on an ``open protocol'' basis before the
drug has been approved for general marketing. The implementing
regulations for these statutory requirements have been codified under
part 316 (21 CFR part 316) and specify procedures that sponsors of
orphan drugs use in availing themselves of the incentives provided for
orphan drugs in the FD&C Act and sets forth procedures FDA will use in
administering the FD&C Act with regard to orphan drugs. Section 316.10
specifies the content and format of a request for written
recommendations concerning the non-clinical laboratory studies and
clinical investigations necessary for approval of marketing
applications. Section 316.12 provides that, before providing such
recommendations, FDA may require results of studies to be submitted for
review. Section 316.14 contains provisions permitting FDA to refuse to
provide written recommendations under certain circumstances. Within 90
days of any refusal, a sponsor may submit additional information
specified by FDA. Based on past experience, FDA estimates that there
will be two respondents to Sec. Sec.  316.10, 316.12, and 316.14
requiring 200 hours of human resources annually.
    Section 316.20 specifies the content and format of an orphan drug
application which includes requirements that an applicant document that
the disease is rare (affects fewer than 200,000 persons in the United
States annually) or that the sponsor of the drug has no reasonable
expectation of recovering costs of research and development of the
drug. Section 316.21 specifies content of a request for orphan drug
designation required for verification of orphan-drug status. Section
316.26 allows an applicant to amend the applications under certain
circumstances. The Common EMA/FDA Application Form for Orphan Medicinal
Product Designation (Form FDA 3671) is intended to benefit sponsors who
desire to seek orphan designation of drugs intended for rare diseases
or conditions from both the European Commission and FDA by reducing the
burden of preparing separate applications to meet the regulatory
requirements in each jurisdiction. It highlights the regulatory
cooperation between the United States and the European Union mandated
by the Transatlantic Economic Council. FDA does not believe the new
form will result in any increased burden on the respondents and
therefore we estimate no additional burden. Based on past experience,
FDA estimates there will be 214 respondents requiring 64,200 hours of
human resources annually. Section 316.22 specifies requirement of a
permanent resident agent for foreign sponsors. Based on past
experience, FDA estimates 55 respondents requiring 110 hours of human
resources annually. Section 316.27 specifies content of a change in
ownership of orphan-drug designation. Based on past experience, FDA
estimates 43 respondents requiring 215 hours of human resources
annually. Section 316.30 requires submission of annual reports,
including progress reports on studies, a description of the
investigational plan, and a discussion of changes that may affect
orphan status. Based on number of orphan-drug designations, the number
of respondents is estimated as 1,652 requiring 4,956 hours of human
resources annually. Finally, Sec.  316.36 describes information
required of sponsor when there is insufficient quantity of approved
orphan drug. Based on past experience, FDA estimates 1 respondent
requiring 45 hours of human resources annually.
    The information requested will provide the basis for an FDA
determination that the drug is for a rare disease or condition and
satisfies the requirements for obtaining orphan drug status. Secondly,
the information will describe the medical and regulatory history of the
drug. The respondents to this collection of information are
biotechnology firms, drug companies, and academic clinical researchers.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
   21 CFR Section and Form FDA       Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
Content and format when seeking                2               1               2             100             200
 written recommendations;
 results of studies; amendments
 (Sec.  Sec.   316.10, 316.12,
 316.14)........................
Content and format of a request              214               2             428             150          64,200
 for orphan-drug designation;
 request for verification of
 orphan-drug status; amendments
 (Sec.  Sec.   316.20, 316.21,
 316.26) Form FDA 3671..........
Notifications of changes in                   55               1              55               2             110
 agents (Sec.   316.22).........
Submissions to change ownership               43               1              43               5             215
 of orphan-drug designation
 (Sec.   316.27)................
Annual reports (Sec.   316.30)..           1,652               1           1,652               3           4,956
Assurance of the availability of               1               3               3              15              45
 sufficient quantities of the
 orphan drug; holder's consent
 for the approval of other
 marketing applications for the
 same drug (Sec.   316.36)......
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............          69,726
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: June 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13858 Filed 6-11-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 100 (Tuesday, May 24, 2011)]
[Proposed Rules]
[Pages 30072-30080]
[FR Doc No: 2011-12374]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

Docket No. USCG-2011-0264
RIN 1625-AA00

Safety Zones; Annual Events Requiring Safety Zones in the Captain
of the Port Lake Michigan Zone

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to amend 33 CFR Part 165.929 Safety
Zones; Annual Events requiring safety zones in the Captain of the Port
Lake Michigan zone. This proposed rule is intended to amend, establish,
or delete the rules that restrict vessels from portions of water areas
during events that pose a hazard to public safety. The safety zones
amended or established by this proposed rule are necessary to protect
spectators, participants, and vessels from the hazards associated with
various maritime events.

DATES: Comments and related materials must be received by the Coast
Guard on or before June 23, 2011.

ADDRESSES: You may submit comments identified by docket number USCG-
2011-0264 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or e-mail BM1 Adam Kraft, Prevention Department, Coast
Guard, Sector Lake Michigan, Milwaukee, WI, telephone<PHONE_NUMBER>,
e-mail<EMAIL_ADDRESS>If you have questions on viewing or
submitting material to the docket, call Renee V. Wright, Program
Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change, to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2011-0264), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online via http://www.regulations.gov, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand deliver, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an e-mail address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Proposed Rule'' and insert ``USCG-2011-0264'' in the ``Keyword'' box.
Click ``Search'' then click on the balloon shape in the ``Actions''
column. If you submit your comments by mail or hand delivery, submit
them in an unbound format, no larger than 8\1/2\ by 11 inches, suitable
for copying and electronic filing. If you submit comments by mail and
would like to know that they reached the Facility, please enclose a
stamped, self-addressed postcard or envelope. We will consider all
comments and material received during the comment period and may change
the rule based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
click on the ``read comments'' box, which will then become highlighted
in blue. In the ``Keyword'' box insert ``USCG-2011-0264'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
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. We have an
agreement with the Department of Transportation to use the Docket
Management Facility.

Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one using one of the four methods specified under
ADDRESSES. Please explain why you believe a public meeting would be
beneficial. If we determine that one would aid this rulemaking, we will
hold one at a time and place announced by a later notice in the Federal
Register.

Background and Purpose

    Currently, 33 CFR 165.929 lists eighty-three different locations in
the Captain of the Port Lake Michigan zone at which safety zones have
been permanently established. Each of these eighty-three safety zones
correspond to an annually recurring marine event. On April 1, 2011, the
Coast Guard refined the internal boundaries of its Ninth District,
resulting in changes to the Captain of the Port Lake Michigan zone.
Consequently, eleven of the aforementioned eighty-three safety zones
are now located within Captain of the Port Sault Ste. Marie zone. In
addition to the boundary change initiated by the Coast Guard, the
details of four of the annually recurring events have changed. Finally,
the Captain of the Port, Sector Lake Michigan has determined that three
additional recurring marine events require the implementation of
permanent safety zones.

Discussion of Proposed Rule

    This proposed rule will amend the regulations found in 33 CFR
165.929, Annual Events requiring safety zones in the Captain of the
Port Lake Michigan zone. Specifically, this proposed rule will revise
Sec.  165.929 in its entirety. The revision will include the deletion
of eleven of the safety zones; the modification of the name, location,
and enforcement periods of four other safety zones; and the addition of
three new safety zones. These safety zones are necessary to protect
vessels and people from the hazards associated with

firework displays, boat races, and other marine events. Such hazards
include obstructions to the navigable channels, explosive dangers
associated with fireworks, debris falling into the water, high speed
boat racing, and general congestion of waterways. Although this
proposed rule will remain in effect year round, the safety zones within
it will be enforced only immediately before, during, and after each
corresponding marine event.
    The Captain of the Port, Sector Lake Michigan, will notify the
public when the safety zones in this proposal will be enforced. In
keeping with 33 CFR 165.7(a), the Captain of the Port, Sector Lake
Michigan, will use all appropriate means to notify the affected
segments of the public. This will include, as practicable, publication
in the Federal Register, Broadcast Notice to Mariners and/or Local
Notice to Mariners. The Captain of the Port, Sector Lake Michigan,
will, as practicable, issue a Broadcast Notice to Mariners notifying
the public when any enforcement period is cancelled.
    Entry into, transiting, or anchoring within each of the proposed
safety zones is prohibited unless authorized by the Captain of the
Port, Sector Lake Michigan, or his or her designated representative.
All persons and vessels permitted to enter one of the safety zones
established by this proposed rule shall comply with the instructions of
the Captain of the Port, Sector Lake Michigan, or his or her designated
representative. The Captain of the Port, Sector Lake Michigan, or his
or her designated representative may be contacted via VHF Channel 16.

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This proposed 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. It is not ``significant''
under the regulatory policies and procedures of the Department of
Homeland Security (DHS). We conclude that this proposed rule is not a
significant regulatory action because we anticipate that it will have
minimal impact on the economy, will not interfere with other agencies,
will not adversely alter the budget of any grant or loan recipients,
and will not raise any novel legal or policy issues. The safety zones
created by this proposed rule will be relatively small and enforced for
a relatively short time. Also, each safety zone is designed to minimize
its impact on navigable waters. Furthermore, each safety zone has been
designed to allow vessels to transit unrestricted to portions of the
waterways not affected by the safety zones. Thus, restrictions on
vessel movements within that particular area are expected to be
minimal. Under certain conditions, moreover, vessels may still transit
through each safety zone when permitted by the Captain of the Port,
Sector Lake Michigan. On the whole, the Coast Guard expects
insignificant adverse impact to mariners from the activation of these
safety zones.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed 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 proposed
rule would not have a significant economic impact on a substantial
number of small entities. This proposed rule would affect the following
entities, some of which might be small entities: The owners and
operators of vessels intending to transit or anchor in any one of the
below established safety zones while the safety zone is being enforced.
These safety zones will not have a significant economic impact on a
substantial number of small entities for the following reasons: Each
safety zone in this proposed rule will be in effect for only a few
hours within any given 24 hour period. Each of the safety zones will be
in effect only once per year. Furthermore, these safety zones have been
designed to allow traffic to pass safely around each zone. Moreover,
vessels will be allowed to pass through each zone at the discretion of
the Captain of the Port, Sector Lake Michigan, or his or her designated
representative.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this rule would economically affect it.

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 proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. 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 BM1 Adam Kraft, Prevention
Department, Coast Guard Sector Lake Michigan, Milwaukee, WI at (414)
747-7154. The Coast Guard will not retaliate against small entities
that question or complain about this proposed rule or any policy or
action of the Coast Guard.

Collection of Information

    This proposed 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 a 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 proposed 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 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

Taking of Private Property

    This proposed rule will not affect the 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 proposed 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 proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This proposed rule is not an economically significant rule and
would not create an environmental risk to health or risk to safety that
might disproportionately affect children.

Indian Tribal Governments

    This proposed 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.

Energy Effects

    We have analyzed this proposed 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 procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed 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 made a preliminary determination that this action is one of a
category of actions that do not individually or cumulatively have a
significant effect on the human environment. A preliminary
environmental analysis checklist supporting this preliminary
determination is available in the docket where indicated under
ADDRESSES. This proposed rule involves the establishment,
disestablishment, and changing of safety zones, and thus, paragraph
34(g) of figure 2-1 in Commandant Instruction M16475.lD applies. We
seek any comments or information that may lead to the discovery of a
significant environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 165

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

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR Part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

    1. 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; Department of Homeland Security Delegation
No. 0170.1.

    2. Revise Sec.  165.929 to read as follows:

Sec.  165.929  Safety Zones; Annual events requiring safety zones in
the Captain of the Port Lake Michigan zone.

    (a) St. Patrick's Day Fireworks; Manitowoc, WI.
    (1) Location. All waters of the Manitowoc River and Manitowoc
Harbor, near the mouth of the Manitowoc River on the south shore,
within the arc of a circle with a 100-foot radius from the fireworks
launch site located in position 44[deg]05'30'' N, 087[deg]39'12'' W
(NAD 83).
    (i) Enforcement date and time. The third Saturday of March; 5:30
p.m. to 7 p.m.
    (2) [Reserved]
    (b) Michigan Aerospace Challenge Sport Rocket Launch; Muskegon, MI.
    (1) Location. All waters of Muskegon Lake, near the West Michigan
Dock and Market Corp facility, within the arc of a circle with a 1500-
yard radius from the rocket launch site located in position
43[deg]14'21'' N, 086[deg]15'35'' W (NAD 83).
    (2) Enforcement date and time. The last Saturday of April; 8 a.m.
to 4 p.m.
    (c) Tulip Time Festival Fireworks; Holland, MI.
    (1) Location. All waters of Lake Macatawa, near Kollen Park, within
the arc of a circle with a 1000-foot radius from the fireworks launch
site in position 42[deg]47'23'' N, 086[deg]07'22'' W (NAD 83).
    (i) Enforcement date and time. The first Friday of May; 7 p.m. to
11 p.m. If the Friday fireworks are cancelled due to inclement weather,
then this safety zone will be enforced on the first Saturday of May; 7
p.m. to 11 p.m.
    (2) [Reserved]
    (d) Rockets for Schools Rocket Launch; Sheboygan, WI.
    (1) Location. All waters of Lake Michigan and Sheboygan Harbor,
near the Sheboygan South Pier, within the arc of a circle with a 1500-
yard radius from the rocket launch site located with its center in
position 43[deg]44'55'' N, 087[deg]41'52'' W (NAD 83).
    (2) Enforcement date and time. The first Saturday of May; 8 a.m. to
5 p.m.
    (e) Celebrate De Pere; De Pere, WI.
    (1) Location. All waters of the Fox River, near Voyageur Park,
within the arc of a circle with a 500 foot radius from the fireworks
launch site located in position 44[deg]27'10'' N, 088[deg]03'50'' W
(NAD 83).
    (2) Enforcement date and time. The Sunday before Memorial Day; 8:30
p.m. to 10 p.m.
    (f) Michigan Super Boat Grand Prix; Michigan City, IN.
    (1) Location. All waters of Lake Michigan in the vicinity of
Michigan City, IN. bound by a line drawn from 41[deg]43'42'' N,
086[deg]54'18'' W; then north to 41[deg]43'49'' N, 086[deg]54'31'' W;
then east to 41[deg]44'48'' N, 086[deg]51'45'' W; then south to
41[deg]44'42'' N, 086[deg]51'31'' W; then west returning to the point
of origin. (NAD 83).
    (2) Enforcement date and time. The first Sunday of August; 9 a.m.
to 4 p.m.
    (g) River Splash; Milwaukee, WI.
    (1) Location. All waters of the Milwaukee River, near Pere
Marquette Park, within the arc of a circle with a 300-foot radius from
the fireworks

launch site located on a barge in position 43[deg]02'32'' N,
087[deg]54'45'' W (NAD 83).
    (2) Enforcement date and time. The first Friday and Saturday of
June; 9 p.m. to 11 p.m. each day.
    (h) International Bayfest; Green Bay, WI.
    (1) Location. All waters of the Fox River, near the Western Lime
Company 1.13 miles above the head of the Fox River, within the arc of a
circle with a 1000-foot radius from the fireworks launch site located
in position 44[deg]31'24'' N, 088[deg]00'42'' W (NAD 83).
    (2) Enforcement date and time. The second Friday of June; 9 p.m. to
11 p.m.
    (i) Harborfest Music and Family Festival; Racine, WI.
    (1) Location. All waters of Lake Michigan and Racine Harbor, near
the Racine Launch Basin Entrance Light, within the arc of a circle with
a 200-foot radius from the fireworks launch site located in position
42[deg]43'43'' N, 087[deg]46'40'' W (NAD 83).
    (2) Enforcement date and time. Friday and Saturday of the third
complete weekend of June; 9 p.m. to 11 p.m. each day.
    (j) Spring Lake Heritage Festival Fireworks; Spring Lake, MI.
    (1) Location. All waters of the Grand River, near buoy 14A, within
the arc of a circle with a 500-foot radius from the fireworks launch
site located on a barge in position 43[deg]04'24'' N, 086[deg]12'42'' W
(NAD 83).
    (2) Enforcement date and time. The third Saturday of June; 9 p.m.
to 11 p.m.
    (k) Elberta Solstice Festival Fireworks; Elberta, MI.
    (1) Location. All waters of Betsie Bay, near Waterfront Park,
within the arc of a circle with a 500-foot radius from the fireworks
launch site located in position 44[deg]37'43'' N, 086[deg]14'27'' W
(NAD 83).
    (2) Enforcement date and time. The last Saturday of June; 9 p.m. to
11 p.m.
    (l) Pentwater July Third Fireworks; Pentwater, MI.
    (1) Location. All waters of Lake Michigan and the Pentwater Channel
within the arc of a circle with a 1000-foot radius from the fireworks
launch site located in position 43[deg]46'57'' N, 086[deg]26'38'' W
(NAD 83).
    (2) Enforcement date and time. July 3; 9 p.m. to 11 p.m. If the
July 3 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 4; 9 p.m. to 11 p.m.
    (m) Taste of Chicago Fireworks; Chicago, IL.
    (1) Location. All waters of Monroe Harbor and all waters of Lake
Michigan bounded by a line drawn from 41[deg]53'24'' N, 087[deg]35'59''
W; then east to 41[deg]53'15'' N, 087[deg]35'26'' W; then south to
41[deg]52'49'' N, 087[deg]35'26'' W; then southwest to 41[deg]52'27''
N, 087[deg]36'37'' W; then north to 41[deg]53'15'' N, 087[deg]36'33''
W; then east returning to the point of origin (NAD 83).
    (2) Enforcement date and time. July 3; 9 p.m. to 11 p.m. If the
July 3 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 4; 9 p.m. to 11 p.m.
    (n) U.S. Bank Fireworks; Milwaukee, WI.
    (1) Location. All waters and adjacent shoreline of Milwaukee
Harbor, in the vicinity of Veteran's park, within the arc of a circle
with a 1200-foot radius from the center of the fireworks launch site
which is located on a barge with its approximate position located at
43[deg]02'22'' N, 087[deg]53'29'' W (NAD 83).
    (2) Enforcement date and time. July 3; 9 p.m. to 11 p.m. If the
July 3 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 4; 9 p.m. to 11 p.m.
    (o) Independence Day Fireworks; Manistee, MI.
    (1) Location. All waters of Lake Michigan, in the vicinity of the
First Street Beach, within the arc of a circle with a 1000-foot radius
from the fireworks launch site located in position 44[deg]14'51'' N,
086[deg]20'46'' W (NAD 83)
    (2) Enforcement date and time. July 3; 9 p.m. to 11 p.m. If the
July 3 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 4; 9 p.m. to 11 p.m.
    (p) Frankfort Independence Day Fireworks; Frankfort, MI.
    (1) Location. All waters of Lake Michigan and Frankfort Harbor,
bounded by a line drawn from 44[deg]38'05'' N, 086[deg]14'50'' W; then
south to 44[deg]37'39'' N, 086[deg]14'50'' W; then west to
44[deg]37'39'' N, 086[deg]15'20'' W; then north to 44[deg]38'05'' N,
086[deg]15'20'' W; then east returning to the point of origin (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (q) Freedom Festival Fireworks; Ludington, MI.
    (1) Location. All waters of Lake Michigan and Ludington Harbor, in
the vicinity of the Loomis Street Boat Ramp, within the arc of a circle
with a 1000-foot radius from the fireworks launch site located in
position 43[deg]57'16'' N, 086[deg]27'42'' W (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (r) White Lake Independence Day Fireworks; Montague, MI.
    (1) Location. All waters of White Lake, in the vicinity of the
Montague boat launch, within the arc of a circle with a 1000-foot
radius from the fireworks launch site located in position
43[deg]24'33'' N, 086[deg]21'28'' W (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (s) Muskegon Summer Celebration July Fourth Fireworks; Muskegon,
MI.
    (1) Location. All waters of Muskegon Lake, in the vicinity of
Heritage Landing, within the arc of a circle with a 1000-foot radius
from a fireworks launch site located on a barge in position
43[deg]14'00'' N, 086[deg]15'50'' W (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (3) Impact on Special Anchorage Area regulations: Regulations for
that portion of the Muskegon Lake East Special Anchorage Area, as
described in 33 CFR 110.81(b), which are overlapped by this regulation,
are suspended during this event. The remaining area of the Muskegon
Lake East Special Anchorage Area not impacted by this regulation
remains available for anchoring during this event.
    (t) Grand Haven Jaycees Annual Fourth of July Fireworks; Grand
Haven, MI.
    (1) Location. All waters of The Grand River between longitude
087[deg]14'00'' W, near The Sag, then west to longitude 087[deg]15'00''
W, near the west end of the south pier (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (u) Celebration Freedom Fireworks; Holland, MI.
    (1) Location. All waters of Lake Macatawa, in the vicinity of
Kollen Park, within the arc of a circle with a 1000-foot radius from
the fireworks launch site located in position 42[deg]47'23'' N,
086[deg]07'22'' W (NAD 83).
    (2) Enforcement date and time. July 4, 2007; 9 p.m. to 11 p.m.
Thereafter, this section will be enforced the Saturday prior to July 4;
9 p.m. to 11 p.m. If the fireworks are cancelled due to inclement
weather, then this safety zone will be enforced the Sunday prior to
July 4; 9 p.m. to 11 p.m.
    (v) Van Andel Fireworks Show; Holland, MI.

    (1) Location. All waters of Lake Michigan and the Holland Channel
within the arc of a circle with a 1000-foot radius from the fireworks
launch site located in position 42[deg]46'21'' N, 086[deg]12'48'' W
(NAD 83).
    (2) Enforcement date and time. July 3; 9 p.m. to 11 p.m. If the
July 3 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 4; 9 p.m. to 11 p.m.
    (w) Independence Day Fireworks; Saugatuck, MI.
    (1) Location. All waters of Kalamazoo Lake within the arc of a
circle with a 1000-foot radius from the fireworks launch site in
position 42[deg]38'52'' N, 086[deg]12'18'' W (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (x) South Haven Fourth of July Fireworks; South Haven, MI.
    (1) Location. All waters of Lake Michigan and the Black River
within the arc of a circle with a 1000-foot radius from the fireworks
launch site located in position 42[deg]24'08'' N, 086[deg]17'03'' W
(NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (y) St. Joseph Fourth of July Fireworks; St. Joseph, MI.
    (1) Location. All waters of Lake Michigan and the St. Joseph River
within the arc of a circle with a 1000-foot radius from the fireworks
launch site located in position 42[deg]06'48'' N, 086[deg]29'5'' W (NAD
83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (z) Town of Dune Acres Independence Day Fireworks; Dune Acres, IN.
    (1) Location. All waters of Lake Michigan within the arc of a
circle with a 1000-foot radius from the fireworks launch site located
in position 41[deg]39'23'' N, 087[deg]04'59'' W (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (aa) Gary Fourth of July Fireworks; Gary, IN.
    (1) Location. All waters of Lake Michigan, approximately 2.5 miles
east of Gary Harbor, within the arc of a circle with a 500-foot radius
from the fireworks launch site located in position 41[deg]37'19'' N,
087[deg]14'31'' W (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (bb) Joliet Independence Day Celebration Fireworks; Joliet, IL.
    (1) Location. All waters of the Des Plains River, at mile 288,
within the arc of a circle with a 500-foot radius from the fireworks
launch site located in position 41[deg]31'31'' N, 088[deg]05'15'' W
(NAD 83).
    (2) Enforcement date and time. July 3; 9 p.m. to 11 p.m. If the
July 3 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 4; 9 p.m. to 11 p.m.
    (cc) Glencoe Fourth of July Celebration Fireworks; Glencoe, IL.
    (1) Location. All waters of Lake Michigan, in the vicinity of Lake
Front Park, within the arc of a circle with a 500-foot radius from the
fireworks launch site located in position 42[deg]08'17'' N,
087[deg]44'55'' W (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (dd) Lakeshore Country Club Independence Day Fireworks; Glencoe,
IL.
    (1) Location. All waters of Lake Michigan within the arc of a
circle with a 1000-foot radius from the fireworks launch site located
in position 42[deg]08'27'' N, 087[deg]44'57'' W (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (ee) Shore Acres Country Club Independence Day Fireworks; Lake
Bluff, IL.
    (1) Location. All waters of Lake Michigan, approximately one mile
north of Lake Bluff, IL, within the arc of a circle with a 1000-foot
radius from the fireworks launch site located in position
42[deg]17'59'' N, 087[deg]50'03'' W (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (ff) Kenosha Independence Day Fireworks; Kenosha, WI.
    (1) Location. All waters of Lake Michigan and Kenosha Harbor within
the arc of a circle with a 1000-foot radius from the fireworks launch
site located in position 42[deg]35'17'' N, 087[deg]48'27'' W (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (gg) Fourthfest of Greater Racine Fireworks; Racine, WI.
    (1) Location. All waters of Lake Michigan and Racine Harbor, in the
vicinity of North Beach, within the arc of a circle with a 1000-foot
radius from the fireworks launch site located in position
42[deg]44'17'' N, 087[deg]46'42'' W (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (hh) Sheboygan Fourth of July Celebration Fireworks; Sheboygan, WI.
    (1) Location. All waters of Lake Michigan and Sheboygan Harbor, in
the vicinity of the south pier, within the arc of a circle with a 1000-
foot radius from the fireworks launch site located in position
43[deg]44'55'' N, 087[deg]41'51'' W (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (ii) Manitowoc Independence Day Fireworks; Manitowoc, WI.
    (1) Location. All waters of Lake Michigan and Manitowoc Harbor, in
the vicinity of south breakwater, within the arc of a circle with a
1000-foot radius from the fireworks launch site located in position
44[deg]05'24'' N, 087[deg]38'45'' W (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (jj) Sturgeon Bay Independence Day Fireworks; Sturgeon Bay, WI.
    (1) Location. All waters of Sturgeon Bay, in the vicinity of Sunset
Park, within the arc of a circle with a 1000-foot radius from the
fireworks launch site located on a barge in position 44[deg]50'37'' N,
087[deg]23'18'' W (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (kk) Fish Creek Independence Day Fireworks; Fish Creek, WI.
    (1) Location. All waters of Green Bay, in the vicinity of Fish
Creek Harbor, within the arc of a circle with a 1000-foot radius from
the fireworks launch site located on a barge in position 45[deg]07'52''
N, 087[deg]14'37'' W (NAD 83).
    (2) Enforcement date and time. The first Saturday after July 4; 9
p.m. to 11 p.m.
    (ll) Celebrate Americafest Fireworks; Green Bay, WI.

    (1) Location. All waters of the Fox River between the railroad
bridge located 1.03 miles above the mouth of the Fox River and the Main
Street Bridge located 1.58 miles above the mouth of the Fox River,
including all waters of the turning basin east to the mouth of the East
River.
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (mm) Marinette Fourth of July Celebration Fireworks; Marinette, WI.
    (1) Location. All waters of the Menominee River, in the vicinity of
Stephenson Island, within the arc of a circle with a 1000-foot radius
from the fireworks launch site located in position 45[deg]06'09'' N,
087[deg]37'39'' W and all waters located between the Highway U.S. 41
bridge and the Hattie Street Dam (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (nn) Evanston Fourth of July Fireworks; Evanston, IL.
    (1) Location. All waters of Lake Michigan, in the vicinity of
Centennial Park Beach, within the arc of a circle with a 500-foot
radius from the fireworks launch site located in position
42[deg]02'56'' N, 087[deg]40'21'' W (NAD 83).
    (2) Enforcement date and time. July 4; 9 p.m. to 11 p.m. If the
July 4 fireworks are cancelled due to inclement weather, then this
safety zone will be enforced July 5; 9 p.m. to 11 p.m.
    (oo) Muskegon Summer Celebration Fireworks; Muskegon,MI.
    (1) Location. All waters of Muskegon Lake, in the vicinity of
Heritage Landing, within the arc of a circle with a 1000-foot radius
from a fireworks barge located in position 43[deg]14'00'' N,
086[deg]15'50'' W (NAD 83).
    (2) Enforcement date and time. The Sunday following July 4; 9 p.m.
to 11 p.m.
    (3) Impact on Special Anchorage Area regulations. Regulations for
that portion of the Muskegon Lake East Special Anchorage Area, as
described in 33 CFR 110.81(b), which are overlapped by this regulation,
are suspended during this event. The remaining area of the Muskegon
Lake East Special Anchorage Area is not impacted by this regulation and
remains available for anchoring during this event.
    (pp) Gary Air and Water Show; Gary, IN.
    (1) Location. All waters of Lake Michigan bounded by a line drawn
from 41[deg]37'42'' N, 087[deg]16'38'' W; then east to 41[deg]37'54''
N, 087[deg]14'00'' W; then south to 41[deg]37'30'' N, 087[deg]13'56''
W; then west to 41[deg]37'17'' N, 087[deg]16'36'' W; then north
returning to the point of origin (NAD 83).
    (2) Enforcement date and time. Friday, Saturday, and Sunday of the
second weekend of July; from 10 a.m. to 9 p.m. each day.
    (qq) Milwaukee Air and Water Show; Milwaukee, WI.
    (1) Location. All waters and adjacent shoreline of Lake Michigan
and Bradford Beach located within a 4000-yard by 1000-yard rectangle.
The rectangle will be bounded by the points beginning at 43[deg]02'50''
N, 087[deg]52'36'' W; then northeast to 43[deg]04'33'' N,
087[deg]51'12'' W; then northwest to 43[deg]04'40'' N, 087[deg]51'29''
W; then southwest to 43[deg]02'57'' N, 087[deg]52'53'' W; the southeast
returning to the point of origin (NAD 83).
    (2) Enforcement date and time. Thursday, Friday, Saturday, and
Sunday of the first weekend of August; from 10 a.m. to 5 p.m. each day.
    (rr) Annual Trout Festival Fireworks; Kewaunee, WI.
    (1) Location. All waters of Kewaunee Harbor and Lake Michigan
within the arc of a circle with a 1000-foot radius from the fireworks
launch site located in position 44[deg]27'29'' N, 087[deg]29'45'' W
(NAD 83).
    (2) Enforcement date and time. Friday of the second complete
weekend of July; 9 p.m. to 11 p.m.
    (ss) Michigan City Summerfest Fireworks; Michigan City, IN.
    (1) Location. All waters of Michigan City Harbor and Lake Michigan
within the arc of a circle with a 1000-foot radius from the fireworks
launch site located in position 41[deg]43'42'' N, 086[deg]54'37'' W
(NAD 83).
    (2) Enforcement date and time. Sunday of the first complete weekend
of July; 9 p.m. to 11 p.m.
    (tt) Port Washington Fish Day Fireworks; Port Washington, WI.
    (1) Location. All waters of Port Washington Harbor and Lake
Michigan, in the vicinity of the WE Energies coal dock, within the arc
of a circle with a 1000-foot radius from the fireworks launch site
located in position 43[deg]23'07'' N, 087[deg]51'54'' W (NAD 83).
    (2) Enforcement date and time. The third Saturday of July; 9 p.m.
to 11 p.m.
    (uu) Bay View Lions Club South Shore Frolics Fireworks; Milwaukee,
WI.
    (1) Location. All waters of Milwaukee Harbor and Lake Michigan, in
the vicinity of South Shore Park, within the arc of a circle with a
500-foot radius from the fireworks launch site in position
42[deg]59'42'' N, 087[deg]52'52'' W (NAD 83).
    (2) Enforcement date and time. Friday, Saturday, and Sunday of the
second or third weekend of July; 9 p.m. to 11 p.m. each day.
    (vv) Venetian Festival Fireworks; St. Joseph, MI.
    (1) Location. All waters of Lake Michigan and the St. Joseph River,
near the east end of the south pier, within the arc of a circle with a
1000-foot radius from the fireworks launch site located in position
42[deg]06'48'' N, 086[deg]29'15'' W (NAD 83).
    (2) Enforcement date and time. Saturday of the third complete
weekend of July; 9 p.m. to 11 p.m.
    (ww) Joliet Waterway Daze Fireworks; Joliet, IL.
    (1) Location. All waters of the Des Plaines River, at mile 287.5,
within the arc of a circle with a 300-foot radius from the fireworks
launch site located in position 41[deg]31'15'' N, 088[deg]05'17'' W
(NAD 83).
    (2) Enforcement date and time. Friday and Saturday of the third
complete weekend of July; 9 p.m. to 11 p.m. each day.
    (xx) EAA Airventure; Oshkosh, WI.
    (1) Location. All waters of Lake Winnebago bounded by a line drawn
from 43[deg]57'30'' N, 088[deg]30'00'' W; then south to 43[deg]56'56''
N, 088[deg]29'53'' W; then east to 43[deg]56'40'' N, 088[deg]28'40'' W;
then north to 43[deg]57'30'' N, 088[deg]28'40'' W; then west returning
to the point of origin (NAD 83).
    (2) Enforcement date and time. The last complete week of July,
beginning Monday and ending Sunday; from 8 a.m. to 8 p.m. each day.
    (yy) Venetian Night Fireworks; Saugatuck, MI.
    (1) Location. All waters of Kalamazoo Lake within the arc of a
circle with a 500-foot radius from the fireworks launch site located on
a barge in position 42[deg]38'52'' N, 086[deg]12'18'' W (NAD 83).
    (2) Enforcement date and time. The last Saturday of July; 9 p.m. to
11 p.m.
    (zz) Roma Lodge Italian Festival Fireworks; Racine, WI.
    (1) Location. All waters of Lake Michigan and Racine Harbor within
the arc of a circle with a 1000-foot radius from the fireworks launch
site located in position 42[deg]44'04'' N, 087[deg]46'20'' W (NAD 83).
    (2) Enforcement date and time. Friday and Saturday of the last
complete weekend of July; 9 p.m. to 11 p.m.
    (aaa) Venetian Night Fireworks; Chicago, IL.
    (1) Location. All waters of Monroe Harbor and all waters of Lake
Michigan

bounded by a line drawn from 41[deg]53'03'' N, 087[deg]36'36'' W; then
east to 41[deg]53'03'' N, 087[deg]36'21'' W; then south to
41[deg]52'27'' N, 087[deg]36'21'' W; then west to 41[deg]52'27'' N,
087[deg]36'37'' W; then north returning to the point of origin (NAD
83).
    (2) Enforcement date and time. Saturday of the last weekend of
July; 9 p.m. to 11 p.m.
    (bbb) Port Washington Maritime Heritage Festival Fireworks; Port
Washington, WI.
    (1) Location. All waters of Port Washington Harbor and Lake
Michigan, in the vicinity of the WE Energies coal dock, within the arc
of a circle with a 1000-foot radius from the fireworks launch site
located in position 43[deg]23'07'' N, 087[deg]51'54'' W (NAD 83).
    (2) Enforcement date and time. Saturday of the last complete
weekend of July or the second weekend of August; 9 p.m. to 11 p.m.
    (ccc) Grand Haven Coast Guard Festival Fireworks; Grand Haven, MI.
    (1) Location. All waters of the Grand River between longitude
087[deg]14'00'' W, near The Sag, then west to longitude 087[deg]15'00''
W, near the west end of the south pier (NAD 83).
    (2) Enforcement date and time. First weekend of August; 9 p.m. to
11 p.m.
    (ddd) Sturgeon Bay Yacht Club Evening on the Bay Fireworks;
Sturgeon Bay, WI.
    (1) Location. All waters of Sturgeon Bay, in the vicinity of the
Sturgeon Bay Yacht Club, within the arc of a circle with a 500-foot
radius from the fireworks launch site located on a barge in position
44[deg]49'33'' N, 087[deg]22'26'' W (NAD 83).
    (2) Enforcement date and time. The first Saturday of August; 9 p.m.
to 11 p.m.
    (eee) Hammond Marina Venetian Night Fireworks; Hammond, IN.
    (1) Location. All waters of Hammond Marina and Lake Michigan within
the arc of a circle with a 1000-foot radius from the fireworks launch
site located in position 41[deg]41'53'' N, 087[deg]30'43'' W (NAD 83).
    (2) Enforcement date and time. The first Saturday of August; 9 p.m.
to 11 p.m.
    (fff) North Point Marina Venetian Festival Fireworks; Winthrop
Harbor, IL.
    (1) Location. All waters of Lake Michigan within the arc of a
circle with a 1000-foot radius from the fireworks launch site located
in position 42[deg]28'55'' N, 087[deg]47'56'' W (NAD 83).
    (2) Enforcement date and time. The second Saturday of August; 9
p.m. to 11 p.m.
    (ggg) Waterfront Festival Fireworks; Menominee, MI.
    (1) Location. All waters of Green Bay, in the vicinity of Menominee
Marina, within the arc of a circle with a 1000-foot radius from a
fireworks barge in position 45[deg]06'17'' N, 087[deg]35'48'' W (NAD
83).
    (2) Enforcement date and time. Saturday following first Thursday in
August; 9 p.m. to 11 p.m.
    (hhh) Ottawa Riverfest Fireworks; Ottawa, IL.
    (1) Location. All waters of the Illinois River, at mile 239.7,
within the arc of a circle with a 300-foot radius from the fireworks
launch site located in position 41[deg]20'29'' N, 088[deg]51'20'' W
(NAD 83).
    (2) Enforcement date and time. The first Sunday of August; 9 p.m.
to 11 p.m.
    (iii) Algoma Shanty Days Fireworks; Algoma, WI.
    (1) Location. All waters of Lake Michigan and Algoma Harbor within
the arc of a circle with a 1000-foot radius from the fireworks launch
site located in position 44[deg]36'24'' N, 087[deg]25'54'' W (NAD 83).
    (2) Enforcement date and time. Sunday of the second complete
weekend of August; 9 p.m. to 11 p.m.
    (jjj) New Buffalo Ship and Shore Festival Fireworks; New Buffalo,
MI.
    (1) Location. All waters of Lake Michigan and New Buffalo Harbor
within the arc of a circle with a 1000-foot radius from the fireworks
launch site located in position 41[deg]48'09'' N, 086[deg]44'49'' W
(NAD 83).
    (2) Enforcement date and time. The second Sunday of August; 9 p.m.
to 11 p.m.
    (kkk) Pentwater Homecoming Fireworks; Pentwater, MI.
    (1) Location. All waters of Lake Michigan and the Pentwater Channel
within the arc of a circle with a 1000-foot radius from the fireworks
launch site located in position 43[deg]46'56.5'' N, 086[deg]26'38'' W
(NAD 83).
    (2) Enforcement date and time. Saturday following the second
Thursday of August; 9 p.m. to 11 p.m.
    (lll) Chicago Air and Water Show; Chicago, IL.
    (1) Location. All waters and adjacent shoreline of Lake Michigan
and Chicago Harbor bounded by a line drawn from 41[deg]55'54'' N at the
shoreline, then east to 41[deg]55'54'' N, 087[deg]37'12'' W, then
southeast to 41[deg]54'00'' N, 087[deg]36'00'' W (NAD 83), then
southwestward to the northeast corner of the Jardine Water Filtration
Plant, then due west to the shore.
    (2) Enforcement date and time. The third Thursday, Friday,
Saturday, and Sunday of August; from 9 a.m. to 6 p.m. each day.
    (mmm) Downtown Milwaukee BID 21 Fireworks; Milwaukee, WI.
    (1) Location. All waters of the Milwaukee River between the
Kilbourn Avenue Bridge at 1.7 miles above the Milwaukee Pierhead Light
to the State Street Bridge at 1.79 miles above the Milwaukee Pierhead
Light.
    (2) Enforcement date and time. The third Thursday of November; 6
p.m. to 8 p.m.
    (nnn) New Year's Eve Fireworks; Chicago, IL.
    (1) Location. All waters of Monroe Harbor and Lake Michigan within
the arc of a circle with a 1000-foot radius from the fireworks launch
site located on a barge in position 41[deg]52'41'' N, 087[deg]36'37'' W
(NAD 83).
    (2) Enforcement date and time. December 31; 11 p.m. to January 1; 1
a.m.
    (ooo) Cochrane Cup; Blue Island, IL.
    (1) Location. All waters of the Calumet Saganashkee Channel from
the South Halstead Street Bridge at 41[deg]39'27'' N, 087[deg]38'29''
W; to the Crawford Avenue Bridge at 41[deg]39'05'' N, 087[deg]43'08''
W; and the Little Calumet River from the Ashland Avenue Bridge at
41[deg]39'7'' N, 087[deg]39'38'' W; to the junction of the Calumet
Saganashkee Channel at 41[deg]39'23'' N, 087[deg]39'00'' W (NAD 83).
    (2) Enforcement date and time. The first Saturday of May; 6:30 a.m.
to 5 p.m.
    (ppp) World War II Beach Invasion Re-enactment; St. Joseph, MI.
    (1) Location. All waters of Lake Michigan in the vicinity of
Tiscornia Park in St. Joseph, MI beginning at 42[deg]06'55'' N,
086[deg]29'23'' W; then west/northwest along the north breakwater to
42[deg]06'59'' N, 086[deg]29'41'' W; then northwest 100 yards to
42[deg]07'01'' N, 086[deg]29'44'' W; then northeast 2,243 yards to
42[deg]07'50'' N, 086[deg]28'43'' W; then southeast to the shoreline at
42[deg]07'39'' N, 086[deg]28'27'' W; then southwest along the shoreline
to the point of origin (NAD 83).
    (2) Enforcement date and time. The third Saturday of June; 8 a.m.
to 2 p.m.
    (qqq) Ephraim Fireworks; Ephraim, WI.
    (1) Location. All waters of Eagle Harbor and Lake Michigan within
the arc of a circle with a 750-foot radius from the fireworks launch
site located on a barge in position 45[deg]09'18'' N, 087[deg]10'51'' W
(NAD 83).
    (2) Enforcement date and time. The third Saturday of June; 9 p.m.
to 11 p.m.
    (rrr) Thunder on the Fox; Elgin, IL.
    (1) Location. All waters of the Fox River, near Elgin, Illinois,
between Owasco Avenue, located at approximate position 42[deg]03'06''
N, 088[deg]17'28'' W and the Kimball Street bridge, located at

approximate position 42[deg]02'31'' N, 088[deg]17'22'' W (NAD 83).
    (2) Enforcement date and time. Friday, Saturday, and Sunday of the
third weekend in June; 10 a.m. to 7 p.m. each day.
    (i) Definitions. The following definitions apply to this section:
    (A) Designated representative means any Coast Guard commissioned,
warrant, or petty officer designated by the Captain of the Port, Sector
Lake Michigan, to monitor a safety zone, permit entry into a zone, give
legally enforceable orders to persons or vessels within a safety zone,
and take other actions authorized by the Captain of the Port, Sector
Lake Michigan.
    (B) Public vessel means a vessel that is owned, chartered, or
operated by the United States, or by a State or political subdivision
thereof.
    (ii) Regulations.
    (A) The general regulations in 33 CFR 165.23 apply.
    (B) All persons and vessels must comply with the instructions of
the Captain of the Port, Sector Lake Michigan, or his or her designated
representative. Upon being hailed by the U.S. Coast Guard by siren,
radio, flashing light or other means, the operator of a vessel shall
proceed as directed.
    (C) All vessels must obtain permission from the Captain of the
Port, Sector Lake Michigan, or his or her designated representative to
enter, move within or exit a safety zone established in this section
when the safety zone is enforced. Vessels and persons granted
permission to enter one of the safety zones listed in this section
shall obey all lawful orders or directions of the Captain of the Port,
Sector Lake Michigan, or his or her designated representative. While
within a safety zone, all vessels shall operate at the minimum speed
necessary to maintain a safe course.
    (iii) Suspension of Enforcement. If the Captain of the Port, Sector
Lake Michigan, suspends enforcement of any of these zones earlier than
listed in this section, the Captain of the Port, Sector Lake Michigan,
or his or her designated representative will notify the public by
suspending the respective Broadcast Notice to Mariners.
    (iv) Exemption. Public vessels, as defined in paragraph (b) of this
section, are exempt from the requirements in this section.
    (v) Waiver. For any vessel, the Captain of the Port, Sector Lake
Michigan, or his or her designated representative may waive any of the
requirements of this section, upon finding that operational conditions
or other circumstances are such that application of this section is
unnecessary or impractical for the purposes of safety or environmental
safety.

    Dated: May 5, 2011.
L. Barndt,
Captain, U.S. Coast Guard, Captain of the Port, Sector Lake Michigan.
[FR Doc. 2011-12374 Filed 5-23-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 101 (Wednesday, May 27, 2015)]
[Notices]
[Pages 30314-30315]
[FR Doc No: 2015-12685]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736

Extension:
    Rule 23c-3 and Form N-23c-3, OMB Control No. 3235-0422, SEC File
No. 270-373.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et. seq.), the Securities and Exchange
Commission (the ``Commission'') is soliciting comments on the
collection of information summarized below. The Commission plans to
submit this existing collection of information to the Office of
Management and Budget (``OMB'') for extension and approval.
    Rule 23c-3 (17 CFR 270.23c-3) under the Investment Company Act of
1940 (15 U.S.C. 80a-1 et seq.) permits a registered closed-end
investment company (``closed-end fund'' or ``fund'') that meets certain
requirements to repurchase common stock of which it is the issuer from
shareholders at periodic intervals, pursuant to repurchase offers made
to all holders of the stock. The rule enables these funds to offer
their shareholders a limited ability to resell their shares in a manner
that previously was available only to open-end investment company
shareholders. To protect shareholders, a closed-end fund that relies on
rule 23c-3 must send shareholders a notification that contains
specified information each time the fund makes a repurchase offer (on a
quarterly, semi-annual, or annual basis, or, for certain funds, on a
discretionary basis not more often than every two years). The fund also
must file copies of the shareholder notification with the Commission
(electronically through the Commission's Electronic Data Gathering,
Analysis, and Retrieval System (``EDGAR'')) on Form N-23c-3, a filing
that provides certain information about the fund and the type of offer
the fund is making.\1\ The fund must describe in its annual report to
shareholders the fund's policy concerning repurchase offers and the
results of any repurchase offers made during the reporting period. The
fund's board of directors must adopt written procedures designed to
ensure that the fund's investment portfolio is sufficiently liquid to
meet its repurchase obligations and other obligations under the rule.
The board periodically must review the composition of the fund's
portfolio and change the liquidity procedures as necessary. The fund
also must file copies of advertisements and other sales literature with
the Commission as if it were an open-end investment company subject to
section 24 of the Investment Company Act (15 U.S.C. 80a-24) and the
rules that implement section 24. Rule 24b-3 under the Investment
Company Act (17 CFR 270.24b-3), however, exempts the fund from that
requirement if the materials are filed instead with the Financial
Industry Regulatory Authority (``FINRA'').
---------------------------------------------------------------------------

    \1\ Form N-23c-3, entitled ``Notification of Repurchase Offer
Pursuant to Rule 23c-3,'' requires the fund to state its
registration number, its full name and address, the date of the
accompanying shareholder notification, and the type of offer being
made (periodic, discretionary, or both).
---------------------------------------------------------------------------

    The requirement that the fund send a notification to shareholders
of each offer is intended to ensure that a fund provides material
information to shareholders about the terms of each offer. The
requirement that copies be sent to the Commission is intended to enable
the Commission to monitor the fund's compliance with the notification
requirement. The requirement that the shareholder notification be
attached to Form N-23c-3 is intended to ensure that the fund provides
basic information necessary for the Commission to process the
notification and to monitor the fund's use of repurchase offers. The
requirement that the fund describe its current policy on repurchase
offers and the results of recent offers in the annual shareholder
report is intended to provide shareholders current information about
the fund's repurchase policies and its recent experience. The
requirement that the board approves and review written procedures
designed to maintain portfolio liquidity is intended to ensure that the
fund has enough cash or liquid securities to meet its repurchase
obligations, and that written procedures are available for review by
shareholders and examination by the Commission. The requirement that
the fund file advertisements and sales literature as if it were an
open-end fund is intended to facilitate the review

of these materials by the Commission or FINRA to prevent incomplete,
inaccurate, or misleading disclosure about the special characteristics
of a closed-end fund that makes periodic repurchase offers.
    Based on staff experience, the Commission staff estimates that 21
funds make use of rule 23c-3 annually, including six funds that are
relying upon rule 23c-3 for the first time. The Commission staff
estimates that on average a fund spends 89 hours annually in complying
with the requirements of the rule and Form N-23c-3, with funds relying
upon rule 23c-3 for the first time incurring an additional one-time
burden of 28 hours. The Commission therefore estimates the total annual
burden of the rule's and form's paperwork requirements to be 2,037
hours. In addition to the burden hours, the Commission estimates that
the average yearly cost to each fund that relies on rule 23c-3 to print
and mail repurchase offers to shareholders is approximately $29,966.50.
The Commission estimates total annual cost is therefore approximately
$629,297.
    Estimates of average burden hours and costs are made solely for the
purposes of the Paperwork Reduction Act and are not derived from a
comprehensive or even representative survey or study of the costs of
Commission rules and forms. Compliance with the collection of
information requirements of the rule and form is mandatory only for
those funds that rely on the rule in order to repurchase shares of the
fund. The information provided to the Commission on Form N-23c-3 will
not be kept confidential. An agency may not conduct or sponsor, and a
person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number.
    Written comments are invited on: (a) Whether the proposed
collections of information are necessary for the proper performance of
the functions of the agency, including whether the information has
practical utility; (b) the accuracy of the agency's estimate of the
burdens of the collections of information; (c) ways to enhance the
quality, utility, and clarity of the information collected; and (d)
ways to minimize the burdens of the collections of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    Please direct your written comments to Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, C/O Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email
to<EMAIL_ADDRESS>
    Dated: May 20, 2015.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-12685 Filed 5-26-15; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 195 (Friday, October 7, 2011)]
[Notices]
[Pages 62429-62431]
[FR Doc No: 2011-25978]

-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2011-0015]

Agency Information Collection Activities: Proposed Collection;
Comment Request, OMB No. 1660-0002; Disaster Assistance Registration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a proposed revision of a currently approved information
collection. In accordance with the Paperwork Reduction Act of 1995,
this notice seeks comments concerning the Disaster Assistance
Registration process.

DATES: Comments must be submitted on or before December 6, 2011.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at http://www.regulations.gov under
Docket ID FEMA-2011-0015. Follow the instructions for submitting
comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street, SW., Room 835, Washington, DC
20472-3100.
    (3) Facsimile. Submit comments to<PHONE_NUMBER>.
    (4) E-mail. Submit comments to<EMAIL_ADDRESS>Include Docket
ID FEMA-2011-0015 in the subject line.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: John Quintanilla, Supervisory Program
Specialist, FEMA, Recovery Directorate,<PHONE_NUMBER> for additional
information. You may contact the Records Management Division for copies
of the proposed collection of information at facsimile number (202)
646-3347 or e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Robert T. Stafford Disaster Relief and
Emergency Assistance Act (Pub. L. 93-288) (the Stafford Act), as
amended, is the legal basis for the Federal Emergency Management Agency
(FEMA) to provide financial needs and services to individuals who apply
for disaster assistance benefits in the event of a federally declared
disaster. Regulations in title 44 Code of Federal Regulations (CFR),
Subpart D, ``Federal Assistance to Individuals and Households'',
implement the policy and procedures set forth in section 408 of the
Stafford Act, 42 U.S.C. 5174, as amended. This program provides
financial assistance and, if necessary, direct assistance to eligible
individuals and households who, as a direct result of a major disaster,
have uninsured or under-insured, damage, necessary expenses, and
serious needs which are not covered through other means.
    Individuals and households may apply for assistance under the
Individuals and Households program via telephone or Internet. FEMA
utilizes paper forms 009-0-1 (English) Disaster Assistance Registration
or FEMA Form 009-0-2 (Spanish), Solicitud/Registro Para Asistencia De
Resastre to register individuals.
    FEMA provides direct assistance to eligible applicants pursuant to
the requirements in 44 CFR 206.117. To receive direct assistance for
housing (e.g., mobile home or travel trailer) from FEMA, the applicant
is required to acknowledge and accept the conditions for occupying
government property. The form used is the Declaration and Release; FEMA
Form 009-0-4, or the Declaraci[oacute]n Y Autorizaci[oacute]n; FEMA
Form 009-0-5 Receipt for Government Property. In addition, the
applicant is required to acknowledge that he or she has been informed
of the conditions for continued direct housing assistance. To
accomplish these notifications, FEMA uses the applicant's household
composition data in National Emergency Management Information System
NEMIS to prepare a Receipt for Government Property FEMA Form 009-0-5,
or Recibo de Propiedad del Gobierno FEMA Form 009-0-6.
    Federal public benefits are to be provided to U.S. citizens, non-
citizen nationals, or qualified aliens. A parent or guardian of a minor
child may be eligible for disaster assistance if the

minor child is a U.S. citizen, non-citizen national, or qualified
alien, and the minor child lives with the parent or guardian. See 8
U.S.C. 1601-1646.
    By signing FEMA Forms 009-0-3, Declaration and Release or 009-0-4,
Declaraci[oacute]n Y Autorizaci[oacute]n an applicant or a member of
the applicant's household is attesting to being a U.S. citizen, non-
citizen national, or qualified alien. A parent or guardian of a minor
child signing FEMA Forms 009-0-3, Declaration and Release or 009-0-4,
Declaraci[oacute]n Y Autorizaci[oacute]n is attesting that the minor
child is a U.S. citizen, non-citizen national, or qualified alien.

Collection of Information

    Title: Disaster Assistance Registration.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0002.
    Form Titles and Numbers: FEMA Form 009-0-1T (English) Tele-
Registration, Disaster Assistance Registration; FEMA Form 009-0-1Int
(English) Internet, Disaster Assistance Registration; FEMA Form 009-0-
2Int (Spanish) Internet, Registro Para Asistencia De Desastre; FEMA
Form 009-0-1 (English) Paper Application/Disaster Assistance
Registration; FEMA Form 009-0-2 (Spanish), Solicitud en Papel/Registro
Para Asistencia De Desastre; FEMA Form 009-0-1S (English) Smartphone,
Disaster Assistance Registration; FEMA Form 009-0-2S (Spanish)
Smartphone, Registro Para Asistencia De Desastre; FEMA Form 009-0-3
(English), Declaration and Release; FEMA Form 009-0-4 (Spanish),
Declaraci[oacute]n Y Autorizaci[oacute]n; FEMA Form 009-0-5 (English)
Receipt for Government Property; FEMA Form 009-0-6 (Spanish) Recibo de
la Propiedad del Gobierno.
    Abstract: The Disaster Assistance Registration form is used to
collect pertinent information to provide financial assistance, and if
necessary, direct assistance to eligible individuals and households
who, as a direct result of a disaster or emergency, have uninsured or
under-insured, necessary or serious expenses that they are unable to
meet through other means.
    Affected Public: Individuals or Households.
    Estimated Total Annual Burden Hours: 555,009 hours.

                                                                           Estimated Annualized Burden Hours and Costs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                      Avg. burden    Total annual
              Type of respondent                     Form name/form number          Number of     responses per   Total number    per response     burden  (in     Avg. hourly     Total annual
                                                                                respondents     respondent     of responses     (in hours)        hours)         wage rate    respondent cost
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Individuals or Households....................  Tele-Registration Application          1,151,255               1       1,151,255             0.3         345,377          $30.66      $10,589,258
                                                for Disaster Assistance                                                              (18 mins.)
                                                (English)/FEMA Forms 009-0-1T.
Individuals or Households....................  Internet Application for              323,039.80               1      323,039.80             0.3          96,912           30.66     2,971,321.90
                                                Disaster Assistance (English                                                         (18 mins.)
                                                and Spanish)/FEMA Forms 009-0-
                                                1Int and 009-0-2Int.
Individuals or Households....................  Paper Application for Disaster            51,549               1          51,549             0.3          15,465           30.66       474,156.90
                                                Assistance (English and                                                              (18 mins.)
                                                Spanish)/FEMA Forms 009-0-1 and
                                                009-0-2.
Individuals or Households....................  Smartphone Application for            192,447.20               1      192,447.20              .3          57,734           30.66     1,770,124.40
                                                Disaster Assistance/FEMA Forms                                                       (18 mins.)
                                                (English and Spanish) 009-0-1S
                                                and 009-0-2S.
Individuals or Households....................  Declaration and Release (English       1,099,706               1       1,099,706            .033          36,657           30.66     1,123,903.60
                                                and Spanish)/FEMA Forms 009-0-3                                                       (2 mins.)
                                                and 009-0-4.
Individuals or Households....................  Receipt of Government Property            17,183               1          17,183              .1           2,864           30.66        87,810.24
                                                (English and Spanish)/FEMA Form                                                       (10 mins)
                                                009-0-5 and 009-0-6.
                                              --------------------------------------------------------------------------------------------------------------------------------------------------
    Total....................................  ................................       2,835,180  ..............       2,835,180  ..............         555,009  ..............    17,016,572.24
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Estimated Cost: There are no operation and maintenance, or capital
and start-up costs associated with this collection of information.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of

information, including the validity of the methodology and assumptions
used; (c) enhance the quality, utility, and clarity of the information
to be collected; and (d) minimize the burden of the collection of
information on those who are to respond, including through the use of
appropriate automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology, e.g.,
permitting electronic submission of responses.

    Dated: September 30, 2011.
Lesia M. Banks,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2011-25978 Filed 10-6-11; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 80, Number 80 (Monday, April 27, 2015)]
[Notices]
[Pages 23270-23271]
[FR Doc No: 2015-09782]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9926-84-OA]

Request for Nominations of Candidates to the EPA's Science
Advisory Board (SAB)

AGENCY: Environmental Protection Agency.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The U.S. Environmental Protection Agency (EPA) invites
nominations of scientific experts from a diverse range of disciplines
to be considered for appointment to the Science Advisory Board (SAB)
and six SAB committees described in this notice. Appointments are
anticipated to be filled by the start of Fiscal Year 2016 (October
2015).

DATES: Nominations should be submitted in time to arrive no later than
May 27, 2015.

FOR FURTHER INFORMATION CONTACT: Nominators unable to submit
nominations electronically as described below may submit a paper copy
to the Designated Federal Officers for the committees, as identified
below. General inquiries regarding the work of the SAB or SAB
committees may also be directed to the designated DFOs.
    Background: The SAB is a chartered Federal Advisory Committee,
established in 1978 under the authority of the Environmental Research,
Development and Demonstration Authorization Act (ERDDAA), codified at
42 U.S.C. 4365, to provide independent scientific and technical peer
review, consultation, advice and recommendations to the EPA
Administrator on the scientific bases for EPA's actions and programs.
Members of the SAB constitute a distinguished body of non-EPA
scientists, engineers, economists, and behavioral and social scientists
who are nationally and internationally recognized experts in their
respective fields. Members are appointed by the EPA Administrator for a
3-year term. Additional information about the SAB is available at
http://www.epa.gov/sab.
    Expertise Sought for the SAB: The chartered SAB provides strategic
advice to the EPA Administrator on a variety of EPA science and
research programs. All the work of SAB committees and panels is under
the direction of the chartered SAB. The chartered SAB reviews all SAB
committee and panel draft reports and determines whether they are
appropriate to send to the EPA Administrator. The SAB Staff Office is
seeking nominations of experts to serve on the chartered SAB in the
following disciplines as they relate to human health and the
environment: Analytical chemistry; ecological sciences and ecological
assessment; economics; engineering; geochemistry; health disparities;
health sciences; hydrology; hydrogeology; medicine; microbiology;
modeling; pediatrics; public health; risk assessment; social,
behavioral and decision sciences; statistics; and toxicology.
    The SAB Staff Office is especially interested in scientists with
expertise described above who have knowledge and experience in air
quality; agricultural sciences; climate change; drinking water; energy
and the environment; water quality; water quantity; water reuse;
ecosystem services; community environmental health; sustainability;
chemical safety; green chemistry; human health risk assessment;
homeland security; and waste and waste management.
    For further information about the chartered SAB membership
appointment process and schedule, please contact Mr. Thomas Carpenter,
DFO, by telephone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>    The SAB Staff Office is also seeking nominations for experts for
six SAB committees: The Chemical Assessment Advisory Committee; the
Drinking Water Committee; the Ecological Processes and Effects
Committee; the Environmental Economics Advisory Committee; the
Environmental Engineering Committee; and the Radiation Advisory
Committee.
    (1) The SAB Chemical Assessment Advisory Committee (CAAC) provides
advice through the chartered SAB regarding selected toxicological
reviews of environmental chemicals available on EPA's Integrated Risk
Information System (IRIS). The SAB Staff Office is seeking nominations
of experts with experience in chemical assessments. Members should have
expertise in one or more of the following disciplines: Public health;
epidemiology; toxicology, including neurotoxicology, developmental/
reproductive toxicology, and inhalation toxicology; carcinogenesis;
PBPK modeling; biostatistics; risk assessment; and health disparities.
For further information about the CAAC membership appointment process
and schedule, please contact Dr. Suhair Shallal, DFO, by telephone at
202-564-2057 or by email at<EMAIL_ADDRESS>    (2) The SAB Drinking Water Committee (DWC) provides advice on the
scientific and technical aspects of EPA's national drinking water
program. The SAB Staff Office is seeking nominations of experts with
experience on drinking water issues. Members should have expertise in
one or more of the following disciplines: Environmental chemistry;
environmental engineering; epidemiology; microbiology; public health;
risk assessment; and toxicology. For further information about the DWC
membership appointment process and schedule, please contact Ms. Iris
Goodman, DFO, by telephone at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>    (3) The SAB Ecological Processes and Effects Committee (EPEC)
provides advice on science and research to assess, protect and restore
the health of ecosystems. The SAB Staff Office is seeking nominations
of experts with demonstrated expertise in the following disciplines:
Aquatic ecology; marine and estuarine ecology; ecological risk
assessment; ecotoxicology; systems ecology; and statistics. For further
information about the EPEC membership appointment process and schedule,
please contact Dr. Thomas Armitage, DFO, by telephone at<PHONE_NUMBER>
or by email at<EMAIL_ADDRESS>    (4) The SAB Environmental Economics Advisory Committee (EEAC)
provides advice on methods and analyses related to economics, costs,

and benefits of EPA environmental programs. The SAB Staff Office is
cseeking nominations of experts in environmental economics to serve on
the EEAC. In particular, expertise will be sought in the following
areas: Eonomic approaches for health risk valuation, e.g., stated
preference approaches, hedonic analyses, averting behavior analyses,
and/or cost of illness approaches; meta-analytic approaches to
assessing and aggregating valuation estimates, e.g., expertise in meta-
regression models; and approaches for treating uncertainty in benefit
cost analyses, particularly for health risks. For further information
about the EEAC membership appointment process and schedule, please
contact Dr. Holly Stallworth, DFO, by telephone at<PHONE_NUMBER> or by
email at<EMAIL_ADDRESS>    (5) The SAB Environmental Engineering Committee (EEC) provides
advice on risk management technologies to control and prevent
pollution. The SAB Staff Office is seeking nominations of experts in
chemical fate and transport; chemical engineering; civil engineering;
environmental engineering; environmental system modeling; and
wastewater treatment systems to serve on the EEC. For further
information about the EEC membership appointment process and schedule,
please contact Mr. Edward Hanlon, DFO, by telephone at<PHONE_NUMBER> or
by email at<EMAIL_ADDRESS>    (6) The Radiation Advisory Committee (RAC) provides advice on
radiation protection, radiation science, and radiation risk assessment.
The SAB Staff Office is seeking nominations of experts to serve on the
RAC with demonstrated expertise in the following disciplines: Fate and
transport of radionuclides; nuclear waste remediation; radiation
biostatistics; radiation dosimetry; and radiation exposure. For further
information about the RAC membership appointment process and schedule,
please contact Mr. Edward Hanlon, DFO, by telephone at<PHONE_NUMBER> or
by email at<EMAIL_ADDRESS>    Selection Criteria for the SAB and six SAB Committees includes:
    --Demonstrated scientific credentials and disciplinary expertise in
relevant fields;
    --Willingness to commit time to the committee and demonstrated
ability to work constructively and effectively on committees;
    --Background and experiences that would help members contribute to
the diversity of perspectives on the committee, e.g., geographic,
economic, social, cultural, educational backgrounds, professional
affiliations; and other considerations; and
    --For the committee as a whole, consideration of the collective
breadth and depth of scientific expertise; and a balance of scientific
perspectives.
    As these committees undertake specific advisory activities, the SAB
Staff Office will consider two additional criteria for each new
activity: Absence of financial conflicts of interest and absence of an
appearance of a loss of impartiality.
    How to Submit Nominations: Any interested person or organization
may nominate qualified persons to be considered for appointment to
these advisory committees. Individuals may self-nominate. Nominations
should be submitted in electronic format (preferred) following the
instructions for ``Nominating Experts for Annual Membership'' provided
on the SAB Web site. The form can be accessed through the ``Nomination
of Experts'' link on the blue navigational bar on the SAB Web site at
http://www.epa.gov/sab. To be considered, all nominations should
include the information requested. EPA values and welcomes diversity.
In an effort to obtain nominations of diverse candidates, EPA
encourages nominations of women and men of all racial and ethnic
groups.
    Nominators are asked to identify the specific committee for which
nominees are to be considered. The following information should be
provided on the nomination form: Contact information for the person
making the nomination; contact information for the nominee; the
disciplinary and specific areas of expertise of the nominee; the
nominee's curriculum vitae; and a biographical sketch of the nominee
indicating current position, educational background; research
activities; sources of research funding for the last 2 years; and
recent service on other national advisory committees or national
professional organizations. To help the agency evaluate the
effectiveness of its outreach efforts, please indicate how you learned
of this nomination opportunity. Persons having questions about the
nomination process or the public comment process described below, or
who are unable to submit nominations through the SAB Web site, should
contact the Designated Federal Officer for the committee, as identified
above. The DFO will acknowledge receipt of nominations and in that
acknowledgement will invite the nominee to provide any additional
information that the nominee feels would be useful in considering the
nomination, such as availability to participate as a member of the
committee; how the nominee's background, skills and experience would
contribute to the diversity of the committee; and any questions the
nominee has regarding membership. The names and biosketches of
qualified nominees identified by respondents to this Federal Register
notice, and additional experts identified by the SAB Staff, will be
posted in a List of Candidates on the SAB Web site at http://www.epa.gov/sab. Public comments on this List of Candidates will be
accepted for 21 days from the date the list is posted. The public will
be requested to provide relevant information or other documentation on
nominees that the SAB Staff Office should consider in evaluating
candidates.
    Candidates invited to serve will be asked to submit the
``Confidential Financial Disclosure Form for Special Government
Employees Serving on Federal Advisory Committees at the U.S.
Environmental Protection Agency'' (EPA Form 3110-48). This confidential
form allows EPA to determine whether there is a statutory conflict
between that person's public responsibilities as a Special Government
Employee and private interests and activities, or the appearance of a
loss of impartiality, as defined by Federal regulation. The form may be
viewed and downloaded through the ``Ethics Requirements for Advisors''
link on the blue navigational bar on the SAB Web site at http://www.epa.gov/sab. This form should not be submitted as part of a
nomination.

    Dated: April 20, 2015.
Thomas H. Brennan,
Deputy Director, EPA Science Advisory Board Staff Office.
[FR Doc. 2015-09782 Filed 4-24-15; 8:45 am]
 BILLING CODE 6560-50-P