[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Notices]
[Pages 70833-70835]
[FR Doc No: 2022-25274]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0656]

Animal Drug User Fee Act; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``Animal Drug User Fee
Act.'' The purpose of the public meeting is to discuss the proposed
recommendations for the reauthorization of the Animal Drug User Fee Act
(ADUFA V) for fiscal years 2024 through 2028.

DATES: The public meeting will be held virtually on December 7, 2022,
from 1 p.m. to 3 p.m. Eastern Time. Either electronic or written
comments on this public meeting must be submitted by December 19, 2022.
See the SUPPLEMENTARY INFORMATION section for registration date and
further information.

ADDRESSES: The public meeting will be hosted via a live virtual
webcast.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of December 19, 2022. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are received on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2011-N-0656 for ``Animal Drug User Fee Act; Public Meeting; Request
for Comments.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as

``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    Transcripts of the meeting will be available on FDA's website at
https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings approximately 30 days after the meeting.

FOR FURTHER INFORMATION CONTACT: Lisa Kable, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a virtual public meeting to discuss proposed
recommendations for the reauthorization of ADUFA, which authorizes FDA
to collect user fees and use them for the process of reviewing new
animal drug applications and associated submissions. The authority for
ADUFA expires September 30, 2023. Without new legislation, FDA will no
longer have the authority to collect user fees to fund the new animal
drug review process for future fiscal years. Section 740A(d)(4) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-13(d)(4)) requires
that, after holding negotiations with regulated industry and periodic
consultations with stakeholder, and before transmitting the Agency's
final recommendation to Congress for the reauthorized program (ADUFA
V), we do the following: (1) present the recommendation to the relevant
Congressional committees, (2) publish such recommendations in the
Federal Register, (3) provide for a period of 30 days for the public to
provide written comments on such recommendations, (4) hold a meeting at
which the public may present its views on such recommendations, and (5)
consider such public views and comments and revise such recommendations
as necessary. This notice, the 30-day comment period, and the public
meeting will satisfy certain of these requirements. After the public
meeting, we will revise the draft recommendations as necessary. In
addition, the Agency will present the draft recommendations to the
Congressional committees.
    FDA considers the timely review of the safety and effectiveness of
new animal drug applications (NADAs) to be central to the Agency's
mission to protect and promote human and animal health. Prior to 2004,
the timeliness and predictability of the new animal drug review program
was a concern. The Animal Drug User Fee Act of 2003 (Pub. L. 108-130;
hereinafter referred to as ``ADUFA I'') authorized FDA to collect user
fees dedicated to the timely review of new animal drug applications in
accordance with certain performance goals and to expand and modernize
the new animal drug review program from fiscal year (FY) 2004 to 2008.
The Agency agreed, under ADUFA I, to meet a comprehensive set of
performance goals established to show significant improvement in the
timeliness and predictability of the new animal drug review process.
The implementation of ADUFA I provided a significant funding increase
that enabled FDA to increase the number of staff dedicated to the new
animal drug application review process by 30 percent in ADUFA I.
    With the reauthorization of ADUFA for an additional 5 years under
ADUFA II (FY 2009 to FY 2013), FDA agreed to further enhance and
improve the review process. ADUFA II performance goals were established
based on ADUFA I FY 2008 review timeframes. In addition, FDA provided
program enhancements to reduce review cycles and improve communications
during reviews. The ADUFA programs have enabled FDA to meet performance
timeframes for application review for new animal drugs without
compromising the quality of the Agency's review.
    The ADUFA III reauthorization (FY 2014 to FY 2018) maintained the
FY 2013 review timeframes for key submissions in addition to
enhancements to the program. Enhancements included: replacing the End
Review Amendment with a short, second-round review; reducing time for
microbial food safety hazard characterization submissions to 100 days;
and changes to the financial structure. There were also chemistry,
manufacturing, and controls (CMC) enhancements, including developing
guidance for a two-phased CMC technical section submission and review
process under the investigational new animal drug file.
    Most recently, ADUFA was reauthorized for an additional 5 years
under ADUFA IV (FY 2019 to FY 2023). The ADUFA IV authorization
enhancements included adding new performance goals for presubmission
conferences and tissue residue method trial demonstrations, requiring
100 percent electronic submissions, and requiring an ``approved by
FDA'' statement along with a NADA number on approved animal drugs by
September 30, 2023. Additionally, a new provision was added that any
excess collections would be used to offset workload adjuster or
shortfall fee increases, if invoked.
    FDA has published a number of reports that provide useful
background on ADUFA I, II, III, and IV. ADUFA-related Federal Register
notices, guidances, legislation, performance reports, and financial
reports can be found at: https://www.fda.gov/industry/fda-user-fee-programs/animal-drug-user-fee-act-adufa.

II. Topics for Discussion at the Public Meeting

    In preparing the proposed recommendation to Congress for ADUFA
reauthorization, we conducted discussions with the regulated industry,
and consulted with stakeholders as required by the law. We began the
ADUFA reauthorization process with a public meeting held on May 20,
2021 (86 FR 18989, April 12, 2021). Following the May 2021 public
meeting, FDA conducted negotiations with regulated industry and
continued regular consultations with public stakeholders from October
2021 through August 2022. As directed by Congress, FDA posted minutes
of these discussions on its website at https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings.
    The proposed enhancements in ADUFA V will address priorities
identified by stakeholders, regulated industry, and FDA. The full
description of these proposed recommendations can be found in the
proposed ADUFA V Performance Goals and Procedures Letter. FDA intends
to post the full text of the proposed ADUFA V Performance Goals and
Procedures Letter at https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings, no later than 1 week prior to the public
meeting. FDA will post the agenda approximately 5 days before the
meeting at https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings.

III. Participating in the Public Meeting

    Registration: Persons interested in attending this public meeting
must register online at https://fda.zoomgov.com/webinar/register/WN_DBPaDGi5QXaaCoxkJkx7g no later than December 5, 2022. Please provide
complete contact information for each attendee, including name, title,
affiliation, address, email, and telephone. Also, please self-identify
as a member of one of the following stakeholder categories: scientific
or academic experts, veterinary professionals, patients and consumer
advocacy groups, or the regulated industry, and whether you are
requesting a scheduled presentation.
    Early registration is recommended. Registrants will receive
confirmation when their registration has been received and will be
provided the webcast link.
    If you need special accommodations due to a disability, please
contact Lisa Kable (see FOR FURTHER INFORMATION CONTACT) no later than
December 1, 2022.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to present during the public comment session and
which topic(s) you wish to address. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and request time for a joint presentation, or submit
requests for designated representatives to participate.
    We will determine the amount of time allotted to each presenter and
the approximate time each oral presentation is to begin, and we will
notify participants by December 5, 2022. All requests to make oral
presentations must be received by December 1, 2022, 11:59 p.m. Eastern
Time. If selected for presentation, any presentation materials must be
emailed to Lisa Kable (see FOR FURTHER INFORMATION CONTACT) no later
than December 5, 2022. No commercial or promotional material will be
permitted to be presented at the public meeting.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/industry/animal-drug-user-fee-act-adufa/adufa-meetings.

    Dated: November 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-25274 Filed 11-18-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 116 (Friday, June 15, 2012)]
[Rules and Regulations]
[Pages 35844-35846]
[FR Doc No: 2012-14714]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2012-0536]
RIN 1625-AA00

Safety Zone; Olde Ellison Bay Days Fireworks Display, Ellison
Bay, WI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone on
Lake Michigan in Ellison Bay, Wisconsin. This safety zone is intended
to restrict vessels from a portion of Lake Michigan during the Olde
Ellison Bay Days Fireworks display. This temporary safety zone is
necessary to protect spectators and vessels from the hazards associated
with a fireworks display.

DATES: This rule will be effective between 9 p.m. until 10 p.m. on June
25, 2012.

ADDRESSES: Documents mentioned in this preamble are part of docket
[USCG-2012-0536]. To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type the
docket number in the ``SEARCH'' box, and click ``Search.'' You may
visit the Docket Management Facility, Department of Transportation,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or email CWO Jon Grob, U.S. Coast Guard Sector
Lake Michigan; telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>If
you have questions on viewing or submitting material to the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking

A. Regulatory History and Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because doing so would be impracticable. The
final details for this event were not known to the Coast Guard until
there was insufficient time remaining before the event to publish an
NPRM. Thus, delaying the effective date of this rule to wait for a
comment period to run would be impracticable and it would inhibit the
Coast Guard's ability to protect spectators and vessels from the
hazards associated with a maritime fireworks display, which are
discussed further below.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. For the same reasons discussed in
the preceding paragraph, waiting for 30 day notice period run would be
impracticable and contrary to the public interest.

B. Basis and Purpose

    Between 9 p.m. and 10 p.m. on June 25, 2012, a fireworks display
will be held on Lake Michigan in Ellison Bay, WI. The Captain of the
Port, Sector Lake Michigan has determined that fireworks launched
proximate to a gathering of watercraft pose a significant risk to
public safety and property. Such hazards include premature and
accidental detonations, dangerous projectiles, and falling or burning
debris.

C. Discussion of Rule

    With the aforementioned hazards in mind, the Captain of the Port,
Sector Lake Michigan, has determined that this temporary safety zone is
necessary to ensure the safety of spectators and vessels during the
Town of Porter Fireworks. This zone will be effective and enforced from
9 p.m. until 10 p.m. on June 25, 2012. This zone will encompass all
waters of Lake Michigan, Ellison Bay, WI within a 400 foot radius of
position 45[deg]15'39.36'' N and 87[deg]05'03'' W (NAD 83).
    Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the Captain of the Port, Sector Lake
Michigan, or his designated on-scene representative. The Captain of the
Port or his designated on-scene representative may be contacted via VHF
Channel 16.

D. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 14 of these statutes or executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of that Order. Executive Order
12866 or under section 1 of

Executive Order 13563. The Office of Management and Budget has not
reviewed it under those Orders. It is not ``significant'' under the
regulatory policies and procedures of the Department of Homeland
Security (DHS). We conclude that this 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 zone created by
this rule will be relatively small and enforced for relatively short
time. Also, the safety zone is designed to minimize its impact on
navigable waters. Furthermore, the safety zone has been designed to
allow vessels to transit around it. Thus, restrictions on vessel
movement within that particular area are expected to be minimal. Under
certain conditions, moreover, vessels may still transit through the
safety zone when permitted by the Captain of the Port.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The Coast Guard
certifies under 5 U.S.C. 605(b) that this rule will not have a
significant economic impact on a substantial number of small entities.
    This rule will affect the following entities, some of which might
be small entities: The owners or operators of vessels intending to
transit or anchor in a portion of Lake Michigan on the evening of June
25, 2012.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons: This
safety zone would be activated, and thus subject to enforcement, for
only one hour in the evening. Traffic may be allowed to pass through
the zone with the permission of the Captain of the Port. The Captain of
the Port can be reached via VHF channel 16. Before the activation of
the zone, we would issue local Broadcast Notice to Mariners.

3. Assistance for Small Entities

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

4. Collection of Information

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

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

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

7. Unfunded Mandates Reform Act

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

8. Taking of Private Property

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

9. Civil Justice Reform

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

10. Protection of Children

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

11. Indian Tribal Governments

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

12. Energy Effects

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

13. Technical Standards

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

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves the establishment of a safety zone, and
therefore it is categorically excluded from further review under
paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An
environmental analysis checklist supporting this determination and a
Categorical Exclusion

Determination are available in the docket where indicated under
ADDRESSES. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this 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 amends
33 CFR parts 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapters 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.

0
2. Add Sec.  165.T09-0536 to read as follows:

Sec.  165.T09-0536  Safety Zone; Olde Ellison Bay Days Fireworks
Display, Ellison Bay, Wisconsin.

    (a) Location. The safety zone will encompass all waters of Lake
Michigan, Ellison Bay, Wisconsin within a 400 foot radius of position
45[deg]15'36'' N and 87[deg]05'03'' W (NAD 83).
    (b) Effective and enforcement period. This regulation is effective
and will be enforced on June 25, 2012 from 9 p.m. until 10 p.m.
    (c) Regulations. (1) In accordance with the general regulations in
section 165.23 of this part, entry into, transiting, or anchoring
within this safety zone is prohibited unless authorized by the Captain
of the Port, Sector Lake Michigan or his designated on-scene
representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port, Sector Lake Michigan or his
designated on-scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port,
Sector Lake Michigan is any Coast Guard commissioned, warrant or petty
officer who has been designated by the Captain of the Port, Sector Lake
Michigan to act on his behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone shall contact the Captain of the Port, Sector Lake Michigan or his
on-scene representative to obtain permission to do so. The Captain of
the Port, Sector Lake Michigan or his on-scene representative may be
contacted via VHF Channel 16. Vessel operators given permission to
enter or operate in the safety zone must comply with all directions
given to them by the Captain of the Port, Sector Lake Michigan, or his
on-scene representative.

    Dated: June 6, 2012.
M.W. Sibley,
Captain, U. S. Coast Guard, Captain of the Port, Sector Lake Michigan.
[FR Doc. 2012-14714 Filed 6-14-12; 8:45 am]
BILLING CODE 9110-04-P