Application of Leonardo Ortiz for Admission To Practice Before the Federal Maritime Commission; Order Initiating Proceeding, 38627-38628 [E9-18601]
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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
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Dated: July 30, 2009.
Michael J. Bartlett,
Deputy General Counsel.
[FR Doc. E9–18579 Filed 8–3–09; 8:45 am]
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FEDERAL RESERVE SYSTEM
Sunshine Act Meeting
Board of
Governors of the Federal Reserve
System.
TIME AND DATE: 12:00 p.m., Monday,
August 10, 2009.
PLACE: Marriner S. Eccles Federal
Reserve Board Building, 20th and C
Streets, N.W., Washington, D.C. 20551.
STATUS: Closed.
MATTERS TO BE CONSIDERED:
1. Personnel actions (appointments,
promotions, assignments,
reassignments, and salary actions)
involving individual Federal Reserve
System employees.
2. Any items carried forward from a
previously announced meeting.
FOR FURTHER INFORMATION CONTACT:
Michelle Smith, Director, or Dave
Skidmore, Assistant to the Board, Office
of Board Members at 202–452–2955.
SUPPLEMENTARY INFORMATION: You may
call 202–452–3206 beginning at
approximately 5 p.m. two business days
before the meeting for a recorded
announcement of bank and bank
holding company applications
scheduled for the meeting; or you may
contact the Board’s Web site at https://
www.federalreserve.gov for an electronic
announcement that not only lists
applications, but also indicates
procedural and other information about
the meeting.
AGENCY HOLDING THE MEETING:
Board of Governors of the Federal Reserve
System, July 31, 2009.
Robert deV. Frierson,
Deputy Secretary of the Board.
[FR Doc. E9–18757 Filed 7–31–09; 4:15 pm]
BILLING CODE 6210–01–S
FEDERAL MARITIME COMMISSION
[Docket No. 09–05]
Application of Leonardo Ortiz for
Admission To Practice Before the
Federal Maritime Commission; Order
Initiating Proceeding
On December 31, 2007, Respondent
Leonardo Ortiz (‘‘Mr. Ortiz’’) filed his
Application for Admission to Practice
before the Federal Maritime
Commission (‘‘Form FMC–12’’).
According to his application, Mr. Ortiz
is self-employed. His business is located
at 4324 Belton Highway, Anderson, SC
29621.
The Federal Maritime Commission
(‘‘Commission’’) allows for attorney and
non-attorney practitioners. In order to
be admitted to practice before the
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38627
Commission as a non-attorney, Rule 27
of the Commission’s Rules of Practice
and Procedure, 46 CFR § 502.27,
requires that the applicant file proof that
he or she possesses, to the satisfaction
of the Commission, ‘‘the necessary legal,
technical, or other qualifications to
render valuable service before the
Commission and is otherwise competent
to advise and assist in the presentation
of matters before [it].’’ Further, if the
Commission is not satisfied that the
applicant has sufficient qualifications, it
will notify the applicant and, if
requested, the applicant will be granted
a hearing ‘‘for the purpose of showing
his or her qualifications.’’ 46 CFR
502.29.
After reviewing his application, the
Commission determined that Mr. Ortiz
did not demonstrate that he possesses
the qualifications required to practice
before the Commission.1 On April 15,
2009, the Secretary of the Commission
notified Mr. Ortiz of the Commission’s
intent to deny his application for
admission to practice before it and the
procedures permitting a request for a
hearing. On April 29, 2009, Mr. Ortiz
filed his request for a hearing on the
issue.
Now therefore, it is ordered that
pursuant to Rule 29 of the Commission’s
Rules of Practice and Procedure, 46 CFR
502.29, the Commission institute a
proceeding for the purpose of allowing
Mr. Ortiz to show his qualifications to
practice before it as a non-lawyer;
It is further ordered that this matter be
heard before the Commission;
It is further ordered that this
proceeding is limited to the submission
of affidavits of fact and memoranda of
law;
It is further ordered that any person
having an interest and desiring to
intervene in this proceeding shall file a
petition for leave to intervene in
accordance with Rule 72 of the
Commission’s Rules of Practice and
Procedure, 46 CFR 502.72. Such petition
shall be accompanied by the petitioner’s
memorandum of law and affidavit of
fact, if any, and shall be filed no later
than the day fixed below;
It is further ordered that Leonardo
Ortiz is named as Respondent in this
proceeding. Affidavits of fact and
memoranda of law shall be filed by the
Respondent and any intervenors in
support of the Respondent no later than
September 4, 2009;
1 Pursuant to 46 CFR 501.24(a), the Commission
has delegated to the Secretary the authority to
approve applications for permission to practice
before the Commission and to issue admission
certificates to approved applicants.
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Federal Register / Vol. 74, No. 148 / Tuesday, August 4, 2009 / Notices
It is further ordered that the
Commission’s Bureau of Enforcement be
made a party to this proceeding;
It is further ordered that rebuttal
affidavits and memoranda of law shall
be filed by the Bureau of Enforcement
and any intervenors in opposition to the
Respondent no later than October 5,
2009;
It is further ordered that reply
affidavits and memoranda of law shall
be filed by the Respondent and
intervenors in support no later than
October 20, 2009;
It is further ordered that:
(a) Should any party believe that an
evidentiary hearing is required, that
party must submit a request for such a
hearing together with a statement setting
forth in detail the facts to be proved, the
relevance of those facts to the issues in
this proceeding, a description of the
evidence which would be adduced, and
why such evidence cannot be submitted
by affidavit;
(b) Should any party believe that an
oral argument is required, that party
must submit a request specifying the
reasons therefor and why argument by
memorandum is inadequate to present
the party’s case; and
(c) Any request for evidentiary
hearing or oral argument shall be filed
no later than October 5, 2009;
It is further ordered that notice of this
proceeding be published in the Federal
Register and that a copy thereof be
served upon Respondent at his last
known address;
It is further ordered that all
documents submitted by any party of
record in this proceeding shall be filed
in accordance with Rule 118 of the
Commission’s Rules of Practice and
Procedure, 46 CFR 502.118, as well as
being mailed directly to all parties of
record;
Finally, it is ordered that pursuant to
the terms of Rule 61 of the
Commission’s Rules of Practice and
Procedure, 46 CFR 502.61, the final
decision of the Commission in this
proceeding shall be issued by February
17, 2010.
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By the Commission.
Karen V. Gregory,
Secretary.
[FR Doc. E9–18601 Filed 8–3–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Determination and Declarations
Regarding Emergency Use of Certain
In vitro Diagnostic, Antiviral, and
Personal Respiratory Products
Accompanied by Emergency Use
Information
AGENCY:
Office of the Secretary (OS),
HHS.
ACTION:
Notice.
SUMMARY: The Secretary of Health and
Human Services (HHS) is issuing this
notice pursuant to section 564(b) of the
Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 360bbb–3(b)(4). On
April 26, 2009, the Acting Secretary of
HHS determined that a public health
emergency exists nationwide involving
Swine Influenza A (now known as
2009–H1N1 Influenza A, or 2009–H1N1
influenza) that affects or has significant
potential to affect national security. On
the basis of this determination, on April
26 and April 27, 2009, the Acting
Secretary declared emergencies
justifying the authorization of
emergency use of certain in vitro
diagnostic, antiviral, and personal
respiratory protection products
accompanied by emergency use
information subject to the terms of any
authorization issued by the
Commissioner of Food and Drugs
(Commissioner) under 21 U.S.C.
360bbb–3(a). The Acting Secretary also
specified that these declarations are
declarations of emergency as defined by
former Secretary Michael O. Leavitt in
the October 10, 2008 Declaration under
the Public Readiness and Emergency
Preparedness (PREP) Act for Influenza
Antivirals Oseltamivir Phosphate and
Zanamavir, as amended, and the
December 17, 2008 Declaration under
the PREP Act for Pandemic Influenza
Diagnostics, Personal Respiratory
Protection Devices, and Respiratory
Support Devices.
DATES: The declaration of an emergency
justifying the authorization of
emergency use of certain in vitro
diagnostic products is effective April 26,
2009. The declaration of an emergency
justifying the authorization of certain
antiviral products is effective April 26,
2009. The declaration of an emergency
justifying the authorization of
emergency use of certain respiratory
protection products is effective April 27,
2009.
FOR FURTHER INFORMATION CONTACT:
Nicole Lurie, M.D., MSPH, Assistant
Secretary for Preparedness and
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Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue,
SW., Washington, DC 20201, Telephone
(202) 205–2882 (this is not a toll free
number).
SUPPLEMENTARY INFORMATION:
I. Background
Under Section 564 of the FFDCA, the
Commissioner, acting under delegated
authority from the Secretary of HHS,
may issue an Emergency Use
Authorization (EUA) authorizing the
emergency use of an unapproved drug,
an unapproved or uncleared device, or
an unlicensed biological product, or an
unapproved use of an approved drug,
approved or cleared device, or licensed
biological product. Before an EUA may
be issued, the Secretary of HHS must
declare an emergency justifying the
authorization based on one of three
determinations: a determination of a
domestic emergency, or a significant
potential for a domestic emergency, by
the Secretary of Homeland Security; a
determination of a military emergency,
or a significant potential for a military
emergency, by the Secretary of Defense;
or a determination of a public health
emergency by the Secretary of HHS. See
21 U.S.C. 360bbb–3(b)(1). In the case of
a determination by the Secretary of HHS
(as was made here), the Secretary must
determine that a public health
emergency exists under section 319 of
the Public Health Service (PHS) Act that
affects, or has a significant potential to
affect, national security, and that
involves a specified biological,
chemical, radiological, or nuclear agent
or agents, or a specified disease or
condition that may be attributable to
such agent or agents. Based on such a
determination, the Secretary of HHS
may then declare an emergency that
justifies the EUA, at which point the
Commissioner may issue an EUA if the
criteria for issuance of an authorization
under section 564 of the FFDCA are
met.
The Centers for Disease Control and
Prevention (CDC), HHS, requested that
the Food and Drug Administration
(FDA) issue EUAs for certain in vitro
diagnostic, antiviral, and personal
respiratory protection products
accompanied by emergency use
information. The determination of a
public health emergency by the Acting
Secretary of HHS and the declarations of
an emergency by the Acting Secretary of
HHS based on that determination, as
described below, enabled the Acting
Commissioner to issue EUAs for certain
in vitro diagnostic, antiviral, and
personal respiratory protection products
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Agencies
[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38627-38628]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18601]
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FEDERAL MARITIME COMMISSION
[Docket No. 09-05]
Application of Leonardo Ortiz for Admission To Practice Before
the Federal Maritime Commission; Order Initiating Proceeding
On December 31, 2007, Respondent Leonardo Ortiz (``Mr. Ortiz'')
filed his Application for Admission to Practice before the Federal
Maritime Commission (``Form FMC-12''). According to his application,
Mr. Ortiz is self-employed. His business is located at 4324 Belton
Highway, Anderson, SC 29621.
The Federal Maritime Commission (``Commission'') allows for
attorney and non-attorney practitioners. In order to be admitted to
practice before the Commission as a non-attorney, Rule 27 of the
Commission's Rules of Practice and Procedure, 46 CFR Sec. 502.27,
requires that the applicant file proof that he or she possesses, to the
satisfaction of the Commission, ``the necessary legal, technical, or
other qualifications to render valuable service before the Commission
and is otherwise competent to advise and assist in the presentation of
matters before [it].'' Further, if the Commission is not satisfied that
the applicant has sufficient qualifications, it will notify the
applicant and, if requested, the applicant will be granted a hearing
``for the purpose of showing his or her qualifications.'' 46 CFR
502.29.
After reviewing his application, the Commission determined that Mr.
Ortiz did not demonstrate that he possesses the qualifications required
to practice before the Commission.\1\\\ On April 15, 2009, the
Secretary of the Commission notified Mr. Ortiz of the Commission's
intent to deny his application for admission to practice before it and
the procedures permitting a request for a hearing. On April 29, 2009,
Mr. Ortiz filed his request for a hearing on the issue.
---------------------------------------------------------------------------
\1\ Pursuant to 46 CFR 501.24(a), the Commission has delegated
to the Secretary the authority to approve applications for
permission to practice before the Commission and to issue admission
certificates to approved applicants.
---------------------------------------------------------------------------
Now therefore, it is ordered that pursuant to Rule 29 of the
Commission's Rules of Practice and Procedure, 46 CFR 502.29, the
Commission institute a proceeding for the purpose of allowing Mr. Ortiz
to show his qualifications to practice before it as a non-lawyer;
It is further ordered that this matter be heard before the
Commission;
It is further ordered that this proceeding is limited to the
submission of affidavits of fact and memoranda of law;
It is further ordered that any person having an interest and
desiring to intervene in this proceeding shall file a petition for
leave to intervene in accordance with Rule 72 of the Commission's Rules
of Practice and Procedure, 46 CFR 502.72. Such petition shall be
accompanied by the petitioner's memorandum of law and affidavit of
fact, if any, and shall be filed no later than the day fixed below;
It is further ordered that Leonardo Ortiz is named as Respondent in
this proceeding. Affidavits of fact and memoranda of law shall be filed
by the Respondent and any intervenors in support of the Respondent no
later than September 4, 2009;
[[Page 38628]]
It is further ordered that the Commission's Bureau of Enforcement
be made a party to this proceeding;
It is further ordered that rebuttal affidavits and memoranda of law
shall be filed by the Bureau of Enforcement and any intervenors in
opposition to the Respondent no later than October 5, 2009;
It is further ordered that reply affidavits and memoranda of law
shall be filed by the Respondent and intervenors in support no later
than October 20, 2009;
It is further ordered that:
(a) Should any party believe that an evidentiary hearing is
required, that party must submit a request for such a hearing together
with a statement setting forth in detail the facts to be proved, the
relevance of those facts to the issues in this proceeding, a
description of the evidence which would be adduced, and why such
evidence cannot be submitted by affidavit;
(b) Should any party believe that an oral argument is required,
that party must submit a request specifying the reasons therefor and
why argument by memorandum is inadequate to present the party's case;
and
(c) Any request for evidentiary hearing or oral argument shall be
filed no later than October 5, 2009;
It is further ordered that notice of this proceeding be published
in the Federal Register and that a copy thereof be served upon
Respondent at his last known address;
It is further ordered that all documents submitted by any party of
record in this proceeding shall be filed in accordance with Rule 118 of
the Commission's Rules of Practice and Procedure, 46 CFR 502.118, as
well as being mailed directly to all parties of record;
Finally, it is ordered that pursuant to the terms of Rule 61 of the
Commission's Rules of Practice and Procedure, 46 CFR 502.61, the final
decision of the Commission in this proceeding shall be issued by
February 17, 2010.
By the Commission.
Karen V. Gregory,
Secretary.
[FR Doc. E9-18601 Filed 8-3-09; 8:45 am]
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