National Cancer Institute; Notice of Closed Meeting, 57638-57639 [E8-23454]
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Federal Register / Vol. 73, No. 193 / Friday, October 3, 2008 / Notices
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2950. The MAbs that are available for
licensing are the following: 1129, 1153,
1142, 1200, 1214, 1237, 1112, 1269, and
1243. One of these MAbs, 1129, is the
basis for a humanized murine MAb (see
U.S. Patent 5,824,307 to humanized
1129 owned by MedImmune, Inc.),
recently approved for marketing in the
United States. MAbs in the panel
reported by Beeler et al. have been
shown to be effective therapeutically
when administered into the lungs of
cotton rats by small-particle aerosol.
Among these MAbs several exhibited a
high affinity (approximately 109M-1) for
the RSV F glycoprotein and are directed
at epitopes encompassing amino acid
262, 272, 275, 276 or 389. These
epitopes are separate, nonoverlapping
and distinct from the epitope recognized
by the human Fab of U.S. Patent
5,762,905 owned by The Scripps
Research Institute.
Applications: Research and drug
development for treatment of respiratory
syncytial virus.
Inventors: Robert M. Chanock, Brian
R. Murphy, Judith A. Beeler, and
Kathleen L. van Wyke Coelingh (NIAID).
Patent Status: HHS Reference No. B–
056–1994/1—Research Tool. Patent
protection is not being pursued for this
technology.
Licensing Status: Available for nonexclusive licensing under a Biological
Materials License Agreement.
Licensing Contact: Peter A. Soukas,
J.D.; 301/435–4646;
soukasp@mail.nih.gov.
Neutralizing Monoclonal Antibodies to
Respiratory Syncytial Virus
Description of Technology:
Respiratory syncytial virus (RSV) is the
most common cause of bronchiolitis and
pneumonia among infants and children
under 1 year of age. Illness begins most
frequently with fever, runny nose,
cough, and sometimes wheezing. During
their first RSV infection, between 25%
and 40% of infants and young children
have signs or symptoms of bronchiolitis
or pneumonia, and 0.5% to 2% require
hospitalization. Most children recover
from illness in 8 to 15 days. The
majority of children hospitalized for
RSV infection are under 6 months of
age. RSV also causes repeated infections
throughout life, usually associated with
moderate-to-severe cold-like symptoms;
however, severe lower respiratory tract
disease may occur at any age, especially
among the elderly or among those with
compromised cardiac, pulmonary, or
immune systems.
This invention is a human
monoclonal antibody fragment (Fab)
discovered utilizing phage display
technology. The neutralizing
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monoclonal antibody was isolated and
its binding site was identified. Fab F2–
5 is a broadly reactive fusion (F)
protein-specific recombinant Fab
generated by antigen selection from a
random combinatorial library displayed
on the surface of filamentous phage. In
an in vitro plaque-reduction test, the
Fab RSVF2–5 neutralized the infectivity
of a variety of field isolates representing
viruses of both RSV subgroups A and B.
The Fab recognized an antigenic
determinant that differed from the only
other human anti-F monoclonal
antibody (RSV Fab 19) described thus
far. A single dose of 4.0 mg of Fab
RSVF2–5/kg of body weight
administered by inhalation was
sufficient to achieve a 2000-fold
reduction in pulmonary virus titer in
RSV-infected mice. The antigen-binding
domain of Fab RSVF2–5 offers promise
as part of a prophylactic regimen for
RSV infection in humans.
Application: Respiratory Syncytial
Virus prophylaxis/therapeutic.
Development Stage: The antibodies
have been synthesized and preclinical
studies have been performed.
Inventors: Brian Murphy (NIAID),
Robert Chanock (NIAID), James Crowe
(NIAID), et al.
Publication: JE Crowe et al. Isolation
of a second recombinant human
respiratory syncytial virus monoclonal
antibody fragment (Fab RSVF2–5) that
exhibits therapeutic efficacy in vivo. J
Infect Dis. 1998 Apr;177(4):1073–1076.
Patent Status: HHS Reference No. E–
001–1996/0—U.S. and Foreign Rights
Available.
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Peter A. Soukas,
J.D.; 301/435–4646;
soukasp@mail.nih.gov.
Human Neutralizing Monoclonal
Antibodies to Respiratory Syncytial
Virus and Human Neutralizing
Antibodies to Respiratory Syncytial
Virus
Description of Technology: This
invention is a human monoclonal
antibody fragment (Fab) discovered
utilizing phage display technology. It is
described in Crowe et al. , Proc Natl
Acad Sci USA. 1994 Feb 15;91(4):1386–
1390 and Barbas et al. , Proc Natl Acad
Sci USA. 1992 Nov 1;89(21):10164–
10168. This MAb binds an epitope on
the RSV F glycoprotein at amino acid
266 with an affinity of approximately
109M-1. This MAb neutralized each of
10 subgroup A and 9 subgroup B RSV
strains with high efficiency. It was
effective in reducing the amount of RSV
in lungs of RSV-infected cotton rats 24
hours after treatment, and successive
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treatments caused an even greater
reduction in the amount of RSV
detected.
Applications: Research and drug
development for treatment of respiratory
syncytial virus.
Inventors: Robert M. Chanock
(NIAID), Brian R. Murphy (NIAID),
James E. Crowe Jr. (NIAID), et al.
Patent Status: U.S. Patent 5,762,905
issued 09 Jun 1998 (HHS Reference No.
E–032–1993/1–US–01); U.S. Patent
6,685,942 issued 03 Feb 2004 (HHS
Reference No. E–032–1993/1–US–02);
U.S. Patent Application No. 10/768,952
filed 29 Jan 2004 (HHS Reference No. E–
032–1993/1–US–03).
Licensing Status: Available for nonexclusive licensing.
Licensing Contact: Peter A. Soukas,
J.D.; 301/435–4646;
soukasp@mail.nih.gov.
Dated: September 26, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–23437 Filed 10–2–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2); notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The contract proposals and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the contract
proposals, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; Early
Diagnosis Using Nanotechnology-Based
Imaging and Sensing.
Date: October 23, 2008.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6116
Executive Boulevard, Room 406, Rockville,
MD 20852, (Telephone Conference Call).
Contact Person: Joyce C. Pegues, PhD,
Scientific Review Officer, Special Review
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Federal Register / Vol. 73, No. 193 / Friday, October 3, 2008 / Notices
and Logistics Branch, Division of Extramural
Activities, NIH National Cancer Institute,
6116 Executive Boulevard, Room 7149,
Bethesda, MD 20892–8329, 301–594–1286,
peguesj@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: September 26, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–23454 Filed 10–2–08; 8:45 am]
Agenda: To review and evaluate grant
applications.
Place: Gateway Building, 7201 Wisconsin
Avenue, Suite 2C212, Bethesda, MD 20814.
(Telephone Conference Call)
Contact Person: Alicja L. Markowska, PhD,
DSC, National Institute on Aging, 7201
Wisconsin Avenue, Suite 2C212, Bethesda,
MD 20892, 301–496–9666,
markowsa@nia.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: September 26, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–23445 Filed 10–2–08; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
National Institutes of Health
[Docket No. DHS–2008–0007]
National Institute on Aging; Notice of
Closed Meetings
Privacy Act of 1974; Department of
Homeland Security Advisory
Committees System of Records
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel, Sleep,
Circadian Function and Cardiometabolic
Disease.
Date: October 31, 2008.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
2C212, Bethesda, MD 20892. (Telephone
Conference Call)
Contact Person: Elaine Lewis, PhD,
Scientific Review Administrator, Scientific
Review Office, National Institute on Aging,
Gateway Building, Suite 2C212, MSC–9205,
7201 Wisconsin Avenue, Bethesda, MD
20892, 301–402–7707,
elainelewis@nia.nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel SWAN.
Date: November 3, 2008.
Time: 1:30 p.m. to 4 p.m.
23:33 Oct 02, 2008
• Federal e-Rulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: 1–866–466–5370.
• Mail: Hugo Teufel III, Chief Privacy
Officer, Privacy Office, Department of
Homeland Security, Washington, DC
20528.
• Instructions: All submissions
received must include the agency name
and docket number for this rulemaking.
All comments received will be posted
without change and may be read at
https://www.regulations.gov, including
any personal information provided.
• Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov.
For
general questions and privacy issues
please contact: Hugo Teufel III (703–
235–0780), Chief Privacy Officer,
Privacy Office, Department of Homeland
Security, Washington, DC 20528.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
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Privacy Office; DHS.
Notice of Privacy Act system of
AGENCY:
ACTION:
records.
SUMMARY: In accordance with the
Privacy Act of 1974 and as part of the
Department of Homeland Security’s
ongoing effort to review and update
legacy system of record notices, the
Department of Homeland Security
proposes to consolidate two legacy
record systems: FEMA/ADM–3–
Advisory Committee Files (55 FR 37182
September 7, 1990) and DOT/CG 586
Chemical Transportation Industry
Advisory Committee (65 FR 19475 April
11, 2000) into one system, titled
Department of Homeland Security
Advisory Committees. This system will
allow the Department of Homeland
Security to collect and maintain
information on advisory committee
members and applicants. Categories of
individuals, categories of records, and
the routine uses of these legacy system
of records notices have been
consolidated and updated to better
reflect the Department’s advisory
committee record systems. This
consolidated system will be included in
the Department of Homeland Security’s
inventory of system records.
DATES: Submit comments on or before
November 3, 2008.
ADDRESSES: You may submit comments,
identified by docket number DHS–
2008–0007 by one of the following
methods:
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I. Background
Pursuant to the savings clause in the
Homeland Security Act of 2002, Public
Law 107–296, Section 1512, 116 Stat.
2310 (November 25, 2002), the
Department of Homeland Security
(DHS) and its components and offices
have relied on preexisting Privacy Act
systems of records notices for the
collection and maintenance of records
that concern any individual who serves
on a DHS-wide and/or component
specific advisory committee.
As part of its efforts to streamline and
consolidate its records systems, DHS is
establishing a new agency-wide system
of records under the Privacy Act (5
U.S.C. 552a) for DHS advisory
committees. This record system will
allow all component parts of DHS to
collect and preserve the required
personally identifiable information
needed for members who apply for or
participate in DHS advisory committees.
The system will consist of both
electronic and paper records and will be
used by DHS and its components and
offices to maintain records of Federal
government employees and other
persons who participate in DHSsponsored Federal advisory committees.
The data will be collected by individual
name, name of committee, and/or other
unique personal identifier. The
collection and maintenance of this
information will assist DHS in
maintaining a list of members of the
various Federal advisory committees,
internal committees, and interagency
committees to provide DHS with
information on committee functions,
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Agencies
[Federal Register Volume 73, Number 193 (Friday, October 3, 2008)]
[Notices]
[Pages 57638-57639]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-23454]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2); notice is hereby given of the following
meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The contract proposals and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the contract proposals, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Cancer Institute Special Emphasis
Panel; Early Diagnosis Using Nanotechnology-Based Imaging and
Sensing.
Date: October 23, 2008.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, 6116 Executive Boulevard,
Room 406, Rockville, MD 20852, (Telephone Conference Call).
Contact Person: Joyce C. Pegues, PhD, Scientific Review Officer,
Special Review
[[Page 57639]]
and Logistics Branch, Division of Extramural Activities, NIH
National Cancer Institute, 6116 Executive Boulevard, Room 7149,
Bethesda, MD 20892-8329, 301-594-1286, peguesj@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.392,
Cancer Construction; 93.393, Cancer Cause and Prevention Research;
93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer
Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer
Control, National Institutes of Health, HHS)
Dated: September 26, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E8-23454 Filed 10-2-08; 8:45 am]
BILLING CODE 4140-01-P