Government-Owned Inventions; Availability for Licensing, 10228-10229 [E7-3959]
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Federal Register / Vol. 72, No. 44 / Wednesday, March 7, 2007 / Notices
Final regulations at 45 CFR part 60 set
forth these criteria and procedures for
information to be reported to and
disclosed by the NPDB. Section 60.3 of
these regulations defines the terms used
in this announcement.
In determining any changes in the
amount of the user fee, the Department
uses the criteria set forth in section
60.12(b) of the regulations. The
Department must recover the full costs
of operating the Data Bank through user
fees. Paragraph (b) of the regulations
states:
‘‘The amount of each fee will be
determined based on the following
criteria:
a. Use of electronic data processing
equipment to obtain information—the
actual cost for the service, including
computer search time, runs, printouts,
and time of computer programmers and
operators, or other employees,
b. Photocopying or other forms of
reproduction, such as magnetic tapes—
actual cost of the operator’s time, plus
the cost of the machine time and the
materials used,
c. Postage—actual cost, and
d. Sending information by special
methods requested by the applicant,
such as express mail or electronic
transfer—the actual cost of the special
service.’’
An annual subscription fee of $3.25
per practitioner will be charged upon
enrollment. This fee includes the cost of
an initial query, which automatically
occurs when a practitioner is first
enrolled, and all reports received on the
enrolled practitioner over the course of
the subscription period of 1 year. The
fee was determined through economic
analysis of the average annual rate of
queries performed by health care
entities in relationship to the current
query fee that is based on the actual cost
for services. The Department will accept
payment for the subscription fee from
entities via credit card or electronic
funds transfer. When the prototype
period concludes, the Department may
change the subscription fee. Any
changes will be announced through
notice in the Federal Register.
The periodic query fee remains at
$4.75 per name. The practitioner selfquery fee remains at $8.00. Currently
when a periodic query is on one or more
physicians, dentists or other health care
practitioners, the appropriate fee will be
$4.75 multiplied by the number of
individuals about whom the
information is requested. Similarly,
when a PDS prototype participating
entity enrolls one or more physicians,
dentists or other health care
practitioners, the appropriate fee will be
$3.25 multiplied by the number of
individuals whom are enrolled. An
individual practitioner may not enroll
in PDS. For examples, see the tables
below.
Fee per
name in
query
Periodic query method
Entity query (via) internet with electronic payment .......................................................................................
$4.75
Practitioner Self-query ...................................................................................................................................
8.00
Proactive disclosure service (PDS) query method
Fee per
name enrolled
Entity query (via) internet with electronic payment .......................................................................................
$3.25
Dated: March 1, 2007.
Elizabeth M. Duke,
Administrator.
[FR Doc. E7–3974 Filed 3–6–07; 8:45 am]
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
National Institutes of Health,
Public Health Service, HHS.
AGENCY:
sroberts on PROD1PC70 with NOTICES
ACTION:
Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
federally-funded research and
development. Foreign patent
VerDate Aug<31>2005
18:25 Mar 06, 2007
Jkt 211001
Novel System for HIV–1 Vaccine
Development
Description of Technology: The
available technologies describe specific
immunogenic peptides, peptide
modifications and methods for
identifying additional immunogens
against HIV–1 surface proteins, gp120
and gp41. Additionally, detailed
methods for use of the described
PO 00000
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Fmt 4703
Sfmt 4703
Examples
10 names in query.
10 x $4.75 = $47.50.
One self-query =
$8.00.
Examples
10 names in query.
10 x $3.25 = $32.50.
immunogenic peptides in the
development of vaccines and
diagnostics for HIV–1 are disclosed. The
current technologies further include a
comprehensive system for immunogen
design, comprising in silico design
coupled to feedback from X-ray
crystallography, antigenic analysis, and
immunization.
The described methodology
demonstrates how to transplant a given
HIV–1 epitope recognized by broadly
neutralizing antibodies into an
appropriate scaffold, while preserving
its structure and antigenicity.
Conservation of the three dimensional
structure may lead to the generation of
antibodies with broadly neutralizing
characteristics, similar to the template
antibody. Such epitope-transplant
scaffolds may serve as valuable
diagnostics to identify specific serum
reactivity against the target HIV–1
epitopes. The subject scaffolding
technology may be applied to any virus
for which a broadly neutralizing
E:\FR\FM\07MRN1.SGM
07MRN1
sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 44 / Wednesday, March 7, 2007 / Notices
antibody and its respective epitope has
been characterized at the atomic-level.
Applications:
1. Immunogens that elicit immune
responses to HIV–1.
2. Efficient development of vaccines
against HIV–1.
3. Screening tool to isolate antibodies
with activities similar to identified
template antibody.
Inventors: Peter D. Kwong et al.
(NIAID)
Publications:
1. G Ofek, W Schief, J Guenaga, et al.
Epitope-transplant scaffolds: Automated
design, structural analysis, and
antigenic characteristics. Manuscript in
preparation (2007).
2. T Zhou, L Xu, B Dey, AJ Hessell,
DV Ryk, SH Xiang, X Yang, MY Zhang,
MB Zwick, J Arthos, DR Burton, DS
Dimitrov, J Sodroski, R Wyatt, GJ Nabel,
PD Kwong. Structural definition of a
conserved neutralization epitope on
HIV–1 gp120. Nature. 2007 Feb
15;445(7129):732–737.
3. DC Douek, PD Kwong, GJ Nabel.
The rational design of an AIDS vaccine.
Cell. 2006 Feb 24;124(4):677–681.
4. G Ofek, M Tang, A Sambor, H
Katinger, JR Mascola, R Wyatt, PD
Kwong. Structure and mechanistic
analysis of the anti-HIV–1 antibody 2F5
in complex with its gp41 epitope. J
Virol. 2004 Oct;78(19):10724–10737.
Patent Status:
1. PCT Application No. PCT/US2005/
016633 filed 13 May 2005, which
published as WO 2005/111079 on 24
Nov 2005 (HHS Reference No. E–218–
2004/0–PCT–02), and National Stage
filed in the U.S. on 26 Nov 2006 (HHS
Reference No. E–218–2004/0–US–03),
entitled ‘‘HIV Vaccine Immunogens and
Immunization Strategies to Elicit
Broadly-Neutralizing Anti-HIV–1
Antibodies Against the Membrane
Proximal of HIV gp41’’.
2. PCT Application No. PCT/US2006/
034681 filed 06 Sep 2006 (HHS
Reference No. E–324–2005/3–PCT–01),
entitled ‘‘Conformationally Stabilized
HIV Envelope Immunogens and
Triggering HIV-1 Envelope to Reveal
Cryptic V3-Loop Epitopes’’
3. PCT Application No. PCT/US2006/
034882 filed 06 Sep 2006 (HHS
Reference No. E–280–2006/1–PCT–01),
entitled ‘‘HIV gp120 Crystal Structure
and Its Use to Identify Immunogens’’
4. U.S. Provisional Application No.
60/840,119 filed 25 Aug 2006 (HHS
Reference No. E–302–2006/0–US–01),
entitled ‘‘Epitope-Transplant Scaffolds
and Their Use’’
Licensing Availability: Available for
non-exclusive or exclusive licensing.
Licensing Contact: Susan Ano, Ph.D.;
301/435–5515; anos@mail.nih.gov
VerDate Aug<31>2005
18:25 Mar 06, 2007
Jkt 211001
CCR5-Specific Human Monoclonal
Antibodies
Description of Technology: The
subject invention provides the
composition claims related to anti-CCR5
monoclonal antibodies, their fusion
protein, conjugates, derivatives, or
fragments, DNA sequences encoding
such antibodies, host cells containing
such DNA sequences, as well as the
methods to produce them
recombinantly and their
pharmacological composition.
It has been demonstrated that the HIV
co-receptor CCR5 plays an important
role in virus entry. The subject
antibodies exhibited neutralization
activity against HIV–1 infection by
binding to cell associated CCR5 in vitro.
Moreover, subject antibodies have
potentially lower immunogenicity and
toxicity, because they are fully human
antibodies. Therefore, subject anti-CCR5
antibodies have a potential as a
therapeutic and/or prophylactic in
combination with other HIV–1
neutralizing antibodies and antiretroviral drugs.
Applications: HIV treatment and
prevention.
Development Status: In vitro data is
available at this time.
Inventors: Dimiter S. Dimitrov and
Mei-Yun Zhang (NCI).
Related Publications:
1. C Pastori et al. Long-lasting CCR5
internalization by antibodies in a subset
of long-term nonprogressors: A possible
protective effect against disease
progression. Blood. 2006 Jun
15;107(12):4825–4833.
2. MY Zhang, B Vu, CC Huang, I
Sidirov, V Choudhly, PD Kwong, DS
Dimitrov. Identification of human
monoclonal antibodies specific for
CCR5 from an antibody library derived
from HIV-infected long-term nonprogressors. Retrovirology. 2006 Dec
21;3 Suppl 1:S61.
3. DS Dimitrov. Virus entry:
molecular mechanisms and biomedical
applications. Nat Rev Microbiol. 2004
Feb;2(2):109–122.
Patent Status: U.S. Provisional
Application No. 60/859,401 filed 15
Nov 2006 (HHS Reference No. E–297–
2006/0–US–01)
Licensing Availability: Available for
exclusive and non-exclusive licensing.
Licensing Contact: Sally Hu, Ph.D.;
301/435–5606; HuS@mail.nih.gov.
Collaborative Research Opportunity:
The NCI CCR Nanobiology Program is
seeking statements of capability or
interest from parties interested in
collaborative research to further
develop, evaluate, or commercialize
monoclonal antibodies. Please contact
PO 00000
Frm 00118
Fmt 4703
Sfmt 4703
10229
John D. Hewes, Ph.D. at 301–435–3121
or hewesj@mail.nih.gov for more
information.
Dated: February 28, 2007.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer
National Institutes of Health.
[FR Doc. E7–3959 Filed 3–6–07; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of 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 a meeting of the
Advisory Committee on Research on
Women’s Health.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Advisory Committee
on Research on Women’s Health.
Date: March 29–30, 2007.
Time: March 29, 2007, 9 a.m. to 5 p.m.
Agenda: Provide advice to the Office of
Research on Women’s Health (ORWH) on
appropriate research activities with respect to
women’s health and related studies to be
undertaken by the National Research
Institutes; to provide recommendations
regarding ORWH activities; to meet the
mandates of the office; and for discussion of
scientific issues.
Place: National Institutes of Health,
Building 31, 31 Center Drive, 6C/10,
Bethesda, MD 20892.
Time: March 30, 2007, 9 a.m. to 1 p.m.
Agenda: Same as above.
Place: National Institutes of Health,
Building 31, 31 Center Drive, 6C/10,
Bethesda, MD 20892.
Contact Person: Joyce Rudick, Director,
Programs & Management, Office of Research
on Women’s Health, Office of the Director,
National Institutes of Health, Building 1,
Room 201, Bethesda, MD 20892, 301/402–
1770.
Information is also available on the
Institute’s/Center’s home page: https://
www4.od.nih.gov/orwh/, where an agenda
and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
E:\FR\FM\07MRN1.SGM
07MRN1
Agencies
[Federal Register Volume 72, Number 44 (Wednesday, March 7, 2007)]
[Notices]
[Pages 10228-10229]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3959]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions; Availability for Licensing
AGENCY: National Institutes of Health, Public Health Service, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The inventions listed below are owned by an agency of the U.S.
Government and are available for licensing in the U.S. in accordance
with 35 U.S.C. 207 to achieve expeditious commercialization of results
of federally-funded research and development. Foreign patent
applications are filed on selected inventions to extend market coverage
for companies and may also be available for licensing.
ADDRESSES: Licensing information and copies of the U.S. patent
applications listed below may be obtained by writing to the indicated
licensing contact at the Office of Technology Transfer, National
Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville,
Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A
signed Confidential Disclosure Agreement will be required to receive
copies of the patent applications.
Novel System for HIV-1 Vaccine Development
Description of Technology: The available technologies describe
specific immunogenic peptides, peptide modifications and methods for
identifying additional immunogens against HIV-1 surface proteins, gp120
and gp41. Additionally, detailed methods for use of the described
immunogenic peptides in the development of vaccines and diagnostics for
HIV-1 are disclosed. The current technologies further include a
comprehensive system for immunogen design, comprising in silico design
coupled to feedback from X-ray crystallography, antigenic analysis, and
immunization.
The described methodology demonstrates how to transplant a given
HIV-1 epitope recognized by broadly neutralizing antibodies into an
appropriate scaffold, while preserving its structure and antigenicity.
Conservation of the three dimensional structure may lead to the
generation of antibodies with broadly neutralizing characteristics,
similar to the template antibody. Such epitope-transplant scaffolds may
serve as valuable diagnostics to identify specific serum reactivity
against the target HIV-1 epitopes. The subject scaffolding technology
may be applied to any virus for which a broadly neutralizing
[[Page 10229]]
antibody and its respective epitope has been characterized at the
atomic-level.
Applications:
1. Immunogens that elicit immune responses to HIV-1.
2. Efficient development of vaccines against HIV-1.
3. Screening tool to isolate antibodies with activities similar to
identified template antibody.
Inventors: Peter D. Kwong et al. (NIAID)
Publications:
1. G Ofek, W Schief, J Guenaga, et al. Epitope-transplant
scaffolds: Automated design, structural analysis, and antigenic
characteristics. Manuscript in preparation (2007).
2. T Zhou, L Xu, B Dey, AJ Hessell, DV Ryk, SH Xiang, X Yang, MY
Zhang, MB Zwick, J Arthos, DR Burton, DS Dimitrov, J Sodroski, R Wyatt,
GJ Nabel, PD Kwong. Structural definition of a conserved neutralization
epitope on HIV-1 gp120. Nature. 2007 Feb 15;445(7129):732-737.
3. DC Douek, PD Kwong, GJ Nabel. The rational design of an AIDS
vaccine. Cell. 2006 Feb 24;124(4):677-681.
4. G Ofek, M Tang, A Sambor, H Katinger, JR Mascola, R Wyatt, PD
Kwong. Structure and mechanistic analysis of the anti-HIV-1 antibody
2F5 in complex with its gp41 epitope. J Virol. 2004 Oct;78(19):10724-
10737.
Patent Status:
1. PCT Application No. PCT/US2005/016633 filed 13 May 2005, which
published as WO 2005/111079 on 24 Nov 2005 (HHS Reference No. E-218-
2004/0-PCT-02), and National Stage filed in the U.S. on 26 Nov 2006
(HHS Reference No. E-218-2004/0-US-03), entitled ``HIV Vaccine
Immunogens and Immunization Strategies to Elicit Broadly-Neutralizing
Anti-HIV-1 Antibodies Against the Membrane Proximal of HIV gp41''.
2. PCT Application No. PCT/US2006/034681 filed 06 Sep 2006 (HHS
Reference No. E-324-2005/3-PCT-01), entitled ``Conformationally
Stabilized HIV Envelope Immunogens and Triggering HIV-1 Envelope to
Reveal Cryptic V3-Loop Epitopes''
3. PCT Application No. PCT/US2006/034882 filed 06 Sep 2006 (HHS
Reference No. E-280-2006/1-PCT-01), entitled ``HIV gp120 Crystal
Structure and Its Use to Identify Immunogens''
4. U.S. Provisional Application No. 60/840,119 filed 25 Aug 2006
(HHS Reference No. E-302-2006/0-US-01), entitled ``Epitope-Transplant
Scaffolds and Their Use''
Licensing Availability: Available for non-exclusive or exclusive
licensing.
Licensing Contact: Susan Ano, Ph.D.; 301/435-5515;
anos@mail.nih.gov
CCR5-Specific Human Monoclonal Antibodies
Description of Technology: The subject invention provides the
composition claims related to anti-CCR5 monoclonal antibodies, their
fusion protein, conjugates, derivatives, or fragments, DNA sequences
encoding such antibodies, host cells containing such DNA sequences, as
well as the methods to produce them recombinantly and their
pharmacological composition.
It has been demonstrated that the HIV co-receptor CCR5 plays an
important role in virus entry. The subject antibodies exhibited
neutralization activity against HIV-1 infection by binding to cell
associated CCR5 in vitro. Moreover, subject antibodies have potentially
lower immunogenicity and toxicity, because they are fully human
antibodies. Therefore, subject anti-CCR5 antibodies have a potential as
a therapeutic and/or prophylactic in combination with other HIV-1
neutralizing antibodies and anti-retroviral drugs.
Applications: HIV treatment and prevention.
Development Status: In vitro data is available at this time.
Inventors: Dimiter S. Dimitrov and Mei-Yun Zhang (NCI).
Related Publications:
1. C Pastori et al. Long-lasting CCR5 internalization by antibodies
in a subset of long-term nonprogressors: A possible protective effect
against disease progression. Blood. 2006 Jun 15;107(12):4825-4833.
2. MY Zhang, B Vu, CC Huang, I Sidirov, V Choudhly, PD Kwong, DS
Dimitrov. Identification of human monoclonal antibodies specific for
CCR5 from an antibody library derived from HIV-infected long-term non-
progressors. Retrovirology. 2006 Dec 21;3 Suppl 1:S61.
3. DS Dimitrov. Virus entry: molecular mechanisms and biomedical
applications. Nat Rev Microbiol. 2004 Feb;2(2):109-122.
Patent Status: U.S. Provisional Application No. 60/859,401 filed 15
Nov 2006 (HHS Reference No. E-297-2006/0-US-01)
Licensing Availability: Available for exclusive and non-exclusive
licensing.
Licensing Contact: Sally Hu, Ph.D.; 301/435-5606; HuS@mail.nih.gov.
Collaborative Research Opportunity: The NCI CCR Nanobiology Program
is seeking statements of capability or interest from parties interested
in collaborative research to further develop, evaluate, or
commercialize monoclonal antibodies. Please contact John D. Hewes,
Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more information.
Dated: February 28, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer National Institutes of Health.
[FR Doc. E7-3959 Filed 3-6-07; 8:45 am]
BILLING CODE 4140-01-P