Government-Owned Inventions; Availability for Licensing, 18290-18291 [E8-6893]
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18290
Federal Register / Vol. 73, No. 65 / Thursday, April 3, 2008 / Notices
Number of
respondents
Type of respondents
Estimated
number of
responses
per
respondent
Average
burden
hours per
response
Annual
burden
hours
requested
1900
1750
5700
300
1
1
1
1
10.35
.5
.33
1.25
19,665.00
875.00
1881.00
375.00
Subtotal .............................................................................................
9650
........................
........................
22,796.00
Intramural LRPs:
Renewal Applicants ..................................................................................
Advisors/Supervisors ................................................................................
60
60
1
1
7.42
1.33
445.20
79.80
Subtotal .............................................................................................
120
........................
........................
525.00
Extramural LRPs:
Renewal Applicants ..................................................................................
Advisors/Supervisors ................................................................................
Recommenders ........................................................................................
1225
925
3675
1
1
1
8.58
1.00
.33
10,510.50
925.00
1212.75
Subtotal ......................................................................................
5825
........................
........................
12,648.25
Total ...................................................................................................
rwilkins on PROD1PC63 with NOTICES
Initial Applicants ........................................................................................
Advisors/Supervisors ................................................................................
Recommenders ........................................................................................
Financial Institutions .................................................................................
15,755
........................
........................
36,329.75
The annualized cost to respondents is
estimated at $1,298,341. The annualized
cost to the Federal Government for
administering the Loan Repayment
Programs is expected to be
$1,794,667.48. This cost includes
administrative support by the Division
of Loan Repayment and $440,039 for the
continuing development and
maintenance of the LRP Management
Information System/Online Application
System (MIS/OAS).
Request For Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) 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; (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 those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
VerDate Aug<31>2005
17:19 Apr 02, 2008
Jkt 214001
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Suman
King, PhD., Director, Division of Loan
Repayment, National Institutes of
Health, 6011 Executive Blvd., Room 206
(MSC 7650), Bethesda, Maryland
20892–7650. Dr. King may be contacted
via e-mail at SKing1@od.nih.gov or by
calling 301–594–3234.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
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.
Dated: March 27, 2008.
Raynard S. Kington,
Deputy Director, NIH.
[FR Doc. E8–6857 Filed 4–2–08; 8:45 am]
HPV Virus-Like Particles for Delivery of
Gene-Based Vaccines
BILLING CODE 4140–01–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.
ACTION: Notice.
AGENCY:
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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Description of Technology: The
invention describes methods of eliciting
immune responses and treating disease
based on novel vaccine compositions
and vaccination strategies employing
human papilloma virus (HPV) virus-like
particles (VLPs), comprising L1 and L2
proteins. These VLPs have the capacity
to incorporate up to 8 kb of DNA into
the shell and express only the target
antigen. These compositions are
effective at eliciting an immune
response to the transgene product
expressed by the DNA when
administered at epithelial surfaces
including the mucosa (e.g. nasal or
respiratory passages or genital tract) or
skin in conjunction with disruption of
the epithelial layer. It is typically
difficult to elicit an immune response in
E:\FR\FM\03APN1.SGM
03APN1
Federal Register / Vol. 73, No. 65 / Thursday, April 3, 2008 / Notices
the genital tract, so this technology
overcomes a previous deficiency.
Robust B and T cell responses were
elicited in mice using the subject
technology with representative DNA
expressing M/M2 from respiratory
syncytial virus (RSV). This technology
could be used in a prime-boost
vaccination regimen as well to enhance
the immune response.
Applications: Vaccines against a
number of pathogens, including HPV,
HIV, HSV, HCV, and RSV.
Advantages:
Novel, non-invasive vaccine strategy
to elicit both systemic and mucosal
immunity in typically poorly inductive
sites.
Packaging system that can
accommodate up to 8 kb of DNA.
No expression of viral genes.
Potential for multivalent vaccine
development against heterologous
pathogens.
Development Status: Animal (mouse)
data available.
Inventors: Barney S. Graham et al.
(NIAID) and John T. Schiller et al. (NCI).
Publications:
1. Meeting abstract from the Keystone
Symposium on Viral Immunity 2008
can be provided upon request.
2. CB Buck, DV Pastrana, DR Lowy, JT
Schiller. Efficient intracellular assembly
of papillomaviral vectors. J. Virol. 2004
Jan;78(2):751–757.
Patent Status: U.S. Provisional
Application No. 61/022,324 filed 19 Jan
2008 (HHS Reference No. E–077–2008/
0–US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Susan Ano, Ph.D.;
301–435–5515, anos@mail.nih.gov.
Collaborative Research Opportunity:
The NIAID/OTD is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize HPV Virus-Like Particles
for Delivery of Gene-Based Vaccines.
Please contact either Cecelia Pazman or
Barry Buchbinder at 301–496–2644 for
more information.
rwilkins on PROD1PC63 with NOTICES
Avian Influenza Vaccine
Description of Technology: Sustained
outbreaks of highly pathogenic avian
influenza H5N1 in avian species
increase the risk of reassortment and
adaptation to humans. The ability to
contain its spread in birds would reduce
this threat and help maintain the
capacity for egg-based vaccine
production.
This technology describes DNA
vaccines against avian influenza. These
vaccines were used to elicit antibodies
in animals that were effective against
VerDate Aug<31>2005
17:19 Apr 02, 2008
Jkt 214001
homologous and heterologous H5
challenge studies. One vaccine, a
trivalent combination of H5
immunogens, was particularly effective
in conferring protection. These vaccines
can be delivered intramuscularly or
through needle-free delivery
mechanism.
Applications: Avian influenza vaccine
specifically designed for poultry and
other avian species.
Advantages: Protects against
homologous and heterologous
challenges; Needle-free delivery elicits
robust immune response.
Development Status: Animal (mouse
and chicken) data available.
Inventors: Gary Nabel, Srinivas Rao,
Wing-pui Kong, Zhi-yong Yang, and
Chih-jen Wei (VRC/NIAID).
Patent Status:
U.S. Provisional Application No. 61/
021,586 filed 16 Jan 2008 (HHS
Reference No. E–050–2008/0–US–01).
U.S. Provisional Application No. 61/
023,341 filed 24 Jan 2008 (HHS
Reference No. E–050–2008/1–US–01).
U.S. Patent No. 7,094,598 issued 22
Aug 2006 (HHS Reference No. E–241–
2001/1–US–01) and associated foreign
rights (CMV/R vector).
Licensing Status: Available for
exclusive or non-exclusive licensing;
CMV/R vector is available on a nonexclusive basis only.
Licensing Contact: Susan Ano, Ph.D.;
301–435–5515; anos@mail.nih.gov.
Codon Optimized Genes for Subunit
Vaccines
Description of Technology: Available
for licensing from the NIH are gene
constructs that express immunogenic
proteins based on viral genes that have
been optimized for expression in
mammalian cells. Using vaccine vectors
expressing respiratory syncytial virus
(RSV) proteins from the optimized
genes, this technology was shown to
result in a potent RSV-specific cellular
immune responses with favorable
phenotypic patterns. This technology
was shown to generate a superior
immune (both humoral and cellular)
response when utilized as part of a
heterologous vector prime-boost
regimen. Such optimized genes could be
an important component of an effective
RSV vaccine. Further, this optimization
could have possible application of to
other viral genes and their respective
vaccines.
Applications: Vaccines; Improved
protein expression.
Development Status: Animal (mouse)
data available.
Inventors: Barney S. Graham and
Teresa R. Johnson (VRC/NIAID).
Patent Status:
PO 00000
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18291
U.S. Provisional Application No. 60/
872,071 filed 30 Nov 2006 (HHS
Reference No. E–326–2006/0–US–01).
PCT Application No. PCT/US2007/
024625 filed 30 Nov 2007 (HHS
Reference No. E–326–2006/1–PCT–01).
Licensing Status: Available for nonexclusive or exclusive licensing.
Licensing Contact: Susan Ano, Ph.D.;
301–435–5515; anos@mail.nih.gov.
Dated: March 25, 2008.
Steven M. Ferguson,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–6893 Filed 4–2–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of a meeting of the AIDS
Research Advisory Committee, NIAID.
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: AIDS Research
Advisory Committee, NIAID; AIDS Vaccine
Research Subcommittee.
Date: May 30, 2008.
Time: 8:30 a.m. to 5 p.m.
Agenda: To discuss the implication of
recent vaccine trial results for future HIV
vaccine development.
Place: Betheda North Marriott Hotel and
Conference Center, 5701 Marinelli Road,
Rockville, MD 20852.
Contact Person: James A. Bradac, PhD,
Program Official, Preclinical Research and
Development Branch, Division of AIDS,
Room 5116, National Institutes of Health/
NIAID, 6700B Rockledge Drive, Bethesda,
MD 20892–7628, 301–435–3754,
jbradac@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: March 26, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–6711 Filed 4–2–08; 8:45 am]
BILLING CODE 4140–01–M
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03APN1
]]>Agencies
[Federal Register Volume 73, Number 65 (Thursday, April 3, 2008)]
[Notices]
[Pages 18290-18291]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6893]
-----------------------------------------------------------------------
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.
HPV Virus-Like Particles for Delivery of Gene-Based Vaccines
Description of Technology: The invention describes methods of
eliciting immune responses and treating disease based on novel vaccine
compositions and vaccination strategies employing human papilloma virus
(HPV) virus-like particles (VLPs), comprising L1 and L2 proteins. These
VLPs have the capacity to incorporate up to 8 kb of DNA into the shell
and express only the target antigen. These compositions are effective
at eliciting an immune response to the transgene product expressed by
the DNA when administered at epithelial surfaces including the mucosa
(e.g. nasal or respiratory passages or genital tract) or skin in
conjunction with disruption of the epithelial layer. It is typically
difficult to elicit an immune response in
[[Page 18291]]
the genital tract, so this technology overcomes a previous deficiency.
Robust B and T cell responses were elicited in mice using the subject
technology with representative DNA expressing M/M2 from respiratory
syncytial virus (RSV). This technology could be used in a prime-boost
vaccination regimen as well to enhance the immune response.
Applications: Vaccines against a number of pathogens, including
HPV, HIV, HSV, HCV, and RSV.
Advantages:
Novel, non-invasive vaccine strategy to elicit both systemic and
mucosal immunity in typically poorly inductive sites.
Packaging system that can accommodate up to 8 kb of DNA.
No expression of viral genes.
Potential for multivalent vaccine development against heterologous
pathogens.
Development Status: Animal (mouse) data available.
Inventors: Barney S. Graham et al. (NIAID) and John T. Schiller et
al. (NCI).
Publications:
1. Meeting abstract from the Keystone Symposium on Viral Immunity
2008 can be provided upon request.
2. CB Buck, DV Pastrana, DR Lowy, JT Schiller. Efficient
intracellular assembly of papillomaviral vectors. J. Virol. 2004
Jan;78(2):751-757.
Patent Status: U.S. Provisional Application No. 61/022,324 filed 19
Jan 2008 (HHS Reference No. E-077-2008/0-US-01).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Susan Ano, Ph.D.; 301-435-5515,
anos@mail.nih.gov.
Collaborative Research Opportunity: The NIAID/OTD is seeking
statements of capability or interest from parties interested in
collaborative research to further develop, evaluate, or commercialize
HPV Virus-Like Particles for Delivery of Gene-Based Vaccines. Please
contact either Cecelia Pazman or Barry Buchbinder at 301-496-2644 for
more information.
Avian Influenza Vaccine
Description of Technology: Sustained outbreaks of highly pathogenic
avian influenza H5N1 in avian species increase the risk of reassortment
and adaptation to humans. The ability to contain its spread in birds
would reduce this threat and help maintain the capacity for egg-based
vaccine production.
This technology describes DNA vaccines against avian influenza.
These vaccines were used to elicit antibodies in animals that were
effective against homologous and heterologous H5 challenge studies. One
vaccine, a trivalent combination of H5 immunogens, was particularly
effective in conferring protection. These vaccines can be delivered
intramuscularly or through needle-free delivery mechanism.
Applications: Avian influenza vaccine specifically designed for
poultry and other avian species.
Advantages: Protects against homologous and heterologous
challenges; Needle-free delivery elicits robust immune response.
Development Status: Animal (mouse and chicken) data available.
Inventors: Gary Nabel, Srinivas Rao, Wing-pui Kong, Zhi-yong Yang,
and Chih-jen Wei (VRC/NIAID).
Patent Status:
U.S. Provisional Application No. 61/021,586 filed 16 Jan 2008 (HHS
Reference No. E-050-2008/0-US-01).
U.S. Provisional Application No. 61/023,341 filed 24 Jan 2008 (HHS
Reference No. E-050-2008/1-US-01).
U.S. Patent No. 7,094,598 issued 22 Aug 2006 (HHS Reference No. E-
241-2001/1-US-01) and associated foreign rights (CMV/R vector).
Licensing Status: Available for exclusive or non-exclusive
licensing; CMV/R vector is available on a non-exclusive basis only.
Licensing Contact: Susan Ano, Ph.D.; 301-435-5515;
anos@mail.nih.gov.
Codon Optimized Genes for Subunit Vaccines
Description of Technology: Available for licensing from the NIH are
gene constructs that express immunogenic proteins based on viral genes
that have been optimized for expression in mammalian cells. Using
vaccine vectors expressing respiratory syncytial virus (RSV) proteins
from the optimized genes, this technology was shown to result in a
potent RSV-specific cellular immune responses with favorable phenotypic
patterns. This technology was shown to generate a superior immune (both
humoral and cellular) response when utilized as part of a heterologous
vector prime-boost regimen. Such optimized genes could be an important
component of an effective RSV vaccine. Further, this optimization could
have possible application of to other viral genes and their respective
vaccines.
Applications: Vaccines; Improved protein expression.
Development Status: Animal (mouse) data available.
Inventors: Barney S. Graham and Teresa R. Johnson (VRC/NIAID).
Patent Status:
U.S. Provisional Application No. 60/872,071 filed 30 Nov 2006 (HHS
Reference No. E-326-2006/0-US-01).
PCT Application No. PCT/US2007/024625 filed 30 Nov 2007 (HHS
Reference No. E-326-2006/1-PCT-01).
Licensing Status: Available for non-exclusive or exclusive
licensing.
Licensing Contact: Susan Ano, Ph.D.; 301-435-5515;
anos@mail.nih.gov.
Dated: March 25, 2008.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-6893 Filed 4-2-08; 8:45 am]
BILLING CODE 4140-01-P
