Government-Owned Inventions; Availability for Licensing, 75121-75122 [E8-29146]
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Federal Register / Vol. 73, No. 238 / Wednesday, December 10, 2008 / Notices
E-mail comments to
paperwork@hrsa.gov or mail the HRSA
Reports Clearance Officer, Room 10–33,
Parklawn Building, 5600 Fishers Lane,
Rockville, MD 20857. Written comments
should be received within 60 days of
this notice.
Wendy Ponton,
Director, Office of Management.
[FR Doc. E8–29202 Filed 12–9–08; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on PROD1PC66 with NOTICES
Proposed Collection: Comment
Request; Revision of OMB No. 0925–
0001/exp. 1/30/10, ‘‘Research and
Research Training Grant Applications
and Related Forms’’
SUMMARY: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
Office of Extramural Research, the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: Research
and Research Training Grant
Applications and Related Forms. Type
of Information Collection Request:
Revision, OMB 0925–0001, Expiration
Date 11/30/10. Form Numbers: PHS 398,
2590, 2271, 3734 and HHS 568.
Need and Use of Information
Collection: The application is used by
applicants to request Federal assistance
for research and research-related
training. The other related forms are
used for trainee appointment, final
invention reporting, and to relinquish
rights to a research grant.
Frequency of response: Applicants
may submit applications for published
receipt dates. If awarded, annual
progress is reported and trainees may be
appointed or reappointed.
Affected Public: Individuals or
Households; Business or other for-profit;
Not-for-profit institutions; Federal
Government; and State, Local or Tribal
Government.
Type of Respondents: Adult scientific
professionals. The annual reporting
burden is as follows:
Estimated Number of Respondents:
160,135;
Estimated Number of Responses per
Respondent: 1;
Average Burden Hours per Response:
14; and
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16:49 Dec 09, 2008
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Estimated Total Annual Burden
Hours Requested: 2,251,500. The
estimated annualized cost to
respondents is $78,802,500.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on 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.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Ms. Mikia Currie,
Division of Grants Policy, Office of
Policy for Extramural Research
Administration, NIH, Rockledge 1
Building, Room 3505, 6705 Rockledge
Drive, Bethesda, MD 20892–7974, or
call non-toll-free number 301–435–
0941, or E-mail your request, including
your address to: [curriem@od.nih.gov].
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Dated: December 4, 2008.
Joe Ellis,
Director, OPERA, OER, National Institutes of
Health.
[FR Doc. E8–29147 Filed 12–9–08; 8:45 am]
BILLING CODE 4140–01–P
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
PO 00000
Frm 00045
Fmt 4703
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75121
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.
Discovery of Novel Pharmacophores
Inhibiting the Growth of
Mycobacterium tuberculosis
Description of Technology:
Tuberculosis (TB) caused by
Mycobacterium tuberculosis infects
roughly one third of the world
population and approximately 8 million
people develop TB annually. The
emergence of multi-drug resistant
(MDR) and extensively drug-resistant
(XDR) TB strains highlight the need for
new drugs against TB. The inventions
described herein are small molecules
with drug-like properties that inhibit the
growth of Mycobacterium tuberculosis.
The compounds were discovered
utilizing high-throughput screening of a
101,000 compound library. Three
hundred active compounds inhibit
Mycobacterium tuberculosis growth by
90% or greater in in vitro assays with
MIC values ranging from 1.6 to less than
0.1 micrograms/ml, and showing
minimal toxicity in tissue culture cells.
Structure similarity analyses of the
compounds reveal 44 chemical clusters
representing 250 active compounds.
Applications: Treatment of TB
infections.
Advantages: Novel drug candidates
against TB.
Development Status: In vitro data can
be provided upon request.
Market: TB therapeutics.
Inventors: Robert C. Goldman (NIAID)
et al.
Publications: Manuscript in
preparation.
Patent Status: U.S. Provisional
Application No. 61/092,710 filed 28
Aug 2008 (HHS Reference No. E–310–
2008/0–US–01).
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: Kevin W. Chang,
Ph.D.; 301–435–5018;
changke@mail.nih.gov.
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75122
Federal Register / Vol. 73, No. 238 / Wednesday, December 10, 2008 / Notices
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 this ‘‘Discovery of Novel
Pharmacophores Inhibiting the Growth
of Mycobacterium Tuberculosis’’. Please
contact Anna Amar at 301–451–3525 for
more information.
mstockstill on PROD1PC66 with NOTICES
A Varicella-Zoster Virus Mutant That Is
Markedly Impaired for Latent Infection
Available for the Development of
Shingles Vaccines and Diagnostics
Description of Technology:
Reactivation of latent Varicella-Zoster
virus (VZV) infection is the cause of
shingles, which is prominent in adults
over the age of 60 and individuals who
have compromised immune systems,
due to HIV infection, cancer treatment
and/or transplant. Shingles is a
worldwide health concern that affects
approximately 600,000 Americans each
year. The incidence of shingles is also
high in Europe, South America, and
India; the latter having an estimated two
million individuals affected, yearly.
Recent research studies show that VZV
vaccines have a significant effect on
decreasing the incidence of shingles in
elderly.
The current technology describes
compositions, cells and methods related
to the production and use of a mutant
VZV and the development of vaccines
against the infectious agent. Latent VZV
expresses a limited repertoire of viral
genes including the following six open
reading frames (ORFs): 4, 21, 29, 62, 63,
and 66. The present invention describes
an ORF29 mutant VZV that
demonstrates a weakened ability to
establish latency in animal studies. The
current technology provides methods
for using the mutant in the development
of live vaccines and diagnostic tools. A
related invention is described in PCT/
US05/021788 (publication number
WO2006012092).
Applications: Development of
vaccines and diagnostics for prevention
of shingles.
Development Status: Pre-clinical
studies have been performed to
demonstrate the reduced latency of the
ORF29 mutant VZV in animals.
Inventors: Jeffrey Cohen (NIAID) and
Lesley Pesnicak (NIAID).
Patent Status: U.S. Provisional
Application No. 60/857,766 filed 09
Nov 2006 (HHS Reference No. E–029–
2007/0–US–01); PCT Application No.
PCT/US2007/084331 filed 09 Nov 2007,
which published as WO 2008/079539
on 03 Jul 2008 (HHS Reference No. E–
029–2007/0–PCT–02).
VerDate Aug<31>2005
16:49 Dec 09, 2008
Jkt 217001
Licensing Status: Available for
licensing and commercial development.
Licensing Contact: Kevin W. Chang,
Ph.D.; 301–435–5018;
changke@mail.nih.gov.
Collaborative Research Opportunity:
The NIAID Laboratory of Clinical
Infectious Diseases is seeking statements
of capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize vaccine strains of VZV
vaccine with impaired latency. Please
contact Kelly Murphy, J.D., M.S., at 301/
451–3523 or murphykt@niaid.nih.gov
for more information.
Anti-Plasmodium Compositions and
Methods of Use
Description of Technology: The
present invention comprises peptides/
antibodies specific for the binding
proteins of Plasmodium, a parasite
responsible for malaria, hence in effect
blocking the parasite’s binding to the
erythrocytes. Also included are methods
for their use in preventing, diagnosing
or treating the related infections.
Although malaria is virtually
eradicated in the United States, it
continues to be one of the most serious
infectious diseases in the world, killing
millions of people each year in the
countries throughout Africa, Asia and
Latin America. In fact, over 41% of the
world population lives in the regions
affected by malaria. In vitro studies
using the antibodies described in the
current technology showed ∼80%
reduction in the number of blood cells
infected with Plasmodium parasite.
Infectivity studies using peptides
demonstrated that they are also
specifically able to prevent binding of
parasites to blood cells. The claimed
antibodies and peptides can also be
used for immunization of humans and
animals, or for development of
diagnostic kits capable of detecting the
presence, localization and quantity of
the Plasmodium parasites in tissues and
cells.
Applications: Diagnostics
development; Vaccines development.
Inventors: David L. Narum and Kim
Lee Sim (NIAID).
Relevant Publications:
1. Sim BK, Narum DL, Liang H,
Fuhrmann SR, Obaldia N 3rd,
Gramzinski R, Aguiar J, Haynes JD,
Moch JK, Hoffman SL. Induction of
biologically active antibodies in mice,
rabbits, and monkeys by Plasmodium
falciparum EBA–175 region II DNA
vaccine. Mol Med. 2001 Apr;7(4):247–
254.
2. Narum DL, Haynes JD, Fuhrmann
S, Moch K, Liang H, Hoffman SL, Sim
BK. Antibodies against the Plasmodium
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
falciparum receptor binding domain of
EBA–175 block invasion pathways that
do not involve sialic acids. Infect
Immun. 2000 Apr;68(4):1964–1966.
3. Liang H, Narum DL, Fuhrmann SR,
Luu T, Sim BK. A recombinant
baculovirus-expressed Plasmodium
falciparum receptor-binding domain of
erythrocyte binding protein EBA–175
biologically mimics native protein.
Infect Immun. 2000 Jun;68(6):3564–
3568.
Patent Status: HHS Reference No. E–
004–2004/2—
• U.S. Patent No. 7,025,961 issued 11
Apr 2006
• Australian Patent No. 20042011615
issued 11 May 2007
• Canadian Application No.
CA236247
• Japanese Application No. JP2000–
602280 (published as JP,2002–
540770,A)
Licensing Status: Available for
exclusive or non-exclusive licensing.
Licensing Contact: RC Tang, JD, LLM;
301–435–5031; tangr@mail.nih.gov
Dated: December 1, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–29146 Filed 12–9–08; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Mandatory Guidelines for Federal
Workplace Drug Testing Programs
Correction
In notice document E8–26726
beginning on page 71858 in the issue
ofTuesday, November 25, 2008, make
the following correction:
On page 71858, in the first column,
under the DATES heading, in the first
line, ‘‘Effective Date: March 25, 2008’’
shouldread ‘‘Effective Date: May 1,
2010’’.
[FR Doc. Z8–26726 Filed 12–9–08; 8:45 am]
BILLING CODE 1505–01–D
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]]>Agencies
[Federal Register Volume 73, Number 238 (Wednesday, December 10, 2008)]
[Notices]
[Pages 75121-75122]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29146]
-----------------------------------------------------------------------
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.
Discovery of Novel Pharmacophores Inhibiting the Growth of
Mycobacterium tuberculosis
Description of Technology: Tuberculosis (TB) caused by
Mycobacterium tuberculosis infects roughly one third of the world
population and approximately 8 million people develop TB annually. The
emergence of multi-drug resistant (MDR) and extensively drug-resistant
(XDR) TB strains highlight the need for new drugs against TB. The
inventions described herein are small molecules with drug-like
properties that inhibit the growth of Mycobacterium tuberculosis. The
compounds were discovered utilizing high-throughput screening of a
101,000 compound library. Three hundred active compounds inhibit
Mycobacterium tuberculosis growth by 90% or greater in in vitro assays
with MIC values ranging from 1.6 to less than 0.1 micrograms/ml, and
showing minimal toxicity in tissue culture cells. Structure similarity
analyses of the compounds reveal 44 chemical clusters representing 250
active compounds.
Applications: Treatment of TB infections.
Advantages: Novel drug candidates against TB.
Development Status: In vitro data can be provided upon request.
Market: TB therapeutics.
Inventors: Robert C. Goldman (NIAID) et al.
Publications: Manuscript in preparation.
Patent Status: U.S. Provisional Application No. 61/092,710 filed 28
Aug 2008 (HHS Reference No. E-310-2008/0-US-01).
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018;
changke@mail.nih.gov.
[[Page 75122]]
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
this ``Discovery of Novel Pharmacophores Inhibiting the Growth of
Mycobacterium Tuberculosis''. Please contact Anna Amar at 301-451-3525
for more information.
A Varicella-Zoster Virus Mutant That Is Markedly Impaired for Latent
Infection Available for the Development of Shingles Vaccines and
Diagnostics
Description of Technology: Reactivation of latent Varicella-Zoster
virus (VZV) infection is the cause of shingles, which is prominent in
adults over the age of 60 and individuals who have compromised immune
systems, due to HIV infection, cancer treatment and/or transplant.
Shingles is a worldwide health concern that affects approximately
600,000 Americans each year. The incidence of shingles is also high in
Europe, South America, and India; the latter having an estimated two
million individuals affected, yearly. Recent research studies show that
VZV vaccines have a significant effect on decreasing the incidence of
shingles in elderly.
The current technology describes compositions, cells and methods
related to the production and use of a mutant VZV and the development
of vaccines against the infectious agent. Latent VZV expresses a
limited repertoire of viral genes including the following six open
reading frames (ORFs): 4, 21, 29, 62, 63, and 66. The present invention
describes an ORF29 mutant VZV that demonstrates a weakened ability to
establish latency in animal studies. The current technology provides
methods for using the mutant in the development of live vaccines and
diagnostic tools. A related invention is described in PCT/US05/021788
(publication number WO2006012092).
Applications: Development of vaccines and diagnostics for
prevention of shingles.
Development Status: Pre-clinical studies have been performed to
demonstrate the reduced latency of the ORF29 mutant VZV in animals.
Inventors: Jeffrey Cohen (NIAID) and Lesley Pesnicak (NIAID).
Patent Status: U.S. Provisional Application No. 60/857,766 filed 09
Nov 2006 (HHS Reference No. E-029-2007/0-US-01); PCT Application No.
PCT/US2007/084331 filed 09 Nov 2007, which published as WO 2008/079539
on 03 Jul 2008 (HHS Reference No. E-029-2007/0-PCT-02).
Licensing Status: Available for licensing and commercial
development.
Licensing Contact: Kevin W. Chang, Ph.D.; 301-435-5018;
changke@mail.nih.gov.
Collaborative Research Opportunity: The NIAID Laboratory of
Clinical Infectious Diseases is seeking statements of capability or
interest from parties interested in collaborative research to further
develop, evaluate, or commercialize vaccine strains of VZV vaccine with
impaired latency. Please contact Kelly Murphy, J.D., M.S., at 301/451-
3523 or murphykt@niaid.nih.gov for more information.
Anti-Plasmodium Compositions and Methods of Use
Description of Technology: The present invention comprises
peptides/antibodies specific for the binding proteins of Plasmodium, a
parasite responsible for malaria, hence in effect blocking the
parasite's binding to the erythrocytes. Also included are methods for
their use in preventing, diagnosing or treating the related infections.
Although malaria is virtually eradicated in the United States, it
continues to be one of the most serious infectious diseases in the
world, killing millions of people each year in the countries throughout
Africa, Asia and Latin America. In fact, over 41% of the world
population lives in the regions affected by malaria. In vitro studies
using the antibodies described in the current technology showed ~80%
reduction in the number of blood cells infected with Plasmodium
parasite. Infectivity studies using peptides demonstrated that they are
also specifically able to prevent binding of parasites to blood cells.
The claimed antibodies and peptides can also be used for immunization
of humans and animals, or for development of diagnostic kits capable of
detecting the presence, localization and quantity of the Plasmodium
parasites in tissues and cells.
Applications: Diagnostics development; Vaccines development.
Inventors: David L. Narum and Kim Lee Sim (NIAID).
Relevant Publications:
1. Sim BK, Narum DL, Liang H, Fuhrmann SR, Obaldia N 3rd,
Gramzinski R, Aguiar J, Haynes JD, Moch JK, Hoffman SL. Induction of
biologically active antibodies in mice, rabbits, and monkeys by
Plasmodium falciparum EBA-175 region II DNA vaccine. Mol Med. 2001
Apr;7(4):247-254.
2. Narum DL, Haynes JD, Fuhrmann S, Moch K, Liang H, Hoffman SL,
Sim BK. Antibodies against the Plasmodium falciparum receptor binding
domain of EBA-175 block invasion pathways that do not involve sialic
acids. Infect Immun. 2000 Apr;68(4):1964-1966.
3. Liang H, Narum DL, Fuhrmann SR, Luu T, Sim BK. A recombinant
baculovirus-expressed Plasmodium falciparum receptor-binding domain of
erythrocyte binding protein EBA-175 biologically mimics native protein.
Infect Immun. 2000 Jun;68(6):3564-3568.
Patent Status: HHS Reference No. E-004-2004/2--
U.S. Patent No. 7,025,961 issued 11 Apr 2006
Australian Patent No. 20042011615 issued 11 May 2007
Canadian Application No. CA236247
Japanese Application No. JP2000-602280 (published as
JP,2002-540770,A)
Licensing Status: Available for exclusive or non-exclusive
licensing.
Licensing Contact: RC Tang, JD, LLM; 301-435-5031;
tangr@mail.nih.gov
Dated: December 1, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of
Technology Transfer, National Institutes of Health.
[FR Doc. E8-29146 Filed 12-9-08; 8:45 am]
BILLING CODE 4140-01-P
