Government-Owned Inventions; Availability for Licensing, 63309-63310 [2011-26338]

Download as PDF jlentini on DSK4TPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices 301–827–5988, e-mail: lou.gallagher@fda.hhs.gov. Registration: Mail, fax, or e-mail your registration information (including name, title, firm name, address, telephone and fax numbers) to Lou Gallagher (see Contact Person) by November 10, 2011. There is no registration fee for the public workshop. Early registration is recommended because seating is limited. Registration on the day of the public workshop will be provided on a space available basis beginning at 8 a.m. If you need special accommodations due to a disability, please contact Lou Gallagher (see Contact Person) at least 7 days in advance. SUPPLEMENTARY INFORMATION: Quantitative risk assessments (QRAs) are an important tool for evaluating the risks associated with new emerging infectious diseases (EIDs) that are relevant to blood and blood products and the benefits of mitigation options. QRAs make it possible for decisionmakers to develop policy for blood and blood product safety and availability using sound science and the best data and information available. Rapid data collection, information sharing, and analyses estimating the magnitude and probability of risk can be expedited by proactively building and maintaining critical relationships both within the Center for Biologics Evaluation and Research (CBER) and with external stakeholders. In this public workshop, CBER is seeking access to accurate, reliable data on factors such as disease prevalence, incubation periods, behavioral risks associated with disease transmission, potential donor exposure risks, and susceptibility to EIDs, product handling, usage, and other factors. Lack of data and information is a major challenge FDA faces when there is a new EID. The public workshop will: (1) Provide a forum for discussion of data used in conducting quantitative risk assessments for EIDs, (2) address approaches to facilitate the timely access to data required to evaluate public health measures designed to reduce the potential risk associated with EIDs that are relevant to blood and blood products, and (3) provide a forum for discussion of the development of new data sources and enhanced access to already existing data sources. Transcripts: Please be advised that as soon as possible after a transcript of the public workshop is available, it will be accessible on the Internet at: https:// www.fda.gov/BiologicsBloodVaccines/ NewsEvents/ WorkshopsMeetingsConferences/ VerDate Mar<15>2010 17:43 Oct 11, 2011 Jkt 226001 TranscriptsMinutes/default.htm. Transcripts of the public workshop may also be requested in writing from the Division of Freedom of Information (ELEM–1029), Food and Drug Administration, 12420 Parklawn Dr., Rockville, MD 20857. Dated: October 6, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–26295 Filed 10–11–11; 8:45 am] BILLING CODE 4160–01–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: 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. SUMMARY: Human Phospho-Serine134 Glucocorticoid Receptor Polyclonal Antibody: Useful for the Characterization of Glucocorticoid Signaling Processes, e.g., in Cancer and Inflammation Description of Technology: The glucocorticoid receptor (GR) functions as a hormone-dependent transcription factor that is involved in the maintenance of basal and stress-related homeostasis. Serine 134 is a newly discovered phosphorylation target on the human glucocorticoid receptor that becomes phosphorylated during stressactivating conditions such as ultraviolet irradiation, nutrient starvation, and oxidative stress. The inventors have PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 63309 developed a rabbit polyclonal antibody that specifically recognizes the Ser 134 phosphorylated form of the human glucocorticoid receptor. This antibody may be particularly useful for a variety of basic research applications, such as the characterization and study of glucocorticoid signaling in cancer, inflammation, and other diseases. The antibody is available as crude antisera and has been epitope purified; it has cross reactivity with human, rat, and mouse tissues. Potential Commercial Applications: Western analysis, immunoprecipitation, and immunofluorescence studies. Inventors: Amy Beckley and John Cidlowski (NIEHS). Related Publication: Molecular and Cellular Biology, In Press. Intellectual Property: HHS Reference No. E–182–2011/0—Research Tool. Patent protection is not being pursued for this technology. Licensing Status: This technology is available as a research tool under a Biological Materials License. Licensing Contact: Tara Kirby Ph.D.; 301–435–4426; tarak@nih.gov. Collaborative Research Opportunity: The NIEHS, Molecular Endocrine Group, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize Human PhosphoSerine134 Glucocorticoid Receptor Polyclonal Antibody. Please contact Elizabeth M. Denholm at denholme@niehs.nih.gov for more information. Infectious Hepatitis E Virus Genotype 3 Recombinants—Prospective Vaccine Candidates and Vector System Description of Technology: Infection by Hepatitis E virus (HEV) is a relevant health issue in a number of developing countries and it is also an emerging food-borne disease of industrialized countries. Genotype 1 and 2 infections are found exclusively in humans while genotype 3 and 4 viruses have been found not only in humans, but also swine, deer, mongoose, cattle, and rabbits. In particular, genotype 3 and 4 viruses are ubiquitously found in swine and undercooked pork is thought to be one of the sources of infection for cases of human infections in industrialized countries. This technology is a recombinant, infectious genotype 3 HEV that has been adapted to grow in cell culture and can potentially be used to develop vaccines against HEV or as a vector system to insert exogenous sequences into HEV. The virus (strain Kernow-C1, genotype 3) originated from a chronically infected E:\FR\FM\12OCN1.SGM 12OCN1 63310 Federal Register / Vol. 76, No. 197 / Wednesday, October 12, 2011 / Notices jlentini on DSK4TPTVN1PROD with NOTICES human subject and was adapted to grow in human hepatoma cells. The adapted virus is unique in that it contains an insertion of a portion of a human ribosomal protein in Open Reading Frame 1 of the virus. Desired exogenous sequences could potentially be placed in lieu of the insert without inactivating the virus, making the subject technology a prospective HEV vector platform. Potential Commercial Applications: • Vaccine—An infectious, recombinant HEV genotype 3 cDNA clone that could potentially be developed into a vaccine candidate. • HEV Vector Platform— Desired exogenous sequences can be inserted into the viral genome without inactivating the virus. Competitive Advantages: • Most of the HEV vaccines under development are subunit based while the subject technology could potentially be developed into a live, attenuated virus based vaccine. • Ability to insert exogenous sequences into the viral genome without inactivating the virus makes this subject technology a potential HEV based vector platform. Development Stage: • Early-stage • Pre-clinical • In vitro data available Inventors: Suzanne U. Emerson, Priyanka Shukla, Hanh T. Nguyen, and Robert H. Purcell (NIAID). Publication: Shukla P, et al. Crossspecies infections of cultured cells by hepatitis E virus and discovery of an infectious virus-host recombinant. Proc Natl Acad Sci U S A. 2011 Feb 8;108(6):2438–2443. [PMID 21262830]. Intellectual Property: HHS Reference No. E–074–2011/0—U.S. Provisional Patent Application No. 61/431,377 filed 10 Jan 2011. Licensing Contact: Kevin W. Chang, PhD; 301–435–5018; changke@mail.nih.gov. Collaborative Research Opportunities: The National Institute of Allergy and Infectious Diseases is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate or commercialize hepatitis E virus vaccines. For collaboration opportunities, please contact Wade Green, PhD at 301–827–0258 or williamswa@niaid.nih.gov. Diagnostic H5N1 Avian Influenza Virus Peptides Description of Technology: The recent spread of highly pathogenic H5N1 avian influenza viruses among poultry and transmission of these viruses to humans raises concerns of a potential influenza VerDate Mar<15>2010 17:43 Oct 11, 2011 Jkt 226001 pandemic. There is a need to track the spread of these viruses both in the animal and human populations to avert or reduce the impact of any potential influenza pandemic as well as to know the actual number (accurate surveillance) of people infected with H5N1, including individuals with subclinical H5N1 infection. The subject technology is a specific combination of H5N1 peptides useful for assays to detect antibodies generated against a wide range of different H5N1 strains. The combination of peptides was able to specifically detect antiH5N1 antibodies from serum samples of H5N1 survivors at early and later times post infection while excluding antibodies generated in individuals infected with other strains of influenza virus. Also, the peptides did not react with sera from individuals vaccinated with H5N1 vaccine, in contrast to the strain-specific detection of anti-H5N1 antibodies in sera from infected individuals. Immunoassays using the H5N1 peptide combination provide highly specific, sensitive and reproducible methods for diagnosing H5N1 infection in humans and animals. Potential Commercial Applications: Diagnostics for influenza virus specific antibodies in humans and animals. Competitive Advantages: High specificity, sensitivity, and reproducibility. Development Stage: Data obtained from clinical samples can be provided upon request. Inventors: Hana Golding and Surender Khurana (FDA). Intellectual Property: HHS Reference No. E–093–2010/0—PCT Application No. PCT/US2011/032555 filed 14 Apr 2011. Related Technology: HHS Reference No. E–236–2007/3—U.S. Patent Application No. 12/664,052 filed 10 Dec 2008. Licensing Contact: Kevin W. Chang, PhD; 301–435–5018; changke@mail.nih.gov. Dated: October 4, 2011. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 2011–26338 Filed 10–11–11; 8:45 am] BILLING CODE 4140–01–P PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center On Minority and Health Disparities Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the following meetings. 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 grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, 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 Center on Minority Health and Health Disparities Special Emphasis Panel; NIMHD Health Disparities Research (R01). Date: November 7–8, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Gaithersburg Marriott Washington Center, 9751 Washingtonian Boulevard, Gaithersburg, MD 20878. Contact Person: Maryline Laude-Sharp, PhD, Scientific Review Officer, National Institute on Minority Health and Health Disparities, National Institutes of Health, 6707 Democracy Blvd., MSC. 5465, Suite 800, Bethesda, MD 20892, (301) 451–9536, mlaudesharp@mail.nih.gov. Name of Committee: National Center on Minority Health and Health Disparities Special Emphasis Panel; NIMHD Support for Conference and Scientific meetings (R13) 2012. Date: November 14, 2011. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Two Democracy Plaza, 6707 Democracy Blvd., Bethesda, MD 20892 (Virtual Meeting). Contact Person: Maryline Laude-Sharp, PhD, Scientific Review Officer, National Institute on Minority Health and Health Disparities, National Institutes of Health, 6707 Democracy Blvd., MSC. 5465, Suite 800, Bethesda, MD 20892, (301) 451–9536, mlaudesharp@mail.nih.gov. Dated: October 5, 2011. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2011–26360 Filed 10–11–11; 8:45 am] BILLING CODE 4140–01–P Frm 00033 Fmt 4703 Sfmt 9990 E:\FR\FM\12OCN1.SGM 12OCN1

Agencies

[Federal Register Volume 76, Number 197 (Wednesday, October 12, 2011)]
[Notices]
[Pages 63309-63310]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26338]


-----------------------------------------------------------------------

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.

Human Phospho-Serine134 Glucocorticoid Receptor Polyclonal Antibody: 
Useful for the Characterization of Glucocorticoid Signaling Processes, 
e.g., in Cancer and Inflammation

    Description of Technology: The glucocorticoid receptor (GR) 
functions as a hormone-dependent transcription factor that is involved 
in the maintenance of basal and stress-related homeostasis. Serine 134 
is a newly discovered phosphorylation target on the human 
glucocorticoid receptor that becomes phosphorylated during stress-
activating conditions such as ultraviolet irradiation, nutrient 
starvation, and oxidative stress. The inventors have developed a rabbit 
polyclonal antibody that specifically recognizes the Ser 134 
phosphorylated form of the human glucocorticoid receptor. This antibody 
may be particularly useful for a variety of basic research 
applications, such as the characterization and study of glucocorticoid 
signaling in cancer, inflammation, and other diseases.
    The antibody is available as crude antisera and has been epitope 
purified; it has cross reactivity with human, rat, and mouse tissues.
    Potential Commercial Applications: Western analysis, 
immunoprecipitation, and immunofluorescence studies.
    Inventors: Amy Beckley and John Cidlowski (NIEHS).
    Related Publication: Molecular and Cellular Biology, In Press.
    Intellectual Property: HHS Reference No. E-182-2011/0--Research 
Tool. Patent protection is not being pursued for this technology.
    Licensing Status: This technology is available as a research tool 
under a Biological Materials License.
    Licensing Contact: Tara Kirby Ph.D.; 301-435-4426; tarak@nih.gov.
    Collaborative Research Opportunity: The NIEHS, Molecular Endocrine 
Group, is seeking statements of capability or interest from parties 
interested in collaborative research to further develop, evaluate, or 
commercialize Human Phospho-Serine134 Glucocorticoid Receptor 
Polyclonal Antibody. Please contact Elizabeth M. Denholm at 
denholme@niehs.nih.gov for more information.

Infectious Hepatitis E Virus Genotype 3 Recombinants--Prospective 
Vaccine Candidates and Vector System

    Description of Technology: Infection by Hepatitis E virus (HEV) is 
a relevant health issue in a number of developing countries and it is 
also an emerging food-borne disease of industrialized countries. 
Genotype 1 and 2 infections are found exclusively in humans while 
genotype 3 and 4 viruses have been found not only in humans, but also 
swine, deer, mongoose, cattle, and rabbits. In particular, genotype 3 
and 4 viruses are ubiquitously found in swine and undercooked pork is 
thought to be one of the sources of infection for cases of human 
infections in industrialized countries.
    This technology is a recombinant, infectious genotype 3 HEV that 
has been adapted to grow in cell culture and can potentially be used to 
develop vaccines against HEV or as a vector system to insert exogenous 
sequences into HEV. The virus (strain Kernow-C1, genotype 3) originated 
from a chronically infected

[[Page 63310]]

human subject and was adapted to grow in human hepatoma cells. The 
adapted virus is unique in that it contains an insertion of a portion 
of a human ribosomal protein in Open Reading Frame 1 of the virus. 
Desired exogenous sequences could potentially be placed in lieu of the 
insert without inactivating the virus, making the subject technology a 
prospective HEV vector platform.
    Potential Commercial Applications:
     Vaccine--An infectious, recombinant HEV genotype 3 cDNA 
clone that could potentially be developed into a vaccine candidate.
     HEV Vector Platform-- Desired exogenous sequences can be 
inserted into the viral genome without inactivating the virus.
    Competitive Advantages:
     Most of the HEV vaccines under development are subunit 
based while the subject technology could potentially be developed into 
a live, attenuated virus based vaccine.
     Ability to insert exogenous sequences into the viral 
genome without inactivating the virus makes this subject technology a 
potential HEV based vector platform.
    Development Stage:
     Early-stage
     Pre-clinical
     In vitro data available
    Inventors: Suzanne U. Emerson, Priyanka Shukla, Hanh T. Nguyen, and 
Robert H. Purcell (NIAID).
    Publication: Shukla P, et al. Cross-species infections of cultured 
cells by hepatitis E virus and discovery of an infectious virus-host 
recombinant. Proc Natl Acad Sci U S A. 2011 Feb 8;108(6):2438-2443. 
[PMID 21262830].
    Intellectual Property: HHS Reference No. E-074-2011/0--U.S. 
Provisional Patent Application No. 61/431,377 filed 10 Jan 2011.
    Licensing Contact: Kevin W. Chang, PhD; 301-435-5018; 
changke@mail.nih.gov.
    Collaborative Research Opportunities: The National Institute of 
Allergy and Infectious Diseases is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate or commercialize hepatitis E virus vaccines. For 
collaboration opportunities, please contact Wade Green, PhD at 301-827-
0258 or williamswa@niaid.nih.gov.

Diagnostic H5N1 Avian Influenza Virus Peptides

    Description of Technology: The recent spread of highly pathogenic 
H5N1 avian influenza viruses among poultry and transmission of these 
viruses to humans raises concerns of a potential influenza pandemic. 
There is a need to track the spread of these viruses both in the animal 
and human populations to avert or reduce the impact of any potential 
influenza pandemic as well as to know the actual number (accurate 
surveillance) of people infected with H5N1, including individuals with 
subclinical H5N1 infection.
    The subject technology is a specific combination of H5N1 peptides 
useful for assays to detect antibodies generated against a wide range 
of different H5N1 strains. The combination of peptides was able to 
specifically detect anti-H5N1 antibodies from serum samples of H5N1 
survivors at early and later times post infection while excluding 
antibodies generated in individuals infected with other strains of 
influenza virus. Also, the peptides did not react with sera from 
individuals vaccinated with H5N1 vaccine, in contrast to the strain-
specific detection of anti-H5N1 antibodies in sera from infected 
individuals. Immunoassays using the H5N1 peptide combination provide 
highly specific, sensitive and reproducible methods for diagnosing H5N1 
infection in humans and animals.
    Potential Commercial Applications: Diagnostics for influenza virus 
specific antibodies in humans and animals.
    Competitive Advantages: High specificity, sensitivity, and 
reproducibility.
    Development Stage: Data obtained from clinical samples can be 
provided upon request.
    Inventors: Hana Golding and Surender Khurana (FDA).
    Intellectual Property: HHS Reference No. E-093-2010/0--PCT 
Application No. PCT/US2011/032555 filed 14 Apr 2011.
    Related Technology: HHS Reference No. E-236-2007/3--U.S. Patent 
Application No. 12/664,052 filed 10 Dec 2008.
    Licensing Contact: Kevin W. Chang, PhD; 301-435-5018; 
changke@mail.nih.gov.

    Dated: October 4, 2011.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 2011-26338 Filed 10-11-11; 8:45 am]
BILLING CODE 4140-01-P

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