Government-Owned Inventions; Availability for Licensing, 3619-3620 [E9-978]

Download as PDF mstockstill on PROD1PC66 with NOTICES Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Notices b. Data on the growth of L. monocytogenes on non-food surfaces including environmental biofilm growth. 6. Factors that influence the environmental contamination and the cross-contamination of food by L. monocytogenes in retail facilities, including: a. Data and information on the potential transfer of L. monocytogenes to food from the retail environment, e.g., experimental studies on the transfer to food from drains, slicers, food contact surfaces, and non-food contact surfaces; and b. Data and information on food handlers’ activities, e.g., observations of food handlers’ practices and monitoring of specific food safety actions in retail facilities (e.g., glove usage, hand hygiene practices, and cleaning practices). 7. Identity and effectiveness of control measures or interventions intended to reduce levels and frequency of L. monocytogenes in the retail environment, including: a. Environmental sanitation procedures including the sanitizers and protocols used, frequency of application, and efficiency; and b. Worker sanitation procedures including frequencies, protocols, and efficiency. 8. Any other data related to the occurrence, growth, and control of L. monocytogenes in retail facilities. As the project progresses, additional data needs may be identified. Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov. III. References The following references are on display in the Division of Dockets Management (see ADDRESSES) and may VerDate Nov<24>2008 18:54 Jan 16, 2009 Jkt 217001 be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) 1. U.S. Department of Health and Human Services, Healthy People 2010, v. 1. Washington, DC, 2000, https:// healthypeople.gov. 2. U.S. Department of Health and Human Services and U.S. Department of Agriculture/ Food Safety and Inspection Service, ‘‘Quantitative Assessment of Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods,’’ September 2003, https://www.foodsafety.gov/~dms/lmr2toc.html. 3. U.S. Department of Health and Human Services, Food and Drug Administration/ Centers for Disease Control and Prevention, ‘‘Reducing the Risk of Listeria monocytogenes FDA/CDC 2003 Update of the Listeria Action Plan,’’ November 2003, https:// www.cfsan.fda.gov/~dms/lmr2plan.html. 4. Gombas, D.E., Chen, Y., Clavero, R.S., and Scott, V.N. (2003). Survey of Listeria monocytogenes in ready-to-eat foods. Journal of Food Protection, 66(4), 559–569. 5. Draughon, A.F. (2006). A collaborative analysis/risk assessment of Listeria monocytogenes in ready-to-eat processed meat and poultry collected in four FoodNet states. Symposium S–16: Contamination of ready-to-eat foods: transfer and risk: Listeria monocytogenes and other microorganisms. International Association for Food Protection 93rd Annual Meeting, Calgary, Alberta. August 13–16. Dated: January 12, 2009. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E9–938 Filed 1–16–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Advisory Council on Migrant Health; Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting: Name: National Advisory Council on Migrant Health. Dates and Times: February 9, 2009, 8:30 a.m. to 5 p.m.; February 10, 2009, 8:30 a.m. to 5 p.m. Place: The Parklawn Building, Twinbrook Room, 3rd Floor, 5600 Fishers Lane, Rockville, Maryland 20857, Telephone: (301) 594–4303, Fax: (301) 443–0248. Status: The meeting will be open to the public. PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 3619 Purpose: The purpose of the meeting is to discuss services and issues related to the health of migrant and seasonal farmworkers and their families and to formulate recommendations for the Secretary of Health and Human Services. Agenda: The agenda includes an overview of the Council’s general business activities. The Council will also hear presentations from experts on farmworker issues, including the status of farmworker health at the local and national levels. Agenda items are subject to change as priorities indicate. For Further Information Contact: Gladys Cate, Office of Minority and Special Populations, Bureau of Primary Health Care, Health Resources and Services Administration, 5600 Fishers Lane, Maryland 20857; telephone (301) 594–0367. Wendy Ponton, Director, Office of Management. [FR Doc. E9–1067 Filed 1–16–09; 8:45 am] BILLING CODE 4165–15–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 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. Mice With a Conditional LoxP-Flanked Glucosylceramide Synthase Allele Controlling Glycosphingolipid Synthesis Description of Technology: Glycosphingolipids are organizational building blocks of plasma membranes that participate in key cellular E:\FR\FM\21JAN1.SGM 21JAN1 3620 Federal Register / Vol. 74, No. 12 / Wednesday, January 21, 2009 / Notices mstockstill on PROD1PC66 with NOTICES functions, such as signaling and cell-tocell interactions. Glucosylceramide synthase—encoded by the Ugcg gene— controls the first committed step in the major pathway of glycosphingolipid synthesis. Global disruption of the Ugcg gene in mice is lethal during gastrulation. The inventors have established a Ugcg allele flanked by loxP sites (floxed). When cre recombinase was expressed in the nervous system under control of the nestin promoter, the floxed gene underwent recombination, resulting in a substantial reduction of Ugcg expression and of glycosphingolipid ganglio-series levels. The mice deficient in Ugcg expression in the nervous system show a striking loss of Purkinje cells and abnormal neurologic sphingo-lipid behavior. The Research Tools available are mice with a floxed Ugcg allele that can be deleted in a conditional manner. These mice carrying floxed Ugcg alleles will be useful for delineating the functional roles of glycosphingolipid synthesis in the nervous system and in other physiologic systems. Applications • Study of the functional roles of glycosphingolipid synthesis in the nervous system and other physiologic systems. • The floxed Ugcg allele will facilitate analysis of the function of glycosphingolipids in development, physiology, and in diseases such as diabetes and cancer. Development Status: Ready to Use. Inventors: Richard L. Proia (NIDDK). Publication: T Yamashita, ML Allende, DN Kalkofen, N Werth, K Sandhoff, RL Proia. Conditional LoxPflanked glucosylceramide synthase allele controlling glycosphingolipid synthesis. Genesis 2005 Dec;43(4):175– 180. Patent Status: HHS Reference No. E– 320–2007/0—Research Material. Patent protection is not being pursued for this technology. Licensing Status: Available for licensing under a Biological Materials license agreement. Licensing Contact: Suryanarayana (Sury) Vepa, PhD, J.D.; 301–435–5020; vepas@mail.nih.gov. Collaborative Research Opportunity: The NIDDK Genetics of Development and Disease Branch is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize the sphingolipid metabolism in physiology and disease. Please contact Dr. Proia at proia@nih.gov for more information. VerDate Nov<24>2008 18:54 Jan 16, 2009 Jkt 217001 Mutant Nuclear Orphan Receptor for Drug Metabolism Assays Description of Technology: The constitutively active nuclear orphan receptor (CAR) activates transcription of genes encoding various drugmetabolizing enzymes, such as cytochrome P450, in response to drug exposure. While the direct activation of CAR in response to various drugs has been observed in vivo, CAR is always active in cell-based transfection assays, even in the absence of activating drugs. This constitutive activity of CAR makes it difficult to perform accurate in vitro assays to measure drug metabolism. The NIH has obtained patent protection for modified CAR proteins that can be directly activated by drugs in vitro. This technology may potentially be used in the development of more efficient and cost-effective cellbased drug metabolism assays. Applications: Development of improved in vitro assays to measure drug metabolism. Inventors: Masahiko Negishi et al. (NIEHS). Publications 1. T Sueyoshi, T Kawamoto, I Zelko, P Honkakoski, M Negishi. The repressed nuclear receptor CAR responds to phenobarbital in activating the human CYP2B6 gene. J Biol Chem. 1999 Mar 5;274(10):6043–6046. 2. T Kawamoto, S Kakizaki, K Yoshinari, M Negishi. Estrogen activation of the nuclear orphan receptor CAR (constitutive active receptor) in induction of the mouse Cyp2b10 gene. Mol Endocrinol. 2000 Nov;14(11):1897–1905. Patent Status: U.S. Patent No. 7,365,160 issued 29 Apr 2008 (HHS Reference No. E–034–2002/0–US–03). Licensing Status: Available for exclusive and non-exclusive licensing. Licensing Contact: Tara L. Kirby, PhD; 301–435–4426; tarak@mail.nih.gov. Dated: January 8, 2009. Richard U. Rodriguez, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E9–978 Filed 1–16–09; 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. PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 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. Use of Mono-Amine Oxidase Inhibitors To Prevent Herpes Virus Infections and Reactivation From Latency Description of Technology: Available for licensing are methods of using Monoamine Oxidase Inhibitors (MAOIs) to prevent alpha-herpesvirus lytic infections, such as those caused by Herpes simplex virus (HSV–1 or HSV– 2) and Varicella zoster virus (VZV), and to possibly prevent the periodic reactivation of these viruses from latency. MAOIs have been historically used to treat depression, hypertension, and related diseases. The invention describes how MAOIs can also inhibit LSD1, a histone/protein demethylase that is required for initiation of alphaherpesvirus lytic infection. After an initial lytic infection, alphaherpesviruses establish latent infections in sensory neurons and undergo periodic reactivation that results in disease ranging from mild lesions to life threatening encephalitis. Investigators have determined that MAOIs may also block the reactivation process. Due to the nature of the target LSD1 and its role in modulating chromatin modifications, these drugs could also prevent infection by or reactivation of other nuclear viruses. Alpha-herpesviruses infections are common worldwide, with 57% to 80% of adults being seropositive for HSV. Recurrent labial herpes affects roughly one third of the U.S. population, and these patients typically experience 1 to 6 episodes per year. Genital herpes can result from infection with either HSV type and HSV–1 has become an important cause of genital herpes in E:\FR\FM\21JAN1.SGM 21JAN1

Agencies

[Federal Register Volume 74, Number 12 (Wednesday, January 21, 2009)]
[Notices]
[Pages 3619-3620]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-978]


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

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.

Mice With a Conditional LoxP-Flanked Glucosylceramide Synthase Allele 
Controlling Glycosphingolipid Synthesis

    Description of Technology: Glycosphingolipids are organizational 
building blocks of plasma membranes that participate in key cellular

[[Page 3620]]

functions, such as signaling and cell-to-cell interactions. 
Glucosylceramide synthase--encoded by the Ugcg gene--controls the first 
committed step in the major pathway of glycosphingolipid synthesis. 
Global disruption of the Ugcg gene in mice is lethal during 
gastrulation. The inventors have established a Ugcg allele flanked by 
loxP sites (floxed). When cre recombinase was expressed in the nervous 
system under control of the nestin promoter, the floxed gene underwent 
recombination, resulting in a substantial reduction of Ugcg expression 
and of glycosphingolipid ganglio-series levels. The mice deficient in 
Ugcg expression in the nervous system show a striking loss of Purkinje 
cells and abnormal neurologic sphingo-lipid behavior.
    The Research Tools available are mice with a floxed Ugcg allele 
that can be deleted in a conditional manner. These mice carrying floxed 
Ugcg alleles will be useful for delineating the functional roles of 
glycosphingolipid synthesis in the nervous system and in other 
physiologic systems.

Applications

     Study of the functional roles of glycosphingolipid 
synthesis in the nervous system and other physiologic systems.
     The floxed Ugcg allele will facilitate analysis of the 
function of glycosphingolipids in development, physiology, and in 
diseases such as diabetes and cancer.
    Development Status: Ready to Use.
    Inventors: Richard L. Proia (NIDDK).
    Publication: T Yamashita, ML Allende, DN Kalkofen, N Werth, K 
Sandhoff, RL Proia. Conditional LoxP-flanked glucosylceramide synthase 
allele controlling glycosphingolipid synthesis. Genesis 2005 
Dec;43(4):175-180.
    Patent Status: HHS Reference No. E-320-2007/0--Research Material. 
Patent protection is not being pursued for this technology.
    Licensing Status: Available for licensing under a Biological 
Materials license agreement.
    Licensing Contact: Suryanarayana (Sury) Vepa, PhD, J.D.; 301-435-
5020; vepas@mail.nih.gov.
    Collaborative Research Opportunity: The NIDDK Genetics of 
Development and Disease Branch is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize the sphingolipid metabolism in 
physiology and disease. Please contact Dr. Proia at proia@nih.gov for 
more information.

Mutant Nuclear Orphan Receptor for Drug Metabolism Assays

    Description of Technology: The constitutively active nuclear orphan 
receptor (CAR) activates transcription of genes encoding various drug-
metabolizing enzymes, such as cytochrome P450, in response to drug 
exposure. While the direct activation of CAR in response to various 
drugs has been observed in vivo, CAR is always active in cell-based 
transfection assays, even in the absence of activating drugs. This 
constitutive activity of CAR makes it difficult to perform accurate in 
vitro assays to measure drug metabolism.
    The NIH has obtained patent protection for modified CAR proteins 
that can be directly activated by drugs in vitro. This technology may 
potentially be used in the development of more efficient and cost-
effective cell-based drug metabolism assays.
    Applications: Development of improved in vitro assays to measure 
drug metabolism.
    Inventors: Masahiko Negishi et al. (NIEHS).

Publications

    1. T Sueyoshi, T Kawamoto, I Zelko, P Honkakoski, M Negishi. The 
repressed nuclear receptor CAR responds to phenobarbital in activating 
the human CYP2B6 gene. J Biol Chem. 1999 Mar 5;274(10):6043-6046.
    2. T Kawamoto, S Kakizaki, K Yoshinari, M Negishi. Estrogen 
activation of the nuclear orphan receptor CAR (constitutive active 
receptor) in induction of the mouse Cyp2b10 gene. Mol Endocrinol. 2000 
Nov;14(11):1897-1905.
    Patent Status: U.S. Patent No. 7,365,160 issued 29 Apr 2008 (HHS 
Reference No. E-034-2002/0-US-03).
    Licensing Status: Available for exclusive and non-exclusive 
licensing.
    Licensing Contact: Tara L. Kirby, PhD; 301-435-4426; 
tarak@mail.nih.gov.

    Dated: January 8, 2009.
Richard U. Rodriguez,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E9-978 Filed 1-16-09; 8:45 am]
BILLING CODE 4140-01-P

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