Government-Owned Inventions; Availability for Licensing, 75121-75122 [E8-29146]

Download as PDF 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 VerDate Aug<31>2005 16:49 Dec 09, 2008 Jkt 217001 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 Sfmt 4703 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. E:\FR\FM\10DEN1.SGM 10DEN1 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 E:\FR\FM\10DEN1.SGM 10DEN1

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]


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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