Government-Owned Inventions; Availability for Licensing, 10103-10104 [05-3965]

Download as PDF Federal Register / Vol. 70, No. 40 / Wednesday, March 2, 2005 / Notices Measures of Effectiveness (not scored) 1. Does the applicant provide lucrative objective/quantifiable measures regarding the intended outcomes that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement? 2. Does the evaluation demonstrate how the goals and objectives will successfully increase the capacity of injury prevention and control programs to address the prevention of injuries and violence? Budget Justification (not scored) 1. Does the applicant provide a detailed budget with complete line-item justification of all proposed costs consistent with the stated activities in the program announcement? Details must include a breakdown in the categories of personnel (with time allocations for each), staff travel, communications and postage, equipment, supplies and any other costs? Does the budget projection include a narrative justification for all requested costs? Any sources of additional funding beyond the amount stipulated in this cooperative agreement should be indicated, including donated time or services. For each expense category, the budget should indicate CDC share, the applicant share and any other support. These funds should not be used to supplant existing efforts. V.2. Review and Selection Process Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff and for responsiveness by NCIPC. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified that their application did not meet submission requirements. An objective review panel will evaluate complete and responsive applications according to the criteria listed in the ‘‘V.1. Criteria’’ section above. CDC will provide justification for any decision to fund out of rank order. VI. Award Administration Information VI.1. Award Notices Successful applicants will receive a Notice of Award (NOA) from the CDC Procurement and Grants Office. The NOA shall be the only binding, authorizing document between the recipient and CDC. The NOA will be signed by an authorized Grants Management Officer and mailed to the VerDate jul<14>2003 15:00 Mar 01, 2005 Jkt 205001 recipient fiscal officer identified in the application. Unsuccessful applicants will receive notification of the results of the application review by mail. VI.2. Administrative and National Policy Requirements 45 CFR Part 74 and Part 92 For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: https:// www.access.gpo.gov/nara/cfr/cfr-tablesearch. html. An additional Certifications form from the PHS5161–1 application needs to be included in your Grants.gov electronic submission only. Refer to https://www.cdc. gov/od/pgo/funding/ PHS5161-1-Certificates.pdf. Once the form is filled out attach it to your Grants.gov submission as Other Attachments Form. The following additional requirements apply to this project: AR–9 Paperwork Reduction Act Requirements AR–10 Smoke-Free Workplace Requirements AR–11 Healthy People 2010 AR–12 Lobbying Restrictions AR–13 Prohibition on Use of CDC Funds for Certain Gun Control Activities AR–15 Proof of Non-Profit Status Additional information on these requirements can be found on the CDC web site at the following Internet address: https://www.cdc. gov/od/pgo/ funding/ARs.htm. VI.3. Reporting Requirements You must provide CDC with an original, plus two hard copies of the following reports: 1. Interim progress report, due no less than 90 days before the end of the budget period. The progress report will serve as your non-competing continuation application and must contain the following elements: a. Current Budget Period Activities Objectives. b. Current Budget Period Financial Progress. c. New Budget Period Program Proposed Activity Objectives. d. Budget. e. Measures of Effectiveness. f. Additional Requested Information. 2. Financial status report is due no more than 90 days after the end of the budget period. 3. Final financial and performance reports are due no more than 90 days after the end of the project period. These reports must be mailed to the Grants Management Specialist listed in PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 10103 the ‘‘Agency Contacts’’ section of this announcement. VII. Agency Contacts We encourage inquiries concerning this announcement. For general questions, contact: Technical Information Management Section, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770–488–2700. For program technical assistance, contact: Neil Rainford, Project Officer, National Center for Injury Prevention and Control, 2939 Flowers Road South, Atlanta, GA 30341, Telephone Number: 770–488–1122, Fax Number: 770–488– 1360, E-mail: NRainford@cdc. gov. For financial, grants management, or budget assistance, contact: James Masone, Grants Management Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770–488–2736, Email: Zft2@cdc. gov. VIII. Other Information This and other CDC funding opportunity announcements can be found on the CDC Web site, Internet address: https://www.cdc. gov. Click on ‘‘Funding’’ then ‘‘Grants and Cooperative Agreements.’’ Dated: February 23, 2005. William P. Nichols, Director, Procurement and Grants Office, Centers for Disease Control and Prevention. [FR Doc. 05–3981 Filed 3–1–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, DHHS. 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 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 E:\FR\FM\02MRN1.SGM 02MRN1 10104 Federal Register / Vol. 70, No. 40 / Wednesday, March 2, 2005 / Notices 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. Broadly Cross-Reactive HIV–1 Neutralizing Human Monoclonal Antibodies Drs. Dimiter S. Dimitrov and Mei-yun Zhang (NCI), U.S. Provisional Application No. 60/623,394 filed 29 Oct 2004 (DHHS Reference No. E–251–2004/ 0–US–01) Licensing Contact: Sally Hu; 301/435–5606; hus@mail.nih.gov. The invention provides for pharmaceutical compositions of, and methods of using potent cross-reactive human monoclonal antibodies to HIV. Specifically, the invention describes a competitive antigen panning (CAP) method of isolating antibodies that bind to the gp41 subunit of the HIV–1 envelop glycoprotein. Additionally, the invention includes compositions of the aforementioned antibodies and the epitopes recognized by the antibodies. Methods of using the invention in the development of vaccine immunogens for the treatment and prevention of HIV, as well as the detection of HIV in a mammal are also described. The invention has significant implications in the development of HIV inhibitors, vaccines, and research tools for understanding mechanisms of HIV entry. Further development of the disclosed invention may yield novel therapies and methods in the prevention of mother-to-child transmission of HIV, treatment of accidental exposure to HIV, and chronic infection in patients with resistance to current therapies. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. Endotoxin-Free Vaccine Candidate for Moraxella Catarrhalis Xin-Xing Gu and Daxin Peng (NIDCD), U.S. Provisional Application No. 60/577,244 filed 04 Jun 2004 (DHHS Reference No. E–174–2004/0–US–01); U.S. Provisional Application No. 60/ 613,139 filed 23 Sep 23 (DHHS Reference No. E–174–2004/1–US–01), Licensing Contact: Susan Ano; 301/435– 5515; anos@mail.nih.gov. This invention relates to a strain of Moraxella catarrhalis containing a gene mutation that prevents endotoxic lipooligosaccharide (LOS) synthesis and potential use of the mutant for developing novel vaccines against the VerDate jul<14>2003 15:00 Mar 01, 2005 Jkt 205001 pathogen, for which there is currently no licensed vaccine. The mutant is defective in the lpxA gene, whose enzyme product is relevant in lipid A biosynthesis (lipid A is part of the LOS). Previous attempts to produce similar mutants for other bacteria were unsuccessful. The nontoxic mutant was found to elicit high levels of antibodies with bactericidal activity and provided protection against wild type bacterial challenge. Use of this mutant bacterium is envisioned as a new approach for vaccines against M. catarrhalis. In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. Single Lipid Nanoparticle S. Narasimhan Danthi, King Li, Jianwu Xie (NIH/CC/LDRR), U.S. Provisional Application filed 19 Jan 2005 (DHHS Reference No. E–100–2004/ 0–US–01), Michael Shmilovich; 301/ 435–5019; shmilovm@mail.nih.gov. Available for licensing and commercial development are nanoparticle compositions comprising a phospholipid or diphosphatidyl glycerol component, an optional linker and a multifunctional ligand. A patent application has been filed covering the nanoparticle compositions and their methods of use as site-specific imaging or therapeutic agents. The particles are preferably single lipid compounds or single lipid nanoparticles (SLNs) prepared from single lipids (e.g., being a lipid molecule of a single lipid type or of a uniform structural type). In addition to licensing, the technology is available for further development through collaborative research opportunities with the inventors. Identification of a G-protein Coupled Receptor, FPR, as a Functional Receptor for the Leukocyte Chemotactic Activity of the Neutrophil Granule Protein Cathepsin G (CaG) Ji Ming Wang, Ronghua Sun, Joost Oppenheim, and Ye Zhou (NCI), U.S. Provisional Application No. 60/581,765 filed 23 Jun 2004 (DHHS Reference No. E–281–2003/0–US–01), Licensing Contact: Cristina Thalhammer-Reyero; 301/435–4507; thalhamc@mail.nih.gov. This invention relates to methods for identifying peptides of Cathepsin G (CaG), or active variants thereof, which modulate activities of the receptor for bacterial chemotactic formyl peptides (FPR), including chemotactic behavior. It provides methods of designing therapeutic approaches related to the host defense based on the interaction of PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 CaG and FPR, as CaG binds to FPR to mediate the proinflammatory activities of CaG. The inventive aspects relate to the finding that CaG induces a more partial and selective effects upon activation of FPR to mediate a certain and more limited immunological activity than other agonists that are also capable of binding FPR. The limitations in the activity include not inducing calcium flux, having only a week activation of mitogen-activated protein kinases (MAPKs), and being able to activate certain types of atypical protein kinase C (PKC), such as PKCzeta, while not activating PKCalpha and PKCbeta. These limitations are advantageous in attempting to limit the response in mobilizing the phagocytic leukocyte infiltration to mediate the clearance and repair of damaged tissue while not amplifying the general inflammatory response, which may result in damage to healthy and normal tissue. The technology is further described in R. Sun et al., ‘‘Identification of Neutrophil Granule Protein Cathepsin G as a Novel Chemotactic Agonist for the G Protein-Coupled Formyl Peptide Receptor’’, J. Immunol. 2004 173:428– 436. In addition to licensing, the technology is available for further development through collaborative research with the inventors via a Cooperative Research and Development Agreement (CRADA). Dated: February 22, 2005. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. 05–3965 Filed 3–1–05; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of the following meeting. 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 material, and personal information concerning individuals associated with the grant E:\FR\FM\02MRN1.SGM 02MRN1

Agencies

[Federal Register Volume 70, Number 40 (Wednesday, March 2, 2005)]
[Notices]
[Pages 10103-10104]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-3965]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Government-Owned Inventions; Availability for Licensing

AGENCY: National Institutes of Health, Public Health Service, DHHS.

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

[[Page 10104]]

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.

Broadly Cross-Reactive HIV-1 Neutralizing Human Monoclonal Antibodies

    Drs. Dimiter S. Dimitrov and Mei-yun Zhang (NCI), U.S. Provisional 
Application No. 60/623,394 filed 29 Oct 2004 (DHHS Reference No. E-251-
2004/0-US-01) Licensing Contact: Sally Hu; 301/435-5606; 
hus@mail.nih.gov.
    The invention provides for pharmaceutical compositions of, and 
methods of using potent cross-reactive human monoclonal antibodies to 
HIV. Specifically, the invention describes a competitive antigen 
panning (CAP) method of isolating antibodies that bind to the gp41 
subunit of the HIV-1 envelop glycoprotein. Additionally, the invention 
includes compositions of the aforementioned antibodies and the epitopes 
recognized by the antibodies. Methods of using the invention in the 
development of vaccine immunogens for the treatment and prevention of 
HIV, as well as the detection of HIV in a mammal are also described. 
The invention has significant implications in the development of HIV 
inhibitors, vaccines, and research tools for understanding mechanisms 
of HIV entry. Further development of the disclosed invention may yield 
novel therapies and methods in the prevention of mother-to-child 
transmission of HIV, treatment of accidental exposure to HIV, and 
chronic infection in patients with resistance to current therapies.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Endotoxin-Free Vaccine Candidate for Moraxella Catarrhalis

    Xin-Xing Gu and Daxin Peng (NIDCD), U.S. Provisional Application 
No. 60/577,244 filed 04 Jun 2004 (DHHS Reference No. E-174-2004/0-US-
01); U.S. Provisional Application No. 60/613,139 filed 23 Sep 23 (DHHS 
Reference No. E-174-2004/1-US-01), Licensing Contact: Susan Ano; 301/
435-5515; anos@mail.nih.gov.
    This invention relates to a strain of Moraxella catarrhalis 
containing a gene mutation that prevents endotoxic lipooligosaccharide 
(LOS) synthesis and potential use of the mutant for developing novel 
vaccines against the pathogen, for which there is currently no licensed 
vaccine. The mutant is defective in the lpxA gene, whose enzyme product 
is relevant in lipid A biosynthesis (lipid A is part of the LOS). 
Previous attempts to produce similar mutants for other bacteria were 
unsuccessful. The nontoxic mutant was found to elicit high levels of 
antibodies with bactericidal activity and provided protection against 
wild type bacterial challenge. Use of this mutant bacterium is 
envisioned as a new approach for vaccines against M. catarrhalis.
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Single Lipid Nanoparticle

    S. Narasimhan Danthi, King Li, Jianwu Xie (NIH/CC/LDRR), U.S. 
Provisional Application filed 19 Jan 2005 (DHHS Reference No. E-100-
2004/0-US-01), Michael Shmilovich; 301/435-5019; shmilovm@mail.nih.gov.
    Available for licensing and commercial development are nanoparticle 
compositions comprising a phospholipid or diphosphatidyl glycerol 
component, an optional linker and a multifunctional ligand. A patent 
application has been filed covering the nanoparticle compositions and 
their methods of use as site-specific imaging or therapeutic agents. 
The particles are preferably single lipid compounds or single lipid 
nanoparticles (SLNs) prepared from single lipids (e.g., being a lipid 
molecule of a single lipid type or of a uniform structural type).
    In addition to licensing, the technology is available for further 
development through collaborative research opportunities with the 
inventors.

Identification of a G-protein Coupled Receptor, FPR, as a Functional 
Receptor for the Leukocyte Chemotactic Activity of the Neutrophil 
Granule Protein Cathepsin G (CaG)

    Ji Ming Wang, Ronghua Sun, Joost Oppenheim, and Ye Zhou (NCI), U.S. 
Provisional Application No. 60/581,765 filed 23 Jun 2004 (DHHS 
Reference No. E-281-2003/0-US-01), Licensing Contact: Cristina 
Thalhammer-Reyero; 301/435-4507; thalhamc@mail.nih.gov.
    This invention relates to methods for identifying peptides of 
Cathepsin G (CaG), or active variants thereof, which modulate 
activities of the receptor for bacterial chemotactic formyl peptides 
(FPR), including chemotactic behavior. It provides methods of designing 
therapeutic approaches related to the host defense based on the 
interaction of CaG and FPR, as CaG binds to FPR to mediate the 
proinflammatory activities of CaG. The inventive aspects relate to the 
finding that CaG induces a more partial and selective effects upon 
activation of FPR to mediate a certain and more limited immunological 
activity than other agonists that are also capable of binding FPR. The 
limitations in the activity include not inducing calcium flux, having 
only a week activation of mitogen-activated protein kinases (MAPKs), 
and being able to activate certain types of atypical protein kinase C 
(PKC), such as PKCzeta, while not activating PKCalpha and PKCbeta. 
These limitations are advantageous in attempting to limit the response 
in mobilizing the phagocytic leukocyte infiltration to mediate the 
clearance and repair of damaged tissue while not amplifying the general 
inflammatory response, which may result in damage to healthy and normal 
tissue.
    The technology is further described in R. Sun et al., 
``Identification of Neutrophil Granule Protein Cathepsin G as a Novel 
Chemotactic Agonist for the G Protein-Coupled Formyl Peptide 
Receptor'', J. Immunol. 2004 173:428-436.
    In addition to licensing, the technology is available for further 
development through collaborative research with the inventors via a 
Cooperative Research and Development Agreement (CRADA).

    Dated: February 22, 2005.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. 05-3965 Filed 3-1-05; 8:45 am]
BILLING CODE 4140-01-P
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