Government-Owned Inventions; Availability for Licensing, 67740-67741 [E7-23194]

Download as PDF 67740 Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices and for identification of agents which cause or reverse immunosuppression. Development Status: Pre-clinical stage. Inventors: Augusto C. Ochoa et al. (NCI). Patent Status: U.S. Patent No. 5,583,002 issued 10 Dec 1996 (HHS Reference No. E–231–1995/1–US–01); U.S. Patent No. 5,556,763 issued 17 Sep 1996 (HHS Reference No. E–231– 1995/3–US–01); U.S. Patent No. 5,889,143 issued 10 Dec 1996 (HHS Reference No. E–231– 1995/3–US–02); U.S. Patent Application No. 09/ 280,655 filed 29 Mar 1999 (HHS Reference No. E–231–1995/3–US–03); U.S. Patent No. 5,658,744 issued 19 Aug 1997 (HHS Reference No. E–232– 1995/0–US–01); U.S. Patent No. 5,965,366 issued 12 Dec 1999 (HHS Reference No. E–232– 1995/1–US–01); and any foreign equivalent patents and patent applications. Licensing Status: Available for nonexclusive or exclusive licensing. Licensing Contact: John Stansberry; 301/435–5236; stansbej@mail.nih.gov. Dated: November 14, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7–23193 Filed 11–29–07; 8:45 am] BILLING CODE 4140–01–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. rwilkins on PROD1PC63 with NOTICES AGENCY: SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the United States 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 VerDate Aug<31>2005 16:27 Nov 29, 2007 Jkt 214001 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. Monoclonal Antibody to a Specific Peptide–MHC Class II Complex Description of Invention: T lymphocytes play an important role in the immune system by recognizing foreign protein motifs on cells. T lymphocytes are stimulated to recognize these motifs through their interactions with peptide-MHC complexes (pMHC). Thus, studying pMHC is an important aspect of understanding how the immune system works, particularly with regard to the development of vaccines. Unfortunately, the detection of pMHC is largely dependent on indirect assays, due to the difficulty of producing antibodies for specific pMHC. This invention regards the development of hybridomas (C4H3) for the production of antibodies that are highly specific for a particular pMHC complex consisting of hen egg lysozyme peptide 46-61 (HEL) and the I-Ak MHC class II molecule. These antibodies can be used for a myriad of purposes which include studying how cells form pMHC. Applications: Discovery of methods for antigen delivery in the development of vaccines. Quantitation and distribution of pMHC complexes on cells. Study antigen processing in experimental immunological research systems. Advantages: High specificity for the pMHC complex of HEL-I-Ak MHC class II molecule. HEL-I-Ak is widely used in experimental immunological research systems, giving the hybridoma and antibodies great applicability. Inventors: Ronald N. Germain et al. (NIAID). Publications: 1. G Zhong et al. Production, specificity, and functionality of monoclonal antibodies to specific peptide-major histocompatibility complex class II complexes formed by processing of exogenous protein. Proc Natl Acad Sci U S A. 1997 Dec 9; 94(25):13856–13861. 2. A Porgador et al. Localization, quantitation, and in situ detection of specific peptide-MHC class I complexes using a monoclonal antibody. Immunity. 1997 Jun; 6(6):715–726. Patent Status: HHS Reference No. E– 021–2008/0–Research Tool. Patent protection is not being pursued for this technology. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 Licensing Contact: David A. Lambertson, Ph.D.; 301–435–4632; lambertsond@mail.nih.gov. Collaborative Research Opportunity: The NIAID Lymphocyte Biology Section, Laboratory of Immunology is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize monoclonal antibody C4H3, specific for HEL (46-61) bound to the MHC class II molecule I-Ak. Please contact Ronald N. Germain, M.D., Ph.D., at rgermain@nih.gov for more information. Bifunctional Compounds that Bind to Hormone Receptors Description of Technology: The development and progression of prostate cancer is dependent on the androgen receptor (AR), a liganddependent transcription factor. In the inactive form AR resides in the cytosolic region of the cell and when activated, AR is imported into the nucleus. Initial hormonal therapy for prostate cancer involves lowering serum levels of testosterone to shut down AR activity. Despite initial patient responses to testosterone-depleting therapies, prostate cancer becomes refractory to hormonal therapy. Notably, AR is reactivated in hormone-refractory prostate cancer and reinstates its proliferative and survival activity. Available for licensing is a novel chemical compound which is bifunctional and binds to AR. This compound is comprised of tubulinbinding and steroid receptor-binding moieties. This compound is designed to antagonize AR function in a nonclassical manner by several mechanisms and kills hormonerefractory prostate cells better than both functional moieties. This compound is a first-in-class of bifunctional steroid receptor binding agents that can antagonize steroid receptors in a variety of hormone-dependent diseases, such as breast and prostate cancer. Applications: Therapeutic compounds that selectively target steroid receptor-expressing cancer cells resulting in decreased toxicity. Method to treat hormone resistant prostate cancer and potentially other steroid receptor dependent diseases such as breast cancer. Market: Prostate cancer is the second most common type of cancer among men, wherein one in six men will be diagnosed with prostate cancer. An estimated 218,890 new cases of prostate cancer and 27,050 deaths due to prostate cancer in the United States in 2007. E:\FR\FM\30NON1.SGM 30NON1 Federal Register / Vol. 72, No. 230 / Friday, November 30, 2007 / Notices rwilkins on PROD1PC63 with NOTICES An estimated 180,510 new cases of breast cancer and 40,060 deaths due to breast cancer in the United States in 2007. Development Status: The technology is currently in the pre-clinical stage of development. Inventors: Nima Sharifi et al. (NCI). Patent Status: U.S. Provisional Application No. 60/958,351 filed 03 Jul 2007 (HHS Reference No. E–163–2007/ 0–US–01). Licensing Status: Available for exclusive or non-exclusive licensing. Licensing Contact: Jennifer Wong; 301–435–4633; wongje@mail.nih.gov. Collaborative Research Opportunity: The Medical Oncology Branch, National Cancer Institute is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize—treatments of resistant prostate cancer. Please contact John D. Hewes, Ph.D. at 301–435–3121 or hewesj@mail.nih.gov for more information. A Clinically Proven Therapeutic Treatment and Diagnostic Tool for Mesothelin Expressing Cancers: A Novel Recombinant Immunotoxin SS1P (anti-mesothelin dsFv–PE38) Description of Technology: Mesothelin is a glycoprotein, whose expression has been largely restricted to mesothelial cells in normal tissues. Mesothelin has been shown to be expressed in several cancers including mesothelioma, lung cancer, pancreatic cancers, gastric cancers and ovarian cancers, and has the potential of being used as a novel target for the development of new treatments. The technology relates to the SSIP immunotoxin that can be used to kill cells expressing mesothelin on their surfaces, such as mesothelioma, ovarian cancer, lung cancer, ovarian cancer and stomach cancer. Additionally, it can be used for the detection of mesothelin expressing cells present in a biological sample. The SSIP immunotoxin is a recombinant immunotoxin generated by the fusion of a high affinity antimesothelin Fv (SS1) with a 38 kDa portion of Pseudomonas Exotoxin A (PE38). Applications: SS1P can be used as a therapy for mesothelin expressing cancers. The immunotoxin can be used as a stand alone treatment and in combination with standard chemotherapy. Advantage: SS1P immunotoxin is available for use and has been successfully tested clinically for the VerDate Aug<31>2005 16:27 Nov 29, 2007 Jkt 214001 treatment of mesothelioma and ovarian cancer with low side effects. Development Status: Phase 1 studies have been completed for mesothelin expressing cancers such as mesothelioma, ovarian cancer and pancreatic cancer. Phase 2 studies to begin shortly for combination therapy using SS1P and standard chemotherapy. Inventors: Ira Pastan (NCI) et al. Relevant Publications: 1. R Hassan et al. Phase I study of SS1P, a recombinant anti-mesothelin immunotoxin given as a bolus I.V. infusion to patients with mesothelin-expressing mesothelioma, ovarian, and pancreatic cancers. Clin Cancer Res. 2007 Sep 1;13 (17):5144– 5149. 2. Y Zhang et al. Synergistic antitumor activity of taxol and immunotoxin SS1P in tumor-bearing mice. Clin Cancer Res. 2006 Aug 1;12(15):4695–4701. Patent Status: U.S. Patent No. 7,081,518 issued 25 Jul 2006, entitled ‘‘Anti-Mesothelin Antibodies Having High Binding Affinity’’ (HHS Reference No. E–139–1999/0–US–07) Related Intellectual Property: 1. U.S. Patent No. 4,892,827 entitled ‘‘Recombinant Pseudomonas Exotoxin: Construction of an Active Immunotoxin with Low Side Effects’’ [HHS Ref. No. E–385–1986/0]; 2. U.S. Patent Nos. 6,051,405, 5,863,745, and 5,696,237 ‘‘Recombinant Antibody-Toxin Fusion Protein’’ [HHS Ref. No. E–135–1989/0]; 3. U.S. Patents 5,747,654, 6,147,203, and 6,558,672 entitled ‘‘Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding Specificity’’ [HHS Ref. No. E–163–1993/0]; 4. U.S. Patent No. 6,153,430, and U.S. Patent Application No. 09/684,599 ‘‘Nucleic Acid Encoding Mesothelin, a Differentiation Antigen Present on Mesothelium, Mesotheliomas and Ovarian Cancers’’ [HHS Ref. No. E–002– 1996/0]; 5. U.S. Patent 6,083,502 entitled ‘‘Mesothelium Antigen and Methods and Kits for Targeting It’’ [HHS Ref. No. E–002–1996/1]; 6. U.S. Patent Application 09/581,345: ‘‘Antibodies, Including Fv Molecules, and Immunoconjugates Having High Binding Affinity for Mesothelin and Methods for Their Use’’ [HHS Ref. No. E–021–1998/0]; 7. PCT Application No. PCT/US01/ 18503, ‘‘Pegylation of Linkers Improves Antitumor Activity and Reduces Toxicity of Immunoconjugates’’ [HHS Ref. No. E–216–2000/2]; 8. PCT Application No. PCT/US2006/ 018502 and U.S. Patent Application No. 60/681,104, entitled ‘‘Anti-Mesothelin PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 67741 Antibodies Useful For Immunological Assays’’ [HHS Ref. No. E–015–2005/0– US–01]; and 9. Any related foreign filed national stage applications claiming priority to such patent applications and patents listed above. Licensing Status: Available for exclusive and non-exclusive licensing. Licensing Contact: David A. Lambertson, Ph.D.; 301–435–4632; lambertsond@mail.nih.gov. Collaborative Research Opportunity: The National Cancer Institute Laboratory of Molecular Biology is seeking statements of capability or interest from parties interested in collaborative research to further develop, immunotoxin SS1P. Please contact John D. Hewes, Ph.D. at 301– 435–3121 or hewesj@mail.nih.gov for more information. Dated: November 16, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7–23194 Filed 11–29–07; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Notice of Closed Meetings 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 meetings. The meetings 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 applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Inherited Disease Research Access Committee. Date: January 10–11, 2008. Time: 7 a.m. to 3:45 p.m. Agenda: To review and evaluate grant applications and/or proposals. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015. Contact Person: Jerry Roberts, PhD., Scientific Review Officer, Scientific Review Branch, National Human Genome Research Institute, National Institutes of Health, 5635 E:\FR\FM\30NON1.SGM 30NON1

Agencies

[Federal Register Volume 72, Number 230 (Friday, November 30, 2007)]
[Notices]
[Pages 67740-67741]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-23194]


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

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 United States 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.

Monoclonal Antibody to a Specific Peptide-MHC Class II Complex

    Description of Invention: T lymphocytes play an important role in 
the immune system by recognizing foreign protein motifs on cells. T 
lymphocytes are stimulated to recognize these motifs through their 
interactions with peptide-MHC complexes (pMHC). Thus, studying pMHC is 
an important aspect of understanding how the immune system works, 
particularly with regard to the development of vaccines. Unfortunately, 
the detection of pMHC is largely dependent on indirect assays, due to 
the difficulty of producing antibodies for specific pMHC.
    This invention regards the development of hybridomas (C4H3) for the 
production of antibodies that are highly specific for a particular pMHC 
complex consisting of hen egg lysozyme peptide 46-61 (HEL) and the I-
A\k\ MHC class II molecule. These antibodies can be used for a myriad 
of purposes which include studying how cells form pMHC.
    Applications: Discovery of methods for antigen delivery in the 
development of vaccines.
    Quantitation and distribution of pMHC complexes on cells.
    Study antigen processing in experimental immunological research 
systems.
    Advantages: High specificity for the pMHC complex of HEL-I-A\k\ MHC 
class II molecule.
    HEL-I-A\k\ is widely used in experimental immunological research 
systems, giving the hybridoma and antibodies great applicability.
    Inventors: Ronald N. Germain et al. (NIAID).
    Publications: 1. G Zhong et al. Production, specificity, and 
functionality of monoclonal antibodies to specific peptide-major 
histocompatibility complex class II complexes formed by processing of 
exogenous protein. Proc Natl Acad Sci U S A. 1997 Dec 9; 94(25):13856-
13861.
    2. A Porgador et al. Localization, quantitation, and in situ 
detection of specific peptide-MHC class I complexes using a monoclonal 
antibody. Immunity. 1997 Jun; 6(6):715-726.
    Patent Status: HHS Reference No. E-021-2008/0-Research Tool. Patent 
protection is not being pursued for this technology.
    Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632; 
lambertsond@mail.nih.gov.
    Collaborative Research Opportunity: The NIAID Lymphocyte Biology 
Section, Laboratory of Immunology is seeking statements of capability 
or interest from parties interested in collaborative research to 
further develop, evaluate, or commercialize monoclonal antibody C4H3, 
specific for HEL (46-61) bound to the MHC class II molecule I-A\k\. 
Please contact Ronald N. Germain, M.D., Ph.D., at rgermain@nih.gov for 
more information.

Bifunctional Compounds that Bind to Hormone Receptors

    Description of Technology: The development and progression of 
prostate cancer is dependent on the androgen receptor (AR), a ligand-
dependent transcription factor. In the inactive form AR resides in the 
cytosolic region of the cell and when activated, AR is imported into 
the nucleus. Initial hormonal therapy for prostate cancer involves 
lowering serum levels of testosterone to shut down AR activity. Despite 
initial patient responses to testosterone-depleting therapies, prostate 
cancer becomes refractory to hormonal therapy. Notably, AR is 
reactivated in hormone-refractory prostate cancer and reinstates its 
proliferative and survival activity.
    Available for licensing is a novel chemical compound which is 
bifunctional and binds to AR. This compound is comprised of tubulin-
binding and steroid receptor-binding moieties. This compound is 
designed to antagonize AR function in a nonclassical manner by several 
mechanisms and kills hormone-refractory prostate cells better than both 
functional moieties. This compound is a first-in-class of bifunctional 
steroid receptor binding agents that can antagonize steroid receptors 
in a variety of hormone-dependent diseases, such as breast and prostate 
cancer.
    Applications: Therapeutic compounds that selectively target steroid 
receptor-expressing cancer cells resulting in decreased toxicity.
    Method to treat hormone resistant prostate cancer and potentially 
other steroid receptor dependent diseases such as breast cancer.
    Market: Prostate cancer is the second most common type of cancer 
among men, wherein one in six men will be diagnosed with prostate 
cancer.
    An estimated 218,890 new cases of prostate cancer and 27,050 deaths 
due to prostate cancer in the United States in 2007.

[[Page 67741]]

    An estimated 180,510 new cases of breast cancer and 40,060 deaths 
due to breast cancer in the United States in 2007.
    Development Status: The technology is currently in the pre-clinical 
stage of development.
    Inventors: Nima Sharifi et al. (NCI).
    Patent Status: U.S. Provisional Application No. 60/958,351 filed 03 
Jul 2007 (HHS Reference No. E-163-2007/0-US-01).
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Jennifer Wong; 301-435-4633; 
wongje@mail.nih.gov.
    Collaborative Research Opportunity: The Medical Oncology Branch, 
National Cancer Institute is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, evaluate, or commercialize--treatments of resistant prostate 
cancer. Please contact John D. Hewes, Ph.D. at 301-435-3121 or 
hewesj@mail.nih.gov for more information.

A Clinically Proven Therapeutic Treatment and Diagnostic Tool for 
Mesothelin Expressing Cancers: A Novel Recombinant Immunotoxin SS1P 
(anti-mesothelin dsFv-PE38)

    Description of Technology: Mesothelin is a glycoprotein, whose 
expression has been largely restricted to mesothelial cells in normal 
tissues. Mesothelin has been shown to be expressed in several cancers 
including mesothelioma, lung cancer, pancreatic cancers, gastric 
cancers and ovarian cancers, and has the potential of being used as a 
novel target for the development of new treatments.
    The technology relates to the SSIP immunotoxin that can be used to 
kill cells expressing mesothelin on their surfaces, such as 
mesothelioma, ovarian cancer, lung cancer, ovarian cancer and stomach 
cancer. Additionally, it can be used for the detection of mesothelin 
expressing cells present in a biological sample.
    The SSIP immunotoxin is a recombinant immunotoxin generated by the 
fusion of a high affinity anti-mesothelin Fv (SS1) with a 38 kDa 
portion of Pseudomonas Exotoxin A (PE38).
    Applications: SS1P can be used as a therapy for mesothelin 
expressing cancers.
    The immunotoxin can be used as a stand alone treatment and in 
combination with standard chemotherapy.
    Advantage: SS1P immunotoxin is available for use and has been 
successfully tested clinically for the treatment of mesothelioma and 
ovarian cancer with low side effects.
    Development Status: Phase 1 studies have been completed for 
mesothelin expressing cancers such as mesothelioma, ovarian cancer and 
pancreatic cancer.
    Phase 2 studies to begin shortly for combination therapy using SS1P 
and standard chemotherapy.
    Inventors: Ira Pastan (NCI) et al.
    Relevant Publications: 1. R Hassan et al. Phase I study of SS1P, a 
recombinant anti-mesothelin immunotoxin given as a bolus I.V. infusion 
to patients with mesothelin-expressing mesothelioma, ovarian, and 
pancreatic cancers. Clin Cancer Res. 2007 Sep 1;13 (17):5144-5149.
    2. Y Zhang et al. Synergistic antitumor activity of taxol and 
immunotoxin SS1P in tumor-bearing mice. Clin Cancer Res. 2006 Aug 
1;12(15):4695-4701.
    Patent Status: U.S. Patent No. 7,081,518 issued 25 Jul 2006, 
entitled ``Anti-Mesothelin Antibodies Having High Binding Affinity'' 
(HHS Reference No. E-139-1999/0-US-07)
    Related Intellectual Property: 1. U.S. Patent No. 4,892,827 
entitled ``Recombinant Pseudomonas Exotoxin: Construction of an Active 
Immunotoxin with Low Side Effects'' [HHS Ref. No. E-385-1986/0];
    2. U.S. Patent Nos. 6,051,405, 5,863,745, and 5,696,237 
``Recombinant Antibody-Toxin Fusion Protein'' [HHS Ref. No. E-135-1989/
0];
    3. U.S. Patents 5,747,654, 6,147,203, and 6,558,672 entitled 
``Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding 
Specificity'' [HHS Ref. No. E-163-1993/0];
    4. U.S. Patent No. 6,153,430, and U.S. Patent Application No. 09/
684,599 ``Nucleic Acid Encoding Mesothelin, a Differentiation Antigen 
Present on Mesothelium, Mesotheliomas and Ovarian Cancers'' [HHS Ref. 
No. E-002-1996/0];
    5. U.S. Patent 6,083,502 entitled ``Mesothelium Antigen and Methods 
and Kits for Targeting It'' [HHS Ref. No. E-002-1996/1];
    6. U.S. Patent Application 09/581,345: ``Antibodies, Including Fv 
Molecules, and Immunoconjugates Having High Binding Affinity for 
Mesothelin and Methods for Their Use'' [HHS Ref. No. E-021-1998/0];
    7. PCT Application No. PCT/US01/18503, ``Pegylation of Linkers 
Improves Antitumor Activity and Reduces Toxicity of Immunoconjugates'' 
[HHS Ref. No. E-216-2000/2];
    8. PCT Application No. PCT/US2006/018502 and U.S. Patent 
Application No. 60/681,104, entitled ``Anti-Mesothelin Antibodies 
Useful For Immunological Assays'' [HHS Ref. No. E-015-2005/0-US-01]; 
and
    9. Any related foreign filed national stage applications claiming 
priority to such patent applications and patents listed above.
    Licensing Status: Available for exclusive and non-exclusive 
licensing.
    Licensing Contact: David A. Lambertson, Ph.D.; 301-435-4632; 
lambertsond@mail.nih.gov.
    Collaborative Research Opportunity: The National Cancer Institute 
Laboratory of Molecular Biology is seeking statements of capability or 
interest from parties interested in collaborative research to further 
develop, immunotoxin SS1P. Please contact John D. Hewes, Ph.D. at 301-
435-3121 or hewesj@mail.nih.gov for more information.

    Dated: November 16, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-23194 Filed 11-29-07; 8:45 am]
BILLING CODE 4140-01-P
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