Government-Owned Inventions; Availability for Licensing, 35500-35501 [E7-12534]

Download as PDF 35500 Federal Register / Vol. 72, No. 124 / Thursday, June 28, 2007 / Notices The annual reporting burden is as follows: Estimated Number of Respondents: 4,000; Estimated Number of Responses per Respondent: 1; Average Burden Hours Per Response: .333; and Estimated Total Annual Burden Hours Requested: 1,332. The annualized cost to respondents is estimated at: $65,048. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Estimated number of respondents Estimated number of responses per respondent Physician .................................................................................. Medical Practice Administrator ................................................ 2000 2000 1 1 0.333 0.333 666 666 Total .................................................................................. 4000 1 .............................. 1,332 Type of respondent Average burden hours per response Estimated total annual burden hours *Hourly earnings data are taken from the National Compensation Survey: Occupational Wages in the United States, June 2005, U.S. Department of Labor, U.S. Bureau of Labor Statistics. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (a) Whether the proposed collection of information is necessary for the performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. FOR FURTHER INFORMATION CONTACT: Send comments to Ashley Wilder Smith, PhD, M.P.H., Health Sciences Specialist, National Cancer Institute, 6130 Executive Blvd., MSC 7344, Executive Plaza North, Room 4090, Bethesda, MD 20892–7344. Telephone: 301–451–1843; E-mail: smithas@mail.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 should be received by August 27, 2007. Dated: June 20, 2007. Ashley Wilder Smith, National Cancer Institute Task Order Monitor, National Institutes of Health. [FR Doc. E7–12535 Filed 6–27–07; 8:45 am] BILLING CODE 4140–01–P mstockstill on PROD1PC66 with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing National Institutes of Health, Public Health Service, HHS. AGENCY: VerDate Aug<31>2005 18:23 Jun 27, 2007 Jkt 211001 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. Orally Active Derivatives of 1,3,5(10)estratriene Description of Technology: The utility of estrogenic substances in the practice of medicine is well documented. Estrogens may be used for the replacement of the natural hormone estradiol in hypogonadism, and following the removal of the ovaries or cessation of ovarian activity during menopause. They are also widely employed as a component of oral contraceptives. However, orally-active synthetic estrogens are associated with a number of side effects, such as: Enhanced risk of endometrial carcinoma; induction of malignant carcinoma, especially in the cervix, breast, vagina and liver; promotion of gallbladder disease, thromboembolic and thrombotic diseases, myocardial infarction, hepatic adenoma, elevated blood pressure, and hypercalcemia; and reduced glucose tolerance. The NIH announces a new family of novel, active estrogens that are nitrate PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 esters of estradiol. These nitrate esters possess enhanced estrogenic activity following oral administration and lack a 17-ethynyl alcohol, which has been implicated in many side effects attributed to other synthetic estrogens. It is anticipated that these esters could be used in all instances where estrogen is prescribed as a treatment. Applications: Hormone replacement therapies; Oral contraceptives. Market: The hormone replacement market exceeds one billion dollars per year, and the oral contraceptive market is more than three billion dollars per year. Development Status: Early stage. Inventors: Hyun K. Kim et al. (NICHD). Patent Status: U.S. Patent 5,554,603 issued 10 Sep 1996 (HHS Reference No. E–137–1993/0–US–01); Foreign counterparts in Australia, Canada, Japan, and Europe. Licensing Status: Available for exclusive or non-exclusive licensing. Licensing Contact: Tara L. Kirby, PhD; 301/435–4426; tarak@mail.nih.gov. Methods of Inducing Immune Tolerance Using Immunotoxins Description of Invention: The invention concerns immunotoxins and methods of using the immunotoxins for the treatment of rejection response in a patient, including graft-versus-host disease and transplantation of organs, tissues and cells into a host. In a specific embodiment of the invention, the transplant involves pancreatic islet cells. The immunotoxins are targeted via an antibody that is specific to T cells. This allows the specific ablation of resting T cells, resulting in an accentuation of immune tolerizing responses and an increased tolerance to transplants and grafts. The toxin portion of the immunotoxin is genetically engineered to maintain bioactivity when recombinantly produced in Pichia pastoris. Data are available in transgenic animals expressing human CD3e which E:\FR\FM\28JNN1.SGM 28JNN1 mstockstill on PROD1PC66 with NOTICES Federal Register / Vol. 72, No. 124 / Thursday, June 28, 2007 / Notices supports the effects of the immunotoxin against T cells. Applications: Use of immunotoxins decreases T cell population, allowing greater host immune tolerance of transplants and grafts; Specific method for increasing immune tolerance to pancreatic islet transplants. Advantages: Specificity of the immunotoxin avoids the killing of other cells, reducing side-effects associated with other mechanisms of treatment (Xray and cyclophosphamide) such as infection and induced malignancy; A GMP production process for the immunotoxin has already been successfully implemented. Benefits: New methods and compositions with limited side-effects have the potential to revolutionize treatment of transplant/graft recipients; provides an opportunity to capture a significant market share for the millions of people who require transplants/grafts. Inventors: David Neville et al. (NIMH). Patent Status: U.S. Patent No. 5,167,956 issued 01 Dec 1992 (HHS Reference No. E–012–1991/0–US–01); U.S. Patent No. 5,762,927 issued 09 Jun 1998 (HHS Reference No. E–012–1991/ 4–US–02); U.S. Patent No. 6,103,235 issued 15 Aug 2000 (HHS Reference No. E–012–1991/7–US–01); U.S. Patent No. 7,125,553 issued 24 Oct 2006 (HHS Reference No. E–012–1991/7–US–02); U.S. Patent Application No. 09/810,999 filed 16 Mar 2001, which published as U.S. 2001/0024645 on 27 Sep 2001, Allowed (HHS Reference No. E–059– 1998/0–US–02); International Patent Application No. PCT/US00/10253 filed 14 Apr 2000, which published as WO 00/61132 on 19 Oct 2000 (HHS Reference E–168–1999/0–PCT–02); U.S. Patent No. 6,632,928 issued 14 Oct 2003 (HHS Reference No. E–044–1997/0–US– 07); U.S. Patent Application No. 10/ 435,567 filed 09 May 2003, which published as 2003/0185825 on 02 Oct 2003 (HHS Reference No. E–044–1997/ 0–US–08); U.S. Patent Application No. 10/296,085 filed 18 Nov 2002, which published as 2004/0127682 on 01 Jul 2004 (HHS Reference No. E–044–1997/ 1–US–06); Foreign rights are also available. Licensing Status: Available for exclusive or non-exclusive licensing. Licensing Contact: David A. Lambertson, PhD; 301/435–4632; lambertsond@mail.nih.gov. Collaborative Research Opportunity: The National Institute of Mental Health, Laboratory of Molecular Biology, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize VerDate Aug<31>2005 18:23 Jun 27, 2007 Jkt 211001 35501 methods of using the immunotoxins for the treatment of rejection response in a patient. Please contact David Neville at davidn@mail.nih.gov for more information. individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Dated: June 20, 2007. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E7–12534 Filed 6–27–07; 8:45 am] Name of Committee: National Cancer Institute Special Emphasis Panel; Antibody Array for Cancer Detection. Date: July 19, 2007. Time: 1 p.m. to 3 p.m. Agenda: To review and evaluate contract proposals. Place: National Institutes of Health, 6116 Executive Boulevard, Rockville, MD 20852 (Telephone Conference Call). Contact Person: Lalita D. Palekar, PhD, Scientific Review Administrator, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Blvd., Room 7141, Bethesda, MD 20892–7405, 301–496–7575, palekarl@mail.nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Small Grants for Behavioral Research in Cancer Control. Date: July 26, 2007. Time: 8:30 a.m. to 5:30 p.m. Agenda: To review and evaluate grant applications. Place: Courtyard Marriott Gaithersburg Washingtonian Ctr., 204 Boardwalk Place, Gaithersburg, MD 20878. Contact Person: Rhonda J. Moore, PhD, Scientific Review Administrator, Special Review and Logistics Branch, Division of Extramural Activities, National Cancer Institute, NIH, 6116 Executive Boulevard, Suite 701, Room 7151, Bethesda, MD 20892– 8329, 301–451–9385, moorerh@mail.nih.gov. Name of Committee: National Cancer Institute Initial Review Group; Subcommittee A—Cancer Centers. Date: August 2–3, 2007. Time: 8 a.m. to 4 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military Road, NW., Washington, DC 20015. Contact Person: Gail J. Bryant, Scientific Review Administrator, Resources and Training Review Branch, Division of Extramural Activities, National Cancer Institute, 6116 Executive Blvd., Room 8107, MSC 8328, Bethesda, MD 20892–8328, 301– 402–0801, gb30t@nih.gov. Name of Committee: National Cancer Institute Special Emphasis Panel; Lung Cancer and Inflammation. Date: August 7–8, 2007. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hyatt Regency Bethesda, One Bethesda Metro Center, Bethesda, MD 20814. Contact Person: Thomas M. Vollberg, PhD, Scientific Review Administrator, Special Review and Logistics Branch, Division of extramural Activities, National Cancer Institute, 6116 Executive Blvd., Room 7142, Bethesda, MD 20892, 301–594–9582, vollert@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.392, Cancer Construction; BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Cancer Institute Special Emphasis Panel, August 2, 2007, 1:30 p.m. to August 2, 2007, 3:30 p.m., Marriott Bethesda North Hotel & Conference Center, 5701 Marinelli Road, North Bethesda, MD 20852 which was published in the Federal Register on April 24, 2007, 72 FR 20348. This meeting notice is amended to reflect the location change to the Embassy Suites Hotel at Chevy Chase Pavilion, 1400 Military Road, NW., Washington, DC 20015 and meeting time to 3 p.m. to 5 p.m. The meeting is closed to the public. Dated: June 21, 2007. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 07–3185 Filed 6–27–07; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Cancer 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/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 E:\FR\FM\28JNN1.SGM 28JNN1

Agencies

[Federal Register Volume 72, Number 124 (Thursday, June 28, 2007)]
[Notices]
[Pages 35500-35501]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-12534]


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

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.

Orally Active Derivatives of 1,3,5(10)-estratriene

    Description of Technology: The utility of estrogenic substances in 
the practice of medicine is well documented. Estrogens may be used for 
the replacement of the natural hormone estradiol in hypogonadism, and 
following the removal of the ovaries or cessation of ovarian activity 
during menopause. They are also widely employed as a component of oral 
contraceptives. However, orally-active synthetic estrogens are 
associated with a number of side effects, such as: Enhanced risk of 
endometrial carcinoma; induction of malignant carcinoma, especially in 
the cervix, breast, vagina and liver; promotion of gallbladder disease, 
thromboembolic and thrombotic diseases, myocardial infarction, hepatic 
adenoma, elevated blood pressure, and hypercalcemia; and reduced 
glucose tolerance.
    The NIH announces a new family of novel, active estrogens that are 
nitrate esters of estradiol. These nitrate esters possess enhanced 
estrogenic activity following oral administration and lack a 17-ethynyl 
alcohol, which has been implicated in many side effects attributed to 
other synthetic estrogens. It is anticipated that these esters could be 
used in all instances where estrogen is prescribed as a treatment.
    Applications: Hormone replacement therapies; Oral contraceptives.
    Market: The hormone replacement market exceeds one billion dollars 
per year, and the oral contraceptive market is more than three billion 
dollars per year.
    Development Status: Early stage.
    Inventors: Hyun K. Kim et al. (NICHD).
    Patent Status: U.S. Patent 5,554,603 issued 10 Sep 1996 (HHS 
Reference No. E-137-1993/0-US-01); Foreign counterparts in Australia, 
Canada, Japan, and Europe.
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: Tara L. Kirby, PhD; 301/435-4426; 
tarak@mail.nih.gov.

Methods of Inducing Immune Tolerance Using Immunotoxins

    Description of Invention: The invention concerns immunotoxins and 
methods of using the immunotoxins for the treatment of rejection 
response in a patient, including graft-versus-host disease and 
transplantation of organs, tissues and cells into a host. In a specific 
embodiment of the invention, the transplant involves pancreatic islet 
cells. The immunotoxins are targeted via an antibody that is specific 
to T cells. This allows the specific ablation of resting T cells, 
resulting in an accentuation of immune tolerizing responses and an 
increased tolerance to transplants and grafts. The toxin portion of the 
immunotoxin is genetically engineered to maintain bioactivity when 
recombinantly produced in Pichia pastoris. Data are available in 
transgenic animals expressing human CD3[egr] which

[[Page 35501]]

supports the effects of the immunotoxin against T cells.
    Applications: Use of immunotoxins decreases T cell population, 
allowing greater host immune tolerance of transplants and grafts; 
Specific method for increasing immune tolerance to pancreatic islet 
transplants.
    Advantages: Specificity of the immunotoxin avoids the killing of 
other cells, reducing side-effects associated with other mechanisms of 
treatment (X-ray and cyclophosphamide) such as infection and induced 
malignancy; A GMP production process for the immunotoxin has already 
been successfully implemented.
    Benefits: New methods and compositions with limited side-effects 
have the potential to revolutionize treatment of transplant/graft 
recipients; provides an opportunity to capture a significant market 
share for the millions of people who require transplants/grafts.
    Inventors: David Neville et al. (NIMH).
    Patent Status: U.S. Patent No. 5,167,956 issued 01 Dec 1992 (HHS 
Reference No. E-012-1991/0-US-01); U.S. Patent No. 5,762,927 issued 09 
Jun 1998 (HHS Reference No. E-012-1991/4-US-02); U.S. Patent No. 
6,103,235 issued 15 Aug 2000 (HHS Reference No. E-012-1991/7-US-01); 
U.S. Patent No. 7,125,553 issued 24 Oct 2006 (HHS Reference No. E-012-
1991/7-US-02); U.S. Patent Application No. 09/810,999 filed 16 Mar 
2001, which published as U.S. 2001/0024645 on 27 Sep 2001, Allowed (HHS 
Reference No. E-059-1998/0-US-02); International Patent Application No. 
PCT/US00/10253 filed 14 Apr 2000, which published as WO 00/61132 on 19 
Oct 2000 (HHS Reference E-168-1999/0-PCT-02); U.S. Patent No. 6,632,928 
issued 14 Oct 2003 (HHS Reference No. E-044-1997/0-US-07); U.S. Patent 
Application No. 10/435,567 filed 09 May 2003, which published as 2003/
0185825 on 02 Oct 2003 (HHS Reference No. E-044-1997/0-US-08); U.S. 
Patent Application No. 10/296,085 filed 18 Nov 2002, which published as 
2004/0127682 on 01 Jul 2004 (HHS Reference No. E-044-1997/1-US-06); 
Foreign rights are also available.
    Licensing Status: Available for exclusive or non-exclusive 
licensing.
    Licensing Contact: David A. Lambertson, PhD; 301/435-4632; 
lambertsond@mail.nih.gov.
    Collaborative Research Opportunity: The National Institute of 
Mental Health, Laboratory of Molecular Biology, is seeking statements 
of capability or interest from parties interested in collaborative 
research to further develop, evaluate, or commercialize methods of 
using the immunotoxins for the treatment of rejection response in a 
patient. Please contact David Neville at davidn@mail.nih.gov for more 
information.

    Dated: June 20, 2007.
Steven M. Ferguson,
Director, Division of Technology Development and Transfer, Office of 
Technology Transfer, National Institutes of Health.
[FR Doc. E7-12534 Filed 6-27-07; 8:45 am]
BILLING CODE 4140-01-P
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