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