National Center for Research Resources; Notice of Closed Meetings, 65863-65864 [E8-26340]
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Federal Register / Vol. 73, No. 215 / Wednesday, November 5, 2008 / Notices
cancer using fine needle aspiration
(FNA) biopsy. It makes use of gene
expression profiles and/or their proteins
to distinguish accurately malignant
thyroid nodules from benign nodules.
This technique exhibits superior
accuracy to current cytology-based FNA
diagnosis. This improved diagnostic
also has potential use for the staging and
treatment of thyroid cancer, a disease
that disproportionately afflicts women.
hsrobinson on PROD1PC76 with NOTICES
Competitive Advantage of Our
Technology
The identification of markers that can
determine a specific type of tumor,
predict patient outcome or the tumor
response to specific therapies is
currently a major focus of cancer
research. The use of gene profiles to
detect thyroid malignancy has the
advantage that it complements the
current method of diagnosis using FNA,
but greatly increases the accuracy of
detecting malignant thyroid lesions.
Technology Description
This technology is based on the
discovery of differentially expressed
thyroid (DET) genes and their encoded
proteins whose expression levels can be
correlated to benign or malignant states
in a thyroid cell. Specifically, this data
arose from a microarray analysis of
genes expressed in the eight subtypes of
thyroid tumors that are typically
difficult to diagnose by cytology of fine
needle aspiration (FNA) biopsies.
Analysis of the (DET) genes led to the
development of a 6 gene and 10 gene
model that distinguishes benign vs.
malignant papillary thyroid tumors.
Subsequently, a 72 gene model has been
developed for diagnosing less common
forms of thyroid cancer like follicular
carcinoma and others. These results
provide a molecular classification
system for thyroid tumors and this in
turn provides a more accurate
diagnostic tool for the clinician
managing patients with suspicious
thyroid lesions.
The invention employs analysis of
DET genes (C21orf4, Hs.145049,
Hs.296031, KIT, LSM7, SYNGR2,
C11orf8, CDH1, FAM13A1, IMPACT,
and KIAA1128) using microarrays or
quantitative RT–PCR (qRT–PCR) to
distinguish between malignant and
benign tumors. For qRT–PCR, primer
and probe sequences were designed to
amplify the six genes or ten genes that
constitute the model. Other means of
detection may also be used such as in
situ hybridization, Northern blot,
Western blot, and
immunocytochemistry. In addition to
diagnostics, this invention can be used
in the staging of thyroid malignancies
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by measuring changes in DET gene and
protein expression relative to reference
cells. Finally, this invention can also be
used in the discovery of therapeutic
agents through the detection of changes
in DET gene and protein levels prior to
and after treatment.
Market
In 2008, it is expected that about
37,340 new cases of thyroid cancer will
be diagnosed in the United States.
Women will be disproportionately
affected constituting 76% of these new
cases. In contrast to other adult cancers,
thyroid cancer mainly affects younger
people with nearly 2 out of 3 cases
found in patients between the ages of 20
and 55. Fortunately, this is one of the
least deadly cancers; the percentage of
people living at least 5 years after being
diagnosed is about 97%.
Although thyroid cancer is one of the
most curable cancers, current methods
of diagnosis are inaccurate. Thyroid
cancer usually presents itself as nodules
or lumps on the lobes of the gland. The
development of nodules is common
with increasing age; however, most
nodules are usually benign. To
distinguish benign from malignant
nodules, a biopsy is performed using
fine-needle aspiration biopsy (FNA).
Then this sample is examined for
cytological features associated with
cancer. However, cancer is clearly
diagnosed in only 5% of FNA biopsies.
Many biopsy results are inconclusive
and labeled as suspicious or
indeterminate because of difficulties in
distinguishing benign and malignant
thyroid tumors solely on cellular
features. This result greatly impacts
treatment decisions because patients
with benign nodules may be subjected
to unnecessary surgery that will impact
their lives considerably. Thus, there is
a compelling need to develop more
accurate diagnostic tests to detect
thyroid cancer.
Patent Estate
This technology consists of the
following patent applications:
I. United States Patent Application
No. 11/547,995 entitled ‘‘Diagnostic
Tool for Diagnosing Benign Versus
Malignant Thyroid Lesions’’ filed
October 10, 2004 (HHS Ref. No. E–124–
2004/2–US–03); Pre-Grant Publication
No. 2008–0145841.
II. European Patent Application No.
05735973.9 entitled ‘‘Diagnostic Tool
for Diagnosing Benign Versus Malignant
Thyroid Lesions’’ filed April 11, 2005
(HHS Ref. No. E–124–2004/2–PCT–01);
WO publication No. WO/2005/100608.
III. PCT Application No. PCT/
US2008/10139 entitled ‘‘Diagnostic Tool
PO 00000
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65863
for Diagnosing Benign Versus Malignant
Thyroid Lesions’’ filed August 27, 2008
(HHS Ref. No. E–326–2007/0–PCT–01).
Next Step: Teleconference
There will be a teleconference where
the principal investigator will explain
this technology. Licensing and
collaborative research opportunities will
also be discussed. If you are interested
in participating in this teleconference
please call or e-mail Mojdeh Bahar;
(301) 435–2950; baharm@mail.nih.gov.
OTT will then e-mail you the date, time
and number for the teleconference.
Dated: October 23, 2008.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. E8–26334 Filed 11–4–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Research
Resources; 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: National Center for
Research Resources Special Emphasis Panel,
STRB SEP.
Date: November 12, 2008.
Time: 3 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892. (Telephone
Conference Call).
Contact Person: Martha F. Matocha, PhD,
Scientific Review Officer, Office of Review,
National Center for Research Resources,
National Institutes of Health, 6701
Democracy Blvd., 1 Democracy Plaza, Rm.
1070, Bethesda, MD 20892, 301–435–0810,
matocham@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
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65864
Federal Register / Vol. 73, No. 215 / Wednesday, November 5, 2008 / Notices
limitations imposed by the review and
funding cycle.
Name of Committee: National Center for
Research Resources Special Emphasis Panel,
SEPA 09 Review.
Date: December 15–16, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Michael L. Bloom, PhD,
Scientific Review Administrator, Office of
Review, National Center for Research
Resources, 6701 Democracy Blvd., Room
1090, Bethesda, MD 20892, 301–435–0965,
bloomm2@mail.nih.gov.
Name of Committee: National Center for
Research Resources Special Emphasis Panel,
The BIRN-Community Service Award.
Date: February 3, 2009.
Time: 11 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892. (Telephone
Conference Call).
Contact Person: Maratha F. Matocha, PhD,
Scientific Review Officer, Office of Review,
National Center for Research Resources,
National Institutes of Health, 6701
Democracy Blvd., 1 Democracy Plaza, Rm.
1070, Bethesda, MD 20892, 301–435–0810,
matocham@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research; 93.371, Biomedical
Technology; 93.389, Research Infrastructure,
93.306, 93.333, National Institutes of Health,
HHS)
Dated: October 28, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–26340 Filed 11–4–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
hsrobinson on PROD1PC76 with NOTICES
National Institute of Diabetes and
Digestive and Kidney Diseases;
Diabetes Mellitus Interagency
Coordinating Committee; Notice of
Meeting
The Diabetes Mellitus Interagency
Coordinating Committee (DMICC) will
hold a meeting on Tuesday, December 2,
2008, on the NIH campus, Building 31,
C-wing, Conference Room 6, Bethesda,
Maryland 20892 from 12:30 p.m. to
approximately 4:30 p.m. The meeting
will be open to the public, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
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inform the Contact Person listed below
at least 10 days in advance of the
meeting.
The DMICC facilitates cooperation,
communication, and collaboration on
diabetes among government entities.
DMICC meetings, held several times
annually, provide an opportunity for
members to learn about and discuss
current and future diabetes programs in
DMICC member organizations and to
identify opportunities for collaboration.
The topic of the December meeting will
be ‘‘Using Data from Managed Care
Systems to Drive Improved Therapy of
Diabetes.’’
Please Note: The NIH has instituted
security measures to ensure the safety of NIH
employees and property. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport). All visitors should be prepared
to have their personal belongings inspected
and to go through metal detection inspection.
Visitors are strongly encouraged to take
public transportation to the NIH campus as
there are very few visitor parking spaces
available. Building 31 is a 10-minute walk
from the Medical Center Station on the Red
Line of the Metro.
A registration link and information
about the DMICC meeting will be
available on the DMICC Web site:
https://www2.niddk.nih.gov/
AboutNIDDK/
CommitteesAndWorkingGroups/DMICC/
Default.htm.
For further information concerning
this meeting contact Dr. Sanford
Garfield, Executive Secretary of the
Diabetes Mellitus Interagency
Coordinating Committee, National
Institute of Diabetes and Digestive and
Kidney Diseases, 6707 Democracy
Boulevard, Room 654, MSC 5460,
Bethesda, MD 20892–5460, Telephone:
301–594–8803 FAX: 301–402–6271, Email: garfields@mail.nih.gov.
Dated: October 28, 2008.
Sanford Garfield,
Executive Secretary, DMICC, Division of
Diabetes, Endocrinology and Metabolic
Diseases, NIDDK, National Institutes of
Health.
[FR Doc. E8–26333 Filed 11–4–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
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
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel,
ITMA/ITSP Conflicts.
Date: November 14, 2008.
Time: 1:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852. (Telephone
Conference Call)
Contact Person: Christopher S. Sarampote,
PhD, Scientific Review Administrator,
Division of Extramural Activities, National
Institute of Mental Health, NIH,
Neuroscience Center, 6001 Executive Blvd.,
Room 6148, MSC 9608, Bethesda, MD 20892,
301–443–1959, csarampo@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS)
Dated: October 29, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–26335 Filed 11–4–08; 8:45 am]
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Agencies
[Federal Register Volume 73, Number 215 (Wednesday, November 5, 2008)]
[Notices]
[Pages 65863-65864]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-26340]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Center for Research Resources; 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: National Center for Research Resources
Special Emphasis Panel, STRB SEP.
Date: November 12, 2008.
Time: 3 p.m. to 4 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, One Democracy Plaza, 6701
Democracy Boulevard, Bethesda, MD 20892. (Telephone Conference
Call).
Contact Person: Martha F. Matocha, PhD, Scientific Review
Officer, Office of Review, National Center for Research Resources,
National Institutes of Health, 6701 Democracy Blvd., 1 Democracy
Plaza, Rm. 1070, Bethesda, MD 20892, 301-435-0810,
matocham@mail.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing
[[Page 65864]]
limitations imposed by the review and funding cycle.
Name of Committee: National Center for Research Resources
Special Emphasis Panel, SEPA 09 Review.
Date: December 15-16, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Washington/Rockville, 1750 Rockville Pike,
Rockville, MD 20852.
Contact Person: Michael L. Bloom, PhD, Scientific Review
Administrator, Office of Review, National Center for Research
Resources, 6701 Democracy Blvd., Room 1090, Bethesda, MD 20892, 301-
435-0965, bloomm2@mail.nih.gov.
Name of Committee: National Center for Research Resources
Special Emphasis Panel, The BIRN-Community Service Award.
Date: February 3, 2009.
Time: 11 a.m. to 2 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, One Democracy Plaza, 6701
Democracy Boulevard, Bethesda, MD 20892. (Telephone Conference
Call).
Contact Person: Maratha F. Matocha, PhD, Scientific Review
Officer, Office of Review, National Center for Research Resources,
National Institutes of Health, 6701 Democracy Blvd., 1 Democracy
Plaza, Rm. 1070, Bethesda, MD 20892, 301-435-0810,
matocham@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical
Technology; 93.389, Research Infrastructure, 93.306, 93.333,
National Institutes of Health, HHS)
Dated: October 28, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E8-26340 Filed 11-4-08; 8:45 am]
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