National Institute of Diabetes and Digestive and Kidney Diseases; Amended Notice of Meeting, 63843-63844 [2010-26183]
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Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices
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encompassed by this technology are
more potent and/or more specific TSH
receptor activators than currentlyavailable compounds; also, as small
molecules, these compounds are orally
available and are expected to be less
costly and more straightforward to
produce than recombinant protein
counterparts currently on the market.
According to the National Cancer
Institute, over 37,000 new cases of
thyroid cancer were diagnosed in the
United States in 2008, and over 1,500
people died of this disease. These
numbers reflect a progressive increase
in the incidence of thyroid cancer over
the last several years. Because most
cases of thyroid cancer are diagnosed in
patients between the ages of 20 and 54,
these patients will undergo decades of
follow-up monitoring after cancer
treatment. For the last decade,
recombinant TSH protein has been used
in this follow-up to increase detection
sensitivity for recurrent or metastatic
thyroid cancer, and to eliminate side
effects associated with withdrawal of
hormone replacement therapy. A smallmolecule TSH receptor agonist
encompassed by this technology would
have utility similar to recombinant TSH,
but would have several distinct
advantages. For example, as a small
molecule, rather than a recombinant
protein, such a compound would be
orally available, and would be less
difficult and expensive to produce.
These compounds are also more potent
and/or specific for the TSH receptor
than other known small-molecule TSH
receptor agonists. In addition to use in
thyroid cancer screening, these
compounds may also be useful for
adjunctive treatment (with radioactive
iodide) of thyroid cancer, and certain
forms of hypothyroidism.
Hyperthyroidism, or an overactive
thyroid gland, affects about 1% of
people in the United States and is often
caused by autoimmune over-stimulation
of the thyroid gland (Graves’ disease), or
by thyroid tumors. Drugs currently used
for treatment of hyperthyroidism inhibit
synthesis of thyroid hormones; the TSH
receptor antagonist compounds
encompassed by this technology have
the advantage of directly inhibiting
activity of the TSH receptor, rather than
inhibiting thyroid hormone synthesis.
Applications
• Diagnostic tools for evaluation and
treatment of thyroid cancer.
• Therapeutics for thyroid cancer,
hyperthyroidism, and hypothyroidism.
Market: Approximately 1 in 13
Americans suffers from a thyroid
disorder, and 10 million have a thyroid-
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16:45 Oct 15, 2010
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related condition that requires ongoing
immunodiagnostic monitoring.
Development Status: Early stage.
Inventors: Marvin C. Gershengorn et
al. (NIDDK)
Publications
1. Moore S, Jaeschke H, Kleinau G,
Neumann S, Costanzi S, Jiang JK,
Childress J, Raaka BM, Colson A,
Paschke R, Krause G, Thomas CJ,
Gershengorn MC. Evaluation of smallmolecule modulators of the luteinizing
hormone/choriogonadotropin and
thyroid stimulating hormone receptors:
structure-activity relationships and
selective binding patterns. J Med Chem.
2006 Jun 29;49(13):3888–3896.
[PubMed: 16789744]
2. Neumann S, Kleinau G, Costanzi S,
Moore S, Raaka BM, Thomas CJ, Krause
G, Gershengorn MC. A low molecular
weight antagonist for the human
thyrotropin receptor with therapeutic
potential for hyperthyroidism.
Endocrinology 2008 Dec;149(12):5945–
5950. [PubMed: 18669595]
3. Unpublished data are also available
for review under a CDA.
Patent Status
HHS Reference Nos. E–223–2006/0
and E–223–2006/1—
• International Patent Application
No. PCT/US2007/011951 filed 17 May
2007, which published as WO 2007/
136776 on 29 Nov 2007
• National Phase entered in Australia,
Canada, Europe, Japan, and the United
States
HHS Reference No. E–284–2008/0—
• International Patent Application
No. PCT/US2008/011958 filed 20 Oct
2008.
Licensing Status: Available for
licensing.
Licensing Contact: Tara L. Kirby, PhD;
301–435–4426; tarak@mail.nih.gov.
Collaborative Research Opportunity:
The NIDDK Clinical Endocrinology
Branch is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize small molecule TSH
receptor modulators. Please contact
Marguerite J. Miller at 301–496–9003 or
millermarg@mail.nih.gov for more
information.
63843
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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
General Medical Sciences Special Emphasis
Panel; Review of Minority Biomedical
Research Neuro Grant Applications.
Date: November 12, 2010.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency-Bethesda, 7400
Wisconsin Avenue, One Bethesda Metro
Center, Bethesda, MD 20814.
Contact Person: John J. Laffan, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health,
Natcher Building, Room 3AN18J, Bethesda,
MD 20892, 301–594–2773,
laffanjo@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Dated: October 12, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–26185 Filed 10–15–10; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 12, 2010.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
National Institutes of Health
[FR Doc. 2010–26160 Filed 10–15–10; 8:45 am]
Notice is hereby given of a change in
the meeting of the National Institute of
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National Institute of Diabetes and
Digestive and Kidney Diseases;
Amended Notice of Meeting
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63844
Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices
Diabetes and Digestive and Kidney
Diseases Special Emphasis Panel,
October 13, 2010, 7 p.m. to October 14,
2010, 5 p.m., Radisson National Airport,
2020 Jefferson Davis Highway,
Arlington, VA 22202 which was
published in the Federal Register on
September 16, 2010, 179 FR 56551.
The meeting location has changed.
The meeting will be held at the Hilton
Crystal City at Washington Reagan
National Airport, 2399 Jefferson Davis
Highway in Arlington, VA 22202. The
meeting is closed to the public.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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.
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[FR Doc. 2010–26144 Filed 10–15–10; 8:45 am]
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[FR Doc. 2010–26192 Filed 10–15–10; 8:45 am]
Name of Committee: National Institute of
Environmental Health Sciences Special
Emphasis Panel; Toxicology Training Using
Systems-Based Technology.
Date: November 1, 2010.
Time: 2:30 p.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Nat. Inst. of Environmental Health
Sciences, Building 101, Rodbell Auditorium,
111 T. W. Alexander Drive, Research
Triangle Park, NC 27709.
Contact Person: Leroy Worth, PhD,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Research and
Training, Nat. Institute of Environmental
Health Sciences, P. O. Box 12233, MD EC–
30/Room 3171, Research Triangle Park, NC
27709, (919) 541–0670, worth@niehs.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.115, Biometry and Risk
Estimation—Health Risks from
Environmental Exposures; 93.142, NIEHS
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Healthcare Infection Control Practices
Advisory Committee (HICPAC)
Health Resources and Services
Administration CDC/HRSA Advisory
Committee on HIV and STD Prevention
and Treatment (CHACHSPT)
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Jkt 223001
Dated: October 8, 2010.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
Centers for Disease Control and
Prevention
[FR Doc. 2010–26183 Filed 10–15–10; 8:45 am]
16:45 Oct 15, 2010
Dated: October 8, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
authority to sign Federal Register Notices
pertaining to announcements of meetings and
other committee management activities, for
both the CDC and the Agency for Toxic
Substances and Disease Registry.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 7, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
VerDate Mar<15>2010
Hazardous Waste Worker Health and Safety
Training; 93.143, NIEHS Superfund
Hazardous Substances—Basic Research and
Education; 93.894, Resources and Manpower
Development in the Environmental Health
Sciences; 93.113, Biological Response to
Environmental Health Hazards; 93.114,
Applied Toxicological Research and Testing,
National Institutes of Health, HHS)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the CDC announces
the following meeting of the
aforementioned committee:
Times and Dates:
9 a.m.–5 p.m., November 4, 2010.
9 a.m.–12 p.m., November 5, 2010.
Place: Washington Marriott at Metro
Center, Salons C–D, 775 12th Street,
NW., Washington, DC 20005
Status: This meeting is open to the
public, limited only by the space
available. Please register for the meeting
online at https://www.cdc.gov/hicpac or
by sending an e-mail to hicpac@cdc.gov.
Purpose: The Committee is charged
with providing advice and guidance to
the Secretary, the Assistant Secretary for
Health, the Director, CDC, and the
Director, National Center for Emerging
and Zoonotic Infectious Diseases
(NCEZID), regarding the practice of
healthcare infection control and
strategies for surveillance, prevention,
and control of healthcare-associated
infections (e.g., nosocomial infections),
antimicrobial resistance, and related
events in settings where healthcare is
provided, including hospitals,
ambulatory and long-term care facilities,
and home health agencies. The
Committee shall advise CDC on periodic
updating of guidelines and other policy
statements regarding prevention of
healthcare-associated infections and
healthcare-related conditions.
Matters To Be Discussed: The agenda
will include updates on CDC’s activities
for healthcare-associated infections; the
draft guideline for the Prevention of
Norovirus Gastroenteritis Outbreaks in
Healthcare Settings; draft guideline for
prevention of infections among patients
in neonatal intensive care units (NICU);
draft guideline for Infection Control in
Healthcare Personnel; and discussion of
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), CDC/HRSA announces
the following meeting of the
aforementioned committee:
Times and Dates:
8 a.m.–5:30 p.m., November 15, 2010.
8 a.m.–3 p.m., November 16, 2010.
Place: Omni Shoreham Hotel, 2500 Calvert
Street, NW., (at Connecticut Avenue)
Washington, DC 20008. Telephone: (202)
234–0700.
Status: Open to the public, limited only by
the space available. The meeting room will
accommodate approximately 100 people.
Purpose: This Committee is charged with
advising the Director, CDC, and the
Administrator, HRSA, regarding activities
related to prevention and control of HIV/
AIDS and other STDs; the support of health
care services to persons living with HIV/
AIDS; and the education of health
professionals and the public about HIV/AIDS
and other STDs.
Matters To Be Discussed: Agenda items
include issues regarding: (1) HHS
coordination and implementation of the
National HIV/AIDS Strategy; (2) CHACHSPT
Realignment Program Review Workgroup
update; (3) update on strategies to educate
the medical community on the need to
routinely offer HIV testing to females, older
persons, and other patients determined to be
at low risk; and (4) updates on HIV
prevention research and program
implementation.
Agenda items are subject to change as
priorities dictate.
Contact Person for More Information:
Margie Scott-Cseh, CDC, National Center for
HIV/AIDS, Viral Hepatitis, STD, and TB
Prevention, 1600 Clifton Road, NE., Mailstop
E–07, Atlanta, Georgia 30333, Telephone
(404) 639–8317.
The Director, Management Analysis and
Services Office, has been delegated the
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Agencies
[Federal Register Volume 75, Number 200 (Monday, October 18, 2010)]
[Notices]
[Pages 63843-63844]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-26183]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases;
Amended Notice of Meeting
Notice is hereby given of a change in the meeting of the National
Institute of
[[Page 63844]]
Diabetes and Digestive and Kidney Diseases Special Emphasis Panel,
October 13, 2010, 7 p.m. to October 14, 2010, 5 p.m., Radisson National
Airport, 2020 Jefferson Davis Highway, Arlington, VA 22202 which was
published in the Federal Register on September 16, 2010, 179 FR 56551.
The meeting location has changed. The meeting will be held at the
Hilton Crystal City at Washington Reagan National Airport, 2399
Jefferson Davis Highway in Arlington, VA 22202. The meeting is closed
to the public.
Dated: October 7, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-26183 Filed 10-15-10; 8:45 am]
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