Federal Register / Vol. 75, No. 200 / Monday, October 18, 2010 / Notices 63843 

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 thyroidrelated 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. 

Dated: October 12, 2010. 

Richard U. Rodriguez, 

Director, Division of Technology Development 

and Transfer, Office of Technology Transfer, 

National Institutes of Health. 

[FR Doc. 2010–26160 Filed 10–15–10; 8:45 am] 

BILLING CODE 4140–01–P 

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] 

BILLING CODE 4140–01–P 

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 

mstockstill on DSKH9S0YB1PROD with NOTICES

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. 

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] 

BILLING CODE 4140–01–P 

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. 

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 

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) 

Dated: October 8, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–26192 Filed 10–15–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Health Resources and Services 

Administration CDC/HRSA Advisory 

Committee on HIV and STD Prevention 

and Treatment (CHACHSPT) 

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 

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. 

Dated: October 8, 2010. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2010–26144 Filed 10–15–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Healthcare Infection Control Practices 

Advisory Committee (HICPAC) 

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 http://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 

mstockstill on DSKH9S0YB1PROD with NOTICES