Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices 65363 

manufactured by SmithKline Beecham 

Corp. d/b/a (doing business as) 

GlaxoSmithKline and 020–180/S–034, 

trade name PROSCAR (finasteride) 

Tablets, manufactured by Merck & Co., 

Inc. The proposed indication (use) for 

AVODART (dutasteride) is for reduction 

in the risk of prostate cancer in men at 

increased risk of developing the disease. 

The population at increased risk of 

prostate cancer includes men with an 

elevated serum prostate-specific antigen 

(PSA) or men otherwise determined to 

be at increased risk based on other 

associated risk factors such as age, race, 

and family history. There is no 

proposed expansion of the indication 

for PROSCAR (finasteride); however, in 

light of the Prostate Cancer Prevention 

Trial (PCPT) which demonstrated a 

statistically significant reduction in the 

7-year period prevalence of prostate 

cancer with finasteride (PROSCAR) 

treatment, and which reported an 

imbalance in high Gleason grade 

prostate cancers (indicating more 

aggressive cancers) in the finasteride 

treatment arm vs. placebo, the efficacy 

and safety of both products for use in 

prostate cancer risk reduction will be 

examined. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before November 16, 2010. 

Oral presentations from the public will 

be scheduled between approximately 

2:30 p.m. to 3:30 p.m. Those desiring to 

make formal oral presentations should 

notify the contact person and submit a 

brief statement of the general nature of 

the evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before November 8, 2010. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

November 9, 2010. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Nicole 

Vesely at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: October 13, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–26651 Filed 10–21–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Basic Behavioral and Social Science 

Opportunity Network (OppNet) 

ACTION: Notice. 

SUMMARY: A two-day meeting 

highlighting OppNet’s activities and 

future goals is scheduled for Thursday, 

October 28, and Friday, October 29, 

2010, at the Hyatt Regency Washington 

on Capitol Hill, 400 New Jersey Avenue, 

NW., Washington DC 20001. This is the 

first public meeting to promote and 

publicize the Basic Behavioral and 

Social Science Opportunity Network 

(OppNet) initiative. Attendance is 

limited to prior registration via http:// 

www.regonline.com/oppnet. 

Background: The Basic Behavioral 

and Social Science Opportunity 

Network (OppNet) is a trans-NIH 

initiative to expand the agency’s 

funding of basic behavioral and social 

sciences research (b-BSSR). OppNet 

prioritizes activities and initiatives that 

focus on basic mechanisms of behavior 

and social processes that are relevant to 

the missions and public health 

challenges of multiple NIH Institutes, 

Centers, and Offices (ICOs) and that 

build upon existing NIH investments 

without replicating them. http:// 

www.oppnet.nih.gov. 

Participating: The meeting will take 

place on October 28, from 9 a.m. to 4:30 

p.m., and October 29, from 8:30 a.m. to 

2:30 p.m., at the Hyatt Regency 

Washington on Capitol Hill, 400 New 

Jersey Avenue, NW., Washington DC 

20001. 

FOR FURTHER INFORMATION CONTACT: To 

register, visit the registration Web site at 

http://regonline.com/oppnet, call 

William Elwood at 301–402–0116, or email elwoodwi@od.nih.gov. 

Dated: October 15, 2010. 

Lawrence A. Tabak, 

Principal Deputy Director, National Institutes 

of Health. 

[FR Doc. 2010–26709 Filed 10–21–10; 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: December 6, 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, PhD, 

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. 


emcdonald on DSK2BSOYB1PROD with NOTICES
65364 Federal Register / Vol. 75, No. 204 / Friday, October 22, 2010 / Notices 

(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 18, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–26708 Filed 10–21–10; 8:45 am] 

BILLING CODE 4140–01–P 

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. App.), 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 Cancer 

Institute Special Emphasis Panel; EDRN 

Biomarker Development Labs (U01) J1. 

Date: November 2, 2010. 

Time: 8 a.m. to 10:30 a.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 116 

Executive Blvd., Room 8146, Rockville, MD 

20852 (Teleconference Meeting). 

Contact Person: Sherwood Githens, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, 6116 

Executive Blvd., Room 8146, Bethesda, MD 

20892, 301/435–1822, githenss@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to scheduling 

conflicts. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; EDRN 

Biomarker Development Labs (U01) J2. 

Date: November 2, 2010. 

Time: 10:30 a.m. to 1:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6116 

Executive Blvd., Room 8146, Rockville, MD 

20852 (Teleconference Meeting). 

Contact Person: Sherwood Githens, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, 6116 

Executive Blvd., Room 8146, Bethesda, MD 

20892, 301/435–1822, githenss@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to scheduling 

conflicts. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; EDRN 

Biomarker Development Labs (U01) J3. 

Date: November 2, 2010. 

Time: 2 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6116 

Executive Blvd., Room 8146, Rockville, MD 

20852 (Teleconference Meeting). 

Contact Person: Sherwood Githens, PhD, 

Scientific Review Officer, Special Review 

and Logistics Branch, Division of Extramural 

Activities, National Cancer Institute, 6116 

Executive Blvd., Room 8146, Bethesda, MD 

20892, 301/435–1822, githenss@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to scheduling 

conflicts. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: October 18, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–26706 Filed 10–21–10; 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; Conferences and Scientific 

Meetings Support. 

Date: November 16, 2010. 

Time: 1 p.m. to 4 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 (Telephone 

Conference Call). 

Contact Person: Teresa Nesbitt, PhD, DVM, 

Chief, Scientific Review Branch, Division of 

Extramural Research and Training, Nat’l 

Institute of Environmental Health Sciences, 

P.O. Box 12233, MD EC–30, Research 

Triangle Park, NC 27709, (919) 541–7571, 

nesbittt@mail.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 15, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–26704 Filed 10–21–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; 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 contract proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the contract 

proposals, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; Epitope 

Mapping Technologies. 

Date: December 14, 2010. 

Time: 1 p.m. to 4 p.m. 


emcdonald on DSK2BSOYB1PROD with NOTICES