42904 Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices 

General Function of the Committee: To 

provide advice and recommendations to the 

agency on FDA’s regulatory issues. 

Date and Time: The meeting will be held 

on October 5, 2009, from 8 a.m. to 5 p.m. 

Location: Hilton Washington DC North/ 

Gaithersburg, The Ballrooms, 620 Perry 

Pkwy., Gaithersburg, MD. The hotel phone 

number is 301–977–8900. 

Contact Person: Nicole Vesely, Center for 

Drug Evaluation and Research (HFD–21), 

Food and Drug Administration, 5600 Fishers 

Lane (for express delivery, 5630 Fishers 

Lane, rm. 1093), Rockville, MD 20857, 301– 

827–6793, FAX: 301–827–6776, e-mail: 

nicole.vesely@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800–741– 

8138 (301–443–0572 in the Washington, DC 

area), code 3014512542. Please call the 

Information Line for up-to-date information 

on this meeting. A notice in the Federal 

Register about last minute modifications that 

impact a previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide timely 

notice. Therefore, you should always check 

the agency’s Web site and call the 

appropriate advisory committee hot line/ 

phone line to learn about possible 

modifications before coming to the meeting. 

Agenda: The committee will discuss the 

following topics: 

(1) Supplemental biologics license 

application (sBLA) 103949/5153.0, 

PEGINTRON (peginterferon alfa-2b) 

injection, manufactured by Schering Corp. 

The proposed indication (use) for this 

product is as an adjuvant (additional) 

treatment for melanoma, a kind of skin 

cancer. The primary treatment for melanoma 

that is metastatic (has spread) to the lymph 

nodes is surgery to remove both the original 

cancer and lymph nodes surrounding the 

cancer. PEGINTRON’s proposed use is as a 

treatment in addition to, or as an ‘‘adjuvant,’’ 

to surgery. 

(2) New drug application (NDA) 022–465, 

proposed trade name VOTRIENT (pazopanib) 

tablets, manufactured by GlaxoSmithKline. 

The proposed indication (use) for this 

product is for the treatment of patients with 

advanced renal cell carcinoma, a form of 

kidney cancer. 

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 

September 21, 2009. Oral presentations from 

the public will be scheduled between 

approximately 10:30 a.m. and 11 a.m., and 

between approximately 3:30 p.m. and 4 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 

September 11, 2009. 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 September 14, 2009. 

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/AboutAdvisory

Committees/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: August 19, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20379 Filed 8–24–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the Board 

of Scientific Counselors, NIA. 

The meeting will be open to the 

public as indicated below, 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 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public as indicated below in accordance 

with the provisions set forth in section 

552b(c)(6), Title 5 U.S.C., as amended 

for the review, discussion, and 

evaluation of individual intramural 

programs and projects conducted by the 

National Institute on Aging, including 

consideration of personnel 

qualifications and performance, and the 

competence of individual investigators, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Board of Scientific 

Counselors, NIA. 

Date: October 20–21, 2009. 

Closed: October 20, 2009, 8 a.m. to 8:30 

a.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 

Boulevard, 3rd Floor Conference Room, 

Baltimore, MD 21224. 

Open: October 20, 2009, 8:30 a.m. to 11:55 

a.m. 

Agenda: Committee Discussion. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 

Boulevard, 3rd Floor Conference Room, 

Baltimore, MD 21224. 

Closed: October 20, 2009, 11:55 a.m. to 1 

p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 

Boulevard, 3rd Floor Conference Room, 

Baltimore, MD 21224. 

Open: October 20, 2009, 1 p.m. to 2:30 p.m. 

Agenda: Committee Discussion. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 

Boulevard, 3rd Floor Conference Room, 

Baltimore, MD 21224. 

Closed: October 20, 2009, 2:30 p.m. to 2:45 

p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 

Boulevard, 3rd Floor Conference Room, 

Baltimore, MD 21224. 

Open: October 20, 2009, 2:45 p.m. to 3:15 

p.m. 

Agenda: Committee Discussion. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 

Boulevard, 3rd Floor Conference Room, 

Baltimore, MD 21224. 

Closed: October 20, 2009, 3:15 p.m. to 4:15 

p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 

Boulevard, 3rd Floor Conference Room, 

Baltimore, MD 21224. 

Closed: October 21, 2009, 8 a.m. to 8:30 

a.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 


pwalker on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices 42905 

Boulevard, 3rd Floor Conference Room, 

Baltimore, MD 21224. 

Open: October 21, 2009, 8:30 a.m. to 12:45 

p.m. 

Agenda: Committee Discussion. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 

Boulevard, 3rd Floor Conference Room, 

Baltimore, MD 21224. 

Closed: October 21, 2009, 12:45 p.m. to 

1:45 p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institute on Aging, 

Biomedical Research Center, 251 Bayview 

Boulevard, 3rd Floor Conference Room, 

Baltimore, MD 21224. 

Contact Person: Dan L. Longo, MD, 

Scientific Director, National Institute on 

Aging, Gerontology Research Center, 

National Institutes of Health, 5600 Nathan 

Shock Drive, Baltimore, MD 21224–6825. 

410–558–8110. dl14q@nia.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: August 19, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–20509 Filed 8–24–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the AIDS 

Research Advisory Committee, NIAID. 

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 

notify the Contact Person listed below 

in advance of the meeting. 

Name of Committee: AIDS Research 

Advisory Committee, NIAID, AIDS Vaccine 

Research Subcommittee. 

Date: September 15–16, 2009. 

Time: 8:30 a.m. to 5 p.m. 

Agenda: To discuss recent developments 

and future plans in AIDS vaccine research, 

development and clinical testing. 

Place: Bethesda Marriott, 5151 Pooks Hill 

Road, Bethesda, MD 20814. 

Contact Person: James A. Bradac, PhD, 

Program Official, Preclinical Research and 

Development Branch, Division of AIDS, 

Room 5116, National Institutes of Health/ 

NIAID, 6700B Rockledge Drive, Bethesda, 

MD 20892–7628, 301–435–3754, 

jbradac@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: August 18, 2009. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–20314 Filed 8–24–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Healthcare Infection Control Practices 

Advisory Committee (HICPAC); 

Meeting Notice 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), the Centers for Disease 

Control and Prevention (CDC) 

announces the following meeting for the 

aforementioned committee: 

Time and Date: 2 p.m.–3 p.m., September 

9, 2009. 

Place: The teleconference call will 

originate at the CDC. 

Status: Open to the public. Teleconference 

access limited only by availability of 

telephone ports. To participate in the 

teleconference please dial 1–888–324–8568 

and enter conference code 7126207. 

Purpose: The Committee is charged with 

providing advice and guidance to the 

Secretary, HHS; the Assistant Secretary for 

Health; the Director, CDC; and the Director, 

National Center for Preparedness, Detection, 

and Control of Infectious Diseases 

(NCPDCID), regarding: (1) The practice of 

hospital infection control; (2) strategies for 

surveillance, prevention, and control of 

infections (e.g., nosocomial infections), 

antimicrobial resistance, and related events 

in settings where healthcare is provided; and 

(3) 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 a follow-up discussion on the Draft 

Guideline for Prevention of CatheterAssociated Urinary Tract Infections 2008, 

available on the following HICPAC Web 

page: http://www.cdc.gov/ncidod/dhqp/ 

hicpac_schedule.html. 

Agenda items are subject to change as 

priorities dictate. 

Contact Person for More Information: 

Wendy Vance, HICPAC, Division of 

Healthcare Quality Promotion, NCPDCID, 

CDC, 1600 Clifton Road, NE., Mailstop A–07, 

Atlanta, Georgia 30333. 

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 CDC and the Agency for Toxic 

Substances and Disease Registry. 

Dated: August 17, 2009. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention (CDC). 

[FR Doc. E9–20373 Filed 8–24–09; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Committee on Rural 

Health and Human Services; Notice of 

Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

that the following committee will 

convene its sixty-third. 

Name: National Advisory Committee 

on Rural Health and Human Services. 

Dates and Times: September 9, 2009, 

9 a.m.–4:45 p.m.; September 10, 2009, 

8:30 a.m.–4 p.m.; September 11, 2009, 

8:45 a.m.–11 a.m. 

Place: Sheraton Grand Hotel, 1230 J 

Street, Sacramento, California 95814, 

Phone: 916–341–3605. 

Status: The meeting will be open to 

the public. 

Purpose: The National Advisory 

Committee on Rural Health and Human 

Services provides advice and 

recommendations to the Secretary with 

respect to the delivery, research, 

development and administration of 

health and human services in rural 

areas. 

Agenda: Wednesday morning, at 9 

a.m., the meeting will be called to order 

by the Chairperson of the Committee, 

the Honorable David Beasley. The first 

two presentations will be overviews of 

rural California. The remainder of the 

day the Committee will hear 

presentations on the three chosen 

Subcommittee topics. The first panel 

will focus on Primary Care Workforce. 

The second panel is Home-Based Care 

Options for Seniors. The final panel of 

the day is Health Care Provider 

Integration. After the panel discussions, 

the Committee Chair will give an 

overview of the site visits. This will be 

followed by a call for public comment. 

The Tuesday meeting will close at 4:45 

p.m. 

Thursday morning, at 8:30 a.m., the 

Committee will break into 

Subcommittees and depart to the site 

visits. The Primary Care Workforce 

Subcommittee and the Health Care 


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