National Institute on Aging; Notice of Meeting, 42904-42905 [E9-20509]
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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 https://
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
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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 https://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]
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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
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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
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Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices
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]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Meeting
pwalker on DSK8KYBLC1PROD with NOTICES
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.
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(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]
42905
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]
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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: https://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
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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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Agencies
[Federal Register Volume 74, Number 163 (Tuesday, August 25, 2009)]
[Notices]
[Pages 42904-42905]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20509]
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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
[[Page 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]
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