Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting, 55243 [E9-25806]
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Federal Register / Vol. 74, No. 206 / Tuesday, October 27, 2009 / Notices
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3176,
MSC 7848, Bethesda, MD 20892, 301–435–
2309, pluded@csr.nih.gov.
Name of Committee: AIDS and Related
Research Integrated Review Group; HIV/
AIDS Vaccines Study Section.
Date: November 20, 2009.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Mary Clare Walker, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5208,
MSC 7852, Bethesda, MD 20892, (301) 435–
1165, walkermc@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AMCB, AIP
and NAED Member Conflicts.
Date: November 23, 2009.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Eduardo A. Montalvo,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5108,
MSC 7852, Bethesda, MD 20892, (301) 435–
1168, montalve@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: October 19, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–25726 Filed 10–26–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Pediatric Oncology Subcommittee of
the Oncologic Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
pwalker on DSK8KYBLC1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Pediatric Oncology
Subcommittee of the Oncologic Drugs
Advisory Committee.
VerDate Nov<24>2008
16:45 Oct 26, 2009
Jkt 220001
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 December 15, 2009, from 8 a.m. to 5 p.m.
Location: Hilton Washington DC North/
Gaithersburg, Montgomery Ballroom, 620
Perry Pkwy., Gaithersburg, MD. The hotel
phone number is 301–977–8900.
Contact Person: Diem-Kieu Ngo, 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–
827–7001, FAX: 301–827–6776, e-mail:
diem.ngo@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: On December 15, 2009, the
subcommittee will consider and discuss: (1)
FDA expectations regarding the development
of pediatric formulations for cancer drugs,
and (2) the development of dosing regimens
in infants and toddlers with 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
subcommittee. Written submissions may be
made to the contact person on or before
December 1, 2009. Oral presentations from
the public will be scheduled between
approximately 10:45 a.m. to 11:15 a.m., and
3:15 p.m. to 3:45 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 20, 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 November
23, 2009.
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
55243
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 Diem-Kieu
Ngo 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: October 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–25806 Filed 10–26–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Endocrinologic and Metabolic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Endocrinologic and
Metabolic Drugs Advisory Committee.
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 December 15, 2009, from 8 a.m. to 5 p.m.
Location: Hilton Washington DC North/
Gaithersburg, The Ballrooms, 620 Perry
Pkwy., Gaithersburg, MD. The hotel
telephone number is 301–977–8900.
Contact Person: Paul Tran, 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, 301–827–7001,
FAX: 301–827–6776, e-mail:
paul.tran@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–741–
8138 (301–443–0572 in the Washington, DC
area), code 3014512536. 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
E:\FR\FM\27OCN1.SGM
27OCN1
]]>Agencies
[Federal Register Volume 74, Number 206 (Tuesday, October 27, 2009)]
[Notices]
[Page 55243]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-25806]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory
Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
Name of Committee: Pediatric Oncology Subcommittee of the
Oncologic Drugs Advisory Committee.
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 December 15, 2009,
from 8 a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, Montgomery
Ballroom, 620 Perry Pkwy., Gaithersburg, MD. The hotel phone number
is 301-977-8900.
Contact Person: Diem-Kieu Ngo, 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, 301-827-7001, FAX: 301-827-6776, e-mail:
diem.ngo@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: On December 15, 2009, the subcommittee will consider and
discuss: (1) FDA expectations regarding the development of pediatric
formulations for cancer drugs, and (2) the development of dosing
regimens in infants and toddlers with 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
subcommittee. Written submissions may be made to the contact person
on or before December 1, 2009. Oral presentations from the public
will be scheduled between approximately 10:45 a.m. to 11:15 a.m.,
and 3:15 p.m. to 3:45 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 20, 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 November 23, 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 Diem-Kieu Ngo 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/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 22, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25806 Filed 10-26-09; 8:45 am]
BILLING CODE 4160-01-S
