Oncologic Drugs Advisory Committee; Notice of Meeting, 40209 [E9-19108]
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Federal Register / Vol. 74, No. 153 / Tuesday, August 11, 2009 / Notices
The draft meeting agenda and a registration
form will be available on or about August 21,
2009, on the HRSA’s Program Web site at
https://bloodcell.transplant.hrsa.gov/ABOUT/
Advisory_Council/.
The completed registration form should be
submitted by facsimile to Professional and
Scientific Associates (PSA), the logistical
support contractor for the meeting, at fax
number (703) 234–1701 ATTN: Rebecca
Pascoe. Registration can also be completed
electronically at https://www.team-psa.com/
dot/fall2009/acbsct. Individuals without
access to the Internet who wish to register
may call Rebecca Pascoe with PSA at (703)
234–1747.
FOR FURTHER INFORMATION CONTACT:
Remy Aronoff, Executive Secretary,
Healthcare Systems Bureau, Health
Resources and Services Administration,
5600 Fishers Lane, Room 12–105,
Rockville, Maryland 20857; telephone
(301) 443–3264.
Dated: August 4, 2009.
Alexandra Huttinger,
Director, Division of Policy Review and
Coordination.
[FR Doc. E9–19110 Filed 8–10–09; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Oncologic Drugs Advisory Committee;
Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
sroberts on DSKD5P82C1PROD 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: 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 September 1, 2009, from 8 a.m.
to 5 p.m.
Location: Hilton Washington DC/
Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The
hotel phone number is 301–589–5200.
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
VerDate Nov<24>2008
20:51 Aug 10, 2009
Jkt 217001
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
new drug application (sNDA) 021–
673/S–009, CLOLAR (clofarabine)
Injection for intravenous use, Genzyme
Corp., proposed indication for the
treatment of previously untreated adults
aged 60 years or older with acute
myeloid leukemia with at least one
unfavorable baseline prognostic factor
and (2) new drug application (NDA)
022–489, proposed trade name
ONRIGIN (laromustine) Injection, Vion
Pharmaceuticals, Inc., proposed
indication for remission induction
therapy for patients 60 years or older
with de novo poor-risk acute myeloid
leukemia (AML).
CLOLAR (clofarabine) Injection for
intravenous use has a new proposed
indication for treatment of AML in
previously untreated adults aged 60
years or older with at least one medical
or health factor that increases the risk of
an unfavorable outcome. Laromustine
Injection, with the proposed trade name
ONRIGIN, has a proposed use for
‘‘remission induction therapy’’ for AML.
This is an initial approach to AML
treatment designed to induce, or bring
about, remission (reduction or
disappearance) of leukemia in patients
60 years or older with de novo, or first
occurrence, AML designated as ‘‘poorrisk,’’ or more likely to have a poor
outcome.
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,
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
40209
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before August 25, 2009.
Oral presentations from the public will
be scheduled between approximately
10:45 a.m. and 11:15 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 August
25, 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 August 26, 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/Advisory
Committees/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: August 3, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–19108 Filed 8–10–09; 8:45 am]
BILLING CODE 4160–01–S
E:\FR\FM\11AUN1.SGM
11AUN1
Agencies
[Federal Register Volume 74, Number 153 (Tuesday, August 11, 2009)]
[Notices]
[Page 40209]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-19108]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
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: 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 September 1, 2009, from
8 a.m. to 5 p.m.
Location: Hilton Washington DC/Silver Spring, The Ballrooms, 8727
Colesville Rd., Silver Spring, MD. The hotel phone number is 301-589-
5200.
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 new drug application (sNDA) 021-673[sol]S-009, CLOLAR
(clofarabine) Injection for intravenous use, Genzyme Corp., proposed
indication for the treatment of previously untreated adults aged 60
years or older with acute myeloid leukemia with at least one
unfavorable baseline prognostic factor and (2) new drug application
(NDA) 022-489, proposed trade name ONRIGIN (laromustine) Injection,
Vion Pharmaceuticals, Inc., proposed indication for remission induction
therapy for patients 60 years or older with de novo poor-risk acute
myeloid leukemia (AML).
CLOLAR (clofarabine) Injection for intravenous use has a new
proposed indication for treatment of AML in previously untreated adults
aged 60 years or older with at least one medical or health factor that
increases the risk of an unfavorable outcome. Laromustine Injection,
with the proposed trade name ONRIGIN, has a proposed use for
``remission induction therapy'' for AML. This is an initial approach to
AML treatment designed to induce, or bring about, remission (reduction
or disappearance) of leukemia in patients 60 years or older with de
novo, or first occurrence, AML designated as ``poor-risk,'' or more
likely to have a poor outcome.
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
August 25, 2009. Oral presentations from the public will be scheduled
between approximately 10:45 a.m. and 11:15 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 August 25, 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 August
26, 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/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: August 3, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-19108 Filed 8-10-09; 8:45 am]
BILLING CODE 4160-01-S