Oncologic Drugs Advisory Committee; Notice of Meeting, 42907 [E9-20378]
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Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices
Register of August 11, 2009 (74 FR
40207). The amendment is being made
to reflect a change in the Agenda
portion of the document. There are no
other changes.
FOR FURTHER INFORMATION CONTACT:
Kalyani Bhatt, 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:
Kalyani.Bhatt@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington DC area), codes 3014512529
or 3014512535. Please call the
Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the
Federal Register of August 11, 2009,
FDA announced that a meeting of the
Anesthetic and Life Support Drugs
Advisory Committee and the Drug
Safety and Risk Management Advisory
Committee would be held on September
23, 2009, from 8 a.m. to 4:30 p.m. On
page 40207, in the second column, the
Agenda portion of the document is
changed to read as follows:
Agenda: The committees will discuss
new drug application (NDA) 21–217,
EXALGO (hydromorphone HC1),
Neuromed Pharmaceuticals, Inc., a
modified-release hydromorphone drug
product indicated for the treatment of
moderate-to-severe pain in opioidtolerant patients.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: August 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–20377 Filed 8–24–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Oncologic Drugs Advisory Committee;
Notice of Meeting
pwalker on DSK8KYBLC1PROD with NOTICES
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.
VerDate Nov<24>2008
22:52 Aug 24, 2009
Jkt 217001
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 October 6, 2009, from 8 a.m. to 4 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 new
drug application (NDA) 021–825, proposed
trade name FERRIPROX (deferiprone) filmcoated tablets and oral solution,
manufactured by ApoPharma Inc. The
proposed indications (uses) for this product
is as an iron chelating agent, which is a drug
that binds with iron in the body and helps
to make elimination of iron easier, reducing
iron build-up. There are two specific
proposed indications (uses) of FERRIPROX:
(1) the treatment of iron overload, or buildup in patients with transfusion-dependent
thalassemia, an inherited blood disorder that
necessitates frequent transfusion of normal
blood which can lead to iron build-up due
to the iron content in the blood a patient
receives; and (2) for the treatment of iron
overload in patients with other transfusiondependent anemias (other blood disorders
that require frequent transfusions) for which
the use of other iron chelating agents has
been considered inappropriate.
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 1 p.m. and 2 p.m. Those
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
42907
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 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. E9–20378 Filed 8–24–09; 8:45 am]
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ACTION: 30–Day notice and request for
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]]>Agencies
[Federal Register Volume 74, Number 163 (Tuesday, August 25, 2009)]
[Notices]
[Page 42907]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-20378]
-----------------------------------------------------------------------
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 October 6, 2009, from
8 a.m. to 4 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 new drug application (NDA)
021-825, proposed trade name FERRIPROX (deferiprone) film-coated
tablets and oral solution, manufactured by ApoPharma Inc. The
proposed indications (uses) for this product is as an iron chelating
agent, which is a drug that binds with iron in the body and helps to
make elimination of iron easier, reducing iron build-up. There are
two specific proposed indications (uses) of FERRIPROX: (1) the
treatment of iron overload, or build-up in patients with
transfusion-dependent thalassemia, an inherited blood disorder that
necessitates frequent transfusion of normal blood which can lead to
iron build-up due to the iron content in the blood a patient
receives; and (2) for the treatment of iron overload in patients
with other transfusion-dependent anemias (other blood disorders that
require frequent transfusions) for which the use of other iron
chelating agents has been considered inappropriate.
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 1 p.m. and 2 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 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 19, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20378 Filed 8-24-09; 8:45 am]
BILLING CODE 4160-01-S
