[Federal Register: April 3, 2007 (Volume 72, Number 63)]
[Notices]
[Page 15886-15887]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03ap07-61]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Oncologic Drugs Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
[[Page 15887]]
ACTION: Notice.
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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 May 9, 2007, from 8 a.m.
to 4 p.m. and May 10, 2007, from 8 a.m. to 5 p.m.
Location: Hilton Washington DC/Silver Spring, 8727 Colesville Rd.,
Silver Spring, MD, 301-589-5200.
Contact Person: Johanna Clifford, Center for Drug Evaluation and
Research (HFD-21), Food and Drug Administration, 5630 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857,
301-827-6761, FAX: 301-827-6776, e-mail: johanna.clifford@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.
Agenda: On May 9, 2007, the committee will do the following: (1)
Discuss new drug application (NDA) 022-092, proposed trade name JUNOVAN
(mifamurtide), IDM Pharma, Inc., proposed indication for the treatment
of newly diagnosed resectable high grade osteosarcoma following
surgical resection in combination with multiple agent chemotherapy; and
(2) discuss NDA 022-062, proposed trade name ORBEC (beclomethasone
dipropionate), DOR BioPharma, Inc., proposed indication for the
treatment of graft versus host disease (GvHD) involving the
gastrointestinal tract in conjunction with an induction course of high-
dose prednisone or prednisolone. On May 10, 2007, the committee will
discuss updated information on risks of erythropoeisis-stimulating
agents (ARANESP, Amgen, Inc., EPOGEN, Amgen, Inc., and PROCRIT, Amgen,
Inc.) for use in the treatment of anemia due to cancer chemotherapy.
FDA intends to make background material available to the public no
later than 1 business day 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2007 and 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
April 25, 2007. Oral presentations from the public will be scheduled
between approximately 10:30 a.m. to 11 a.m. and 3:30 p.m. to 4 p.m. on
May 9 and from 10:45 a.m. to 11:45 a.m. on May 10. 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 April 19, 2007. 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 April 18, 2007.
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 Johanna Clifford at
least 7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: March 28, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-6171 Filed 4-2-07; 8:45 am]
BILLING CODE 4160-01-S