[Federal Register: April 3, 2007 (Volume 72, Number 63)]
[Page 15886-15887]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

[[Page 15887]]

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 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 
    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 
    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]