[Federal Register: June 14, 2007 (Volume 72, Number 114)]
[Notices]
[Page 32852-32853]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jn07-57]
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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.
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 July 24, 2007, from 8
a.m. to 5 p.m.
Location: Advisors and Consultants Staff Conference Room, 5630
Fishers Lane, rm. 1066, Rockville, MD 20857.
Contact Person: Johanna Clifford, 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,
301-827-6761, 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
[[Page 32853]]
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 new drug
applications (NDAs): (1) NDA 022-042, EVISTA (raloxifene hydrochloride)
Tablets, Eli Lilly and Co., proposed indications for the reduction in
risk of invasive breast cancer in postmenopausal women with
osteoporosis, and for the reduction in risk of invasive breast cancer
in postmenopausal women at high risk of breast cancer; and (2) NDA 021-
801, proposed trade name ORPLATNA (satraplatin capsules), GPC Biotech
Inc., proposed indication for the treatment of patients with androgen
independent (hormone refractory) prostate cancer (HRPC) that has failed
prior chemotherapy.
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 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 July
10, 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. 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 July 2, 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 July 3, 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: June 6, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-11496 Filed 6-13-07; 8:45 am]
BILLING CODE 4160-01-S