[Federal Register: November 5, 2007 (Volume 72, Number 213)]
[Notices]
[Page 62482-62483]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05no07-61]
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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.
ACTION: Notice.
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This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). At least one
portion of the meeting will be closed 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 December 5, 2007, from 8
a.m. to 5 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: On December 5, 2007, from 8 a.m. to 3 p.m., the committee
will discuss supplemental biologics license application (sBLA) 125085/
91, AVASTIN (bevacizumab), Genentech, Inc., proposed indication, in
combination with paclitaxel, for the treatment of patients who have not
received chemotherapy for their locally recurrent or metastatic, HER2
negative breast cancer. From 3:30 p.m. to 5 p.m., the committee will
meet in closed session.
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: On December 5, 2007, from 8 a.m. to 3 p.m., the meeting
is open to the public. 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 November 21, 2007. Oral presentations from the public will be
scheduled between approximately 11 a.m. and 12 noon. 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 November 13, 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 November 14, 2007.
Closed Committee Deliberations: On December 5, 2007, from 3:30 p.m.
to 5 p.m., the meeting will be closed to permit discussion and review
of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)).
During this session, the committee will be briefed on recent and
upcoming applications within the Office of Oncology Products.
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
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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 http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.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: October 24, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-21630 Filed 11-2-07; 8:45 am]
BILLING CODE 4160-01-S