[Federal Register: August 17, 2005 (Volume 70, Number 158)]
[Notices]
[Page 48428-48429]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au05-91]
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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 September 13, 2005, from 8
a.m. to 5 p.m. and on September 14, 2005, from 8 a.m. to 5 p.m.
Location: Holiday Inn, The Ballrooms, 8120 Wisconsin Ave.,
Bethesda, MD.
Contact Person: Johanna M. 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,
301-827-7001, FAX: 301-827-6776, e-mail: cliffordj@cder.fda.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. When available,
background materials for this meeting will be posted 1 business day
before the meeting on FDA's Web site 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 2005 and scroll down to
Oncologic Drugs Advisory Committee.)
Agenda: On September 13, 2005, the committee will discuss the
following: (1) New drug application (NDA) 21-491, proposed trade name
XINLAY (atrasentan hydrochloride) Capsules, Abbott Laboratories,
proposed indication for the treatment of men with metastatic hormone-
refractory prostate cancer; and (2) NDA 21-743, S003, TARCEVA
(erlotinib) Tablets, OSI Pharmaceuticals Inc., proposed indication for
the first-line treatment, in combination with gemcitabine, of patients
with locally advanced, unresectable or metastatic pancreatic cancer. On
September 14, 2005, the committee will discuss the following: (1) NDA
21-880, proposed trade name REVLIMID (lenalidomide), Celgene Corp.,
proposed indication for the treatment of patients with transfusion-
dependent anemia due to low-or intermediate-1-risk myelodysplastic
syndromes associated with a deletion 5q cytogenetic abnormality with or
without additional cytogenetic abnormalities; and (2) NDA 21-877,
proposed trade name ARRANON (nelarabine) Injection, GlaxoSmithKline,
proposed indication for the treatment of patients with T-cell acute
lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease
has not responded to, or has relapsed with, at least two chemotherapy
regimens.
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 by September 2,
2005. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. to 11 a.m., and 2:30 p.m. to 3 p.m. on both
days. Time allotted for each presentation may be limited. Those
desiring to make formal oral presentations should notify the contact
person before September 2, 2005, and
[[Page 48429]]
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.
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
301-827-7001, 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: August 10, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-16331 Filed 8-16-05; 8:45 am]
BILLING CODE 4160-01-S