[Federal Register Volume 64, Number 162 (Monday, August 23, 1999)]
[Notices]
[Pages 45974-45975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21812]
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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 September 16 and 17,
1999, 8 a.m. to 5 p.m.
Location: Holiday Inn, Kennedy Grand Ballroom, 8777 Georgia Ave.,
Silver Spring, MD.
Contact Person: Karen M. Templeton-Somers, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-7001, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 12542. Please call the Information Line for
up-to-date information on this meeting.
Agenda: On September 16, 1999, the committee will discuss: (1) New
drug application (NDA) 21-053, UFT (tegafur and uracil)
Capsules, Bristol-Myers Squibb Co., indicated, with leucovorin calcium
tablets, for the first-line treatment of metastatic colorectal cancer;
and (2) NDA 50-772, EvacetTM (doxorubicin HCl liposome
injection), The Liposome Co., Inc., indicated for the first-line
treatment of metastatic breast cancer in combination with
cyclophosphamide. On September 17, 1999, the committee will discuss:
(1) NDA 20-262/S-033, TAXOL (paclitaxel) Injection, Bristol-
Myers Squibb Co., indicated for the adjuvant treatment of node-positive
breast cancer administered sequentially to standard combination
therapy; and (2) biologics license application (BLA) 97-1001,
Roferon-A, Hoffman-La Roche Inc., indicated for use as
adjuvant treatment of surgically resected malignant melanoma without
clinical evidence of nodal disease, American Joint Committee on Cancer
stage II (Breslow thickness>1.5 millimeter, N0). In addition, FDA will
provide an update on the preliminary results of EST 1690 (ECOG
intergroup study of INTRON A for the adjuvant treatment of melanoma)
for discussion by the 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 by September 8,
1999. Oral presentations from the public will be scheduled between
approximately 8:15 a.m. and 8:45 a.m., and between approximately 1:15
p.m. and 1:30 p.m. on September 16, 1999, and between approximately
8:15 a.m. and 8:45 a.m., and between approximately 1:15 p.m. and 1:30
p.m. on September 17, 1999. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before September 8, 1999, 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. After the scientific presentations, a 30-minute open
public session will be conducted for interested persons who have
submitted their
[[Page 45975]]
request to speak by September 8, 1999, to address issues specific to
the submission or topic before the committee.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 13, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-21812 Filed 8-20-99; 8:45 am]
BILLING CODE 4160-01-F
