[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