[Federal Register Volume 62, Number 157 (Thursday, August 14, 1997)]
[Notices]
[Pages 43539-43540]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21572]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

[[Page 43540]]

    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 regulatory issues.

    Date and Time: The meeting will be held on September 18 and 19, 
1997, 8 a.m. to 5:30 p.m.
    Location: Holiday Inn, Versailles Ballrooms II and III, 8120 
Wisconsin Ave., Bethesda, MD.

    Contact Person: Jannette O'Neill-Gonzalez, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-5455, 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 18, 1997, the committee will discuss: (1) New 
drug application (NDA) 20-817, Rivizor<SUP>TM</SUP> Tablets (vorozole, 
Janssen Research Foundation), indicated for ``the treatment of advanced 
breast cancer in postmenopausal women (natural or artificially-induced 
menopause) with disease progression following antiestrogen therapy''; 
and (2) NDA Supplement 20-451/S002, Photofrin<Register> (porfimer 
sodium, QLT Photo Therapeutics Inc.), indicated for: ``a) reduction of 
obstruction and palliation of symptoms in patients with completely or 
partially obstructing endobronchial nonsmall cell lung cancer (NSCLC), 
and b) treatment of endobronchial carcinoma in situ or microinvasive 
NSCLC in patients for whom surgery and radiotherapy are not 
indicated.'' On September 19, 1997, the committee will discuss: (1) NDA 
20-826, Paxene<Register> (paclitaxel, Baker-Norton Pharmaceuticals, 
Inc.), ``indicated after failure of first line or subsequent systemic 
chemotherapy for the treatment of advanced AIDS-related Kaposi's 
Sarcoma''; and (2) NDA Supplement 16-295/S029, Droxia<Register> 
(hydroxyurea, Bristol-Myers Squibb), ``indicated in the treatment of 
sickle cell anemia in adult patients to prevent painful crises and to 
reduce the need for blood transfusions.''

    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 4, 
1997. Oral presentations from the public will be scheduled between 
approximately 8:05 a.m. and 9:05 a.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 4, 
1997, 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.

    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 7, 1997.
William B. Schultz,
Acting Lead Deputy Commissioner for the Food and Drug Administration.
[FR Doc. 97-21572 Filed 8-13-97; 8:45 am]
BILLING CODE 4160-01-F