[Federal Register Volume 66, Number 152 (Tuesday, August 7, 2001)]
[Notices]
[Pages 41246-41247]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-19625]


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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.

[[Page 41247]]

    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 10, 2001, from 
8:30 a.m. to 5:30 p.m., and September 11, 2001, from 8 a.m. to 5:30 
p.m.
    Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact: 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, e-mail: [email protected], 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 10, 2001, the committee will discuss: (1) 
Clinical trial designs for first-line hormonal treatment of metastatic 
breast cancer; and (2) new drug application (NDA) 21-236, 
IntraDose (cisplatin/epinephrine) Injectable Gel, Matrix 
Pharmaceutical, Inc., indicated for the treatment of recurrent or 
refractory squamous cell carcinoma of the head and neck in patients who 
are not considered curable with surgery or radiotherapy. On September 
11, 2001, the committee will discuss: (1) Biologics license application 
(BLA) 125019, ZevalinTM (ibritumomab tiuxetan), IDEC 
Pharmaceuticals Corp., indicated for the treatment of patients with 
relapsed or refractory low grade, follicular or CD20+ transformed B 
cell non-Hodgkins lymphoma (NHL) and rituximab refractory follicular 
NHL; and (2) supplemental NDA 20-637/S016, Gliadel Wafer 
(carmustine), Guilford Pharmaceuticals, Inc., indicated for use as a 
treatment to significantly prolong survival and maintain overall 
function (as measured by preservation of Karnovsky Perfomance Status) 
and neurological function in patients with malignant glioma undergoing 
primary and/or recurrent surgical resection.
    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 August 31, 
2001. Oral presentations from the public will be scheduled between 
approximately 8:45 a.m. and 9:15 a.m., and 1:30 p.m. and 1:45 p.m. on 
September 10, 2001, and between approximately 8:15 a.m. and 8:45 a.m., 
and 1 p.m. and 1:15 p.m. on September 11, 2001. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentation should notify the contact person before August 31, 2001, 
and submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and address 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 may be conducted for interested persons who 
have submitted their request to speak by August 31, 2001, to address 
issues specific to the topic before the committee.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: July 31, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-19625 Filed 8-6-01; 8:45 am]
BILLING CODE 4160-01-S