[Federal Register Volume 64, Number 97 (Thursday, May 20, 1999)]
[Notices]
[Pages 27581-27582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12852]


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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). At least one 
portion of the meeting will be closed 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 June 7 and 8, 1999, 8 
a.m. to 5:30 p.m.
    Location: Town Center Hotel, Maryland Ballroom, 8727 Colesville 
Rd., 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 20057, 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: The committee will discuss: (1) The use of time-to-
progression as the primary endpoint in breast cancer drug trials; and 
(2) new drug application (NDA) 21-010, epirubicin hydrochloride for 
injection, Pharmacia and Upjohn Co., indicated for use as a component 
of adjuvant therapy in patients with evidence of axillary-node-tumor 
involvement following resection of primary breast cancer (Stage II & 
III). Epirubicin is indicated for the therapy of patients with locally 
advanced or metastatic breast cancer. On June 8, 1999, the committee 
will discuss: (1) NDA 50-718/S-006, Doxil (doxorubicin HCl 
liposome injection), Alza Corp., indicated for the treatment of 
patients with metastatic carcinoma of the ovary who are refractory to 
both paclitaxel- and platinum-based chemotherapy regimens and who may 
also be refractory to topotecan. Refractory is defined as a patient 
having progressive disease while on treatment, or within 6 months of 
completing treatment; and (2) NDA 20-221/S-012, Ethyol 
(amifostine) for injection, U.S. Bioscience, Inc., indicated for use to 
reduce the incidence and severity of radiation induced xerostomia.
    Procedure: On June 7, 1999, from 10:30 a.m. to 5:30 p.m., the 
meeting is open to the public. 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 
May 28, 1999. Oral presentations from the public will be scheduled 
between approximately 10:45

[[Page 27582]]

a.m. and 11 a.m. and 1:45 p.m. and 2:15 p.m. on June 7, 1999, and 
between approximately 8:15 a.m. and 8:45 a.m. on June 8, 1999. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before May 
28, 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 15-minute open public session will be conducted for 
interested persons who have submitted their request to speak by May 28, 
1999, to address issues specific to the submission or topic before the 
committee.
    Closed Committee Deliberations: On June 7, 1999, from 8 a.m. to 10 
a.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). 
This portion of the meeting will be closed to permit discussion of this 
information.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the June 7 and 8, 1999, Oncologic Drugs Advisory Committee meeting. 
Because the agency believes there is some urgency to bring these issues 
to public discussion and qualified members of the Oncologic Drugs 
Advisory Committee were available at this time, the Commissioner 
concluded that it was in the public interest to hold this meeting even 
if there was not sufficient time for the customary 15-day public 
notice.
     Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 14, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-12852 Filed 5-18-99; 11:31 am]
BILLING CODE 4160-01-F