[Federal Register Volume 62, Number 169 (Tuesday, September 2, 1997)]
[Notices]
[Page 46365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23121]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Advisory Committee Meeting; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration is announcing an amendment to 
the notice of meeting of the Oncologic Drugs Advisory Committee which 
is scheduled for September 18 and 19, 1997. This meeting was announced 
in the Federal Register of August 14, 1997 (62 FR 43539). The amendment 
is being made to: (1) Remove the second agenda item scheduled on 
September 19, 1997; (2) change the starting and ending times of the 
meeting on September 19, 1997; and (3) reschedule the time allotted for 
oral presentations from the public on September 19, 1997. There are no 
other changes. This amendment will be announced at the beginning of the 
open portion of the meeting.
FOR FURTHER INFORMATION CONTACT: Jannette O'Neill-Gonzalez or Robinette 
Taylor, 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.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 14, 1997 
(62 FR 43539), FDA announced that a meeting of the Oncologic Drugs 
Advisory Committee would be held on September 18 and 19, 1997. This 
amendment is to provide an update to the information provided earlier 
pertaining to the September 19, 1997, meeting day. There are no changes 
for the September 18, 1997, meeting day. On page 43540, beginning in 
column 1, portions of the notice pertaining to the September 19, 1997, 
meeting day are amended to read as follows:
    Date and Time: The meeting will be held on September 19, 1997, from 
8:30 a.m. to 12:50 p.m.
    Agenda: On September 19, 1997, the committee will discuss: 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.''
    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 8:35 a.m. and 9:05 a.m. on September 19, 1997. 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 25, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-23121 Filed 8-29-97; 8:45 am]
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