[Federal Register Volume 65, Number 18 (Thursday, January 27, 2000)]
[Notices]
[Page 4436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1866]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Quality of Life Subcommittee of the Oncologic Drugs Advisory 
Committee; Notice of Meeting

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

    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: Quality of Life Subcommittee of the 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 February 10, 2000, 8 
a.m. to 4 p.m.
    Location: Ramada Inn, Embassy Ballroom, 8400 Wisconsin Ave., 
Bethesda, 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: The Quality of Life Subcommittee of the Oncologic Drugs 
Advisory Committee will discuss issues related to the study of quality 
of life for patients enrolled in cancer trials. Specific potential 
areas for discussion include definition of patient centered outcomes, 
clinical significance and interpretation of study results, and 
approaches to the statistical analysis of data.
    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 February 3, 
2000. Oral presentations from the public will be scheduled between 
approximately 8:15 a.m. and 8:45 a.m., and between approximately 12:45 
p.m. and 1:15 p.m. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before February 3, 2000, 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 may be 
conducted for interested persons who have submitted their request to 
speak by February 3, 2000, 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: January 18, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-1866 Filed 1-26-00; 8:45 am]
BILLING CODE 4160-01-F