[Federal Register: October 26, 2000 (Volume 65, Number 208)]
[Page 64224]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Biological Response Modifiers Advisory Committee; Notice of 

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: Biological Response Modifiers Advisory 
    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 November 16 and 17, 
2000, 8:30 a.m. to 5:30 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact Person: Gail M. Dapolito or Rosanna L. Harvey, Center 
for Biologics Evaluation and Research (HFM-71), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-
0314, or FDA Advisory Committee Information Line, 1-800-741-8138 
(301-443-0572 in the Washington, DC area), code 12389. Please call 
the Information Line for up-to-date information on this meeting.
    Agenda: On November 16 and 17, 2000, the committee will meet to 
discuss the following issues related to gene therapy clinical 
trials: (1) Product characterization, (2) preclinical models, and 
(3) long term followup.
    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 November 9, 
2000. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 1:30 p.m. on November 16, 2000, and from 9 
a.m. to 9:30 a.m. on November 17, 2000. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before November 9, 
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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 18, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-27455 Filed 10-25-00; 8:45 am]