[Federal Register Volume 66, Number 188 (Thursday, September 27, 2001)]
[Notices]
[Page 49393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-24158]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Biological Response Modifiers 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.
    Name of Committee: Biological Response Modifiers 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 October 24, 2001, from 9 
a.m. to 3 p.m., on October 25, 2001, from 8 a.m. to 6 p.m., and on 
October 26, 2001, from 8 a.m. to 3 p.m.
    Location: Holiday Inn, Two Montgomery Village Ave., Gaithersburg, 
MD.
    Contact: Gail Dapolito or Rosanna L. Harvey (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 October 24, 2001, the committee will meet to discuss 
long-term followup of participants in gene transfer clinical trials. On 
October 25, 2001, the committee will discuss vector design, 
manufacture, and preclinical studies of lentivirus vectors in gene 
transfer clinical trials. On October 26, 2001, the committee will 
discuss development of a lentivirus vector gene transfer product for 
people with human immunodeficiency virus (HIV).
    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 October 18, 
2001. Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. and 11 a.m. on October 24, 2001, between 
approximately 2:45 p.m. and 3 p.m. on October 25, 2001, and between 
approximately 11:15 a.m. and 11:30 a.m. on October 26, 2001. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
October 18, 2001, 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: September 21, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-24158 Filed 9-26-01; 8:45 am]
BILLING CODE 4160-01-S