[Federal Register Volume 66, Number 119 (Wednesday, June 20, 2001)]
[Notices]
[Page 33101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15443]


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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 July 13, 2001, 8:30 a.m. 
to 4 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, 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: The committee will meet to: (1) Discuss responses to the 
March 6, 2000, FDA gene therapy letter (http://www.fda.gov/cber/letters.htm) relating to adenovirus vector titer measurements and 
replication competent adenovirus levels reporting, and (2) hear updates 
on the NIH final action on serious adverse reporting.
    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 July 6, 2001. 
Oral presentations from the public will be scheduled between 
approximately 11 a.m. and 12 noon. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before July 6, 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: June 12, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-15443 Filed 6-19-01; 8:45 am]
BILLING CODE 4160-01-S