[Federal Register Volume 66, Number 54 (Tuesday, March 20, 2001)]
[Notices]
[Pages 15725-15726]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6774]


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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). At least one 
portion of the meeting will be closed 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 April 5, 2001, from 9 
a.m. to 6 p.m. and on April 6, 2001, from 8:30 a.m. to 3:30 p.m.
    Location: Holiday Inn, Versailles I and II Ballroom.
    Contact: Gail M. Dapolito (HFM-71), or Rosanna L. Harvey (HFM-71), 
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-
1448, 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 April 5 and 6, 2001, the committee will meet to discuss: 
(1) Responses to the March 6, 2000, FDA Gene Therapy Letter (http://www.fda.gov/cber/letters.htm); (2) results of gene therapy clinical 
site inspections, (3) long-term follow-up of gene therapy patients, and 
(4) the FDA proposed rule entitled ``Availability for Public Disclosure 
and Submission to FDA for Public Disclosure of Certain Data and 
Information Related to Human Gene Therapy or Xenotransplantation'' 
(http://www.fda.gov/cber/rules.htm). In addition, the committee will 
receive an update on two research programs in the Division of Cellular 
and Gene Therapies and the Division of Monoclonal Antibodies, Center 
for Biologics Evaluation and Research.
    Procedure: On April 5, 2001, from 9 a.m. to 5:15 p.m. and on April 
6, 2001, from 8:30 a.m. to 3:30 p.m., the meeting is open to the 
public. 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 March 26, 2001. Oral 
presentations from the public will be scheduled between approximately 
1:30

[[Page 15726]]

p.m. and 2 p.m. on April 5, 2001, and between approximately 11 a.m. to 
11:30 a.m. on April 6, 2001. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before March 26, 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.
    Closed Committee Deliberations: On April 5, 2001, from 5:15 p.m. to 
6 p.m. the meeting will be closed to permit discussion where disclosure 
would constitute a clearly unwarranted invasion of personal privacy (5 
U.S.C. 5552b(c)(6)). The committee will discuss reports of the review 
of research programs in the Division of Cellular and Gene Therapies and 
the Division of Monoclonal Antibodies, Center for Biologics Evaluation 
and Research.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 12, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-6774 Filed 3-19-01; 8:45 am]
BILLING CODE 4160-01-S