[Federal Register Volume 65, Number 44 (Monday, March 6, 2000)]
[Notices]
[Page 11785]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5395]


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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 March 20, 2000, 9 a.m. 
to 5:30 p.m. and on March 21, 2000, 8 a.m. to 4 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact Person: Gail Dapolito or Rosanna 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 March 20 and 21, 2000, the committee will discuss: (1) 
Issues related to the use of human pancreatic islets for the treatment 
of diabetes, including product development issues relating to the 
procurement, processing and characterization of islets, preclinical 
animal models for islets and a brief clinical perspective; (2) the 
report of the January 13, 2000, meeting of the Xenotransplantation 
Subcommittee; and (3) an update of research programs in the Division of 
Cellular and Gene Therapies and the Division of Therapeutic Proteins.
    Procedure: On March 20, 2000, from 9 a.m. to 5:30 p.m. and on March 
21, 2000, from 8 a.m. to 8:45 a.m. and from 9:30 a.m. to 5 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 10, 2000. Oral presentations from the public will be scheduled 
between approximately 1:45 p.m. and 2:15 p.m. on March 20, 2000, and 
between 11:30 a.m. and 12 noon on March 21, 2000. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before March 10, 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.
    Closed Committee Deliberations: On March 21, 2000, from 8:45 a.m. 
to 9:30 a.m., the meeting will be closed to permit discussion where 
disclosure would constitute a clearly unwarranted invasion of personal 
privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of 
the review of individual research programs in the Division of Cellular 
and Gene Therapies and the Division of Therapeutic Proteins, Center for 
Biologics Evaluation and Research.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the March 20 and 21, 2000, Biological Response Modifiers Advisory 
Committee meeting. Because the agency believes there is some urgency to 
bring these issue to public discussion and qualified members of the 
Biological Response Modifiers Advisory Committee were available at this 
time, the Commissioner of Food and Drugs concluded that it was in the 
public interest to hold this meeting even if there was not sufficient 
time for the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 28, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-5395 Filed 3-1-00; 4:26 pm]
BILLING CODE 4160-01-F