[Federal Register Volume 63, Number 54 (Friday, March 20, 1998)]
[Notices]
[Page 13675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7354]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Transmissible Spongiform Encephalopathies 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: Transmissible Spongiform Encephalopathies 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA regulatory issues.
    Date and Time: The meeting will be held on April 15, 1998, 8 a.m. 
to 5:30 p.m., and April 16, 1998, 8 a.m. to 6 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact Person: William Freas or Sheila D. Langford, Center for 
Biologics Evaluation and Research (HFM-21), 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 12392. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: On April 15, 1998, the committee will: (1) Discuss and make 
recommendations regarding the safety of tallow and tallow derivatives 
used in pharmaceuticals, cosmetics, and other FDA-regulated products; 
and (2) discuss U.S. and global issues on edible and nonedible tallow. 
On April 16, 1998, the committee will discuss gelatin and dura mater 
products as a followup to the April 1997 and October 1997 committee 
meetings.
    Procedure: On April 15, 1998, from 8 a.m. to 5:30 p.m., and on 
April 16, 1998, from 8 a.m. to 4:45 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 April 12, 1998. Oral 
presentations from the public will be scheduled between approximately 
8:30 a.m. and 9:30 a.m on April 15, 1998, and between approximately 
10:50 a.m. and 11:20 a.m. and between approximately 2:45 p.m. and 3 
p.m. on April 16, 1998. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before April 12, 1998, 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 16, 1998, from 4:45 p.m. 
to 6 p.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). 
This portion of the meeting will be closed to permit discussion of this 
material.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 13, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-7354 Filed 3-19-98; 8:45 am]
BILLING CODE 4160-01-F