[Federal Register Volume 62, Number 185 (Wednesday, September 24, 1997)]
[Notices]
[Pages 49988-49989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-25264]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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 October 6 and 7, 1997, 
8:30 a.m. to 5:30 p.m.
    Location: Holiday Inn, Versailles Ballrooms I and II, 8120 
Wisconsin Ave., Bethesda, MD.
    Contact Person: William Freas or Jane S. Brown, Center for 
Biologics Evaluation and Research (HFM-21), 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 12388. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: On October 6, 1997, the committee will discuss FDA 
regulatory controls to address transmission of Creutzfeldt-Jakob 
Disease (CJD) by human dura mater products. On October 7, 1997, the 
committee will discuss appropriate FDA actions concerning CJD-
implicated ``secondary'' products (i.e., products in which a CJD-
implicated plasma derivative was either added as an excipient or used 
as a reagent in the manufacturing process).
    Procedure: On October 6, 1997, from 8:30 a.m. to 5:30 p.m., and 
October 7,

[[Page 49989]]

1997, from 8:30 a.m. to 1:15 p.m., and 1:45 p.m. to 5:30 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 
October 1, 1997. Oral presentations from the public will be scheduled 
between approximately 8:45 a.m. and 9:30 a.m. on both days. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
October 1, 1997, 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 October 7, 1997, from 1:15 p.m. 
to 1:45 p.m., the meeting will be closed to permit discussion and 
review of trade secret and/or confidential commercial or financial 
information (5 U.S.C. 552b(c)(4)). The meeting will be closed to 
discuss trade secret and/or confidential information concerning the 
manufacture of the products under discussion.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the October 6 and 7, 1997, Transmissible Spongiform Encephalopathies 
Advisory Committee meeting. Because the agency believes there is some 
urgency to bring this issue to public discussion and qualified members 
of the Transmissible Spongiform Encephalopathies Advisory Committee 
were available at this time, the Commissioner 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: September 16, 1997.
 Michael A. Friedman,
 Deputy Commissioner for Operations.
[FR Doc. 97-25264 Filed 9-23-97; 8:45 am]
BILLING CODE 4160-01-F