[Federal Register Volume 64, Number 227 (Friday, November 26, 1999)]
[Notices]
[Pages 66480-66481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30704]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Immunology Devices Panel of the Medical Devices 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: Immunology Devices Panel of the Medical Devices 
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 December 13, 1999, 9:30 
a.m. to 5:30 p.m.
    Location: Corporate Bldg., conference room 020B, 9200 Corporate 
Blvd., Rockville, MD.
    Contact Person: Louise E. Magruder, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug

[[Page 66481]]

Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-1293, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area), code 12516. Please call the Information 
Line for up-to-date information on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
on a premarket approval application for an enzyme immunoassay to be 
used as an aid in the diagnosis of patients with transitional cell 
carcinoma of the urinary tract.
    Procedure: On December 13, 1999, from 10 a.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 
December 1, 1999. On December 13, 1999, oral presentations from the 
public will be scheduled between approximately 10:45 a.m. and 11:15 
a.m. Near the end of the committee deliberations, a 30-minute open 
public session will be conducted for interested persons to address 
issues specific to the submission before the committee. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before December 1, 
1999, 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 December 13, 1999, from 9:30 
a.m. to 10 a.m., the meeting will be closed to permit FDA to present to 
the committee trade secret and/or confidential commercial information 
regarding pending and future device submissions (5 U.S.C. 552b(c)(4)). 
This portion of the meeting will be closed to permit discussion of this 
information.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: November 17, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-30704 Filed 11-24-99; 8:45 am]
BILLING CODE 4160-01-F