[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
