[Federal Register Volume 63, Number 13 (Wednesday, January 21, 1998)]
[Notices]
[Page 3145]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1418]
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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 regulatory issues.
Date and Time: The meeting will be held on February 2, 1998, 9:30
a.m. to 6:30 p.m.
Location: Parklawn Bldg., conference rooms D & E, 5600 Fishers
Lane, Rockville, MD.
Contact Person: Peter E. Maxim, Center for Devices and Radiological
Health (HFZ-440), Food and Drug 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 proposed prescription home use
labeling for a unitized bladder cancer tumor marker assay used to aid
in the detection of bladder cancer recurrence. Also, the committee will
discuss, make recommendations, and vote on a premarket approval
application for a free PSA (prostate-specific antigen) assay. The assay
is intended to be used in men over the age of 50 with a negative
digital rectal examination and a total serum PSA measurement of 4.0 to
10.0 nanograms/milliliter. The free PSA/total PSA ratio aids in the
differentiation between benign and malignant prostate disease.
Procedure: On February 2, 1998, from 10 a.m. to 6:30 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
January 29, 1998. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before January 29, 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 February 2, 1998, from 9:30 a.m.
to 10 a.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)).
FDA staff will present to the committee confidential information
regarding present or future issues.
FDA regrets that it was unable to publish this notice 15 days prior
to the February 2, 1998, Immunology Devices Panel of the Medical
Devices Advisory Committee meeting. Because the agency believes there
is some urgency to bring this issue to public discussion and qualified
members of the Immunology Devices Panel of the Medical Devices 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: January 15, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-1418 Filed 1-15-98; 3:51 pm]
BILLING CODE 4160-01-F
