[Federal Register Volume 63, Number 208 (Wednesday, October 28, 1998)]
[Notices]
[Page 57696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28900]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 November 9, 1998, 9:45
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 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 a fluorescence in situ
hybridization assay used in the detection of amplification of the HER-
2/neu gene from subjects with node positive, stage II breast cancer to
aid in the assessment of response to adjuvant therapy.
Procedure: On November 9, 1998, from 10:15 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
November 2, 1998. Oral presentations from the public will be scheduled
between approximately 10:30 a.m. and 11 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 November 2, 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 November 9, 1998, from 9:45 a.m.
to 10:15 a.m., the meeting will be closed to the public to permit FDA
to present to the committee trade secret and/or confidential commercial
information (5 U.S.C. 552b(c)(4)) regarding pending and future device
submissions.
FDA regrets that it was unable to publish this notice 15 days prior
to the November 9, 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: October 22, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-28900 Filed 10-23-98; 3:31 pm]
BILLING CODE 4160-01-F
