[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