[Federal Register Volume 63, Number 21 (Monday, February 2, 1998)]
[Notices]
[Pages 5393-5394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2465]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Microbiology 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: Microbiology 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 12, 1998, 9:30 
a.m. to 5:30 p.m., and February 13, 1998, 9:30 a.m. to 6 p.m.
    Location: Corporate Bldg., conference room 020B, 9200 Corporate 
Blvd., Rockville, MD.
    Contact Person: Freddie M. Poole, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-2096, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 12517. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: On February 12, 1998, the committee will provide advice and 
recommendations to the agency on issues regarding tests for hepatitis 
viruses intended for detecting antigens or nucleic acids of hepatitis 
viruses B and C, or antibodies (total, IgG, or IgM) to antigens of 
hepatitis viruses A, B, and C. These assays may be indicated for the 
diagnosis of current (acute or chronic), recent, or past infection; 
management of current infection; determination of prior immunologic 
experience or pre- and post-vaccination antibody responses. These 
devices are not indicated for screening donors of blood or blood 
products, unless specifically indicated for such uses. The intent of 
the committee discussion is not to resolve issues related to the 
clinical practice or treatment of patients with viral hepatitis. 
Rather, the focus of discussion will be on appropriate clinical studies 
for establishing the safety and effectiveness of devices for these 
hepatitis viruses when used for the previously stated indications for 
use. On February 13, 1998, the committee will discuss a petition for 
reclassification of fully automated short-term incubation cycle 
antimicrobial susceptibility devices from class III to class II.
    Procedure: On February 12, 1998, from 9:30 a.m. to 5:30 p.m., and 
on February 13, 1998, from 10 a.m. to 6

[[Page 5394]]

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 February 4, 1998. Oral presentations from the public will be 
scheduled between approximately 10 a.m. and 11:15 a.m. on February 12, 
1998, and between approximately 10:15 a.m. and 10:45 a.m. on February 
13, 1998. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before February 4, 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 13, 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 trade secret and/
or confidential commercial information regarding pending and future 
device submissions.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the February 12 and 13, 1998, Microbiology Devices Panel of the 
Medical Devices meeting. Because the agency believes there is some 
urgency to bring these issues to public discussion and qualified 
members of the Microbiology Devices Panel of the Medical Devices 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 26, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-2465 Filed 1-30-98; 8:45 am]
BILLING CODE 4160-01-F