[Federal Register Volume 65, Number 129 (Wednesday, July 5, 2000)]
[Notices]
[Pages 41474-41475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-16809]


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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's regulatory issues.
    Date and Time: The meeting will be held on July 27, 2000, 10:30 
a.m. to 5:30 p.m. and July 28, 2000, 8 a.m. to 5 p.m.
    Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery 
Village Ave., Gaithersburg, MD.

[[Page 41475]]

    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 July 27, 2000, the committee will discuss and make 
recommendations on issues concerning the appropriate types of data and 
information required to assess the safety and effectiveness of 
diagnostic tests intended to identify biothreat agents, or to provide 
evidence of exposure to biothreat agents, when used on different 
specimen types and under different conditions for use.
    The following draft questions are proposed for discussion and may 
be subject to changes prior to the committee meeting:
    1. What types of data and information would be recommended to 
evaluate effectiveness when the assay is used:
    (a) To definitively identify or rule-out identification of 
isolates;
    (b) to identify biothreat agents directly in specimens from 
individuals suspected (clinically or using other diagnostic procedures) 
to have been infected with the agent of interest; and
    (c) to identify/detect the biothreat agent directly in specimens 
from individuals without clinical or other diagnostic evidence of 
infection, who may have been exposed to the biothreat agent.
    2. For each of these potential uses what is the level of inaccuracy 
that can be tolerated, or would the same criteria apply to all?
    3. To determine or infer effectiveness for these devices, can 
specimens from naturally- or experimentally-infected animals be used 
when appropriate specimens from humans cannot be obtained? What are the 
constraints/limitations for use of animal data as evidence for 
effectiveness?
    4. Are there any other issues not addressed in the previous 
questions that would affect the reliable use of these assays for human 
diagnosis?
    FDA will consider these recommendations in the future development 
of review criteria for in vitro diagnostic devices, developed in 
response to the threat of bioterrorism, for the identification of 
biothreat agents, as valid scientific evidence to determine whether 
there is reasonable assurance that these devices are safe and 
effective.
    On July 28, 2000, the committee will discuss, make recommendations, 
and vote on a premarket approval application (PMA) for an in vitro 
diagnostic nucleic acid amplification test for the qualitative 
detection of hepatitis C virus (HCV) ribonucleic acid (RNA) in human 
serum or plasma. On the same day the committee will discuss, make 
recommendations, and vote on a PMA for an automated in vitro diagnostic 
nucleic acid amplification test for the qualitative detection of HCV 
RNA in human serum or plasma. These devices are not intended for use in 
blood or plasma donor screening.
    Procedure: On July 27, 2000, from 10:30 a.m. to 5:30 p.m. and on 
July 28, 2000, from 9 a.m. to 5 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 July 12, 2000. Oral 
presentations from the public will be scheduled between approximately 
11:45 a.m. and 12:30 p.m. on July 27, 2000, and between approximately 
11:30 a.m. and 12:15 p.m., and 3 p.m. and 3:30 p.m. on July 28, 2000. 
Time allotted for each presentation may be limited. Those desiring to 
make formal oral presentations should notify the contact person before 
July 12, 2000, 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 July 28, 2000, from 8 a.m. to 9 
a.m., the meeting will be closed to permit FDA staff to present to the 
committee trade secret and/or confidential commercial information 
regarding pending and future device submissions. This portion of the 
meeting will be closed to permit discussion of this information (5 
U.S.C. 552b(c)(4)).
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 26, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-16809 Filed 7-3-00; 8:45 am]
BILLING CODE 4160-01-F