[Federal Register Volume 66, Number 188 (Thursday, September 27, 2001)]
[Notices]
[Pages 49393-49394]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-24159]


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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 October 11, 2001, from 
9:30 a.m. to 6:30 p.m., and October 12, 2001, from 8 a.m. to 5 p.m.
    Location: Hilton DC North--Gaithersburg, Salons A, B, and C, 620 
Perry Pkwy., Gaithersburg, MD.
    Contact: Freddie M. Poole, Center for Devices and Radiological 
Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., 
Rockville, MD 20850, 301-594-2096, ext. 111, 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 October 11, 2001, the committee will discuss, make 
recommendations, and vote on a premarket approval application for an in 
vitro diagnostic device for the determination of endotoxin activity in 
human whole blood samples. On the same day, the committee will provide 
advice and recommendations on a

[[Page 49394]]

premarket notification submission for an in vitro diagnostic device for 
detecting and measuring urinary tract infection by semiquantitative 
analysis of volatile compounds released from a urine sample.
    On October 12, 2001, the committee will discuss, make 
recommendations, and vote on a premarket approval application for an in 
vitro diagnostic device for measuring the release of gamma-interferon 
from sensitized lymphocytes in purified protein derivative (PPD)-
stimulated whole blood, as an aid in the diagnosis of latent 
tuberculosis infection. It is intended to aid in the evaluation of 
individuals who are suspected of having Mycobacterium tuberculosis 
infection or disease, have close contact with infected individuals, or 
originate from an area where tuberculosis is prevalent.
    Background information for each day's topic, including the agenda 
and questions for the committee, will be available to the public 1 
business day before the meeting, on the Internet at http://www.fda.gov/cdrh/panelmtg.html. Material for the October 11, 2001, session will be 
posted on October 10, 2001; material for the October 12, 2001, session 
will be posted on October 11, 2001.
    Procedure: On October 11, 2001, from 9:30 a.m. to 6:30 p.m., and on 
October 12, 2001, from 8:45 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 September 26, 2001. 
Oral presentations from the public will be scheduled on October 11, 
2001, between approximately 11 a.m. and 11:45 a.m. and 5:30 p.m. and 6 
p.m. and on October 12, 2001, between approximately 11 a.m. and 12 
noon. and 3 p.m. and 3:30 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before September 26, 2001, 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 October 12, 2001, from 8 a.m. to 
8:45 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: September 20, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-24159 Filed 9-26-01; 8:45 am]
BILLING CODE 4160-01-S