[Federal Register: September 27, 2001 (Volume 66, Number 188)]
[Notices]
[Page 49393-49394]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se01-89]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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