[Federal Register Volume 66, Number 125 (Thursday, June 28, 2001)]
[Notices]
[Pages 34456-34457]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16197]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Anesthesiology and Respiratory Therapy 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: Anesthesiology and Respiratory Therapy 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 16, 2001, 10 a.m. 
to 5 p.m.
    Location: Corporate Bldg., conference room 20B, 9200 Corporate 
Blvd., Rockville, MD.
    Contact: Michael Bazaral, Center for Devices and Radiological 
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-443-8611, ext. 140, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the

[[Page 34457]]

Washington, DC area), code 12624. 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 high-frequency ventilator 
used in the treatment of acute respiratory failure in adults. 
Background information and questions for the committee will be 
available to the public on July 13, 2001, on the Internet at http://www.fda.gov/cdrh/panelmtg.html.
    Procedure: On July 16, 2001, from 12 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 9, 2001. 
Oral presentations from the public will be scheduled between 
approximately 12:15 p.m. and 12:45 p.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 July 9, 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 July 16, 2001, from 10 a.m. to 
12 noon, the meeting will be closed 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 anesthesiology and 
respiratory therapy device submissions.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: June 19, 2001.
Bonnie Malkin,
Special Assistant to the Senior Associate Commissioner.
[FR Doc. 01-16197 Filed 6-27-01; 8:45 am]
BILLING CODE 4160-01-S