[Federal Register Volume 66, Number 170 (Friday, August 31, 2001)]
[Notices]
[Pages 46018-46019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21963]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Clinical Chemistry and Clinical Toxicology 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). The meeting will 
be open to the public.
    Name of Committee: Clinical Chemistry and Clinical Toxicology 
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 September 24, 2001, from 
8:30 a.m. to 5 p.m.

[[Page 46019]]

    Location: Hilton DC North--Gaithersburg, Salons A, B, C, and D, 620 
Perry Pkwy., Gaithersburg, MD.
    Contact: Veronica J. Calvin, Center for Devices and Radiological 
Health (HFZ-440), Food and Drug Administration, 2098 Gaither Rd., 
Rockville, MD 20850, 301-594-1243, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12514. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The committee will provide advice and recommendations on 
the types of data and/or labeling needed in premarket notification 
(510(k)) submissions for glucose test systems to address problems 
associated with using blood samples from alternate sites, such as the 
forearm, upper arm, thigh, calf, or base of the thumb. Background 
information, including the agenda and questions for the committee, will 
be available to the public on September 21, 2001, on the Internet at 
http://www.fda.gov/cdrh/panelmtg.html.
    Procedure: 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 12, 
2001. Oral presentations from the public will be scheduled between 
approximately 11:30 a.m. and 12 noon and 3 p.m. and 3:30 p.m. on 
September 24, 2001. Time allotted for each presentation may be limited. 
Those desiring to make formal oral presentations should notify the 
contact person before September 12, 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: August 22, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-21963 Filed 8-30-01; 8:45 am]
BILLING CODE 4160-01-S