[Federal Register Volume 66, Number 201 (Wednesday, October 17, 2001)]
[Notices]
[Page 52774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26173]



[[Page 52774]]

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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 October 29, 2001, from 8 
a.m. to 5 p.m.
    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 October 26, 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 October 19, 
2001. Oral presentations from the public will be scheduled between 
approximately 11 a.m. and 12 noon and between approximately 3 p.m. and 
3:30 p.m. on October 29, 2001. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before October 19, 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.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the October 29, 2001, Clinical Chemistry and Clinical Toxicology 
Devices Panel of the Medical Devices Advisory Committee meeting. 
Because the agency believes there is some urgency to bring these issues 
to public discussion and qualified members of the Clinical Chemistry 
and Clinical Toxicology Devices Panel of the Medical Devices Advisory 
Committee were available at this time, the Commissioner of Food and 
Drugs concluded that it was in the public interest to hold this meeting 
even if there was not sufficient time for the customary 15-day public 
notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 11, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-26173 Filed 10-15-01; 9:31 am]
BILLING CODE 4160-01-S