[Federal Register Volume 64, Number 217 (Wednesday, November 10, 1999)]
[Notices]
[Page 61353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29352]


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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). At least one 
portion of the meeting will be closed 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 as provided in 
the Federal Food, Drug, and Cosmetic Act.
    Date and Time: The meeting will be held on December 6, 1999, 9 a.m. 
to 6:30 p.m., and December 7, 1999, 8:30 a.m. to 3 p.m.
    Location: Gaithersburg Marriott Washingtonian Center, 9751 
Washingtonian Blvd., Gaithersburg, MD.
    Contact Person: 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: On December 6, 1999, the committee will discuss, make 
recommendations, and vote on a premarket approval application for a 
device indicated for frequent, automatic, and noninvasive monitoring of 
glucose levels in adults with diabetes. On December 7, 1999, the 
committee will discuss and make recommendations on general issues 
regarding over-the-counter devices for measurement of vaginal pH. The 
discussion will include appropriate claims, study designs to support 
claims, performance expectations, and labeling.
    Procedure: On December 6, 1999, from 9 a.m. to 6:30 p.m., and on 
December 7, 1999, from 9 a.m. to 3 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 November 24, 1999. On 
December 6, 1999, oral presentations from the public will be scheduled 
between approximately 9:15 a.m. and 9:45 a.m. and between approximately 
5:15 p.m. and 5:45 p.m. On December 7, 1999, oral presentations from 
the public will be scheduled between approximately 9:30 a.m. and 10 
a.m. and between approximately 2 p.m. and 2:30 p.m. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before November 24, 
1999, 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 December 7, 1999, from 8:30 a.m. 
to 9 a.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential commercial information (5 U.S.C. 
552b(c)(4)) relating to these products.
     Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: November 2, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-29352 Filed 11-9-99; 8:45 am]
BILLING CODE 4160-01-F