[Federal Register: November 10, 1999 (Volume 64, Number 217)]
[Notices]
[Page 61353]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10no99-96]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

     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