[Federal Register Volume 62, Number 225 (Friday, November 21, 1997)]
[Notices]
[Page 62324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30707]
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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 regulatory issues.
Date and Time: The meeting will be held on December 10, 1997, 9:30
a.m. to 5 p.m.
Location: Corporate Bldg., conference room 020B, 9200 Corporate
Blvd., Rockville, MD.
Contact Person: Sharon K. Lappalainen, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-1243, ext. 144, 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 to
the agency regarding a premarket approval application for a salivary
estriol enzyme immunoassay that is to be used as a risk assessment
marker for spontaneous preterm labor and preterm delivery.
Procedure: On December 10, 1997, from 10 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
December 3, 1997. Oral presentations from the public will be scheduled
between approximately 10 a.m. and 11 a.m. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before December 3, 1997,
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 10, 1997, from 9:30
a.m. to 10 a.m., the meeting will be closed to permit discussion and
review of trade secret and/or confidential information (5 U.S.C.
552b(c)(4)). FDA staff will present to the committee confidential
information regarding pending or future submissions.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: November 17, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-30707 Filed 11-20-97; 8:45 am]
BILLING CODE 4160-01-F
