[Federal Register Volume 62, Number 173 (Monday, September 8, 1997)]
[Notices]
[Pages 47211-47212]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23729]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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.
[[Page 47212]]
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 September 25, 1997, 8
a.m. to 4 p.m.
Location: Holiday Inn, Versailles Ballrooms III and IV, 8120
Wisconsin Ave., Bethesda, 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, 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 over-the-counter drugs of abuse testing systems
and comment on a draft points-to-consider document for these products.
Single copies of the draft points-to-consider document entitled
``Points to Consider for Approval of Home Drugs of Abuse Test Kits''
are available to the public by contacting the Division of Small
Manufacturers Assistance, 1350 Piccard Dr., Rockville, MD 20851, 1-800-
638-2041, or on the Internet using the World Wide Web (WWW) (http://
www.fda.gov/cdrh/draftgui.html).
Procedure: On September 25, 1997, from 9 a.m. to 4 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
September 18, 1997. Oral presentations from the public will be
scheduled between approximately 9 a.m. and 10 a.m. Time allotted for
each presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before September 18,
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 September 25, 1997, from 8 a.m.
to 9 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))
relating to present and future agency issues.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 28, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-23729 Filed 9-5-97; 8:45 am]
BILLING CODE 4160-01-F
