[Federal Register: November 3, 2000 (Volume 65, Number 214)]
[Notices]
[Page 66254-66255]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03no00-59]
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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.
Date and Time: The meeting will be held on November 13, 2000, 10
a.m. to 4:30 p.m., and November 14, 2000, 8:30 a.m. to 4 p.m.
Location: Hilton, Salons C, D, and E, 620 Perry Pkwy.,
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 November 13, 2000, the committee will discuss two draft
guidances: ``Guidance for Prescription Use Drugs of Abuse Assays
Premarket Notifications'' and ``Over the Counter (OTC) Screening Tests
for Drugs of Abuse: Guidance for Premarket Notifications.'' The
prescription use guidance will be available to the public on the
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/ode/odecl052.html and supersedes
the document entitled ``Review Criteria for Assessment of In Vitro
Diagnostic Devices for Drugs of Abuse Assays Using Various
Methodologies.'' The OTC use guidance will be available to the public
on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/ode/91.html and supersedes
the document entitled ``Guidance for Premarket Submissions for Kits for
Screening Drugs of Abuse To Be Used by the Consumer.'' Draft questions
for the committee regarding these guidances will be available to the
public on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html. On
November 14, 2000, the committee will discuss and make recommendations
on a premarket notification (510(k)) for a first-of-a-kind prescription
use screening device for heroin in human hair.
Procedure: On November 13, 2000, from 10 a.m. to 4:30 p.m., and on
November 14, 2000, 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
[[Page 66255]]
committee. Written submissions may be made to the contact person by
November 6, 2000. On November 13, 2000, oral presentations from the
public regarding the prescription use guidance will be scheduled
between approximately 10:45 a.m. and 11:15 a.m., and oral presentations
from the public regarding the OTC use guidance will be scheduled
between approximately 1:15 p.m. and 2 p.m. On November 14, 2000, oral
presentations from the public will be scheduled between approximately
9:15 a.m. and 9:45 a.m. and between approximately 3 p.m. and 3:30 p.m.
Time allotted for each presentation may be limited. Those desiring to
make formal oral presentations should notify the contact person before
November 6, 2000, 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 November 14, 2000, 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 present and future agency issues.
FDA regrets that it was unable to publish this notice 15 days prior
to the November 13 and 14, 2000, 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 27, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-28350 Filed 11-1-00; 2:45 pm]
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