[Federal Register Volume 65, Number 214 (Friday, November 3, 2000)]
[Notices]
[Pages 66254-66255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28350]


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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://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://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://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]
BILLING CODE 4160-01-F