Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

[Federal Register Volume 64, Number 33 (Friday, February 19, 1999)]
[Notices]
[Page 8498]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-3630]



[[Page 8497]]

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Part V





Department of Health and Human Services





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Food and Drug Administration



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Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical 
Devices Advisory Committee; Notice of Meeting; Republication

Federal Register / Vol. 64, No. 33 / Friday, February 19, 1999 / 
Notices

[[Page 8498]]



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

    Editorial note: Due to printing errors notice document FR Doc. 
99-3630 published Thursday, February 18, 1999 at 64 FR 8224 is being 
republished in its entirety.
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 February 26, 1999, 8 
a.m. to 5 p.m.
    Location: Gaithersburg Marriott Washingtonian Center, Salons A, B, 
C, and D, 9751 Washingtonian Blvd., Gaithersburg, 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 discuss, make recommendations, and vote 
on a premarket approval application for a continuous glucose monitoring 
system that is indicated for the continuous recording of interstitial 
glucose levels in persons with diabetes mellitus.
    Procedure: On February 26, 1999, from 8:30 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 
February 22, 1999. Oral presentations from the public will be scheduled 
between approximately 8:45 a.m. and 9:45 a.m. Near the end of the 
committee deliberations, a 30-minute open public session will be 
conducted for interested persons to address issues specific to the 
submission or topic before the committee. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before February 22, 
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 February 26, 1999, from 8 a.m. 
to 8:30 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 February 26, 1999, Clinical Chemistry and Clinical Toxicology 
Devices Panel of the Medical Devices Advisory Committee meeting. 
Because the agency believes there is some urgency to bring this issue 
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 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: February 3, 1999.
 Michael A. Friedman,
 Deputy Commissioner for Operations.
    Editorial note: Due to printing errors notice document FR Doc. 
99-3630 published Thursday, February 18, 1999 at 64 FR 8224 is being 
republished in its entirety.
[FR Doc. 99-3630 Filed 2-10-99; 12:50 pm]
BILLING CODE 1505-01-F