[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
