[Federal Register: August 31, 1998 (Volume 63, Number 168)]
[Notices]
[Page 46227]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31au98-62]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


General Hospital and Personal Use 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: General Hospital and Personal Use 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 September 14, 1998,
10:30 a.m. to 5 p.m.
    Location: Corporate Bldg., conference room 020B, 9200 Corporate
Blvd., Rockville, MD.
    Contact Person: Martha T. O'Lone, Center for Devices and
Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8913, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 12520. Please call the Information Line for
up-to-date information on this meeting.
    Agenda: The committee will discuss and make recommendations on the
classification of unclassified washers and washer-disinfectors intended
to process reusable medical devices.
    Procedure: On September 14, 1998, from 11 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
before September 4, 1998. Oral presentations from the public will be
scheduled between approximately 11 a.m. and 12 m. and between
approximately 3:45 p.m. and 4:15 p.m. Time allotted for each
presentation may be limited. Those individuals desiring to make formal
oral presentations should notify the contact person before September 4,
1998, 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 14, 1998, from 10:30
a.m. to 11 a.m., the meeting will be closed to permit FDA to present to
the committee trade secret and/or confidential commercial information
(5 U.S.C. 552b(c)(4)) regarding pending issues and applications.
    FDA regrets that it was unable to publish this notice 15 days prior
to the September 14, 1998, General Hospital and Personal Use 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 General Hospital and Personal
Use 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: August 25, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-23305 Filed 8-28-98; 8:45 am]
BILLING CODE 4160-01-F