[Federal Register Volume 63, Number 211 (Monday, November 2, 1998)]
[Notices]
[Page 58744]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29274]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


General and Plastic Surgery Devices Panel of the Medical Devices 
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    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 and Plastic Surgery 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 17, 1998, 9 
a.m. to 6 p.m.
    Location: Corporate Bldg., conference room 020B, 9200 Corporate 
Blvd., Rockville, MD.
    Contact Person: David Krause, Center for Devices and Radiological 
Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-3090, ext. 141, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12519. For up-to-date information on this meeting, please 
call the Information Line or access the Internet address at ``http://
www.fda.gov/cdrh''.
    Agenda: The committee will discuss and make recommendations on a 
proposal for the classification of preamendment wound dressing medical 
devices based on: (1) A proposed rule published in the Federal Register 
of September 19, 1989 (54 FR 38600); (2) comments received in response 
to the proposed rule; and (3) comments from the General and Plastic 
Surgery Devices Panel meeting of July 20, 1995. The committee will also 
discuss and make recommendations on the reclassification of 
preamendment class III topical oxygen devices for wound healing on 
extremities based on information received from a call for safety and 
effectiveness information under section 515(i) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360e(i)) published in the Federal 
Registers of August 14, 1995, and June 13, 1997 (60 FR 41986 and 62 FR 
32355, respectively).
    Procedure: On November 17, 1998, from 9:30 a.m. to 6 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 
November 3, 1998. Oral presentations from the public will be scheduled 
between approximately 9:30 a.m. and 10 a.m., and between approximately 
4 p.m. and 4:30 p.m. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before November 3, 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 November 17, 1998, from 9 a.m. 
to 9:30 a.m., the meeting will be closed to the public 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 27, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-29274 Filed 10-30-98; 8:45 am]
BILLING CODE 4160-01-F