[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
