[Federal Register Volume 65, Number 35 (Tuesday, February 22, 2000)]
[Notices]
[Pages 8716-8717]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-4157]


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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.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open 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 March 1, 2, and 3, 2000, 
8 a.m. to 5 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., 
Gaithersburg, 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. Please call the Information Line or access the 
Internet address of http://www.fda.gov/cdrh/panelmtg.html for up-to-
date information on this meeting.
    Agenda: On March 1, 2000, there will be a brief FDA presentation on 
the least burdensome provisions of the FDA Modernization Act of 1997. 
Also, on March 1, 2000, the committee will discuss, make 
recommendations, and vote on a premarket approval application (PMA) for 
saline inflatable breast prostheses. On March 2, 2000, the committee 
will discuss, make recommendations, and vote on two PMA's for saline 
inflatable breast prostheses. These PMA's have been submitted in 
response to a call for PMA's under section 515(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 306e(b)), published in the Federal 
Register of August 19, 1999 (64 FR 45155). On March 3, 2000, the 
committee will discuss content, format, and consistency issues 
involving the labeling information provided to patients considering 
saline-filled breast prostheses. The document entitled ``Guidance on 
Medical Device Patient Labeling'' is the background information for the 
panel discussion and is available to the public on the Internet at 
http://www.fda.gov/cdrh/HumanFactors.html or CDRH Facts-on-Demand at 1-
800-899-0381 or 301-827-0111, specify number 1128 when prompted for the 
document shelf number. As it becomes available, additional information 
specific to saline breast implants will be available to the public on 
FDA's website

[[Page 8717]]

at http://www.fda.gov/ohrms/dockets/ac/00mtbc.htm.
    Procedure: 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 23, 
2000. Oral presentations from the public will be scheduled between 
approximately 8:30 a.m. and 12 noon, and 3:45 p.m. and 4:15 p.m. on 
March 1, 2000; between approximately 8 a.m. and 8:30 a.m., 11:15 a.m. 
and 11:45 a.m., 1 p.m. and 1:30 p.m., and 4:15 p.m. and 4:45 p.m. on 
March 2, 2000; and between approximately 9:15 a.m. and 11:15 a.m., and 
2:45 p.m. and 3:15 p.m. on March 3, 2000. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before February 23, 
2000, 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.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the March 1, 2, and 3, 2000, General and Plastic Surgery Device 
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 General and Plastic Surgery 
Device Panel of the Medical Devices Advisory Committee meeting were 
available at this time, the Commissioner of Food and Drugs 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 14, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-4157 Filed 2-16-00; 4:19 pm]
BILLING CODE 4160-01-F