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). 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 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).