Date: Tue, 11 Jan 2000 09:58:49 -0700

To: Recipient List Suppressed:;

~~~ Thank you Ms. Lorenn ~~~

Subject: FDA Plastic Surgery

[Federal Register: January 3, 2000 (Volume 65, Number 1)]

[Notices]

[Page 133-134]

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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). 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.

[[Page 134]]

Date and Time: The meeting will be held on January 12, 2000, 10 a.m. to 5 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. 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: The committee will discuss, make recommendations, and vote on a premarket approval application for an Absorbable Adhesion Barrier Device.

Procedure: On January 12, 2000, from 10:30 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 by December 29, 1999. Oral presentations from the public will be scheduled between approximately 11 a.m. and 11:30 a.m., and between approximately 3 p.m. and 3:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before January 5, 1999, 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 January 12, 2000, from 10 a.m. to 10:30 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)) relating to pending issues and applications.

FDA regrets that it was unable to publish this notice 15 days prior to the January 12, 2000, General and Plastic Surgery 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 and Plastic Surgery Devices 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: December 21, 1999.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 99-34068 Filed 12-29-99; 2:12 pm]

BILLING CODE 4160-01-F