03-9386. Ophthalmic 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: Ophthalmic 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 May 23, 2003, from 8:30 a.m. to 3:30 p.m.

Location: Gaithersburg Marriott, Salons A, B and C, 9751 Washingtonian Blvd., Gaithersburg, MD.

Contact Person: Sara M. Thornton, Center for Devices and Radiological Health (HFZ-460), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-2053, ext. 127, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12396. Please call the Information Line for up-to-date information on this meeting.

Agenda: The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an intraocular lens for primary implantation in the capsular bag for the correction of aphakia in an adult in whom a cataractous lens has been removed and who may benefit from improved near, intermediate and distance vision without spectacles. Background information for the day's topic, including the attendee list, agenda, and questions for the committee, will be available to the public one business day before the meeting, on the Internet at http://www.fda.gov/​cdrh/​panel/​index.html. Material will be posted on May 22, 2003.

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 May 16, 2003. Oral presentations from the public will be scheduled between approximately 8:45 a.m. and 9:15 a.m., and for 30 minutes near the end of the committee deliberations on the PMA. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 16, 2003 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.

Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact AnnMarie Williams, Conference Management Staff, at 301-594-1283, ext. 113, at least 7 days in advance of the meeting.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated: April 10, 2003.

Linda Arey Skladany,

Associate Commissioner for External Relations.