Food and Drug Administration, HHS.
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: Gastroenterology and Urology 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 June 25, 2008, from 8 a.m. to 5 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and C, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Jeffrey Cooper, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-4151 or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512523. Please call the Information Line for up-to-date information on this meeting. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
Agenda: The committee will discuss, make recommendations, and vote on a premarket approval application, sponsored by Medical Enterprises, Ltd., for a drug/device combination product designed to prevent recurrence of bladder cancer. Synergo SB-3TS 101.1 Device with Mitomycin C is indicated for use for prophylactic treatment of recurrence in patients following endoscopic removal of Ta-T1 and G1-3 superficial transitional cell carcinoma of the bladder (STCCB). Ta-T1 refers to the stage of the tumor, which is a measure of how deep the tumor penetrates into the bladder wall, with Ta and T1 being the most superficial stages for raised bladder tumors. G1-3 refers to the tumor grade, which is a measure of how aggressive the tumor is likely to grow, with G1 being the least aggressive, and G3 the most. Synergo and Mitomycin C treatment is clinically indicated for STCCB patients of intermediate and high risk.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on the year 2008 and scroll down to the appropriate advisory committee link.
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 on or before June 16, 2008. Oral presentations from the public will be scheduled between approximately 8:15 a.m. and 8:45 a.m., and between approximately 2:45 p.m. and 3:15 p.m. Those desiring to make formal oral presentations should notify the contact person 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 on or before June 6, 2008. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by June 9, 2008.
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 Ann Marie Williams, Conference Management Staff, at 240-276-8932, at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/default.htm for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).Start Signature
Dated: May 15, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-11455 Filed 5-21-08; 8:45 am]
BILLING CODE 4160-01-S