[Federal Register Volume 73, Number 100 (Thursday, May 22, 2008)]
[Notices]
[Page 29763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-11455]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Gastroenterology and Urology 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: 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).
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