[Federal Register: December 24, 2002 (Volume 67, Number 247)]


[Page 78478]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]




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.


    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 January 17, 2003, from 

8:30 a.m. to 5 p.m.

    Location: Hilton 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, 301-594-1220, ext. 121, or FDA Advisory Committee 

Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 

area), code 12523. 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 for a device for the treatment of 

gastroesophageal reflux disease. Background information, including the 

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.

 Material will be posted on January 16, 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 January 8, 

2003. Oral presentations from the public will be scheduled between 

approximately 8:45 a.m. and 9:15 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 8, 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 


    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, 

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: December 9, 2002.

Linda Arey Skladany,

Associate Commissioner for External Relations.

[FR Doc. 02-32277 Filed 12-23-02; 8:45 am]