[Federal Register: May 11, 2004 (Volume 69, Number 91)]
[Notices]               
[Page 26168-26169]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11my04-108]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Obstetrics and Gynecology 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 the Committee: Obstetrics and Gynecology Devices Panel of 
the Medical Devices Advisory Committee.

[[Page 26169]]

    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 3, 2004, 8:30 a.m. 
to 4:30 p.m.
    Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery 
Village Ave., Gaithersburg, MD.
    Contact: Joyce M. Whang, Center for Devices and Radiological Health 
(HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-594-1180, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 3014512524. 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 system that ablates uterine 
fibroids using focused ultrasound under the guidance of magnetic 
resonance. Background information, including the agenda and questions 
for the committee, will be available to the public 1 business day 
before the meeting on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html.
 Material will be posted on June 2, 2004.

    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 26, 2004. 
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. on June 3, 2004. Time allotted for each presentation may 
be limited. Those desiring to make formal presentations should notify 
the contact person before May 26, 2004, 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: May 3, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-10591 Filed 5-10-04; 8:45 am]

BILLING CODE 4160-01-S