[Federal Register: May 20, 2003 (Volume 68, Number 97)]
[Page 27566-27567]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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). At least one 
portion of the meeting will be closed to the public.
    Name of the Committee: Obstetrics and Gynecology 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 9, 2003, from 12:30 

[[Page 27567]]

to 5 p.m. and June 10, 2003, from 8:30 a.m. to 4:30 p.m.
    Location: Hilton DC North--Gaithersburg, Salons A, B, and C, 620 
Perry Pkwy., 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 12524. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On June 9, 2003, the committee will hear a presentation on 
post-approval studies and adverse events related to an intrapartum 
fetal pulse oximeter. On June 10, 2003, the committee will discuss, 
make recommendations, and vote on a premarket approval application for 
an endometrial ablation device. 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://www.fda.gov/cdrh/panelmtg.html.
 Material for the June 9, 2003, session 
will be posted on June 6, 2003. Material for the June 10, 2003, session 
will be posted on June 9, 2003.
    Procedure: On June 9, 2003, from 2:30 p.m. to 5 p.m. and on June 
10, 2003, from 8:30 a.m. to 4:30 p.m., the meeting is open to the 
public. 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 30, 2003. Oral 
presentations from the public will be scheduled between approximately 3 
p.m. and 4 p.m. on June 9, 2003, and between approximately 8:45 a.m. 
and 9:15 a.m. and 3 p.m. and 3:30 p.m. on June 10, 2003. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before May 30, 
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.
    Closed Committee Deliberations: On June 9, 2003, from 12:30 p.m. to 
2:30 p.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential commercial information (5 U.S.C. 
552b(c)(4)) presented by a sponsor.
    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, 
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 13, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-12678 Filed 5-19-03; 8:45 am]