[Federal Register: May 16, 2005 (Volume 70, Number 93)]
[Page 25833-25834]
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). The meeting will 
be open 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 23, 2005, from 9 
a.m. to 5 p.m.
    Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery 
Village Ave., Gaithersburg, MD.
    Contact: Michael Bailey, 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 Hotline, 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 hear a presentation on the FDA 
Critical Path Initiative. The committee will also discuss, make 
recommendations, and vote on a premarket approval application for a 
fetal heart monitoring device that, in addition to standard 
features, is used during labor and delivery to measure, display, and 
analyze the ST waveform of the fetal electrocardiogram. 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.

    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 June 16, 
2005. Oral presentations from the public will be scheduled between 
approximately 9:30 a.m. and 10 a.m. and between approximately 3:30 
p.m. and 4 p.m. Time allotted for each presentation may be limited. 
Those desiring to make formal presentations should notify the 
contact person before June 16, 2005, 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 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to 
electrical outlets.

[[Page 25834]]

    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 240-276-0450, 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 9, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-9672 Filed 5-13-05; 8:45 am]