[Federal Register: May 20, 2003 (Volume 68, Number 97)]
[Notices]
[Page 27566-27567]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20my03-77]
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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.
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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
p.m.
[[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
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 13, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-12678 Filed 5-19-03; 8:45 am]
BILLING CODE 4160-01-S