[Federal Register Volume 61, Number 136 (Monday, July 15, 1996)]
[Notices]
[Page 36889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17828]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Advisory Committee Meeting; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of a meeting of the Obstetrics and Gynecology
Devices Panel of the Medical Devices Advisory Committee. This meeting
was announced in the Federal Register of June 24, 1996 (61 FR 32443 at
32445). The amendment is being made to announce the cancellation of the
third day of the meeting and to change the agenda for the meeting. The
location previously announced for the first 2 days remains the same.
This amendment will be announced at the beginning of the open portion
of the meeting.
FOR FURTHER INFORMATION CONTACT:
For matters relating to electronic fetal monitoring or implantable
fetal stents: Alfred W. Montgomery, Center for Devices and Radiological
Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd.,
Rockville, MD 20850, 301-594-1180.
For matters relating to commercial kits for Group B Streptococcus
detection: Freddie M. Poole, Center for Devices and Radiological Health
(HFZ-440), Food and Drug Administration, 2098 Gaither Rd., Rockville,
MD 20850, 301-594-2096.
SUPPLEMENTARY INFORMATION: In the Federal Register of June 24, 1996,
FDA announced that a meeting of the Obstetrics and Gynecology Devices
Panel of the Medical Devices Advisory Committee would be held on July
22, 23, and 24, 1996. On page 32445, in the first column, the ``Date,
time, and place'' portion is amended to read as follows:
Date, time, and place. July 22 and 23, 1996, 8:30 a.m.,
Gaithersburg Marriott Washingtonian Center, Ballroom, 9751
Washingtonian Blvd., Gaithersburg, MD.
On the same page, in the first and second columns, the ``Type of
meeting and contact person'' and ``Open committee discussion'' portions
are amended as follows:
Type of meeting and contact person. Open committee discussion, July
22, 1996, 8:30 a.m. to 2 p.m.; open public hearing, 2 p.m. to 3 p.m.,
unless public participation does not last that long; open committee
discussion, 3 p.m. to 7 p.m.; open committee discussion, July 23, 1996,
8:30 a.m. to 11 a.m.; open public hearing, 11 a.m. to 11:30 a.m.,
unless public participation does not last that long; open committee
discussion, 11:30 a.m. to 3 p.m.; open public hearing, 3 p.m. to 4
p.m., unless public participation does not last that long; open
committee discussion, 4 p.m. to 6:15 p.m.; Alfred W. Montgomery, 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), Obstetrics and Gynecology
Devices Panel, code 12524. Please call the hotline for information
concerning any possible changes.
Open committee discussion. On July 22, 1996, the committee will be
asked to consider new technological advances in intrapartum electronic
fetal monitoring (EFM). After hearing a series of presentations on the
subject, the committee will discuss appropriate recommended testing for
such new technology applications. FDA will consider these
recommendations in the future development of testing guidelines.
Committee deliberations on this subject will continue on July 23, 1996.
FDA recognizes that there continues to be questions asked about EFM and
its place in the clinical management of the patient in labor. The
intent of the committee discussion is not to resolve issues related to
clinical practice and clinical standards in the area of EFM. Rather,
the focus of discussions will be on reasonable study methodologies for
establishing the safety and effectiveness of the new fetal monitoring
technologies. On July 23, 1996, following the discussions on new
technological advances in intrapartum EFM, the committee will discuss
and vote on a premarket approval application (PMA) for an implantable
stent used for in utero treatment of fetal post-vesicular uropathy.
Also, on July 23, 1996, following deliberations on the above PMA, the
committee will discuss issues concerning the performance of commercial
kits for the direct detection of Group B Streptococcus from clinical
specimens obtained from pre-term and intrapartum women, and neonates,
in relation to the kits' indications for use.------------
Dated: July 3, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-17828 Filed 7-12-96; 8:45 am]
BILLING CODE 4160-01-F
