[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