[Federal Register Volume 63, Number 191 (Friday, October 2, 1998)]
[Notices]
[Page 53060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26502]
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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 October 19, 1998, 10
a.m. to 6 p.m., and October 20, 1998, 8:30 a.m. to 5 p.m.
Location: Parklawn Bldg., conference rooms G and H, 5600 Fishers
Lane, Rockville, MD.
Contact Person: Elisa D. Harvey, 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 October 19, 1998, the committee will discuss, make
recommendations, and vote on a premarket approval application for a
thermal endometrial ablation system intended to treat women with
abnormal uterine bleeding. On October 20, 1998, in the context of the
current guidance document on thermal endometrial ablation devices
entitled ``Thermal Endometrial Ablation Devices,'' the committee will
discuss: (1) Initial safety studies, as well as the pivotal safety and
effectiveness study, for postmenopausal patients on hormone replacement
therapy, which will include inclusion/exclusion criteria, type(s) of
control, and length of followup, both premarket and postmarket; and (2)
proposed labeling for vacuum-assisted delivery devices. Single copies
of the guidance document are available to the public by contacting the
Division of Small Manufacturers Assistance, Center for Devices and
Radiological Health, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 1-800-638-2041 or 301-443-6597 or by faxing your
request to 301-443-8818 and requesting the document by shelf No. 547.
Procedure: On October 19, 1998, from 10:45 a.m. to 6 p.m. and on
October 20, 1998, from 8:30 a.m. to 5 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 October 14, 1998. Oral
presentations from the public will be scheduled between approximately
11 a.m. and 11:30 a.m. on October 19, 1998. Near the end of the
committee deliberations on October 19, 1998, a 30-minute open public
session will be conducted for interested persons to address issues
specific to the submission before the committee. Oral presentations
from the public will be scheduled between approximately 8:45 a.m. and
9:15 a.m. and between approximately 1:15 p.m. and 1:45 p.m. on October
20, 1998. Time allotted for each presentation may be limited. Those
desiring to make formal presentations should notify the contact person
before October 14, 1998, and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
address of proposed participants, and an indication of the approximate
time requested to make their presentation.
Closed Committee Deliberations: On October 19, 1998, from 10 a.m.
to 10:45 a.m., the meeting will be closed to the public to permit FDA
to present to the committee trade secret and/or confidential commercial
information (5 U.S.C. 552b(c)(4)) regarding pending issues.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: September 24, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-26502 Filed 10-1-98; 8:45 am]
BILLING CODE 4160-01-F
