[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