[Federal Register: January 13, 1998 (Volume 63, Number 8)]
[Notices]               
[Page 1974]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ja98-59]

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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 regulatory issues.
    Date and Time: The meeting will be held on January 27, 1998, 10:30 
a.m. to 5 p.m., and January 28, 1998, 8:30 a.m. to 5 p.m.
    Location: Corporate Bldg., conference room 020B, 9200 Corporate 
Blvd., 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 January 27, 1998, the Committee will consider issues 
relating to the study and evaluation of device systems for thermal 
endometrial ablation. In the context of the current guidance document 
on thermal endometrial ablation devices, the Committee's discussion 
will address initial safety studies, as well as the pivotal safety and 
effectiveness study. This will include inclusion/exclusion criteria, 
type(s) of control, alternative study endpoints, and length of 
followup, both premarket and postmarket. Single copies of the guidance 
document are available to the public by contacting the Division of 
Small Manufacturers Assistance (DSMA), Center for Devices and 
Radiological Health, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 1-800-638-2041 or by FAX 301-443-8818, and 
requesting the document by shelf #547.
    Procedure: On January 27, 1998, from 12:30 p.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 
January 20, 1998. Oral presentations from the public will be scheduled 
between approximately 12:30 p.m. and 1:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal 
presentations should notify the contact person before January 20, 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 January 27, 1998, from 10:30 
a.m. to 12:30 p.m., the meeting will be closed to permit discussion and 
review of trade secret and/or confidential information (5 U.S.C. 
552b(c)(4)). This portion of the meeting will be closed to permit 
discussion of secret and/or confidential commercial information on 
present and future device issues. On January 28, 1998, from 8:30 a.m. 
to 5 p.m., the meeting will be closed to permit discussion and review 
of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). 
This portion of the meeting will be closed to hear and review trade 
secret and/or confidential commercial information on a product 
development protocol.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the January 27 and 28, 1998, Obstetrics and Gynecology Devices Panel 
of the Medical Devices Advisory Committee meeting. Because the agency 
believes there is some urgency to bring these issues to public 
discussion and qualified members of the Obstetrics and Gynecology 
Devices Panel of the Medical Devices Advisory Committee meeting were 
available at this time, the Commissioner concluded that it was in the 
public interest to hold this meeting even if there was not sufficient 
time for the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: January 8, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-884 Filed 1-9-98; 2:09 pm]
BILLING CODE 4160-01-F