[Federal Register Volume 67, Number 130 (Monday, July 8, 2002)]
[Notices]
[Page 45129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17115]


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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 July 22, 2002, from 8:30 
a.m. to 5 p.m., and on July 23, 2002, from 8 a.m. to 11 a.m.
    Location: DoubleTree Hotel, Plaza I and II, 1750 Rockville Pike, 
Rockville, MD.
    Contact Person: Joyce M. Whang, 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), code 12524. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On July 22, 2002, the committee will hear a presentation on 
post-market surveillance of vacuum assisted delivery devices. The 
committee will also discuss, make recommendations, and vote on a 
premarket approval application for a permanent contraceptive device. 
Background information, including the agenda and questions for the 
committee, will be available to the public 1 business day before the 
meeting on the Internet at http://www.fda.gov/cdrh/panelmtg.html. 
Material for the July 22, 2002, session will be posted on July 19, 
2002.
    Procedure: On July 22, 2002, 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 
July 11, 2002. Oral presentations from the public will be scheduled 
between approximately 9:30 a.m. and 10 a.m., and 3:30 p.m. and 4 p.m. 
on July 22, 2002. Time allotted for each presentation may be limited. 
Those desiring to make formal presentations should notify the contact 
person before July 11, 2002, and submit a brief statement of the 
general nature of the evidence or arguments they wish to present, the 
names and addresses of proposed participants, and an indication of the 
approximate time requested to make their presentation.
    Closed Committee Deliberations: On July 23, 2002, from 8 a.m. to 11 
a.m., the meeting will be closed to permit discussion and review of 
trade secret and/or confidential commercial information (5 U.S.C. 
552b(c)(4)) regarding pending and future device issues. In addition, 
the committee will discuss and review trade secret and/or confidential 
commercial information presented by a sponsor.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact AnnMarie Williams, 
Conference Management Staff, at 301-594-1283, ext. 113, at least 7 days 
in advance of the meeting.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the July 22, 2002, Obstetrics and Gynecology Devices Panel of the 
Medical Devices Advisory Committee meeting. Because the agency believes 
there is some urgency to bring these issue(s) to public discussion and 
qualified members of the Obstetrics and Gynecology Devices Panel of the 
Medical Devices Advisory Committee were available at this time, the 
Commissioner of Food and Drugs 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: July 2, 2002.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 02-17115 Filed 7-5-02; 8:45 am]
BILLING CODE 4160-01-S