[Federal Register: March 16, 2006 (Volume 71, Number 51)]
[Notices]               
[Page 13605]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16mr06-52]                         

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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 March 27, 2006, from 10 
a.m. to 5:45 p.m., and on March 28, 2006, from 8 a.m. to 3 p.m.
    Location: Gaithersburg Hilton, Salons A, B, and C, 620 Perry Pkwy., 
Gaithersburg, MD.
    Contact: Michael Bailey, 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 3014512524. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: On March 27, 2006, the committee will discuss, make 
recommendations, and vote on a premarket approval application for a 
post-surgical adhesion prevention device for use in patients undergoing 
gynecological laparoscopic surgical procedures. On March 28, 2006, the 
committee will have a general topic discussion of clinical trial design 
issues for new devices intended to treat symptomatic uterine fibroids. 
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/panelmtg.html.

    Procedure: On March 27, 2006, from 10 a.m. to 5:45 p.m., and on 
March 28, 2006, from 9 a.m. to 3 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 March 20, 2006. Oral 
presentations from the public will be scheduled on March 27, 2006, 
between approximately 10:10 a.m. and 10:40 a.m. and between 
approximately 4:15 p.m. and 4:45 p.m., and on March 28, 2006, between 
approximately 10:15 a.m. and 11:15 a.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before March 20, 2006, 
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 March 28, 2006, from 8 a.m. to 9 
a.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)) 
regarding pending and future device issues.
    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 240-276-0450, 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 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 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: March 7, 2006.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. E6-3786 Filed 3-15-06; 8:45 am]

BILLING CODE 4160-01-S