[Federal Register: March 26, 2003 (Volume 68, Number 58)]
[Notices]               
[Page 14667]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr03-92]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Circulatory System Devices Panel of the Medical Devices Advisory 
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Circulatory System 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 April 10, 2003, from 9 
a.m. to 5 p.m.
    Location: Hilton DC North/Gaithersburg, Salons A, B, and C, 620 
Perry Pkwy., Gaithersburg, MD.
    Contact Person: Geretta Wood, Center for Devices and Radiological 
Health (HFZ-450), Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850, 301-443-8320, ext. 143, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 12625. Please call the Information Line for up-to-date 
information on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
on a premarket approval application for an endovascular graft and 
delivery system intended for the treatment of patients with abdominal 
aortic, aortoiliac, or iliac aneurysm. Background information for the 
topic, 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 will be 

Internet at http://www.fda.gov/cdrh/panelmtg.html. Material will be 

posted on April 9, 2003.
    Procedure: 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 April 3, 2003. 
Oral presentations from the public will be scheduled for approximately 
30 minutes at the beginning of committee deliberations and for 
approximately 30 minutes near the end of the deliberations. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before April 
3, 2003, 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.
    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 Shirley Meeks, 
Conference Management Staff, at 301-594-1283, ext. 105, at least 7 days 
in advance of the meeting.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the April 10, 2003, Circulatory System 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 Circulatory System 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 20, 2003.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 03-7278 Filed 3-25-03; 8:45 am]

BILLING CODE 4160-01-S