[Federal Register: May 16, 2005 (Volume 70, Number 93)]
[Page 25832]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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 June 22, 2005, from 8 
a.m. to 4:30 p.m., and on June 23, 2005, from 8 a.m. to 4:30 p.m.
    Location: Hilton Washington DC North/Gaithersburg, The 
Ballrooms, 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 3014512625. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: On June 22, 2005, the committee will discuss, make 
recommendations, and vote on a premarket approval application for a 
cardiac device intended to treat patients with heart failure. On 
June 23, 2005, the committee will discuss, make recommendations, and 
vote on a humanitarian device exemption for an artificial heart. 
Background information for the topics, 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: 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 June 8, 
2005. On both days, 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 
committee deliberations. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should 
notify the contact person before June 8, 2005, 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 
    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 240-276-0450, ext. 105, at least 7 
days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: May 9, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-9673 Filed 5-13-05; 8:45 am]