[Federal Register: November 24, 2006 (Volume 71, Number 226)]
[Page 67879]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Medical Devices Dispute Resolution 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: Medical Devices Dispute Resolution Panel of the 
Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on scientific disputes between the Center 
for Devices and Radiological Health and sponsors, applicants, and 
    Date and Time: The meeting will be held on December 15, 2006, from 
9 a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B, and 
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Nancy Collazo-Braier, Office of the Center Director 
(HFZ-1), Food and Drug Administration, 9200 Corporate Blvd., Rockville, 
MD 20850, 240-276-3959, nancy.braier@fda.hhs.gov, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014510232. Please call the Information Line 
for up-to-date information on this meeting.
    Agenda: The committee will discuss, make recommendations, and vote 
regarding a scientific dispute between the agency and Acorn Corp. 
related to the approvability of a premarket approval application for 
the CorCap Cardiac Support Device for patients with dilated 
cardiomyopathy. Background information for the topic, including the 
attendee list, 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/panel (click on Upcoming CDRH 

Advisory Panel/Committee Meetings).
    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 on or before 
December 1, 2006. Oral presentations from the public will be scheduled 
between approximately 9 a.m. and 9:30 a.m. and between approximately 1 
p.m. and 1:30 p.m. on December 15, 2006. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person 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 
on or before December 1, 2006.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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 Ann Marie Williams, 
Conference Management Staff, at 301-827-7291, 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: November 17, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-19895 Filed 11-22-06; 8:45 am]