[Federal Register: May 10, 2005 (Volume 70, Number 89)]
[Notices]               
[Page 24605]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10my05-93]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Neurological 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). The meeting will 
be open to the public.
    Name of Committee: Neurological 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 17, 2005, from 8:30 
a.m. to 5 p.m.
    Location: Hilton Washington DC North/Gaithersburg, Salons A, B and 
C, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Janet L. Scudiero, Center for Devices and 
Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1184, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 3014512513. Please call the Information Line 
for up-to-date information on this meeting.
    Agenda: The committee will hear a presentation on the FDA Critical 
Path Initiative and a presentation by the Office of Surveillance and 
Biometrics in the Center for Devices and Radiological Health outlining 
their responsibility for the review of postmarket study design. The 
committee will also hear an update on the status of recent devices 
brought before the committee. Subsequently, the committee will discuss, 
make recommendations, and vote on a premarket approval application for 
a selective head cooling system intended for use in infants 36 weeks of 
gestation or older at risk for moderate to severe hypoxic-ischemic 
encephalopathy (HIE) to prevent or reduce the severity of HIE. 
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://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 3, 2005. 
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 by June 3, 
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 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 AnnMarie Williams at 
240-276-0450, ext. 113 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 3, 2005.
Lester M. Crawford,
Acting Commissioner of Food and Drugs.
[FR Doc. 05-9296 Filed 5-9-05; 8:45am]

BILLING CODE 4160-01-S