[Federal Register: June 23, 2005 (Volume 70, Number 120)]
[Page 36402]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Immunology 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: Immunology 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 July 15, 2005, from 
8:30 a.m. to 5 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Rufina Carlos, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD. 20850, 240-276-0493, ext. 167, or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 3014512516. 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 discuss, make 
recommendations, and vote on a premarket approval application for a 
laboratory assay designed to measure levels of neural thread protein 
in urine specimens from patients presenting with cognitive 
complaints or other signs and symptoms of suspected Alzheimer's 
disease. Results from this test are intended for use, in conjunction 
with and not in lieu of current standard diagnostic procedures, to 
aid the physician in the differential diagnosis of Alzheimer's 
    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 July 1, 
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 
before July 1, 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 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: June 15, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-12401 Filed 6-22-05; 8:45 am]