[Federal Register: June 23, 2005 (Volume 70, Number 120)]
[Notices]
[Page 36402]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jn05-56]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Immunology 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: 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
disease.
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]
BILLING CODE 4160-01-S