[Federal Register: October 3, 2006 (Volume 71, Number 191)]
[Notices]
[Page 58416]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03oc06-79]
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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 November 16, 2006, from
8 a.m. to 5 p.m.
Location: Holiday Inn, Walker/Whetstone Rooms, Two Montgomery
Village Ave., Gaithersburg, MD.
Contact Person: Rufina Carlos, Office of In Vitro Diagnostic Device
Evaluation and Safety (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 discuss, make recommendations, and vote
on a premarket approval application for a laboratory assay designed for
the rapid detection of clinically relevant (greater than 0.2
millimeters) metastases in lymph node tissue removed from breast cancer
patients. Results from the assay can be used to guide the surgeon's
decision to excise additional lymph nodes and aid in staging.
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/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
October 30, 2006. 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 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 October 30, 2006.
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 301-827-7292, 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: September 25, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-16319 Filed 10-2-06; 8:45 am]
BILLING CODE 4160-01-S