Food and Drug Administration, HHS.
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://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).Start Signature
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