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| Name of Committee | Clinical Chemistry and Clinical Toxicology Devices Panel |
| Date and Time | The meeting was held on the following dates:
Dec 6, 06 8:00 AM - 4:30 PM
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| Location | Holiday Inn, Ballroom
Two Montgomery Village Ave.
Gaithersburg
, MD |
| Contact Information | Veronica J. Calvin, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 2098 Gaither Road, Rockville, MD 20850, 240-276-0491, ext. 161, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512514. Please call the Information Line for up-to-date information on this meeting. |
| Agenda | The committee will hear an update on the status of recent devices brought before the committee. The committee will also hear a presentation regarding the FDA Critical Path Initiative. The committee will discuss general issues concerning lipoprotein (HDL and LDL) subfraction assays. Background information, 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/index.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 on or before November 24, 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 November 24, 2006. |
| | Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. |
| Conduct | FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/ for procedures on public conduct during advisory committee meetings. |
| Related Documents |
| Agenda: | December 6, 2006 Meeting |  |
| Brief Summary: | December 6, 2006 Meeting |  |
| Briefing: | December 6, 2006 Meeting | |
| Minutes: | Minutes for December 6, 2006 Meeting | |
| Notice of Meeting: | December 6, 2006 Meeting | |
| Roster: | December 6, 2006 Meeting | |
| Roster: | | |
| Slides: | | |
| Transcript: | December 6, 2006 Meeting (Pages 301 - 387) | |
| Transcript: | December 6, 2006 Meeting (Pages 1 - 100) | |
| Transcript: | December 6, 2006 Meeting (Pages 101 - 200) | |
| Transcript: | December 6, 2006 Meeting (Pages 201 - 300) | |
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| Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). |
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