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| Name of Committee | Dental Products Panel |
| Date and Time | The meeting was held on the following dates:
Jul 13, 04 8:00 AM - 5:00 AM
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| Location | Hilton Washington DC North/Gaithersburg, Ballroom Salons A and B
620 Perry Parkway
Gaithersburg
, MD |
| Contact Information | Michael E. Adjodha, Center for Devices and Radiological Health (HFZ–480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, via email at mea@cdrh.fda.gov, or by phone: 301–827–5283, ext. 123. Please call the FDA Advisory Committee Information Line at 800–741–8138 (301–443–0572 in the Washington, DC area), code 3014512518, for updated information on this meeting. (E-mail contact mea@cdrh.fda.gov) |
| Agenda | The committee will discuss, make recommendations, and vote on a premarket approval application for a bone grafting material, which contains a wound-healing and revascularization agent, for treatment of dental osseous defects. Background information, including the agenda and questions for the committee, will be available to the public one business day before the meeting on the internet at http://www.fda.gov/cdrh/panel/index.html. Material will be posted on July 12, 2004. |
| Procedure | On July 13, 2004, from 8:30 a.m. to 5 p.m., the meeting will be open to the public. 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, 2004. 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, 2004, 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. |
| Closed Committee Information | On July 13, 2004, from 8 a.m. to 8:30 a.m., the meeting will be closed to the public to permit FDA to present to the committee trade secret and/or confidential commercial information regarding pending and future agency issues (5 U.S.C.552b(c)(4)). |
| | 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 |
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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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