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Notice

Sentinel Network To Promote Medical Product Safety; Public Meeting

Document Details

Information about this document as published in the Federal Register.

Published Document

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; extension of registration period.

SUMMARY:

The Food and Drug Administration (FDA) is extending to February 28, 2007, registration for the public meeting that will be held on March 7 and 8, 2007, regarding FDA's exploration and development of an integrated national network to link private sector and public sector postmarket safety efforts, creating a virtual, integrated, electronic “Sentinel Network”. Such a network would integrate existing and planned efforts to collect, analyze, and disseminate medical product safety information to health care practitioners and patients at the point-of-care. It would be established through multiple, broad-based, public-private partnerships.

Dates and Times: The public meeting will be held on March 7 and 8, 2007, from 8 a.m. to 5 p.m.

Location: The public meeting will be held at the University System of Maryland Shady Grove Center, 8630 Gudelsky Dr., Rockville, MD 20850.

ADDRESSES:

Submit written registration to Erik Mettler, Office of Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, rm. 14-101, Rockville, MD 20852, 301-827-3360, FAX: 301-594-6777. Submit electronic registration to Erik.Mettler@fda.hhs.gov.

For Registration to Attend and/or Participate in the Meeting: Seating at the meeting is limited. People interested in attending should e-mail or submit written registration to Erik Mettler (see ADDRESSES) by close of business on February 28, 2007. Registration is free and will be on a first-come, first-serve basis. All individuals wishing to speak during the open session of the meeting must indicate their intent, the question to be addressed, and provide an abstract of the presentation by February 28, 2007.

We have set aside a portion of the agenda (http://www.fda.gov/​oc/​op/​sentinel/​) for individuals who would like to make presentations at the meeting. If you wish to make an oral presentation during the open session of the meeting, you must state your intention on your registration submission (see ADDRESSES). To speak, submit your name, title, business affiliation, address, telephone number, fax number, and e-mail address. FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and to request time for a joint presentation. FDA may require joint presentations by persons with common interests. FDA will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin.

If you require special accommodations due to a disability, please inform Erik Mettler (see ADDRESSES) when you register.

For Information On the Meeting Contact: Erik Mettler (see ADDRESSES).

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SUPPLEMENTARY INFORMATION:

In the Federal Register of January 18, 2007 (72 FR 2284), FDA announced a public meeting to explore opportunities to link private sector and public sector postmarket safety efforts to create a virtual, integrated, electronic “Sentinel Network”. Such a network would integrate existing and planned efforts to collect, analyze, and disseminate medical product safety information to health care practitioners and patients at the point-of-care. It would be established through multiple, broad-based, public-private partnerships. We are seeking input on a number of specific questions, included in the original Federal Register notice, regarding opportunities for collaboration, the efficient use of information technology, and the collection and analysis of medical product safety information. A tentative agenda for the 2-day meeting has been posted on FDA's Web site and can be viewed at http://www.fda.gov/​oc/​op/​sentinel/​. We will post a final agenda by March 1, 2007, at the same Web site.

During the course of the registration period, FDA became aware that some registrations were not properly recorded. Because of this and because of the strong interest being expressed in this meeting, the agency has decided to reopen and extend the registration period to February 28, 2007.

In light of the fact that we have experienced some registration difficulties, individuals who have already registered can contact Erik Mettler (see ADDRESSES) if they wish to receive confirmation that their registration has been recorded.

Interested parties who have not yet registered may, on or before February 28, 2007, submit to Erik Mettler (see ADDRESSES) an electronic or written registration. Please include your name, title, business affiliation, address, telephone number, fax number, and e-mail address. Please also indicate if you wish to speak during the open public session or if you would like to register to make a presentation.

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Dated: February 12, 2007.

Jeffrey Shuren,

Assistant Commissioner for Policy.

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[FR Doc. 07-710 Filed 2-12-07; 2:59 pm]

BILLING CODE 4160-01-S