[Federal Register Volume 72, Number 31 (Thursday, February 15, 2007)]
[Notices]
[Page 7441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-710]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0016]


Sentinel Network To Promote Medical Product Safety; Public 
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of registration period.

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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 <a href="/cdn-cgi/l/email-protection#f1b483989adfbc9485859d9483b1979590df999982df969e87"><span class="__cf_email__" data-cfemail="e5a0978c8ecba8809191898097a5838184cb8d8d96cb828a93">[email protected]</span></a>.
    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).

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.

    Dated: February 12, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-710 Filed 2-12-07; 2:59 pm]
BILLING CODE 4160-01-S


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