Document ID: FDA-2008-N-0612-0001
Agency: fda
Document Type: Notice
Title: Sentinel Initiative: Structure, Function, and Scope; Public Workshop; Request for Comments
Posted Date: 2008-12-05T05:00Z

[Federal Register: December 5, 2008 (Volume 73, Number 235)]
[Notices]               
[Page 74176-74177]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05de08-87]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0612]

 
Sentinel Initiative: Structure, Function, and Scope; Public 
Workshop; Request for Comments

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA) is announcing a public 
workshop entitled Sentinel Initiative: Structure, Function, and Scope. 
The workshop is co-sponsored by the Food and Drug Administration and 
the eHealth Initiative Foundation, and convened by the Engelberg Center 
for Health Care Reform at the Brookings Institution. The workshop is 
intended to bring together academia; government; patient, consumer, and 
provider groups; health care data owners; industry; and other 
interested organizations for an update on the current status of the 
Sentinel Initiative and to allow for comment from all interested 
stakeholders. Specific topics for discussion include potential 
governance models and their implications, and approaches for ensuring 
continued involvement of all stakeholders as the Initiative evolves.
    Date and Time: The public workshop will be held on December 16, 
2008, from 9 a.m. to 3:30 p.m.
    Location: The public workshop will be held at the Omni Shoreham 
Hotel, 2500 Calvert Street NW., Washington, DC 20008.
    Contact Person: Melissa Robb, Office of Critical Path Programs (HF-
18), Food and Drug Administration, 5600 Fishers Lane, Rockville MD 
20857, 301-827-1516, or e-mail: Melissa.Robb@fda.hhs.gov.
    Registration: To register, please visit: http://guest.cvent.com/ 
and insert ``7SN5MQKXSVQ'' for the event code. For questions regarding 
registration, e-mail: engelbergevents@brookings.edu.
    If you need special accommodations due to a disability, please 
contact Keviar Warner, 202-624-3271, or e-mail: 
Keviar.Warner@ehealthinitiative.org at least 7 days in advance.
    Comments: FDA is holding this public workshop to provide an update 
on the current status of the Sentinel Initiative. The deadline for 
submitting comments regarding this topic is January 16, 2009.
    Regardless of attendance at the public workshop, interested persons 
may submit written or electronic comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. Submit a single copy of electronic comments or two 
paper copies of any mailed comments, except that individuals may submit 
one paper copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management

[[Page 74177]]

System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is 
available, it will be accessible at http://www.fda.gov/oc/initiatives/
advance/sentinel/. It may be viewed at the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD. A transcript will also be available in either 
hardcopy or on CD-ROM, after submission of a Freedom of Information 
request. Written requests are to be sent to Division of Freedom of 
Information (HFI-35), Office of Management Programs, Food and Drug 
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857.

    Dated: December 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28797 Filed 12-4-08; 8:45 am]

BILLING CODE 4160-01-S