[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