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

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop; request for comments.

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 Start Printed Page 74177System (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.

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Dated: December 1, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

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[FR Doc. E8-28797 Filed 12-4-08; 8:45 am]

BILLING CODE 4160-01-S