E9-30971. Second Annual Sentinel Initiative Public Workshop

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of public workshop.

The Food and Drug Administration (FDA) is announcing the following workshop: Second Annual Sentinel Initiative Public Workshop. This 1-day workshop, organized and hosted by the Engelberg Center for Health Care Reform at Brookings, is supported by a grant from FDA. This workshop is intended to communicate the current status and future vision of active medical product surveillance activities and explore stakeholder perspectives on a broad range of issues. The workshop will feature a series of presentations on recently completed FDA contracts to inform various aspects of the development of the Sentinel System; an update on FDA's ongoing pilot projects in active surveillance of medical product safety; and a discussion of three issues of broad interest: maintaining patient privacy while conducting medical product safety surveillance, developing the Sentinel System as a national resource for medical product safety surveillance for others outside of FDA, and developing a multi-purpose distributed system that can be used to conduct safety surveillance, comparative effectiveness research, product quality assessment and to address other types of public health questions.

Date and Time: The workshop will be held on January 11, 2010, from 8:30 a.m. to 4:45 p.m.

Location: The workshop will be held at Marriott Metro Center at 775 12th Street NW., Washington, DC 20005.

Contact: Kayla Garvin, Center for Drug Evaluation and Research, Bldg. 22, rm. 4339, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20903, 301-796-3755, e-mail: [e-mail].

Registration: To attend the workshop, please register at http://tinyurl.com/​yce6c3z. When registering, provide the following information: Your name, title, company or organization (if applicable), address, phone number, and e-mail address. There is no fee to register for the public workshop and because seating is limited, registration will be on a first-come, first-served basis. A 1-hour lunch break is scheduled; however no food will be provided. There are multiple restaurants within walking distance of the hotel where attendees can purchase lunch. If you need special accommodations due to a disability, please contact Brookings' event coordinator at 202-797-4391 or by e-mail: [e-mail] at least 7 days in advance.

Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.fda.gov/​Safety/​FDAsSentinelInitiative/​ucm149341.htm. 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 the 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 23, 2009.

David Horowitz,

Assistant Commissioner for Policy.