Document ID: FDA-2009-N-0664-0132
Agency: fda
Document Type: Notice
Title: Second Annual Sentinel Initiative Public Workshop
Posted Date: 2009-12-30T05:00Z

[Federal Register: December 30, 2009 (Volume 74, Number 249)]
[Notices]               
[Page 69122]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30de09-81]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

 
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: 
Kayla.Garvin@fda.hhs.gov.
    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: sentinelevent@brookings.edu 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.
[FR Doc. E9-30971 Filed 12-29-09; 8:45 am]

BILLING CODE 4160-01-S