FDA NOTE TO CORRESPONDENTS
SILVER SPRING, Md., Nov. 2 The U.S. Food and Drug Administration will seek comments on three specific issues related to transparency at the agency during a daylong public meeting on Tuesday, Nov. 3, 2009.
The meeting is scheduled for 9 a.m. to 3 p.m. at the National Transportation Safety Board Conference Center, 429 L'Enfant Plaza, S.W., Washington, D.C., 20594. Directions to the NTSB Conference Center are at http://www.ntsb.gov/events/newlocation.htm
The purpose of the meeting is to receive detailed comments on the following three specific issues related to transparency at the FDA:
The FDA formed an internal Transparency Task Force in response to the Obama Administration's commitment to achieve "an unprecedented level of openness in Government." The Task Force is developing recommendations for making useful and understandable information about FDA activities and decision-making more readily available in a timely manner and in a user-friendly format, while appropriately protecting confidential information.
The task force held its first daylong meeting in June 2009.
Those interested can submit electronic or written comments by Nov. 6, 2009. Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
There is no fee to register for the public meeting. Registration on the day of the meeting will be permitted on a space-available basis, beginning at 7:30 a.m. Those who cannot attend the meeting can view it via live Webcast at http://www.capitolconnection.net/capcon/fda/110309/FDAlive.htm
The Webcast will be archived on the FDA Transparency Task Force page http://www.fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/default.htm
A media room with dial-up Internet access will be provided. Please note there is no wireless service within the NTSB Conference Center.
For more information
Hypothetical Case Studies for November 3 Public Meeting on Transparency
November 3 Public Meeting on Transparency http://www.fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/ucm188633.htm
Media Inquiries: Raymond Formanek Jr., 301-796-4677; email@example.com
Other Inquiries: Afia Asamoah, 301-796-4625; firstname.lastname@example.org
-- Early communication about emerging safety issues concerning FDA-regulated products -- Disclosure of information about product applications that are abandoned, i.e., no work is being done or will be undertaken to have the application approved, or withdrawn by the applicant before approval -- Communication of agency decisions about pending product applications.
SOURCE U.S. Food and Drug Administration