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FDA NOTE TO CORRESPONDENTS

For Immediate Release: Oct. 2, 2009

Media Inquiries: Raymond Formanek Jr., 301-796-4677; raymond.formanek@fda.hhs.gov
Other Inquiries: Afia Asamoah, 301-796-4625; afia.asamoah@fda.hhs.gov

FDA Transparency Task Force to Hold 2nd Public Meeting on Ensuring That Agency Information is Useful, Understandable, Accessible

The U.S. Food and Drug Administration will seek comments on how to ensure that information on FDA activities and decision-making is useful, understandable, and accessible to the public, during a daylong public meeting on 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.
The purpose of the meeting is to receive detailed comments on three specific issues related to transparency at the FDA:

  • 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applications that are abandoned, i.e., no work is being done or will be undertaken to have the application approved, or withdrawn by the applicant before approval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.

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 to the public 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 in attending the public meeting must register by 5 p.m. on Oct. 27, 2009. 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 meeting and registration is on a first-come, first-served basis. Seating is limited and early registration is recommended. Registration on the day of the public meeting will be permitted on a space-available basis, beginning at 7:30 a.m.

A media room with dial-up Internet access will be provided. Please note there is no wireless service within the NTSB Conference Center. Those who cannot attend the meeting can view it via live Webcast.

The Webcast will be archived and available for viewing on the FDA Web site.

For more information:
Federal Register
http://edocket.access.gpo.gov/2009/E9-23916.htm

FDA Transparency Task Force
http://www.fda.gov/AboutFDA/WhatWeDo/FDATransparencyTaskForce/default.htm

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