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Archive for November, 2008

About this Blog

November 10, 2008 Comments off

Background
The purpose of this Transparency Blog is to discuss various ways in which the Food and Drug Administration (FDA) could provide information to the public about what FDA is doing, the bases for FDA’s decisions, and the processes used to make agency decisions.  The blog is expected to run for the next six months (June through November 2009). We will provide blog posts and updates over the coming weeks asking for your feedback on these topics.  The first blog post is to inform you of this process and our policy.  Thereafter, we will be asking for your feedback on specific topics.

FDA is establishing a Task Force to develop recommendations for making FDA processes and decision making more transparent to the public and the Task Force will hold a public meeting on June 24, 2009.  Prior to that meeting, we will be posting questions for you to comment on that will inform the work of the Transparency Task Force.  Following FDA’s June 24 public meeting on transparency, we will provide information on this blog about the public meeting, including comments from the meeting, so that we can get additional feedback from you.  The Task Force will continue to use your feedback to inform its work during the next six months.

We encourage your comments; your ideas and concerns are important to ensure that a broad range of Americans are active and informed participants in the discussion.

Task Force Actions

The Task Force will take the following actions:

  • Seek public input on issues related to transparency;
  • Recommend ways that the agency can better explain its operations, activities, processes, and decision making, compatible with the agency’s goal of appropriately protecting confidential information;
  • Identify information FDA should provide about specific agency operations, activities, processes, and decision making, including enforcement actions, recalls, and product approvals;
  • Identify problems and barriers, both internal and external, to providing useful and understandable information about FDA activities and decision making to the public, taking into consideration health literacy and the needs of special populations;
  • Identify appropriate tools and new technologies for informing the public;
  • Recommend changes to FDA’s current operations (e.g., internal policies and procedures, standards, information formats,  and guidance) to improve the agency’s ability to provide such information to the public in a timely and effective manner;
  • Recommend legislative or regulatory changes, if appropriate, to improve FDA’s ability to provide such information to the public; and
  • Submit a written report to the Commissioner on the Task Force’s findings and recommendations.

Implementation of the Task Force’s recommendations should make agency actions, decisions, and underlying processes more transparent to the public, while still meeting the agency’s goal of appropriately protecting confidential information.  Further, implementation of the recommendations should also reduce the need for requests by the public for agency information under FOIA.

Report to the Commissioner

The Task Force will submit a written report to the Commissioner approximately six months after the task force is convened.

Membership of the Task Force

The Task Force will include the following individuals to provide high level, agency-wide representation:

  • Principal Deputy Commissioner (Chair) – Joshua M. Sharfstein, M.D.
  • Center Directors;
    • Center for Food Safety and Applied Nutrition – Stephen F. Sundlof, D.V.M., Ph.D.
    • Center for Veterinary Medicine – Bernadette M. Dunham, D.V.M., Ph.D.
    • Center for Biologics Evaluation and Research – Karen Midthun, M.D. (Acting)
    • Center for Drug Evaluation and Research – Janet Woodcock, M.D.
    • Center for Devices and Radiological Health – Jeffrey Shuren, M.D., J.D. (Acting)
  • Associate Commissioner for Regulatory Affairs – Michael Chappell (Acting)
  • Chief Counsel – Michael M. Landa, J.D. (Acting)
  • Chief Scientist – Jesse Goodman, M.D., MPH (Acting)

The Blog Team Also Consist of:

  • Katie Burns – Blog Coordinator

Comment Policy

November 10, 2008 Comments off

This is a moderated blog. We expect that participants will treat each other with respect. All comments will be reviewed before posting. We will not post comments that contain vulgar or profane language; personal attacks of any kind; or offensive terms that target specific ethnic, religious or racial groups. We will not post comments that are clearly off topic, spam, or that promote services or products. Comments that make unsupported accusations will also not be posted.

Reporters are asked to send questions to the FDA Media Office through their normal channels and to refrain from submitting questions here as comments. Reporter questions will not be posted.

We recognize that the Web is a 24/7 medium, and your comments are welcome at any time.  However, given the need to manage federal resources, moderating and posting of comments will occur during regular business hours Monday through Friday.  Comments submitted after hours or on weekends will be read and posted as early as possible the next business day.

For the benefit of robust discussion, we ask that comments remain on-topic.

To protect your own privacy and the privacy of others, please do not include phone numbers or email addresses in the body of your comment.

Thank you for taking the time to read this comment policy. We encourage your participation in our discussion and look forward to an active exchange of ideas.

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