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U.S. Department of Health and Human Services

About FDA

Blood Risk Assessment Workshop

Description: Conduct Blood Risk Assessment Workshop with stakeholders. The workshop conveys information to stakeholders on important statistical, epidemiological, and risk assessment considerations for the regulation of blood and blood products. The workshop advances the FDA Transparency Initiative by enhancing stakeholders' understanding of risk assessment and its role in the regulatory decision-making process.

Accomplishment: On May 13 and 14, 2010, CBER held a workshop on quantitative risk assessment on blood safety and availability for CBER stakeholders. The purpose of the workshop was to discuss the structure of risk assessment, to present a case-study (Malaria exposure and blood donor deferral) demonstrating risk assessment principles, and to solicit stakeholder input on how to better involve stakeholders in complex risk assessments. Stakeholders from the patient advocacy groups and from the regulated industry provided feedback in presentations and during panel discussions. Stakeholder input from the workshop has enabled OBE to consider new strategies for addressing questions regarding risk management and communications. For example, complex risk assessments may require special consideration. Public meetings might be needed either within or outside of the advisory committees meetings to present and discuss the critical assumptions of a risk assessment early in the process. OBE is planning on web posting workshop presentations along with edited transcripts by February 2011.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Finalize statement of work

8/20/2009

Completed 8/20/2009

B. Select contractor for workshop

9/10/2009

Completed 9/10/2009

C. Develop summary and goals

2/12/2010

Completed 3/1/2010

D. Draft workshop agenda

2/12/2010

Completed 3/31/2010

E. Identify workshop speakers

2/26/2010

Completed 4/7/2010

F. Select/invite speakers

3/15/2010

Completed 4/11/2010

G. Finalize workshop agenda

5/3/2010

Completed 5/3/2010

H. Announce workshop in Federal Register and FDA website

4/13/2010

Completed 4/1/2010

I. Pre-meeting review

5/5/2010

Completed 5/5/2010

J. Hold Joint Public Workshop

5/13-14/2010

Completed 5/14/2010

K. Evaluate workshop to determine next steps for OBE

6/14/2010

Completed 6/14/2010

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.