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U.S. Department of Health and Human Services

Advisory Committees

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Minutes of the June 24, 2013 Meeting of the Science Board to the FDA

FDA White Oak Campus, Bldg 31, Room 1503C
10903 New Hampshire Ave, Silver Spring MD, 20993

Monday, June 24, 2013

The Science Board to the FDA (Science Board) meeting was convened at approximately 1:30 p.m.

Members Present (Voting)

Elazer R. Edelman, M.D., Ph.D., Acting Chair
Jeffrey Bender, DVM, MS, DACVM
Paul R. Billings, M.D., Ph.D., FACP, FACMG
John Floros, Ph.D.
Maria Freire, Ph.D.
Lynn R. Goldman, M.D., MPH
William N. Hait, M.D., Ph.D.
Frederick Kushner, M.D.
Suzanne P. Murphy, Ph.D., R.D.
Steven M. Paul, M.D.
P. Hunter Peckham, Ph.D.
Bruce M. Psaty, M.D., Ph.D., MPH
Dan M. Roden, M.D.
Alan J. Russell, Ph.D.

Designated Federal Officer

Martha Monser, Office of Chief Scientist (OCS), Office of the Commissioner (OC)

FDA Participants

Jesse L. Goodman, M.D., M.P.H., Chief Scientist, OCS, OC
Jan Johannessen, Ph.D., Deputy Director for Science, Office of Translational Sciences, Center for Drug Evaluation and Research, (CDER)
Carolyn Wilson, Ph.D., Associate Director for Science, Center for Biologics Evaluation and Research (CBER)
Donald Zink, Senior Science Advisor, Center for Food Safety and Applied Nutrition (CFSAN)
David White, M.S., Ph.D., Chief Science Officer (Acting), Office of Foods and Veterinary Medicine

The following is a summary of the discussion.  Additional information and specific details may be obtained from the transcript of the meeting.

Summary of Committee Discussions and Recommendations

CDRH Subcommittee Science Review - Alan Russell, Ph.D. subcommittee chair

  • Dr. Russell provided an overview of the updates to the report as recommended by the Board at the February 27, 2013, meeting.

Relevant Discussion:

  • The Board accepted the report with the revisions incorporated.

“Science Looking Forward” Subcommittee Update - Jesse L. Goodman, MD, MPH, Chief Scientist, FDA

  • Dr. Goodman provided an overview of the revised charge to the subcommittee as presented in the briefing material.  Over the next few months, FDA will be working on a detailed progress report including more specific questions for the subcommittee which will constitute the work for the subcommittee.  The goal is to provide the report before the next Board meeting.

 Relevant Discussion:

  • The Board members asked several clarifying questions and provided feedback and suggestions for the report.  The Board members were supportive of the subcommittee’s charge.

There were no requests from the public to make statements during the open public hearing session.
The meeting adjourned at approximately 2:15 p.m.

I certify that I attended the June 24, 2013, meeting of the Science Board and that these minutes accurately reflect what transpired.

__  /s/__________________
Martha E. Monser
Designated Federal Officer

Elazer Edelman, M.D., Ph.D.
Acting Chair