1. Role of the Executive Secretary Gail Dapolito Advisory Committee Coordinator Div. Scientific Advisors and Consultants Center for Biologics Evaluation and Research

2. THE EXECUTIVE SECRETARY Provides Administrative Oversight Ensures Advisory Committee Process Adheres to Gov’t/FDA Regulations and Policies

3. THE EXECUTIVE SECRETARY  Advisory Committee Process Includes :  Maintenance of Committee Charter  Recruitment of New Members  Preparation and Conduct of AC Meetings  Designated Federal Official

4. EXECUTIVE SECRETARY RESPONSIBILITIES Prevent little problems from becoming big issues Coordinate activities of all meeting participants

6. COMMITTEE MEMBER RESPONSIBILITIES Attend scheduled meetings Read the briefing documents Be an active participant in the committee discussions at each meeting Be prepared to vote Disclose conflicts of interest Protect confidentiality of privileged information Participate in FDA Site Visits Complete necessary documentation to ensure proper compensation

7. COMMITTEE MEMBER RESPONSIBILITIES  ATTEND SCHEDULED MEETINGS  Schedules Set on Annual Basis  Emergency Meetings  Cancelled Meetings  New Members Can Have Prior Commitments

8. COMMITTEE MEMBER RESPONSIBILITIES  ATTEND SCHEDULED MEETINGS  Entire Meeting  Notify Exec Sec Well in Advance if Unable to Attend

9. COMMITTEE MEMBER RESPONSIBILITIES  READ THE BRIEFING DOCUMENTS  Provided Approx. 3 Weeks Prior to Meeting  May Contain Confidential Information  Do Not Distribute  Public Version On Web Prior to Meeting  Refrain From Discussing  Contact Exec Sec If Any Questions

10. COMMITTEE MEMBER RESPONSIBILITIES  BE AN ACTIVE PARTICIPANT  How Is An AC Meeting Conducted?  Committees Meet at the Request of FDA  Chair “Runs” the Meeting  Variable Public Attendance  Agenda Developed by Division/Exec Sec/Chair

11. COMMITTEE MEMBER RESPONSIBILITIES  BE AN ACTIVE PARTICIPANT  AGENDA  Issue Topics – FDA Medical/Product Review Staff  Format – Exec Sec  Open/Closed Meeting  PROTECT PRIVILEGED INFO  Input From Committee Chair

12. COMMITTEE MEMBER RESPONSIBILITIES  BE AN ACTIVE PARTICIPANT  OPEN PUBLIC HEARING  Opportunity for Public To Address the Committee on the Issue at Hand  Encouraged to Pre-Register with Exec Sec  Questions Permitted by Committee

13. COMMITTEE MEMBER RESPONSIBILITIES  BE AN ACTIVE PARTICIPANT  QUESTIONS  Primary Focus of Committee Discussion  Open Committee Deliberations Must Be Public  Formulated by FDA Medical/Product Review Staff  Can Change Up to Time of Meeting

14. COMMITTEE MEMBER RESPONSIBILITIES  BE AN ACTIVE PARTICIPANT  Be Prepared to Comment on All Issues and Questions for Committee Discussion  Need to be Recognized by Chair  Ask Questions of Presenters  FDA Needs Your Comments During the Meeting

15. COMMITTEE MEMBER RESPONSIBILITIES  BE AN ACTIVE PARTICIPANT ADVICE RENDERED BY A COMMITTEE IS MOST USEFUL TO THE AGENCY WHEN IT RESULTS FROM A PROCESS OF FULL SCIENTIFIC INQUIRY FOLLOWED BY THOUGHTFUL DISCUSSION, FRAMING OF RECOMMENDATIONS, AND CLEAR IDENTIFICATION OF THE REASONS FOR THE RECOMMENDED ACTIONS.*

16. COMMITTEE MEMBER RESPONSIBILITIES  BE PREPARED TO VOTE  Committee Polled for the Public Record  Yes/No/Abstain  Must Be Present To Vote  Cannot Change Vote After Meeting Adjourns  Impact of Final Vote  Who Can Vote  Determined by Charter  Affected by Potential Conflicts of Interest

17. COMMITTEE MEMBER RESPONSIBILITIES  DISCLOSE CONFLICTS OF INTEREST  Accurately Complete Paperwork  Return on Time  FDA Needs Sufficient Time to Review  Cannot Participate at Meeting until COI Paperwork Approved  Disclosures Read Into Public Record  Product Approval Meetings

18. COMMITTEE MEMBER RESPONSIBILITIES  Participate in FDA Site Visits  Complete and Return Post-Meeting Paperwork  Ensures Proper Compensation  Assists FDA to Reconcile End-of-Year Accounts  Post-Meeting Information  “Quick Minutes”  Transcripts  Official Minutes

19. THE EXECUTIVE SECRETARY Point-of-Contact for all Matters Related to Advisory Committee Service Assist You to Meet Your Responsibilities as Committee Members

20. YOUR SERVICE IS INVALUABLE! THANK YOU