2. Agency for Healthcare Research and Quality Advancing Excellence in Health Care www.ahrq.gov The “Centers for Education & Research on Therapeutics” (CERTs) Request for Applications (RFA) Request for Applications (RFA) HS-05-014 Technical Assistance Workshop January 5, 2005

3. Advancing Excellence in Health Care Agency for Healthcare Quality (AHRQ) Mission Improve the outcomes and quality of health care services Reduce its costs Improve patient safety Broaden access to effective services

4. Advancing Excellence in Health Care CERTs Research demonstration program funded by the Agency for Healthcare Research and Quality (AHRQ), in partnership with the Food and Drug Administration (FDA) Research demonstration program funded by the Agency for Healthcare Research and Quality (AHRQ), in partnership with the Food and Drug Administration (FDA) Focus on research and education on therapeutic products (drugs, medical devices and biologics) already marketed in the US Focus on research and education on therapeutic products (drugs, medical devices and biologics) already marketed in the US The Centers provide research support for other Department of Health and Human Services activities The Centers provide research support for other Department of Health and Human Services activities

5. Advancing Excellence in Health Care CERTs Overview Food and Drug Modernization Act (FDAMA) of 1997 and AHRQ reauthorization of 1999 Food and Drug Modernization Act (FDAMA) of 1997 and AHRQ reauthorization of 1999 – Perform state of the art clinical and laboratory research – Drugs, Biologics, and Medical Devices Seven research centers, coordinating center, and steering committee Seven research centers, coordinating center, and steering committee – Cooperative agreements – Allows for government involvement but not control – Sharing resources Public private partnerships Public private partnerships $800,000 per center $800,000 per center

6. Advancing Excellence in Health Care Private Industry Foundations etc. Steering Committee AHRQ FDA Research Center Other Federal Agencies Coordinating Center Centers for Education and Research on Therapeutics

7. Advancing Excellence in Health Care Vision and Mission Vision: To be a trusted national resource for people seeking to improve health through the best use of medical therapies. Vision: To be a trusted national resource for people seeking to improve health through the best use of medical therapies. Mission: To conduct research and provide education that will advance the optimal use of drugs, medical devices, and biological products. Mission: To conduct research and provide education that will advance the optimal use of drugs, medical devices, and biological products.

8. Advancing Excellence in Health Care New Funds New Funds Four CERTs – $3.2 million $800,000 total cost per CERTs research center per year $800,000 total cost per CERTs research center per year – 5 year funding

9. Advancing Excellence in Health Care Purpose of the new RFA Expand the work of the existing CERTs program to eleven centers Address existing gaps through specific themes Integrate new and existing centers Develop additional research and educational strategies and translate knowledge into practice Develop additional program outcome goals Address therapeutic themes determined to be complementary to AHRQ, FDA and DHHS Improve geographic diversity

10. Advancing Excellence in Health Care Center Description Infrastructure rather than large scale studies Supports Department of Health and Human Services (DHHS) agency missions Flexibility to modify project to support programmatic needs Identifiable/quantifiable program goals based on patient outcomes Outreach to improve both local and national health outcomes through partnerships

11. Advancing Excellence in Health Care Themes Themes Therapeutic Medical Devices Mental Health Consumers and Patients The Elderly

12. Advancing Excellence in Health Care Key Dates Technical Assistance Workshop and Conference Call: January 5, 2005 Technical Assistance Workshop and Conference Call: January 5, 2005 Letter of Intent Receipt Date: February 11, 2005 Letter of Intent Receipt Date: February 11, 2005 Application Receipt Date: March 11, 2005 Application Receipt Date: March 11, 2005 Peer Review Date: May 2005 Peer Review Date: May 2005 Earliest Anticipated Start Date: July 2005 Earliest Anticipated Start Date: July 2005