1. The “Centers for Education & Research on Therapeutics” (CERTs) Funding Opportunity Announcements FOAs RFA-HS-07-004 and RFA-HS-07-008 Technical Assistance Call November 9, 2006 1

2. AHRQ’s Mission Improve the quality, safety, efficiency and effectiveness of health care for all Americans 2

3. CERTs Program Funded and administered as a cooperative agreement program by AHRQ in consultation with the FDA CERTs is a national demonstration program whose mission is to conduct research and provide education that advances the optimal use of drugs, biologicals, and medical devices. Serves therapeutic interests of AHRQ, FDA, CMS, and other Federal partners involved with therapeutics 3

4. CERTs Overview Authorized under Food and Drug Modernization Act (FDAMA) of 1997 and AHRQ reauthorization of 1999. Authorized under Food and Drug Modernization Act (FDAMA) of 1997 and AHRQ reauthorization of 1999. Cooperative agreements - permits sharing of resources, substantial government involvement but without level of control seen in contracts. Cooperative agreements - permits sharing of resources, substantial government involvement but without level of control seen in contracts. Leverages AHRQ funding with additional public- private partnerships. Leverages AHRQ funding with additional public- private partnerships. Currently 11 research centers, 1 coordinating center, and 1 steering committee. Currently 11 research centers, 1 coordinating center, and 1 steering committee. 4

5. Private Industry Foundations etc. Steering Committee AHRQ FDA Research Center Other Federal Agencies Coordinating Center Centers for Education and Research on Therapeutics 5

6. CERTs 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. 6

7. FOA Announcements CERTs Research Centers CERTs Research Centers http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-07-004.html CERTs Coordinating Center CERTs Coordinating Center http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-07-008.html Addendum for Health IT Addendum for Health IT http://grants.nih.gov/grants/guide/notice-files/NOT-HS-07-005.html

8. FOA Announcements CERTs Technical Assistance Call CERTs Technical Assistance Call http://grants.nih.gov/grants/guide/notice-files/NOT-HS-07-025.html Budget Submission Instructions http://grants.nih.gov/grants/guide/notice-files/NOT-HS-07-030.html

9. HIT Research Center Open to those eligible to apply to RC & CC FOAs + currently funded CERTs Open to those eligible to apply to RC & CC FOAs + currently funded CERTs Objectives: To develop, demonstrate, & disseminate evidence and educational/ translational materials on the role and use of HIT tools in safe and effective therapeutics use Objectives: To develop, demonstrate, & disseminate evidence and educational/ translational materials on the role and use of HIT tools in safe and effective therapeutics use 8 potential areas for study listed in FOA 8 potential areas for study listed in FOA

10. Projected Funding 8 Research Centers: $8 million – – $1,000,000 total cost per RC/yr – – Dedicated funding for one RC on Health IT – – 4 year funding anticipated One Coordinating Center: $400 thousand – – 4 year funding anticipated Separate, ongoing funding of 4 RCs intially funded in 2006 – – Iowa – Aging – – Rutgers – Mental Health – – Cornell – Devices – – MD Anderson/Baylor – Patient Adherence/Consumer Education 10

11. 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

12. Key Dates Letter of Intent Receipt Date: November 10, 2006 Letter of Intent Receipt Date: November 10, 2006 Opening date: November 14, 2006 Opening date: November 14, 2006 Application Submission/Receipt Date: December 14, 2006 Application Submission/Receipt Date: December 14, 2006 Peer Review Date: Approx March 1, 2007 Peer Review Date: Approx March 1, 2007 Earliest Anticipated Start Date: July 2007 Earliest Anticipated Start Date: July 2007 12