The “Centers for Education & Research on The “Centers for Education & Research on Therapeutics” (CERTs) Therapeutics” (CERTs)

Funding Opportunity Announcements Funding Opportunity Announcements

FOAs RFA-HS-07-004 and RFA-HS-07-008FOAs RFA-HS-07-004 and RFA-HS-07-008Technical Assistance CallTechnical Assistance Call

November 9, 2006November 9, 2006

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AHRQ’s MissionAHRQ’s Mission

Improve the quality, safety, efficiency and Improve the quality, safety, efficiency and effectiveness of health care for all Americanseffectiveness of health care for all Americans

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CERTs ProgramCERTs 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

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CERTs Overview CERTs Overview

Authorized under Food and Drug Modernization Act Authorized under Food and Drug Modernization Act (FDAMA) of 1997 and AHRQ reauthorization of 1999.(FDAMA) of 1997 and AHRQ reauthorization of 1999.

Cooperative agreements - permits sharing of Cooperative agreements - permits sharing of resources, substantial government involvement but resources, substantial government involvement but without level of control seen in contracts.without level of control seen in contracts.

Leverages AHRQ funding with additional public- Leverages AHRQ funding with additional public- private partnerships. private partnerships.

Currently 11 research centers, 1 coordinating Currently 11 research centers, 1 coordinating center, and 1 steering committee.center, and 1 steering committee.

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Private Industry Private Industry Foundations etc.Foundations etc.

Steering CommitteeSteering Committee

AHRQ

FDAFDA

Research CenterResearch Center Other Federal Other Federal AgenciesAgencies

Coordinating Coordinating CenterCenter

Centers for Education and Centers for Education and Research on TherapeuticsResearch on Therapeutics

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CERTs Vision and MissionCERTs Vision and Mission

Vision:Vision: To be a trusted national resource for To be a trusted national resource for people seeking to improve health through the people seeking to improve health through the best use of medical therapies. best use of medical therapies.

Mission:Mission: To conduct research and provide To conduct research and provide education that will advance the optimal use of education that will advance the optimal use of drugs, medical devices, and biological drugs, medical devices, and biological products.products.

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FOA AnnouncementsFOA Announcements

CERTs Research CentersCERTs Research Centershttp://grants.nih.gov/grants/guide/rfa-files/RFA-HS-07-004.htmlhttp://grants.nih.gov/grants/guide/rfa-files/RFA-HS-07-004.html

CERTs Coordinating CenterCERTs Coordinating Centerhttp://grants.nih.gov/grants/guide/rfa-files/RFA-HS-07-008.htmlhttp://grants.nih.gov/grants/guide/rfa-files/RFA-HS-07-008.html

Addendum for Health ITAddendum for Health IThttp://grants.nih.gov/grants/guide/notice-files/NOT-HS-07-005.html

FOA AnnouncementsFOA Announcements

CERTs Technical Assistance CallCERTs Technical Assistance Callhttp://grants.nih.gov/grants/guide/notice-files/NOT-HS-07-025.htmlhttp://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

HIT Research CenterHIT Research Center

Open to those eligible to apply to RC & CC Open to those eligible to apply to RC & CC FOAs + currently funded CERTsFOAs + currently funded CERTs

Objectives: To develop, demonstrate, & Objectives: To develop, demonstrate, & disseminate evidence and educational/ disseminate evidence and educational/ translational materials on the role and use of translational materials on the role and use of HIT tools in safe and effective therapeutics use HIT tools in safe and effective therapeutics use

8 potential areas for study listed in FOA8 potential areas for study listed in FOA

Projected Funding 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

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Center DescriptionCenter 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.

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Key DatesKey Dates

Letter of Intent Receipt Date: November 10, 2006Letter of Intent Receipt Date: November 10, 2006

Opening date: November 14, 2006Opening date: November 14, 2006

Application Submission/Receipt Date: December 14, Application Submission/Receipt Date: December 14, 20062006

Peer Review Date: Approx March 1, 2007Peer Review Date: Approx March 1, 2007

Earliest Anticipated Start Date: July 2007Earliest Anticipated Start Date: July 2007

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