Cancer Centers Program Update and Future Directions Linda K. Weiss, PhD Director, Office of Cancer Centers Cancer Center Administrators Forum April 5,

Overview Portfolio FY 2010 Funding, Parent Grant and Special Initiatives FY 2011 Budget Organizational Changes Database, Website, and Centers Report Miscellaneous Items Program Announcement Cancer Center Support Grant Guidelines: Where Next?

Portfolio Geographic Distribution of Cancer Centers –66 Centers in 33/50 states and DC –40 Comprehensive: 23 states and DC –26 Cancer Centers: 17 states: 17 states

CCSG Funding By Application Type, FY2010, $271,490,840 Total Costs, Parent Grant

FY 10 Funding for Special Initiatives Supplemental Initiatives through OCC: $7.4 M –Ca BIG: 0.8 M –AMC: 1.0 M –CFAR: 1.5 M –NCCCP: 0.8 M –RaPID: 3.0 M –Miscellaneous: 0.6 M Additional Supplements –CTRP (NCI CCCT): 5.2 M –Core Consolidation (NCRR): 8.0 M

FY 2011 Budget Centers Baseline Budget –Continuing Resolution now in effect until 4/8 –Centers budget has not been finalized –T3/5 funded under NIH policy at 90% –T1/2 budget pending Anticipated Supplements –Clinical Investigator Team Leadership Award –Clinical Trials Reporting Program –CFAR – CC Pilot Project Awards –AMC – CC Pilot Project Awards

Organizational Changes New NCI Leadership –Dr. Harold Varmus, Director –Dr. Douglas Lowy, Deputy Director –Dr. Peter Greenwald, Associate Director for Prevention and Control –John Czajkowski, Deputy Director for Management –Searches underway Associate Director for Clinical Research Director Center for Center for Cancer Genomics Director for Center for Global Health Director for Division of Cancer Prevention Office of Cancer Centers New Staff –Nga Nguyen, Program Analyst –Searches underway Program Director IT Database Specialist

Database, Website and Centers Report Summaries –Send as before to –Send content questions to your program director Website Updates –Send center name, address, directorship changes to your program director –More complex changes will be deferred Centers Report –Nearing completion –Some information will be web-based (e.g., publications, clinical trials)

Miscellaneous Items Include PMCID numbers with publications list Large carryover balances are discouraged, particularly as a repeated pattern; there is no guaranteed approval Fewer administrative supplements (extensions with funds) than in previous years, no ‘recycling’ New programs and shared resources can’t be established with CCSG funds during non-competing years; realigned programs must be approved by staff

Program Announcement Overview O pportunity Announcement –Effective September 25, 2010, NIH required that all mechanisms have a Funding Opportunity Announcement in the NIH Guide for Grants and Contracts –All applications will have to respond to the PAR –The PAR, new Guidelines, and a comparison of 2008 and 2010 Guidelines are on our website.

Program Announcement Face page of the application must indicate the PAR # Resubmission applications (A1) now allowed within 37 months New page limits for components are in effect Appendices must be included in the application and can’t exceed 50 pages Late materials must follow NIH policy – much more stringent limitations Submission procedures for letter of approval and request for preliminary information have changed

Program Announcement Applicants will no longer receive and respond to an administrative review letter Applicants will no longer submit posters and updated summaries prior to the site visit; information not provided in the original application can be provided at the site visit. The SRO can no longer selectively accept parts of the application The application can be returned without review if it doesn’t meet guidelines requirements

Program Announcement –The 5 review criteria mandated by NIH (significance, investigator, innovation, approach and environment) are now incorporated into the Guidelines. –The 5 criteria will be incorporated into the evaluation of overall center impact but not individual components –Prior to the site visit assigned reviewers will submit criterion scores for the overall application on the 5 NIH mandated criteria. These scores will be in the summary statement, but won’t be discussed at the review. –The 6 th year of funding for centers scoring in the outstanding range has been eliminated. –NIH policy and document citations have been updated.

The CCSG Guidelines: Where Next? Major Objectives –Foster collaboration and integration –Facilitate clinical and translational research –Reduce the burden of the application process –Provide new guidance on eligibility and budget requests

The CCSG Guidelines: Where Next? Foster Collaboration and Integration –Recognize research collaborations that extend beyond the walls of the center, including ‘hand-offs’ to other mechanisms or entities that move scientific findings forward –Encourage productive interactions with other NCI and NIH programs –Allow sharing of core services across centers –Eliminate the benchmark ratio

The CCSG Guidelines: Where Next? Facilitate Clinical and Translational Research –Make Clinical Trial and Data Management (the CTO) a separate component and broaden options for support –Harmonize guidelines to recognize leadership and participation in the cooperative groups –Recognize variety and quality in clinical and translational research –Promote team contributions in clinical research

The CCSG Guidelines: Where Next? Reduce the Burden of the Application Process –Eliminate multiple redundancies across components detailed capacity and usage tables in shared resource components data on non-aligned members requirements for program meeting agendas –Streamline clinical and other data requirements requirements for the administrative component

The CCSG Guidelines: Where Next? Provide New Guidance on Eligibility and Budget –Raise eligibility minimum, e.g., from $4 to $10 M –Budget Requests Base request on percent over prior award or a minimum level or ‘floor’ whichever is greater, e.g., –20% over last T5 award or $2 M DC Allow for exceptions, e.g., –First T2 –First application after no-cost extension –Major expansion of research Funding level would still be dependent on merit and NCI budget

The CCSG Guidelines: Where Next? Other Potential Changes –More specificity in language for consortium centers –Expansion/redefinition of staff investigator category –Modification in criteria for Protocol specific resaerch support –Elimination of the limited site visit

The CCSG Guidelines: Where Next? Process –Collaborators/Consultants NCI –Review –Grants Administration –Senior leadership Cancer Centers –Approvals NCI senior leadership NCAB Subcommittee on Cancer Centers NIH (to include a new PAR) Tentative timeline for implementation: 2012

QUESTIONS?Questions?