The Office of Portfolio Analysis and Strategic Initiatives (OPASI)

1. The Office of Portfolio Analysis and Strategic Initiatives (OPASI) Dr. Raynard Kington Deputy Director National Institutes of Health Council of Public Representatives Briefing October 24, 2005

2. What is OPASI’s mission? • To provide NIH and its constituent ICs with the methods and information necessary to manage their large and complex scientific portfolios • To identify -- in concert with multiple other inputs -- important areas of emerging scientific opportunities or rising public health challenges • To assist in acceleration of investments in these areas, focusing on those involving multiple ICs • To coordinate and make more effective use of the NIH-wide evaluation process.

3. Why Does NIH Need OPASI? • While NIH is world-renowned for the quality of its scientific peer review of applications submitted for funding, less attention has been devoted to coordinated assessment and management of the overall portfolio of NIH-funded research • Concerns have in fact been raised about: -- The process by which the agency codes its funded portfolio for its relatedness to specific diseases and conditions (KM presentation) -- The process by which the agency assesses public health needs and integrates those needs into funding priorities -- The lack of infrastructure to assess and coordinate funding of research areas that cut across or fall between the missions of individual institutes and centers (ICs) • NIH recognizes that it must do a better job in continually re-assessing whether the research it has funded is addressing the most important scientific and public health needs of the country

4. OPASI Organizational Chart NIH Director When Fully Staffed: 76 FTEs Office of Portfolio Analysis and Strategic Initiatives (OPASI) Director 4 FTEs Steering Committee OPASI Working Group Division of Resource Development and Analysis (DRDA) 23 FTEs Division of Strategic Coordination (DSC) 30 FTEs Division of Evaluation and Systemic Assessments (DESA) 19 FTEs Portfolio Analysis and Scientific Opportunities Branch 8 FTEs Public Health Branch 5 FTEs Data, Tools, and Analysis Branch 6 FTEs Systemic Assessments Branch 5 FTEs Evaluation Branch 14 FTEs Operations Branch Analysis Branch FY 2006 $2 Million in budget 13 FTEs transfer from Roadmap and OSP Maximum of 16-17 FTEs recruited in ’06 In-house Studies Team 3 FTEs Data Warehouse Team 3 FTEs IC Liaison Team 3 FTEs

5. WhatStrategic Initiatives Should Qualify for OPASI Involvement? Roadmap Criteria: • Is the initiative truly transforming – will it dramatically change the content or the process of medical research in the next decade? • Would outcomes from the initiative be used by, and synergize the work of, many institutes? • Can the initiative be implemented by one or two ICs, or does it require participation from NIH as a whole? • Can the NIH afford not to do it? • Will the initiative be compelling to NIH stakeholders, especially the public? • Does the initiative position the NIH to do something that no other entity can or will do? An additional important question for OPASI initiatives: Do they involve science that falls between the cracks?

6. How Will Formal Criteria Be Developed and Approved?  A working group of the NIH Steering Committee could be established to lay the foundation for institutionalizing the work of OPASI, including: • Defining, in broad terms, the parameters/dimensions of initiatives to be considered/supported (variation in the size of initiatives is expected) • Determining the most appropriate processes for review and evaluation of initiatives • Developing guidance on the periodicity/timeframe for assessing and launching initiatives (e.g., incubation in OPASI v. graduation to ICs).

7. How Will OPASI Select and Implement Trans-NIH Research? • Stakeholders, including the scientific and advocacy communities, submit suggestions for potential research projects to OPASI • These proposals are reviewed by: • OPASI leadership • Institute and Center (IC) Directors • Council of Councils • Advisory Committee to the Director (ACD) • NIH Director • Once approved for funding: • Initiatives are assigned to a lead IC or ICs • Research is supported by the Common Fund • Evaluation of progress: • Annual review of initiatives • Major review at year 3-4 • Decision at year 5 • Renew for final 5-year period • Continue research at IC(s) • Sunset Initiative

8. OPASI Process for Development, Review, and Approval of Trans-NIH Initiatives Total Process: ~1 Year * Concept Approval 1 Regular Roadmap-like Process Council of Councils1 2 Scientific Analysis/Burden of Illness Data May ‘06 * 3 OPASI Leadership Input Evaluation OPASI2: Flesh Out Initiative Detail Budget Incl. Management Costs3 IC Directors 4 5 OD Programmatic Offices IC Directors ACD NIH Director 6 Stakeholder Input * Final Decision Included in FY ‘08 Budget * Fall ‘05 Potential Trans-NIH Concepts or Strategic Initiatives * Indicates Key Decision Point

9. Common Fund for Shared Needs • Common Fund will be part of a prospective, planning process to fund initiatives that are in areas of interest to multiple ICs • Common Fund is not a transfer authority – it is a set aside fund of a percentage of the annual budgets of the NIH ICs to support research identified by the transparent OPASI planning process • Current Roadmap funds will serve as the baseline for the Common Fund: 1.1% of the total NIH budget in FY 2006, growing to ~1.7% in FY 2008 • Future growth of the Common Fund: • No growth above the FY 2008 percent until the annual NIH budget increase exceeds BRDPI • The rate of growth will be determined annually by the NIH Director and the IC Directors • Common Fund will increase up to 5% of the total NIH budget, dependent on and consistent with identified trans-NIH scientific opportunities and public health needs

10. Evaluation Planning Begins (Assemble Evaluation Team) Planning Funded Initiative Assign Lead IC FTEs & $ Assigned to Lead IC for Duration of Initiative1 Budget Sources Finalized Assemble Team to Oversee Trans-NIH Effort Granting Implement Grants Management Structure Outlined in Business Plan Develop and Issue RFAs/RFPs Lead Council(s) Review Proposals Grants/Contracts Funded * * Reviewing Decision Every 4 or 5 years Major Review at 3 or 4 Year Mark Annual Review Of Initiative Renewed 1 5-year Renewal Allowed Completed Continued by ICs2 OPASI Process for Implementation of Trans-NIH Initiatives Note: 10 year Maximum for Initiative in OPASI 1 According to initiative business plan 2 Phased model of support may be included in business plan * Indicates Key Decision Point

11. OPASI • A bold new approach to assuring that NIH is effective and efficient in meeting its mission