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I am pleased to announce that the President signed the National Institutes of Health Reform Act of 2006 on January 15, 2007. This follows bipartisan support by the Congress. The Act affirms the importance of the NIH and its vital role in advancing biomedical research to improve the health of the Nation.

This is only the third omnibus reauthorization in the NIH’s history, and the first in 14 years.

We have initiated an implementation process ar Â鶹´«Ã½ to carry out the new legislation. The work is already under way. I have formed Ad Hoc Working Group of the NIH Steering Committee, to be chaired by the Â鶹´«Ã½ Deputy Director, Dr. Raynard Kington, and comprising Institute and Center (IC) Directors and leadership in legislation, policy, management, communications, extramural and intramural activities, budget, and the Office of the General Counsel, to make recommendations on the implementation of the legislation. The Ad Hoc Working Group will be charged to complete a careful, detailed analysis of the legislation and propose plans for its implementation that will aid the Â鶹´«Ã½ in serving the public and our scientific community more effectively.

Key provisions in the Act include items related to (1) the Division of Program Coordination, Planning and Strategic Initiatives; (2) the Common Fund; (3) the Council of Councils; (4) the Scientific Management Review Board; (5) Authorization of Appropriations; (6) Reorganization; and (7) Reporting.

1. The Division of Program Coordination, Planning and Strategic Initiatives (DPCPSI)

The DPCPSI, within the Office of the Director, is officially established. The purpose of DPCPSI is to identify and report on research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis and would benefit from the conduct or support of additional research that involves collaboration between two or more ICs, or would otherwise benefit from strategic coordination and planning.

2. The Common Fund

The Common Fund (CF) will support trans-NIH research. CF amounts will be reserved by the Â鶹´«Ã½ Director, subject to any applicable provisions in appropriations Acts, but the amount reserved as a percentage of the total appropriation in any fiscal year may not be less than the percentage from the preceding fiscal year. The first year that the CF reaches the 5 percent mark, the Director will be required, in consultation with the Council of Councils, to submit recommendations to Congress for changes regarding amounts for the CF.

3. Council of Councils

A new Council of Councils will advise on research proposals that would be funded by the Common Fund. It will be composed of 27 members selected from the IC Advisory Councils, individuals nominated by OD offices, and members of the NIH Council of Public Representatives.

4. Scientific Management Review Board (SMRB)

At least every 7 years, the SMRB will be required to examine the use of the NIH’s organizational authorities, provide a report on the review, and make recommendations regarding the use of such authorities. If the SMRB recommends an organizational change, the process to effect the change must begin within 100 days of the report, and the change must be fully implemented within 3 years. These requirements do not apply if the Â鶹´«Ã½ Director formally objects to all or part of the recommended organizational change within 90 days, and the objection includes a rationale.

5. Authorization of Appropriations

Most expired authorizations of appropriations sections relevant to the NIH will be deleted from the Statute and replaced with one authorization of appropriations for the entire Agency for the following amounts: $30,331,309,000 for FY 2007; $32,831,309,000 for FY 2008; and such sums as may be necessary for FY 2009.

6. Reorganization

The legislation requires a public process for certain reorganizations and identifies procedures for any reorganization.

7. Reporting

Most reports pertaining to Â鶹´«Ã½ in current law will be deleted and replaced by one biennial report to Congress. Additional reports with respect to collaboration with other DHHS agencies, clinical trials, tissue samples, whistleblowers, and experts and consultants are required. Reports will be required from each institution receiving an NIH award for the training of graduate students for doctoral degrees. ICs will also be required to report to the Director of NIH on the amount of that IC’s budget made available for trans-NIH research. Detailed information about these elements and others is available on the Web.

This affirmation from Congress and the President has come at a critical time, and we want to ensure that we take the best possible advantage of this opportunity. We will be communicating with the community regularly as we make progress in this process.

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Elias A. Zerhouni, M.D.
Â鶹´«Ã½ Director