Public Laws | Pending Legislation
National Institutes of Health Reform Act of 2006
P.L. 109-482 (H.R. 6164)
Impact of Public Law
The National Institutes of Health (NIH), part of the U.S. Department of Health and Human Services (DHHS), is the primary Federal agency for conducting and supporting medical research. Comprising 27 Institutes and Centers (ICs), NIH provides leadership and financial support to researchers in every State and around the world. Throughout NIH’s history, its ICs, program offices within the Office of the Director (OD), and congressionally directed research programs were regularly reauthorized either through stand-alone or omnibus bills; the last omnibus NIH reauthorization bill was enacted in 1993 (P.L. 103-43). An attempt was made to reauthorize the agency in 1996 when the Senate passed S. 1897, the National Institutes of Health Revitalization Act of 1996; however, the House did not take action on the measure. It should be noted that because Section 301 of the Public Health Service Act provides the Secretary of Health and Human Services (HHS) with permanent statutory authority to conduct and sponsor research, NIH can continue to operate. The annual appropriations process provides a de facto reauthorization for NIH.
When Representative Joe Barton (R-TX) became the chair of the House Committee on Energy and Commerce in May 2004, he vowed to reauthorize the agency, and he held numerous reauthorization and oversight hearings. When crafting legislation, the Chair took into account the 14 recommendations contained in the 2003 Institute of Medicine report entitled “Enhancing the Vitality of the National Institutes of Health: Organizational Change to Meet New Challenges” (http://www.iom.edu/CMS/3740/4866/14300.aspx).
In contrast to the last two omnibus reauthorization bills (P.L. 99-158 and P.L. 103-43), which expanded ICs, OD offices, and programs aimed at specific diseases, P.L. 109-482 caps the number of ICs at 27, provides the Director of NIH with expanded authority to manage the agency, encourages ICs to collaborate on trans-NIH research, and reforms the agency’s reporting system so that Congress can evaluate the NIH research portfolio. Specific provisions of the law address the following areas:
- OD: The law provides the Director of NIH with new oversight and coordination responsibilities across ICs. For example, in consultation with Directors of the ICs, the Director of NIH will be responsible for program coordination across the ICs, including conducting priority-setting reviews, to ensure that NIH’s research portfolio is balanced; free of unnecessary duplication; and takes advantage of collaborative, cross-cutting research. The Director of NIH will be required to assemble accurate data to be used to assess research priorities, including information to better evaluate scientific opportunity, public health burdens, and progress in reducing health disparities. The Director will also be required to ensure that scientifically based strategic planning is implemented in support of research priorities as determined by the ICs and that NIH’s resources are sufficiently allocated for research projects identified in strategic plans. In coordination with the Directors of the ICs, the Director of NIH will be required to ensure that investigator-initiated research is maximized, when appropriate. This portion of the law contains a provision preserving the current authorities of the ICs.
- Reorganization: The law reaffirms the Secretary of HHS’s authority to reorganize ICs after notifying Congress 180 days in advance. The legislation requires that certain reorganizations be carried out pursuant to a regulatory notice and comment process and with congressional review. In addition, the Director of NIH will be authorized to reorganize the offices within OD, following a series of public hearings and approval of the Secretary. ICs will be authorized to reorganize their divisions, centers, or other administrative units, including adding, removing, or transferring the functions of such units, following a series of public hearings and approval of the Director of NIH.
- Scientific Management Review Board: The law establishes a Scientific Management Review Board to conduct periodic organizational reviews. The Board, which must be established within 60 days of enactment, will be required to examine the use of NIH’s organizational authorities at least every 7 years, provide a report on its review, and make recommendations regarding the use of such authorities. If the Board 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 Director of NIH objects to all or part of the recommended organizational change within 90 days, and the objection includes a rationale.
- Division of Program Coordination, Planning, and Strategic Initiatives: The law establishes a new Division of Program Coordination, Planning, and Strategic Initiatives within OD. The following program offices will be moved within the Division: the Office of AIDS Research, Office of Research on Women’s Health, Office of Behavioral and Social Sciences Research, Office of Disease Prevention, Office of Dietary Supplements, and Office of Rare Diseases. The law contains a provision stating that these offices will retain the authorities in effect prior to enactment of the Act. The Director of NIH, acting through the Division, will be authorized 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 conducting or supporting additional research that involves collaboration between two or more ICs, or would otherwise benefit from strategic coordination and planning. The law establishes a common fund to pay for such research. The research proposals will be considered by a new Council of Councils, comprising members from IC advisory councils, individuals nominated by OD offices, and members of the Council of Public Representatives. Trans-NIH proposals must include milestones and goals for the research activities and timeframes for funding the research. The law stipulates that appropriate consideration be given to proposals for which the investigator is a first-time applicant to NIH.
- Common Fund: The Director of NIH will have the authority to allocate Common Fund money to the ICs to fund trans-NIH research. Common Fund amounts will be reserved by the Director and subject to appropriations, but the percentage constituted by the amount reserved relative to the total appropriation in any fiscal year (FY) may not be less than the percentage from the preceding fiscal year. The first year that the Common Fund reaches the 5-percent mark, the Director, in consultation with the Council of Councils, will be required to submit recommendations to Congress for changes regarding amounts for the Common Fund.
- Authorization of Appropriations: Expired authorizations of appropriations sections relevant to 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. Report language accompanying the House-passed bill states that the elimination of other authorizations of appropriations may not be construed as terminating the authority of the IC/OD office to carry out the program. Of the amount authorized to be appropriated for NIH, the law authorizes for OD such sums as may be necessary for each of FYs 2007 through 2009.
- Coding System: The law requires the establishment of an electronic system to uniformly code research grants and activities. This system must be searchable by a variety of codes, such as type of research grant, research entity managing the grant, and public health area of interest. When permissible, the Secretary of HHS, acting through the Director of NIH, will be required to provide information on relevant literature and patents that are associated with NIH’s research activities.
- Reporting: ICs will be required to annually report to the Director of NIH the amount of the IC budget made available for trans-NIH research. The appropriation levels of ICs that fail to report trans-NIH funding will be held at the FY 2006 level. The Director of NIH will be allowed to waive the reporting requirement in certain circumstances.
Most reports pertaining to NIH in current law will be deleted and replaced with one biennial report to Congress, with instructions on the information that must be included. Additional reports with respect to collaboration with other DHHS agencies, clinical trials, human tissue samples, whistleblowers, and experts and consultants will be required. Reports will also be required from each institution receiving an NIH award for the training of graduate students for doctoral degrees.
- Demonstration Programs: The Director of NIH will be authorized, in consultation with the Director of the National Science Foundation, the Secretary of the U.S. Department of Energy, and other agency heads, as necessary, to allocate funds for ICs to make grants for interdisciplinary demonstration projects designed to improve public health. The Director of NIH will also be authorized to allocate funds for ICs to make awards of grants or contracts or to engage in other transactions for demonstration projects for high-impact, cutting-edge research; in providing for such research, the Director of NIH or of the IC, as applicable, will be required to seek to facilitate partnerships between public and private entities. Such funds will be allocated from amounts appropriated to OD. Grant applications must undergo both peer review and advisory council review.
- Clinical and Translational Science Awards (CTSAs): The Director of NIH will be required to establish a mechanism to preserve independent funding and infrastructure for pediatric clinical research centers in administering CTSAs. In addition, as part of the new biennial report to Congress, the Director of NIH must provide an evaluation and comparison of the outcomes and effectiveness of CTSA training programs.
- Foundation for NIH: The law makes minor technical corrections regarding the Foundation for NIH Board of Directors, as well as other clarifying amendments. The law requires NIH to transfer between $500,000 and $1,250,000 to the Foundation annually.
A hearing was held on the original unnumbered bill on September 19, 2006, and on September 20, the bill was marked up by the House Committee on Energy and Commerce and passed by a vote of 42 to 1. On September 26, H. Rept. 109-687 was issued, and the bill was introduced as H.R. 6164. It was passed by the House by a vote of 414 to 2. The measure was passed by the Senate with an amendment by unanimous consent on December 8, and the amended version was passed by the House the next day. On January 15, 2007, the President signed the bill into law as P.L. 109-482.