NIH REAUTHORIZATION DRAFT LEGISLATION

July 15, 2005

Following is a brief summary of the NIH reauthorization discussion draft provided to us by House Energy and Commerce committee chairman, Rep. Joe Barton (R-Texas).  This is a preliminary summary, based solely on that draft.  That said, a few issues bear watching as this draft is refined by the committee:

  • Still open for discussion are the authorization levels to be included in Section 4 of the legislation.  Currently, there are authorized to be appropriated to the NIH research institutes "such sums as are necessary."  That language afforded Congress the flexibility to double NIH over five years (1998 – 2003) without requiring special legislative authority.  If the committee opts to include specific dollar amounts, that could limit flexibility and growth in the future.
  • Section 4 of the draft establishes four authorizations, presumably leaving open the possibility (or the intent) to compress all of NIH into four line items in the annual appropriations bill.  While that may not preclude the appropriations committees from allocating funds institute-by-institute, as has been it's tradition, this approach could shift that decision to the NIH Director.
  • The draft leaves open the percentage of funds the NIH Director has discretion to transfer between and among research institutes.  

On Tuesday, July 19, the House Energy and Commerce committee will be holding a hearing on this draft.  After the hearing, we hope to provide you with more in-depth information and analysis.  A mark-up date has not been set, but could occur before Congress leaves for the August recess.

Section 1.  Title; Table of Contents

Section 2.  Organization of the National Institutes of Health (NIH)

This draft amends Section 401 of the Public Health Service Act (the Act), which describes the organizational structure of the NIH.  The draft reauthorization does not eliminate or consolidate any existing national research institute or center.  Instead, the draft divides the existing institutes and centers into two categories, mission-specific institutes and science-enabling institutes and centers.  The draft limits the number of mission-specific institutes to 15 and science-enabling institutes to 9; currently, there are 15 of the former and 9 of the latter.  Under the Act, all of the institutes and centers are considered NIH agencies. 

Another major change the draft proposes is creating a Division of Program Coordination, Planning, and Strategic Initiatives within the Office of the Director of NIH.  This Division will house the Office of AIDS Research, the Office of Research on Women's Health, the Office for Behavioral and Social Science Research, the Office of Disease Prevention, the Office of Dietary Supplements, the Office of Rare Diseases, and any other office established within the Office of the Director.

The draft alters the process for reorganizing the institutes and centers.  Under the Act, the Secretary has the authority to reorganize the functions of any institute or abolish one if he deems it is no longer required; the reorganization or abolition cannot take effect until 180 days after both the House and Senate Committees of jurisdiction receive written notice.  The draft authorizes the Director of NIH to reorganize the institutes and centers if three requirements are met; they are: approval of the Secretary, a public process through regulation, and notice to Congress.  Also, the Director, with approval of the Secretary, would have the authority to reorganize the offices within the Offices of the Director.

Section 3.  Authority of Director of NIH

The discussion draft amends Section 402 of the Act by giving new authorities to the NIH Director.  Under the draft, the Director would be responsible for program coordination, which includes conducting priority setting reviews and ensuring that the NIH research portfolio is free of unnecessary, duplicative research, assembling accurate data to assess research priorities, strategic planning and priority setting of all NIH conducted or supported research, and ensuring that NIH resources are allocated adequately for projects identified in the strategic plan.  Also, through the new Division of Program Coordination, Planning and Strategic Initiatives, the Director will identify trans-NIH research activities and will have the authority to provide grants for these activities; these new grant making authorities would be subject to the approval by an Advisory Council of the Director.

Section 4.  Authorization of Appropriations

Four new specific appropriation line items for FY 2007-09 are established; they are as follows:

  1. Office of the Director
  2. Division of Program Coordination, Planning and Strategic Initiatives within the Office of the Director
  3. Institutes with mission-specific responsibilities
  4. Institutes and centers with science-enabling responsibilities.

The draft removes the statutory authorization of appropriations line items that have expired or have never received a direct appropriation.  Also, authority is given to the Director to transfer a specified dollar amount between institutes and centers.  However, this authority is limited.  The Director will not be able to reduce the total funds made available to a particular institute or agency by a specified percentage that has yet to be determined.  Another check on this authority is transfers made by the Director must be approved by an advisory council.

Section 5.  Reports

The draft directs the NIH to establish an electronic system to uniformly code research grants and activities throughout the NIH; this system must be searchable in a variety of ways, including by the type of grant, the entity managing the grant and the public health interest area. 

The Director will be required to submit a biennial report to Congress.  It must include an assessment of the state of biomedical research, a description of the activities conducted or supported by NIH, and a justification of agency activities, including a strategic plan and recommendation for future initiatives.  Also, the report must include both a catalogue and summary of all of the research activities.  The Director may also submit additional reports to Congress as he deems necessary. 

The draft removes the language in the Act regarding reporting requirements that does not fit within the new reporting system.

Section 6.  Demonstration Projects

The Director, in consultation with the Director of the National Science Foundation and the Secretary of Energy, will have the authority to award grants for demonstration projects for research on topics at the intersection of the biological sciences and the physical, chemical, mathematical and computation sciences.  Also, the Director will have the authority to award grants, contracts or engage in other activities for cutting edge research demonstration programs.

Section 7.  Foundation for the National Institutes of Health

The draft makes technical corrections to Section 499 of the Act, which establishes the Foundation for the National Institutes of Health.