Public Law 109-482: The National Institutes of Health Reform Act of 2006 (Relevant Provisions)
To amend title IV of the Public Health Service Act to revise and extend the authorities of the
National Institutes of Health, and for other purposes.
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the "National Institutes of Health Reform Act of 2006".
TITLE I—NIH REFORM
SEC. 102. AUTHORITY OF DIRECTOR OF NIH.
(b) Additional Authorities.—Section 402(b) of the Public Health Service Act, as amended by subsection (a) of this section, is amended by striking paragraphs (2) and (3) and inserting the following:
||(7)(A) shall, through the Division of Program Coordination, Planning, and
- (i) identify 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 2 or more national research
institutes or national centers, or would otherwise benefit from strategic coordination and planning;
- (ii) include information on such research in reports under section 403;
SEC. 104. REPORTS
(a) Report of Director of NIH.—The Public Health Service Act (42 U.S.C. 201 et seq.), as amended by section 103(a) of this Act, is amended—
(3) by striking section 403 <<NOTE: 42 USC 283.>> and inserting the following sections:
SEC. 403. <NOTE: 42 USC 283.> BIENNIAL REPORTS OF DIRECTOR OF NIH.
- (a) In General.—The Director of NIH shall submit to the Congress
on a biennial basis a report in accordance with this section. The first
report shall be submitted not later than 1 year after the date of the
enactment of the National Institutes of Health Reform Act of 2006. Each
such report shall include the following information:
- (1) An assessment of the state of biomedical and behavioral research.
- (2) A description of the activities conducted or supported
by the agencies of the National Institutes of Health and
policies respecting the programs of such agencies.
- (3) Classification and justification for the priorities
established by the agencies, including a strategic plan and
recommendations for future research initiatives to be carried
out under section 402(b)(7) through the Division of Program
Coordination, Planning, and Strategic Initiatives.
- (4) A catalog of all the research activities of the agencies, prepared in accordance with the
- (A) The catalog shall, for each such activity—
- (i) identify the agency or agencies involved;
- (ii) state whether the activity was carried out directly by the agencies or was supported by the agencies and describe to what extent the agency was involved; and
- (iii) identify whether the activity was carried out through a center of
- (B) In the case of clinical research, the catalog
shall, as appropriate, identify study populations by
demographic variables and other variables that
contribute to research on minority health and health
- (C) Research activities listed in the catalog shall include, where applicable, the
- (i) Epidemiological studies and longitudinal studies.
- (ii) Disease registries, information clearinghouses, and other data systems.
- (iii) Public education and information campaigns.
- (iv) Training activities, including—
- (I) National Research Service Awards and Clinical Transformation Science
- (II) graduate medical education
programs, including information on the
number and type of graduate degrees
awarded during the period in which the
programs received funding under this
- (III) investigator-initiated
awards for postdoctoral training;
- (IV) a breakdown by demographic
variables and other appropriate
- (V) an evaluation and comparison
of outcomes and effectiveness of various
- (v) Clinical trials, including a breakdown
of participation by study populations and
demographic variables and such other information
as may be necessary to demonstrate compliance with
section 492B (regarding inclusion of women and
minorities in clinical research).
- (vi) Translational research activities with other agencies of the Public Health
- (5) A summary of the research activities throughout the
agencies, which summary shall be organized by the following
categories, where applicable:
- (A) Cancer.
- (B) Neurosciences.
- (C) Life stages, human development, and rehabilitation.
- (D) Organ systems.
- (E) Autoimmune diseases.
- (F) Genomics.
- (G) Molecular biology and basic science.
- (H) Technology development.
- (I) Chronic diseases, including pain and palliative care.
- (J) Infectious diseases and bioterrorism.
- (K) Minority health and health disparities.
- (L) Such additional categories as the Director determines to be appropriate.
- (6) A review of each entity receiving funding under this
title in its capacity as a center of excellence (in this
paragraph referred to as a `center of excellence'), including
- (A) An evaluation of the performance and research outcomes of each center of excellence.
- (B) Recommendations for promoting coordination of information among the centers of excellence.
- (C) Recommendations for improving the effectiveness, efficiency, and outcomes of the centers of excellence.
- (D) If no additional centers of excellence have been funded under this title since the previous report under this section, an explanation of the reasons for not funding any additional centers.
- (b) Requirement Regarding Disease-Specific Research Activities.—
In a report under subsection (a), the Director of NIH, when reporting on
research activities relating to a specific disease, disorder, or other
adverse health condition, shall—
- (1) present information in a standardized format;
- (2) identify the actual dollar amounts obligated for such activities; and
- (3) include a plan for research on the specific disease,
disorder, or other adverse health condition, including a
statement of objectives regarding the research, the means for
achieving the objectives, a date by which the objectives are
expected to be achieved, and justifications for revisions to the
SEC. 106. <NOTE: 42 USC 284 note.> ENHANCING THE CLINICAL AND TRANSLATIONAL SCIENCE AWARD.
(a) In General.—In administering the Clinical and Translational
Science Award, the Director of NIH shall establish a mechanism to
preserve independent funding and infrastructure for pediatric clinical
research centers by—
(b) Report.—As part of the biennial report under section 403 of the
Public Health Service Act, the Director of NIH shall provide an
evaluation and comparison of outcomes and effectiveness of training
programs under subsection (a).