In the nature of a substitute.

SA 6751. Mr. HICKENLOOPER (for himself and Mr. Moran) proposed an
amendment to the bill S. 1838, to amend the Public Health Service Act
to authorize the Secretary of Health and Human Services to carry out a
program of research, training, and investigation related to Down
syndrome, and for other purposes; as follows:

Strike all after the enacting clause and insert the
following:

SECTION 1. SHORT TITLE.

This Act may be cited as the ``DeOndra Dixon INCLUDE
Project Act of 2026''.

SEC. 2. DEONDRA DIXON INCLUDE PROJECT.

Part B of title IV of the Public Health Service Act (42
U.S.C. 284 et seq.) is amended by adding at the end the
following:

``SEC. 409K. DOWN SYNDROME RESEARCH.

``(a) In General.--The Director of NIH shall carry out a
program of research, training, and investigation related to
Down syndrome to be known as the `INvestigation of Co-
occurring conditions across the Lifespan to Understand Down
syndromE Project' or the `INCLUDE Project'.
``(b) Program Elements.--The program under subsection (a)
shall include--
``(1) high-risk, high-reward research on the effects of
trisomy 21 on human development and health;
``(2) promoting research for participants with Down
syndrome across the lifespan, including cohort studies to
facilitate improved

[[Page S4529]]

understanding of Down syndrome and co-occurring conditions
and development of new interventions;
``(3) expanding the number of clinical trials that are
inclusive of, or expressly for, participants with Down
syndrome, including novel biomedical and pharmacological
interventions and other therapies designed to promote or
enhance activities of daily living;
``(4) research on the biological mechanisms in individuals
with Down syndrome pertaining to structural, functional, and
behavioral anomalies and dysfunction as well as stunted
growth;
``(5) supporting research to improve diagnosis and
treatment of conditions co-occurring with Down syndrome,
including the identification of biomarkers related to risk
factors, diagnosis, and clinical research and therapeutics;
``(6) research on the causes of increased prevalence, and
concurrent treatment, of co-occurring conditions, such as
Alzheimer's disease and related dementias and autoimmunity,
in individuals with Down syndrome; and
``(7) research, training, and investigation on improving
the quality of life of individuals with Down syndrome and
their families.
``(c) Coordination; Prioritizing Nonduplicative Research.--
The Director of NIH shall ensure that--
``(1) the programs and activities of the institutes and
centers of the National Institutes of Health relating to Down
syndrome and co-occurring conditions are coordinated,
including through the Office of the Director of NIH and
priority-setting reviews conducted pursuant to section
402(b)(3); and
``(2) such institutes and centers, prioritize, as
appropriate, Down syndrome research that does not duplicate
existing research activities of the National Institutes of
Health.
``(d) Consultation With Stakeholders.--In carrying out
activities under this section, the Director of NIH shall, as
appropriate and to the maximum extent feasible, consult with
relevant stakeholders, including patient advocates, to ensure
that such activities take into consideration the needs of
individuals with Down syndrome.
``(e) Biennial Reports to Congress.--
``(1) In general.--The Director of NIH shall submit, on a
biennial basis, to the Committee on Energy and Commerce and
the Subcommittee on Labor, Health and Human Services,
Education, and Related Agencies of the Committee on
Appropriations of the House of Representatives and the
Committee on Health, Education, Labor, and Pensions and the
Subcommittee on Labor, Health and Human Services, Education,
and Related Agencies of the Committee on Appropriations of
the Senate, a report that catalogs the research conducted or
supported under this section.
``(2) Contents.--Each report under paragraph (1) shall
include--
``(A) identification of the institute or center involved;
``(B) a statement of whether the research is or was being
carried out directly by such institute or center or by
multiple institutes and centers; and
``(C) identification of any resulting real-world evidence
that is or may be used for clinical research and medical care
for patients with Down syndrome.''.
______