S 1838 — DeOndra Dixon INCLUDE Project Act of 2026

1838 IntroducedEngrossed in Senate (IS)](ES)] <DOC> 119th CONGRESS 1st2d Session S.

1838 _______________________________________________________________________ AN ACT 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.

_______________________________________________________________________ IN THE SENATE OF THE UNITED STATES May 21, 2025 Mr.

Hickenlooper (for himself, Mr.

Moran, Mr.

Booker, and Mr.

Mullin) introduced the following bill;

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions _______________________________________________________________________ A BILL 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.

This Act may be cited as the ``DeOndra Dixon INCLUDE Project Act of 2025''.2026''.

FINDINGS.DEONDRA DIXON INCLUDE PROJECT.

CongressPart findsB of title IV of the following:Public Health Service Act (42 U.S.C.

(1)284 Downet syndromeseq.) is theamended mostby commonadding chromosomalat disorder.the end the following:

Each year, about 6,000 babies born in the United States have Down syndrome, affecting about 1 in every 700 babies born.

(2) Individuals with Down syndrome have a full or partial extra copy of chromosome 21 that leads to certain physical, intellectual, and developmental challenges.

(3) Life expectancy of individuals with Down syndrome in the United States has increased dramatically in recent decades.

In 1960, the average life expectancy was about 10 years.

Today, the average life expectancy of an individual with Down syndrome is nearly 60 years.

(4) Individuals with Down syndrome can attend school, work, make their own life decisions, have meaningful relationships, vote, and contribute to society.

(5) Individuals with Down syndrome are at an increased risk for certain medical conditions, such as autoimmune disorders, leukemia, congenital heart disease, sleep dysfunction, and Alzheimer's disease, but may be at a decreased risk for other conditions.

(6) Research and medical care supporting individuals with Down syndrome and their unique disease profile will improve health outcomes and may potentially lead to treatments for individuals born with or without Down syndrome who suffer from diseases associated with that unique profile.

SEC.

3.

DOWN SYNDROME RESEARCH.

Part A of title IV of the Public Health Service Act (42 U.S.C.

281 et seq.) is amended by adding at the end the following:

404P.409K.

``(a) In General.--The Secretary, acting through the Office of the Director of NIH,NIH and in consultation with other Federal agencies and partners, shall carry out,out directly or through grants or contracts, a program of research, training, and investigation related to Down syndrome to be known as the INvestigation`INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE ProjectProject' or the INCLUDE`INCLUDE Project.Project'.

``(b) Program Elements.--The program under subsection (a) shall includeinclude-- research, training, and investigation related to-- ``(1) high-risk, highhigh-reward rewardresearch basicon science studies of the effects of chromosometrisomy 21 on human development and health;

``(2) assemblingpromoting andresearch maintainingfor aparticipants largewith studyDown populationsyndrome ofacross individualsthe withlifespan, including cohort studies to facilitate improved understanding of Down syndrome;syndrome and co- occurring conditions and development of new interventions;

``(3) expanding the number of clinical trials that are inclusive of, or expressly for, individualsparticipants 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 responsiblepertaining forto structuralstructural, functional, and functionalbehavioral anomalies in cells, tissues, and organs,dysfunction cognitiveas andwell behavioralas dysfunction, and stunted growth;

``(5) thesupporting identificationresearch to improve diagnosis and treatment of biomarkersconditions forco-occurring with Down syndrome, including the detectionidentification of biomarkers related to risk factors, diagnosis, and customizedclinical interventionsresearch and treatmentstherapeutics; for conditions co-occurring with Down syndrome;

``(6) whyresearch severalon co-occurringthe conditions,causes suchof asincreased Alzheimer'sprevalence, disease and autoimmunity,concurrent aretreatment, prevalentof inco-occurring individualsconditions, withsuch Downas syndromeAlzheimer's disease and howrelated suchdementias conditionsand canautoimmunity, bein treatedindividuals concurrently with Down syndrome;

and ``(7) research, training, and investigation on improving the quality of life of individuals with Down syndrome and their families.

Prioritizing Nonduplicative Research.--The SecretaryDirector of NIH shall ensure that-- ``(1) the programs and activities of the institutes,institutes centers, agencies, and officescenters of the National Institutes of Health relating to Down syndrome and co-occurring conditions are coordinated, including through the DivisionOffice of Programthe Coordination,Director Planning,of NIH and Strategicpriority-setting Initiativesreviews underconducted sectionspursuant 402(b)(7)to andsection 402A(c);402(b)(3);

and ``(2) such institutes,institutes centers, agencies, and officescenters, prioritize, as appropriate, Down syndrome research that does not duplicate existing research activities of the National Institutes of Health.

``(d) TechnicalConsultation Assistance.--TheWith SecretaryStakeholders.--In shallcarrying provideout technicalactivities assistanceunder tothis granteessection, andthe otherDirector involvedof entities,NIH shall, as appropriate,appropriate forand carryingto outthe activitiesmaximum pursuantextent feasible, consult with relevant stakeholders, including patient advocates, to thisensure section.that such activities take into consideration the needs of individuals with Down syndrome.

``(e) Biennial Reports to Congress.-- ``(1) In general.--The SecretaryDirector 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,institute center, agency, office, or entitycenter involved;

``(B) a statement of whether the research is or was being carried out directly by thesuch institute,institute center, agency, office, or entitycenter or by multiple institutes,institutes centers,and agencies,centers; offices, or entities;