[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 3981 Introduced in Senate (IS)]

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118th CONGRESS
  2d Session
                                S. 3981

 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

                             March 19, 2024

 Mr. Hickenlooper (for himself and Mr. Moran) 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.

    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 ``DeOndra Dixon INCLUDE Project Act of 
2024''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Down syndrome is the most common chromosomal disorder. 
        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:

``SEC. 404P. DOWN SYNDROME RESEARCH.

    ``(a) In General.--The Secretary, acting through the Office of the 
Director of NIH, and in consultation with other Federal agencies and 
partners, shall carry out, directly or through grants or contracts, 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 research, training, and investigation related to--
            ``(1) high-risk, high reward basic science studies of the 
        effects of chromosome 21 on human development and health;
            ``(2) assembling and maintaining a large study population 
        of individuals with Down syndrome;
            ``(3) expanding the number of clinical trials that are 
        inclusive of, or expressly for, individuals with Down syndrome, 
        including novel biomedical and pharmacological interventions 
        and other therapies designed to promote or enhance activities 
        of daily living;
            ``(4) the biological mechanisms in individuals with Down 
        syndrome responsible for structural and functional anomalies in 
        cells, tissues, and organs, cognitive and behavioral 
        dysfunction, and stunted growth;
            ``(5) the identification of biomarkers for the detection of 
        risk factors, diagnosis, and customized interventions and 
        treatments for conditions co-occurring with Down syndrome;
            ``(6) why several co-occurring conditions, such as 
        Alzheimer's disease and autoimmunity, are prevalent in 
        individuals with Down syndrome and how such conditions can be 
        treated concurrently with Down syndrome; and
            ``(7) improving the quality of life of individuals with 
        Down syndrome and their families.
    ``(c) Coordination; Prioritizing Nonduplicative Research.--The 
Secretary shall ensure that--
            ``(1) the programs and activities of the institutes, 
        centers, agencies, and offices of the National Institutes of 
        Health relating to Down syndrome and co-occurring conditions 
        are coordinated, including through the Division of Program 
        Coordination, Planning, and Strategic Initiatives under 
        sections 402(b)(7) and 402A(c); and
            ``(2) such institutes, centers, agencies, and offices 
        prioritize, as appropriate, Down syndrome research that does 
        not duplicate existing research activities of the National 
        Institutes of Health.
    ``(d) Technical Assistance.--The Secretary shall provide technical 
assistance to grantees and other involved entities, as appropriate, for 
carrying out activities pursuant to this section.
    ``(e) Biennial Reports to Congress.--
            ``(1) In general.--The Secretary 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, center, 
                agency, office, or entity involved;
                    ``(B) a statement of whether the research is or was 
                being carried out directly by the institute, center, 
                agency, office, or entity or by multiple institutes, 
                centers, agencies, offices, or entities; 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.
    ``(f) Authorization of Appropriations.--
            ``(1) In general.--To carry out this section, there is 
        authorized to be appropriated $250,000,000 for each of fiscal 
        years 2025 through 2029.
            ``(2) Supplement, not supplant.--Funds appropriated to 
        carry out this section shall be used to supplement, not 
        supplant, other funds allocated by the National Institutes of 
        Health for research and other activities relating to Down 
        syndrome.''.
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