II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘DeOndra Dixon IN5 CLUDE Project Act of 2024’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 


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1 (1) Down syndrome is the most common chro2 mosomal disorder. Each year, about 6,000 babies 

3 born in the United States have Down syndrome, af4 fecting about 1 in every 700 babies born. 

5 (2) Individuals with Down syndrome have a full 

6 or partial extra copy of chromosome 21 that leads 

7 to certain physical, intellectual, and developmental 

8 challenges. 

9 (3) Life expectancy of individuals with Down 

10 syndrome in the United States has increased dra11 matically in recent decades. In 1960, the average life 

12 expectancy was about 10 years. Today, the average 

13 life expectancy of an individual with Down syndrome 

14 is nearly 60 years. 

15 (4) Individuals with Down syndrome can attend 

16 school, work, make their own life decisions, have 

17 meaningful relationships, vote, and contribute to so18 ciety. 

19 (5) Individuals with Down syndrome are at an 

20 increased risk for certain medical conditions, such as 

21 autoimmune disorders, leukemia, congenital heart 

22 disease, sleep dysfunction, and Alzheimer’s disease, 

23 but may be at a decreased risk for other conditions. 

24 (6) Research and medical care supporting indi25 viduals with Down syndrome and their unique disVerDate Sep 11 2014 18:34 Apr 04, 2024 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3981.IS S3981

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1 ease profile will improve health outcomes and may 

2 potentially lead to treatments for individuals born 

3 with or without Down syndrome who suffer from 

4 diseases associated with that unique profile. 

5 SEC. 3. DOWN SYNDROME RESEARCH. 

6 Part A of title IV of the Public Health Service Act 

7 (42 U.S.C. 281 et seq.) is amended by adding at the end 

8 the following: 

9 ‘‘SEC. 404P. DOWN SYNDROME RESEARCH. 

10 ‘‘(a) IN GENERAL.—The Secretary, acting through 

11 the Office of the Director of NIH, and in consultation with 

12 other Federal agencies and partners, shall carry out, di13 rectly or through grants or contracts, a program of re14 search, training, and investigation related to Down syn15 drome to be known as the INvestigation of Co-occurring 

16 conditions across the Lifespan to Understand Down syn17 dromE Project or the INCLUDE Project. 

18 ‘‘(b) PROGRAM ELEMENTS.—The program under 

19 subsection (a) shall include research, training, and inves20 tigation related to— 

21 ‘‘(1) high-risk, high reward basic science studies 

22 of the effects of chromosome 21 on human develop23 ment and health; 

24 ‘‘(2) assembling and maintaining a large study 

25 population of individuals with Down syndrome; 


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1 ‘‘(3) expanding the number of clinical trials 

2 that are inclusive of, or expressly for, individuals 

3 with Down syndrome, including novel biomedical and 

4 pharmacological interventions and other therapies 

5 designed to promote or enhance activities of daily 

6 living; 

7 ‘‘(4) the biological mechanisms in individuals 

8 with Down syndrome responsible for structural and 

9 functional anomalies in cells, tissues, and organs, 

10 cognitive and behavioral dysfunction, and stunted 

11 growth; 

12 ‘‘(5) the identification of biomarkers for the de13 tection of risk factors, diagnosis, and customized 

14 interventions and treatments for conditions co-occur15 ring with Down syndrome; 

16 ‘‘(6) why several co-occurring conditions, such 

17 as Alzheimer’s disease and autoimmunity, are preva18 lent in individuals with Down syndrome and how 

19 such conditions can be treated concurrently with 

20 Down syndrome; and 

21 ‘‘(7) improving the quality of life of individuals 

22 with Down syndrome and their families. 

23 ‘‘(c) COORDINATION; PRIORITIZING NONDUPLICA24 TIVE RESEARCH.—The Secretary shall ensure that— 


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1 ‘‘(1) the programs and activities of the insti2 tutes, centers, agencies, and offices of the National 

3 Institutes of Health relating to Down syndrome and 

4 co-occurring conditions are coordinated, including 

5 through the Division of Program Coordination, 

6 Planning, and Strategic Initiatives under sections 

7 402(b)(7) and 402A(c); and 

8 ‘‘(2) such institutes, centers, agencies, and of9 fices prioritize, as appropriate, Down syndrome re10 search that does not duplicate existing research ac11 tivities of the National Institutes of Health. 

12 ‘‘(d) TECHNICAL ASSISTANCE.—The Secretary shall 

13 provide technical assistance to grantees and other involved 

14 entities, as appropriate, for carrying out activities pursu15 ant to this section. 

16 ‘‘(e) BIENNIAL REPORTS TO CONGRESS.— 

17 ‘‘(1) IN GENERAL.—The Secretary shall submit, 

18 on a biennial basis, to the Committee on Energy and 

19 Commerce and the Subcommittee on Labor, Health 

20 and Human Services, Education and Related Agen21 cies of the Committee on Appropriations of the 

22 House of Representatives and the Committee on 

23 Health, Education, Labor, and Pensions and the 

24 Subcommittee on Labor, Health and Human Serv25 ices, Education, and Related Agencies of the ComVerDate Sep 11 2014 18:34 Apr 04, 2024 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S3981.IS S3981

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1 mittee on Appropriations of the Senate, a report 

2 that catalogs the research conducted or supported 

3 under this section. 

4 ‘‘(2) CONTENTS.—Each report under para5 graph (1) shall include— 

6 ‘‘(A) identification of the institute, center, 

7 agency, office, or entity involved; 

8 ‘‘(B) a statement of whether the research 

9 is or was being carried out directly by the insti10 tute, center, agency, office, or entity or by mul11 tiple institutes, centers, agencies, offices, or en12 tities; and 

13 ‘‘(C) identification of any resulting real 

14 world evidence that is or may be used for clin15 ical research and medical care for patients with 

16 Down syndrome. 

17 ‘‘(f) AUTHORIZATION OF APPROPRIATIONS.— 

18 ‘‘(1) IN GENERAL.—To carry out this section, 

19 there is authorized to be appropriated $250,000,000 

20 for each of fiscal years 2025 through 2029. 

21 ‘‘(2) SUPPLEMENT, NOT SUPPLANT.—Funds 

22 appropriated to carry out this section shall be used 

23 to supplement, not supplant, other funds allocated 


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1 by the National Institutes of Health for research 

2 and other activities relating to Down syndrome.’’. 

Æ 


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