“(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 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 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 $90,000,000 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.”.