DeOndra Dixon INCLUDE Project Act of 2025

119 HR 3491 IH: DeOndra Dixon INCLUDE Project Act of 2025 U.S. House of Representatives 2025-05-19 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. I 119th CONGRESS 1st Session H. R. 3491 IN THE HOUSE OF REPRESENTATIVES May 19, 2025 Ms. DeGette (for herself, Mr. Hudson , Ms. DeLauro , Mr. Cole , Ms. Norton , and Mr. Stauber ) introduced the following bill; which was referred to the Committee on Energy and Commerce 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. Short title This Act may be cited as the DeOndra Dixon INCLUDE Project Act of 2025 . 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: 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 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. .