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.