[House Report 118-504]
[From the U.S. Government Publishing Office]


118th Congress }                                          { Report 
                        HOUSE OF REPRESENTATIVES
  2d Session   }                                          { 118-504

======================================================================
 
               DEONDRA DIXON INCLUDE PROJECT ACT OF 2024

                                _______
                                

  May 14, 2024.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

Mrs. Rodgers of Washington, from the Committee on Energy and Commerce, 
                        submitted the following

                              R E P O R T

                        [To accompany H.R. 7406]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 7406) 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, having considered the 
same, reports favorably thereon with an amendment and 
recommends that the bill as amended do pass.

                                CONTENTS

                                                                   Page
Purpose and Summary..............................................     3
Background and Need for Legislation..............................     3
Committee Action.................................................     3
Committee Votes..................................................     4
Oversight Findings and Recommendations...........................     6
New Budget Authority, Entitlement Authority, and Tax Expenditures     6
Congressional Budget Office Estimate.............................     6
Federal Mandates Statement.......................................     6
Statement of General Performance Goals and Objectives............     6
Duplication of Federal Programs..................................     6
Related Committee and Subcommittee Hearings......................     6
Committee Cost Estimate..........................................     7
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     7
Advisory Committee Statement.....................................     7
Applicability to Legislative Branch..............................     7
Section-by-Section Analysis of the Legislation...................     7
Changes in Existing Law Made by the Bill, as Reported............     7

    The amendment is as follows:
    Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``DeOndra Dixon INCLUDE Project Act of 
2024''.

SEC. 2. 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 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.''.

                          Purpose and Summary

    H.R. 7406 reauthorizes the INCLUDE (Investigation of Co-
occurring conditions across the Lifespan to Understand Down 
syndromE) Project at the National Institutes of Health (NIH), 
which is currently funded to promote the scientific 
understanding of Down syndrome and co-occurring conditions and 
improve the quality of life of individuals with Down syndrome 
and their families. This bill would also require reporting to 
Congress on the program's progress and related research. The 
legislation reauthorizes the program for five fiscal years from 
2025 to 2029.

                  Background and Need for Legislation

    People with Down syndrome have an increased risk of some 
medical conditions, such as congenital cardiac issues, 
autoimmune conditions, and early onset Alzheimer's-type 
dementia.\1\ Over the past 50 years, average life expectancy 
for people with Down syndrome has increased by 25 years to the 
current average age of 60 years.\2\ If an adult with Down 
syndrome develops Alzheimer's disease, the onset will often 
happen by the age of 40.\3\ Alzheimer's disease is the leading 
cause of death for people with Down syndrome.\4\ Further 
research would help improve the quality of life for people with 
Down syndrome, as well as other individuals who may be facing 
the same medical issues.
---------------------------------------------------------------------------
    \1\ GLOBAL Down Syndrome Foundation, ``GLOBAL Medical Care 
Guidelines for Adults with Down Syndrome'', 2023. https://
www.globaldownsyndrome.org/wp-content/uploads/2020/10/Global -Down-
Syndrome-Foundation-Medical-Care-Guidelines-for-Adults-with-Down-
Syndrome-v.1-10-20-2020.pdf.
    \2\ Id.
    \3\ Fortea, et al., ``Down syndrome-associated Alzheimer's disease: 
a genetic form of dementia'', Lancet Neurol, 2022. https://
www.ncbi.nlm.nih.gov/pmc/articles/PMC9387748/#::text=Adults%20 
with%20Down%20syndrome%20develop%20the%20neuropathological%20hallmarks,o
f%20therapi 
es%20to%20prevent%20or%20delay%20Alzheimer%E2%80%99s%20disease.
    \4\ Id.
---------------------------------------------------------------------------

                            Committee Action

    On February 14, 2024, the Subcommittee on Health held a 
hearing on H.R. 7406. The title of the hearing was 
``Legislative Proposals to Support Patients and Caregivers.'' 
The Subcommittee received testimony from:
           Andy Shih, PhD, Chief Science Officer, 
        Autism Speaks;
           Corey Feist, JD, MBA, Co-Founder and CEO, 
        Dr. Lorna Breen Heroes' Foundation;
           Joanne Pike, DrPH, President and CEO, 
        Alzheimer's Association;
           Gordon Tomaselli, MD, Former President, 
        American Heart Association; Marilyn and Stanley Katz 
        Dean, Emeritus and Professor of Medicine, Albert 
        Einstein College of Medicine; Adjunct Professor of 
        Medicine, Johns Hopkins University School of Medicine;
           Michelle Whitten, President, CEO, and Co-
        Founder, Global Down Syndrome Foundation;
           Randy Strozyk, President, American Ambulance 
        Association; and,
           Christina Annunziata, MD, PhD, Senior Vice 
        President of Extramural Discovery Science, American 
        Cancer Society.
    On March 12, 2024, the Subcommittee on Health met in open 
markup session and forwarded H.R. 7406, as amended, to the full 
Committee by a voice vote.
    On March 20, 2024, the full Committee on Energy and 
Commerce met in open markup session and ordered H.R. 7406, as 
amended, favorably reported to the House by a record vote of 46 
yeas and 0 nays.

                            Committee Votes

    Clause 3(b) of rule XIII requires the Committee to list the 
record votes on the motion to report legislation and amendments 
thereto. The following reflects the record votes taken during 
the Committee consideration:


                 Oversight Findings and Recommendations

    Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of 
rule XIII, the Committee held a hearing and made findings that 
are reflected in this report.

              New Budget Authority, Entitlement Authority,
                          and Tax Expenditures

    Pursuant to clause 3(c)(2) of rule XIII, the Committee 
finds that H.R. 7406 would result in no new or increased budget 
authority, entitlement authority, or tax expenditures or 
revenues.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII, at the time this 
report was filed, the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974 was not available.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

         Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(4) of rule XIII, the general 
performance goal or objective of this legislation is to 
establish a research program focused on investigating 
comorbidities of Down syndrome, with the goal of utilizing 
research findings to improve the quality of life for people 
with Down syndrome.

                    Duplication of Federal Programs

    Pursuant to clause 3(c)(5) of rule XIII, no provision of 
H.R. 7406 is known to be duplicative of another Federal 
program, including any program that was included in a report to 
Congress pursuant to section 21 of Public Law 111-139 or the 
most recent Catalog of Federal Domestic Assistance.

              Related Committee and Subcommittee Hearings

    Pursuant to clause 3(c)(6) of rule XIII, the following 
related hearing was used to develop or consider H.R. 7406:
           On February 14, 2024, the Subcommittee on 
        Health held a hearing on H.R. 7406. The title of the 
        hearing was ``Legislative Proposals to Support Patients 
        and Caregivers.'' The Subcommittee received testimony 
        from:
                  Andy Shih, PhD, Chief Science 
                Officer, Autism Speaks;
                  Corey Feist, JD, MBA, Co-Founder 
                and CEO, Dr. Lorna Breen Heroes' Foundation;
                  Joanne Pike, DrPH, President and 
                CEO, Alzheimer's Association;
                  Gordon Tomaselli, MD, Former 
                President, American Heart Association; Marilyn 
                and Stanley Katz Dean, Emeritus and Professor 
                of Medicine, Albert Einstein College of 
                Medicine; Adjunct Professor of Medicine, Johns 
                Hopkins University School of Medicine;
                  Michelle Whitten, President, CEO, 
                and Co-Founder, Global Down Syndrome 
                Foundation;
                  Randy Strozyk, President, 
                American Ambulance Association; and,
                  Christina Annunziata, MD, PhD, 
                Senior Vice President of Extramural Discovery 
                Science, American Cancer Society.

                        Committee Cost Estimate

    Pursuant to clause 3(d)(1) of rule XIII, the Committee 
adopts as its own the cost estimate prepared by the Director of 
the Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974. At the time this report was 
filed, the estimate was not available.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the 
Committee finds that H.R. 7406 contains no earmarks, limited 
tax benefits, or limited tariff benefits.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 provides that the Act may be cited as the 
``DeOndra Dixon INCLUDE Project Act of 2024''.

Section 2. Down syndrome research

    Section 2 directs the Secretary of the Department of Health 
and Human Services, acting through the Director of the National 
Institutes of Health to establish and oversee the 
implementation of a research program focused on Down syndrome. 
This section also specifies certain topics that should be 
investigated within the research program, as well as implements 
Congressional reporting requirements.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (new matter is 
printed in italics and existing law in which no change is 
proposed is shown in roman):

                       PUBLIC HEALTH SERVICE ACT




           *       *       *       *       *       *       *
                 TITLE IV--NATIONAL RESEARCH INSTITUTES


Part A--National Institutes of Health

           *       *       *       *       *       *       *



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 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.

           *       *       *       *       *       *       *


                                  [all]