I 
111TH CONGRESS 
1ST SESSION H. R. 3656 
To amend the Public Health Service Act to expand and intensify programs 
of the National Institutes of Health and the Centers for Disease Control 
and Prevention with respect to translational research and related activi-
ties concerning Down syndrome, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 25, 2009 
Mrs. MCMORRIS RODGERS (for herself, Mr. KENNEDY, and Mr. SESSIONS) in-
troduced the following bill; which was referred to the Committee on En-
ergy and Commerce 
A BILL 
To amend the Public Health Service Act to expand and 
intensify programs of the National Institutes of Health 
and the Centers for Disease Control and Prevention with 
respect to translational research and related activities 
concerning Down syndrome, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Trisomy 21 
Translational Research Parity Act of 2009’’ or the ‘‘21 
Act’’. 
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SEC. 2. FINDINGS. 
The Congress makes the following findings: 
(1) Down syndrome was named after John 
Langdon Down, the first physician to identify the 
syndrome. 
(2) Down syndrome is the most frequent ge-
netic cause of mild to moderate intellectual disabil-
ities (mental retardation) and associated medical 
problems and occurs in one out of 733 live births, 
in all races and economic groups. Intellectual dis-
ability is a disability characterized by significant lim-
itations both in intellectual functioning and in 
adaptive behavior, which covers many everyday so-
cial and practical skills. This disability originates be-
fore the age of 18. 
(3) Down syndrome is a chromosomal condition 
caused by an error in cell or chromosome division 
that usually results in the presence of an additional 
third chromosome 21 or ‘‘trisomy 21’’. Three other 
forms of Down syndrome exist: translocation Down 
syndrome (where cells have two copies of chro-
mosome 21 and a third hybrid copy of chromosome 
21 and another chromosome), mosaic Down syn-
drome (where some but not all, cells have three cop-
ies of chromosome 21), and segmental trisomy Down 
syndrome (where cells have an extra copy of a part 
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of chromosome 21 either added to an otherwise nor-
mal 21 or as a hybrid copy of a part of chromosome 
21 and another chromosome). 
(4) There are more than 400,000 people living 
with Down syndrome in the United States. 
(5) Down syndrome incidence increases with the 
age of the mother, but due to higher fertility rates 
in younger women, the majority of children with 
Down syndrome are born to women under 35 years 
of age. 
(6) Life expectancy for people with Down syn-
drome has increased dramatically in recent decades, 
but varies significantly across various ethnic groups. 
People with Down syndrome attend school, work, 
participate in decisions that concern them, and con-
tribute to society in many meaningful ways. 
(7) The Children’s Health Act of 2000 (Public 
Law 106–310) amended the Public Health Service 
Act (42 U.S.C. 201 et seq.) and included a number 
of provisions that addressed the research and sur-
veillance needs of many disabilities such as autism, 
traumatic brain injury, Fragile X, juvenile diabetes, 
asthma, epilepsy, and others. However, this land-
mark legislation did not address the significant re-
search, surveillance, and clinical care needs of Down 
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syndrome and thus has been an impediment to 
progress in the Down syndrome research community 
over the last decade. This Act attempts to incor-
porate Down syndrome as an area of permissible re-
search and surveillance at the National Institutes of 
Health and the Centers for Disease Control and 
Prevention and will foster a better understanding of 
Down syndrome. 
SEC. 3. NIH DOWN SYNDROME TRANSLATIONAL RESEARCH 
AND SERVICE DEVELOPMENT ACTIVITIES. 
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: 
‘‘SEC. 409J. DOWN SYNDROME TRANSLATIONAL RESEARCH 
AND SERVICE DEVELOPMENT ACTIVITIES. 
‘‘(a) EXPANSION, INTENSIFICATION, AND COORDINA-
TION OF ACTIVITIES.— 
‘‘(1) IN GENERAL.—The Director of NIH, in 
coordination with the directors of the National Insti-
tute of Child Health and Human Development, the 
National Heart, Lung, and Blood Institute, the Na-
tional Institute of Allergy and Infectious Diseases, 
the National Institute of Neurological Disorders and 
Stroke, the National Cancer Institute, the National 
Institute on Aging, the National Institute of Mental 
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Health, and the other national research institutes as 
appropriate, shall expand and intensify programs of 
the National Institutes of Health with respect to 
translational research and related activities con-
cerning Down syndrome. 
‘‘(2) COORDINATION.—The directors referred to 
in paragraph (1) shall jointly coordinate the pro-
grams referred to in such paragraph and consult 
with the Down Syndrome Coordinating Committee 
established under subsection (d). 
‘‘(3) ALLOCATIONS BY DIRECTOR OF NIH.—The 
Director of NIH shall allocate the amounts appro-
priated to carry out this section for each fiscal year 
among the national research institutes referred to in 
paragraph (1). 
‘‘(b) CENTERS OF EXCELLENCE.— 
‘‘(1) IN GENERAL.—The Director of NIH shall 
award grants and contracts under subsection (a)(1) 
to public or nonprofit private entities to pay all or 
part of the cost of planning, establishing, improving, 
and providing basic operating support for centers of 
excellence regarding translational research on Down 
syndrome. To the extent and in the amount of ap-
propriations made in advance, the Director of NIH 
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shall provide for the establishment of at least 6 such 
centers of excellence. 
‘‘(2) TRANSLATIONAL RESEARCH.—Each center 
under paragraph (1) shall contribute to a com-
prehensive research portfolio for Down syndrome 
building upon the recommendations set forth in the 
NIH Research Plan on Down Syndrome published in 
October 2007, have a primary focus on Down syn-
drome, provide an optimal venue and infrastructure 
for patient-oriented research, and conduct basic, 
clinical, and translational research on Down syn-
drome, including, but not limited to, research on the 
following: 
‘‘(A) Early detection, diagnosis, and treat-
ment of Down syndrome. 
‘‘(B) The biological mechanisms respon-
sible for structural and functional anomalies in 
cells and tissues affected by Down syndrome. 
‘‘(C) The biological mechanisms respon-
sible for cognitive and behavioral dysfunction 
resulting from Down syndrome. 
‘‘(D) 
Novel 
biomedical 
and 
pharma-
cological interventions designed to promote or 
enhance cognition and related brain functions 
and activities of daily living (ADLs). 
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‘‘(E) Co-occurrence of and treatments for 
associated medical and neurobehavioral dis-
orders. 
‘‘(F) Developmental disorders, interven-
tions for congenital heart disease, obstructive 
sleep apnea, coronary heart disease, obesity, 
and metabolism. 
‘‘(G) Contributions of genetic variation to 
clinical presentation as targets for therapy. 
‘‘(H) Identification of biomarkers for com-
plex phenotypes. 
‘‘(I) Accessibility of health care, evidence- 
based health practice research and support 
services, referral patterns, and complications. 
‘‘(J) Noninvasive imaging in support of ef-
forts to other genotype and phenotypes of Down 
syndrome. 
‘‘(K) Pharmacological and other therapies 
for common features of Down syndrome includ-
ing Alzheimer’s disease and other Down syn-
drome-related disorders. 
‘‘(3) SERVICES FOR PATIENTS.— 
‘‘(A) IN GENERAL.—A center under para-
graph (1) shall expend amounts provided under 
such paragraph to carry out a program to make 
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