I 
112TH CONGRESS 
1ST SESSION H. R. 2695 
To amend the Public Health Service Act to expand and intensify programs 
of the National Institutes of Health with respect to translational research 
and related activities concerning Down syndrome, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 29, 2011 
Mrs. MCMORRIS RODGERS (for herself, Mr. VAN HOLLEN, and Mr. SESSIONS) 
introduced 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 
with respect to translational research and related activi-
ties 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 Research 
Centers of Excellence Act of 2011’’. 
VerDate Mar 15 2010 
02:53 Jul 30, 2011
Jkt 099200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H2695.IH
H2695
smartinez on DSK6TPTVN1PROD with BILLS
SEC. 2. NIH DOWN SYNDROME RESEARCH 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 
of the title the following: 
‘‘SEC. 409K. DOWN SYNDROME RESEARCH ACTIVITIES. 
‘‘(a) EXPANSION, INTENSIFICATION, AND COORDINA-
TION OF ACTIVITIES.— 
‘‘(1) IN GENERAL.—The Director of NIH, act-
ing through the Director of the Eunice Kennedy 
Shriver National Institute of Child Health and 
Human Development, shall expand and intensify 
programs of the National Institutes of Health with 
respect to research and related activities concerning 
Down syndrome. The Director of NIH shall carry 
out such programs in coordination with a working 
group composed of representatives of the relevant in-
stitutes, centers, offices, and agencies of the Na-
tional Institutes of Health. 
‘‘(2) NIH RESEARCH
PLAN
ON
DOWN
SYN-
DROME.—The Director of NIH shall publish a re-
search plan on Down syndrome, and update it every 
5 years or as appropriate. 
‘‘(b) CENTERS OF EXCELLENCE.— 
‘‘(1) IN GENERAL.—In carrying out subsection 
(a)(1), the Director of NIH shall award grants and 
contracts to public or nonprofit private entities to 
VerDate Mar 15 2010 
02:53 Jul 30, 2011
Jkt 099200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H2695.IH
H2695
smartinez on DSK6TPTVN1PROD with BILLS
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 appropriations made in advance, the Di-
rector of NIH shall provide for the establishment of 
at least 6 such centers of excellence. 
‘‘(2) BASIC, TRANSLATIONAL, AND
CLINICAL 
RESEARCH.—Each center receiving funds under 
paragraph (1) shall contribute to a comprehensive 
research portfolio for Down syndrome building upon 
the recommendations set forth in the NIH Research 
Plan on Down Syndrome published on October 8, 
2007, have a primary focus on Down syndrome, pro-
vide an optimal venue and infrastructure for patient- 
oriented research, and conduct basic, clinical, and 
translational research on Down syndrome, including 
research on one or more of 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. 
VerDate Mar 15 2010 
02:53 Jul 30, 2011
Jkt 099200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H2695.IH
H2695
smartinez on DSK6TPTVN1PROD with BILLS
‘‘(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). 
‘‘(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) Noninvasive imaging in support of ef-
forts regarding other genotype and phenotypes 
of Down syndrome. 
‘‘(J) Pharmacological and other therapies 
for common features of Down syndrome includ-
ing Alzheimer’s disease and other Down syn-
drome-related disorders. 
VerDate Mar 15 2010 
02:53 Jul 30, 2011
Jkt 099200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H2695.IH
H2695
smartinez on DSK6TPTVN1PROD with BILLS
‘‘(K) Research related to improving the 
quality of life for individuals with Down syn-
drome and their families. 
‘‘(L) Research training programs aimed at 
increasing the numbers of scientists who are 
trained to carry out these research directions. 
‘‘(3) SERVICES FOR PATIENTS.— 
‘‘(A) IN
GENERAL.—A center receiving 
funds under paragraph (1) shall expend 
amounts provided under such paragraph to 
carry out a program to make individuals aware 
of opportunities to participate as subjects in re-
search conducted by the centers receiving funds 
under such paragraph. 
‘‘(B) REFERRALS AND COSTS.—A program 
under subparagraph (A) shall, in accordance 
with such criteria as the Director of NIH may 
establish, provide to the subjects described in 
such subparagraph referrals for health and 
other services and such patient care costs as 
are required for research. 
‘‘(C) 
AVAILABILITY
AND
ACCESS.—In 
awarding grants under this section, the Direc-
tor of NIH shall require the applicant to dem-
onstrate, and shall take into consideration, the 
VerDate Mar 15 2010 
02:53 Jul 30, 2011
Jkt 099200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H2695.IH
H2695
smartinez on DSK6TPTVN1PROD with BILLS
availability of and access to health and medical 
services described in subparagraph (B). 
‘‘(4) TRAINING PROGRAM FOR CLINICIANS AND 
SCIENTISTS.—Each center receiving funds under 
paragraph (1) shall establish or expand training pro-
grams for medical and allied health clinicians and 
scientists in research relevant to Down syndrome. 
‘‘(5) COORDINATION OF CENTERS; REPORTS.— 
The Director of NIH shall— 
‘‘(A) provide for the coordination of infor-
mation sharing among the centers receiving 
funds under paragraph (1) and ensure regular 
communication among such centers; and 
‘‘(B) require the centers to submit periodic 
reports to the Director on their activities. 
‘‘(6) ORGANIZATION OF CENTERS.—Each cen-
ter receiving funds under paragraph (1) shall use 
the facilities of a single institution meeting such re-
quirements as may be prescribed by the Director of 
NIH, be formed from a virtual consortium or net-
work of such institutions, or both. 
‘‘(7) DURATION OF SUPPORT.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the Director of NIH may not pro-
vide support to a center receiving funds under 
VerDate Mar 15 2010 
02:53 Jul 30, 2011
Jkt 099200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H2695.IH
H2695
smartinez on DSK6TPTVN1PROD with BILLS
paragraph (1) for a period of more than 5 
years. 
‘‘(B) EXTENSION.—The period referred to 
in subparagraph (A) may be extended for 1 or 
more additional periods not exceeding 5 years 
if— 
‘‘(i) the operations of the center have 
been reviewed by an appropriate technical 
and scientific peer review group established 
by the Director of NIH; and 
‘‘(ii) such group has recommended to 
the Director that such period be extended. 
‘‘(c) DOWN SYNDROME CONSORTIUM.—In carrying 
out subsection (a)(1), the Director of NIH may establish 
a Down Syndrome Consortium to facilitate the exchange 
of information and to make the research effort on Down 
syndrome more efficient and effective by assuring con-
sistent communication, minimizing duplication of effort, 
and integrating the varied perspectives of partner agen-
cies, organizations, and individuals. 
‘‘(d) REPORT TO CONGRESS.—Not later than Janu-
ary 1, 2012, and each January 1 thereafter, the Secretary 
of Health and Human Services shall prepare and submit 
to the appropriate committees of the Congress a report 
concerning the implementation of this section. 
VerDate Mar 15 2010 
02:53 Jul 30, 2011
Jkt 099200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H2695.IH
H2695
smartinez on DSK6TPTVN1PROD with BILLS
‘‘(e) AUTHORIZATION
OF
APPROPRIATIONS.—To 
carry out this section, there are authorized to be appro-
priated $6,000,000 for each of fiscal years 2012 through 
2017.’’. 
Æ 
VerDate Mar 15 2010 
02:53 Jul 30, 2011
Jkt 099200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6301
E:\BILLS\H2695.IH
H2695
smartinez on DSK6TPTVN1PROD with BILLS