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 Energy 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 activities concerning Down syndrome, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Trisomy 21 Research 

5 Centers of Excellence Act of 2011’’. 


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1 SEC. 2. NIH DOWN SYNDROME RESEARCH ACTIVITIES. 

2 Part B of title IV of the Public Health Service Act 

3 (42 U.S.C. 284 et seq.) is amended by adding at the end 

4 of the title the following: 

5 ‘‘SEC. 409K. DOWN SYNDROME RESEARCH ACTIVITIES. 

6 ‘‘(a) EXPANSION, INTENSIFICATION, AND COORDINA7 TION OF ACTIVITIES.— 

8 ‘‘(1) IN GENERAL.—The Director of NIH, act9 ing through the Director of the Eunice Kennedy 

10 Shriver National Institute of Child Health and 

11 Human Development, shall expand and intensify 

12 programs of the National Institutes of Health with 

13 respect to research and related activities concerning 

14 Down syndrome. The Director of NIH shall carry 

15 out such programs in coordination with a working 

16 group composed of representatives of the relevant in17 stitutes, centers, offices, and agencies of the Na18 tional Institutes of Health. 

19 ‘‘(2) NIH RESEARCH PLAN ON DOWN SYN20 DROME.—The Director of NIH shall publish a re21 search plan on Down syndrome, and update it every 

22 5 years or as appropriate. 

23 ‘‘(b) CENTERS OF EXCELLENCE.— 

24 ‘‘(1) IN GENERAL.—In carrying out subsection 

25 (a)(1), the Director of NIH shall award grants and 

26 contracts to public or nonprofit private entities to 


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1 pay all or part of the cost of planning, establishing, 

2 improving, and providing basic operating support for 

3 centers of excellence regarding translational research 

4 on Down syndrome. To the extent and in the 

5 amount of appropriations made in advance, the Di6 rector of NIH shall provide for the establishment of 

7 at least 6 such centers of excellence. 

8 ‘‘(2) BASIC, TRANSLATIONAL, AND CLINICAL

9 RESEARCH.—Each center receiving funds under 

10 paragraph (1) shall contribute to a comprehensive 

11 research portfolio for Down syndrome building upon 

12 the recommendations set forth in the NIH Research 

13 Plan on Down Syndrome published on October 8, 

14 2007, have a primary focus on Down syndrome, pro15 vide an optimal venue and infrastructure for patient16 oriented research, and conduct basic, clinical, and 

17 translational research on Down syndrome, including 

18 research on one or more of the following: 

19 ‘‘(A) Early detection, diagnosis, and treat20 ment of Down syndrome. 

21 ‘‘(B) The biological mechanisms respon22 sible for structural and functional anomalies in 

23 cells and tissues affected by Down syndrome. 


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1 ‘‘(C) The biological mechanisms respon2 sible for cognitive and behavioral dysfunction 

3 resulting from Down syndrome. 

4 ‘‘(D) Novel biomedical and pharma5 cological interventions designed to promote or 

6 enhance cognition and related brain functions 

7 and activities of daily living (ADLs). 

8 ‘‘(E) Co-occurrence of and treatments for 

9 associated medical and neurobehavioral dis10 orders. 

11 ‘‘(F) Developmental disorders, interven12 tions for congenital heart disease, obstructive 

13 sleep apnea, coronary heart disease, obesity, 

14 and metabolism. 

15 ‘‘(G) Contributions of genetic variation to 

16 clinical presentation as targets for therapy. 

17 ‘‘(H) Identification of biomarkers for com18 plex phenotypes. 

19 ‘‘(I) Noninvasive imaging in support of ef20 forts regarding other genotype and phenotypes 

21 of Down syndrome. 

22 ‘‘(J) Pharmacological and other therapies 

23 for common features of Down syndrome includ24 ing Alzheimer’s disease and other Down syn25 drome-related disorders. 


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1 ‘‘(K) Research related to improving the 

2 quality of life for individuals with Down syn3 drome and their families. 

4 ‘‘(L) Research training programs aimed at 

5 increasing the numbers of scientists who are 

6 trained to carry out these research directions. 

7 ‘‘(3) SERVICES FOR PATIENTS.— 

8 ‘‘(A) IN GENERAL.—A center receiving 

9 funds under paragraph (1) shall expend 

10 amounts provided under such paragraph to 

11 carry out a program to make individuals aware 

12 of opportunities to participate as subjects in re13 search conducted by the centers receiving funds 

14 under such paragraph. 

15 ‘‘(B) REFERRALS AND COSTS.—A program 

16 under subparagraph (A) shall, in accordance 

17 with such criteria as the Director of NIH may 

18 establish, provide to the subjects described in 

19 such subparagraph referrals for health and 

20 other services and such patient care costs as 

21 are required for research. 

22 ‘‘(C) AVAILABILITY AND ACCESS.—In 

23 awarding grants under this section, the Direc24 tor of NIH shall require the applicant to dem25 onstrate, and shall take into consideration, the 


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1 availability of and access to health and medical 

2 services described in subparagraph (B). 

3 ‘‘(4) TRAINING PROGRAM FOR CLINICIANS AND

4 SCIENTISTS.—Each center receiving funds under 

5 paragraph (1) shall establish or expand training pro6 grams for medical and allied health clinicians and 

7 scientists in research relevant to Down syndrome. 

8 ‘‘(5) COORDINATION OF CENTERS; REPORTS.— 

9 The Director of NIH shall— 

10 ‘‘(A) provide for the coordination of infor11 mation sharing among the centers receiving 

12 funds under paragraph (1) and ensure regular 

13 communication among such centers; and 

14 ‘‘(B) require the centers to submit periodic 

15 reports to the Director on their activities. 

16 ‘‘(6) ORGANIZATION OF CENTERS.—Each cen17 ter receiving funds under paragraph (1) shall use 

18 the facilities of a single institution meeting such re19 quirements as may be prescribed by the Director of 

20 NIH, be formed from a virtual consortium or net21 work of such institutions, or both. 

22 ‘‘(7) DURATION OF SUPPORT.— 

23 ‘‘(A) IN GENERAL.—Subject to subpara24 graph (B), the Director of NIH may not pro25 vide support to a center receiving funds under 


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1 paragraph (1) for a period of more than 5 

2 years. 

3 ‘‘(B) EXTENSION.—The period referred to 

4 in subparagraph (A) may be extended for 1 or 

5 more additional periods not exceeding 5 years 

6 if— 

7 ‘‘(i) the operations of the center have 

8 been reviewed by an appropriate technical 

9 and scientific peer review group established 

10 by the Director of NIH; and 

11 ‘‘(ii) such group has recommended to 

12 the Director that such period be extended. 

13 ‘‘(c) DOWN SYNDROME CONSORTIUM.—In carrying 

14 out subsection (a)(1), the Director of NIH may establish 

15 a Down Syndrome Consortium to facilitate the exchange 

16 of information and to make the research effort on Down 

17 syndrome more efficient and effective by assuring con18 sistent communication, minimizing duplication of effort, 

19 and integrating the varied perspectives of partner agen20 cies, organizations, and individuals. 

21 ‘‘(d) REPORT TO CONGRESS.—Not later than Janu22 ary 1, 2012, and each January 1 thereafter, the Secretary 

23 of Health and Human Services shall prepare and submit 

24 to the appropriate committees of the Congress a report 

25 concerning the implementation of this section. 


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1 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—To 

2 carry out this section, there are authorized to be appro3 priated $6,000,000 for each of fiscal years 2012 through 

4 2017.’’. 

Æ 


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