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 activities 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) 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 

and the Centers for Disease Control and Prevention 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 

5 Translational Research Parity Act of 2009’’ or the ‘‘21 

6 Act’’. 


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1 SEC. 2. FINDINGS. 

2 The Congress makes the following findings: 

3 (1) Down syndrome was named after John 

4 Langdon Down, the first physician to identify the 

5 syndrome. 

6 (2) Down syndrome is the most frequent ge7 netic cause of mild to moderate intellectual disabil8 ities (mental retardation) and associated medical 

9 problems and occurs in one out of 733 live births, 

10 in all races and economic groups. Intellectual dis11 ability is a disability characterized by significant lim12 itations both in intellectual functioning and in 

13 adaptive behavior, which covers many everyday so14 cial and practical skills. This disability originates be15 fore the age of 18. 

16 (3) Down syndrome is a chromosomal condition 

17 caused by an error in cell or chromosome division 

18 that usually results in the presence of an additional 

19 third chromosome 21 or ‘‘trisomy 21’’. Three other 

20 forms of Down syndrome exist: translocation Down 

21 syndrome (where cells have two copies of chro22 mosome 21 and a third hybrid copy of chromosome 

23 21 and another chromosome), mosaic Down syn24 drome (where some but not all, cells have three cop25 ies of chromosome 21), and segmental trisomy Down 

26 syndrome (where cells have an extra copy of a part 


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1 of chromosome 21 either added to an otherwise nor2 mal 21 or as a hybrid copy of a part of chromosome 

3 21 and another chromosome). 

4 (4) There are more than 400,000 people living 

5 with Down syndrome in the United States. 

6 (5) Down syndrome incidence increases with the 

7 age of the mother, but due to higher fertility rates 

8 in younger women, the majority of children with 

9 Down syndrome are born to women under 35 years 

10 of age. 

11 (6) Life expectancy for people with Down syn12 drome has increased dramatically in recent decades, 

13 but varies significantly across various ethnic groups. 

14 People with Down syndrome attend school, work, 

15 participate in decisions that concern them, and con16 tribute to society in many meaningful ways. 

17 (7) The Children’s Health Act of 2000 (Public 

18 Law 106–310) amended the Public Health Service 

19 Act (42 U.S.C. 201 et seq.) and included a number 

20 of provisions that addressed the research and sur21 veillance needs of many disabilities such as autism, 

22 traumatic brain injury, Fragile X, juvenile diabetes, 

23 asthma, epilepsy, and others. However, this land24 mark legislation did not address the significant re25 search, surveillance, and clinical care needs of Down 


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1 syndrome and thus has been an impediment to 

2 progress in the Down syndrome research community 

3 over the last decade. This Act attempts to incor4 porate Down syndrome as an area of permissible re5 search and surveillance at the National Institutes of 

6 Health and the Centers for Disease Control and 

7 Prevention and will foster a better understanding of 

8 Down syndrome. 

9 SEC. 3. NIH DOWN SYNDROME TRANSLATIONAL RESEARCH 

10 AND SERVICE DEVELOPMENT ACTIVITIES. 

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

12 (42 U.S.C. 284 et seq.) is amended by adding at the end 

13 the following: 

14 ‘‘SEC. 409J. DOWN SYNDROME TRANSLATIONAL RESEARCH 

15 AND SERVICE DEVELOPMENT ACTIVITIES. 

16 ‘‘(a) EXPANSION, INTENSIFICATION, AND COORDINA17 TION OF ACTIVITIES.— 

18 ‘‘(1) IN GENERAL.—The Director of NIH, in 

19 coordination with the directors of the National Insti20 tute of Child Health and Human Development, the 

21 National Heart, Lung, and Blood Institute, the Na22 tional Institute of Allergy and Infectious Diseases, 

23 the National Institute of Neurological Disorders and 

24 Stroke, the National Cancer Institute, the National 

25 Institute on Aging, the National Institute of Mental 


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1 Health, and the other national research institutes as 

2 appropriate, shall expand and intensify programs of 

3 the National Institutes of Health with respect to 

4 translational research and related activities con5 cerning Down syndrome. 

6 ‘‘(2) COORDINATION.—The directors referred to 

7 in paragraph (1) shall jointly coordinate the pro8 grams referred to in such paragraph and consult 

9 with the Down Syndrome Coordinating Committee 

10 established under subsection (d). 

11 ‘‘(3) ALLOCATIONS BY DIRECTOR OF NIH.—The 

12 Director of NIH shall allocate the amounts appro13 priated to carry out this section for each fiscal year 

14 among the national research institutes referred to in 

15 paragraph (1). 

16 ‘‘(b) CENTERS OF EXCELLENCE.— 

17 ‘‘(1) IN GENERAL.—The Director of NIH shall 

18 award grants and contracts under subsection (a)(1) 

19 to public or nonprofit private entities to pay all or 

20 part of the cost of planning, establishing, improving, 

21 and providing basic operating support for centers of 

22 excellence regarding translational research on Down 

23 syndrome. To the extent and in the amount of ap24 propriations made in advance, the Director of NIH 


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1 shall provide for the establishment of at least 6 such 

2 centers of excellence. 

3 ‘‘(2) TRANSLATIONAL RESEARCH.—Each center 

4 under paragraph (1) shall contribute to a com5 prehensive research portfolio for Down syndrome 

6 building upon the recommendations set forth in the 

7 NIH Research Plan on Down Syndrome published in 

8 October 2007, have a primary focus on Down syn9 drome, provide an optimal venue and infrastructure 

10 for patient-oriented research, and conduct basic, 

11 clinical, and translational research on Down syn12 drome, including, but not limited to, research on the 

13 following: 

14 ‘‘(A) Early detection, diagnosis, and treat15 ment of Down syndrome. 

16 ‘‘(B) The biological mechanisms respon17 sible for structural and functional anomalies in 

18 cells and tissues affected by Down syndrome. 

19 ‘‘(C) The biological mechanisms respon20 sible for cognitive and behavioral dysfunction 

21 resulting from Down syndrome. 

22 ‘‘(D) Novel biomedical and pharma23 cological interventions designed to promote or 

24 enhance cognition and related brain functions 

25 and activities of daily living (ADLs). 


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

2 associated medical and neurobehavioral dis3 orders. 

4 ‘‘(F) Developmental disorders, interven5 tions for congenital heart disease, obstructive 

6 sleep apnea, coronary heart disease, obesity, 

7 and metabolism. 

8 ‘‘(G) Contributions of genetic variation to 

9 clinical presentation as targets for therapy. 

10 ‘‘(H) Identification of biomarkers for com11 plex phenotypes. 

12 ‘‘(I) Accessibility of health care, evidence13 based health practice research and support 

14 services, referral patterns, and complications. 

15 ‘‘(J) Noninvasive imaging in support of ef16 forts to other genotype and phenotypes of Down 

17 syndrome. 

18 ‘‘(K) Pharmacological and other therapies 

19 for common features of Down syndrome includ20 ing Alzheimer’s disease and other Down syn21 drome-related disorders. 

22 ‘‘(3) SERVICES FOR PATIENTS.— 

23 ‘‘(A) IN GENERAL.—A center under para24 graph (1) shall expend amounts provided under 

25 such paragraph to carry out a program to make 


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1 individuals aware of opportunities to participate 

2 as subjects in research conducted by the cen3 ters. 

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

5 under subparagraph (A) shall, in accordance 

6 with such criteria as the Director may establish, 

7 provide to the subjects described in such sub8 paragraph referrals for health and other serv9 ices and such patient care costs as are required 

10 for research. 

11 ‘‘(C) AVAILABILITY AND ACCESS.—In 

12 awarding grants under this section, the Direc13 tor of NIH shall require the applicant to dem14 onstrate, and shall take into consideration, the 

15 availability of and access to health and medical 

16 services described in subparagraph (B). 

17 ‘‘(4) TRAINING PROGRAM FOR CLINICIAN AND

18 SCIENTISTS.—Each center under paragraph (1) shall 

19 establish or expand training programs for medical 

20 and allied health clinicians and scientists in research 

21 relevant to Down syndrome. 

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

23 The Director of NIH shall— 

24 ‘‘(A) provide for the coordination of infor25 mation sharing among the centers under paraVerDate Nov 24 2008 02:19 Sep 26, 2009 Jkt 079200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3656.IH H3656

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1 graph (1) and ensure regular communication 

2 among such centers; and 

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

4 reports to the Director on their activities. 

5 ‘‘(6) ORGANIZATION OF CENTERS.—Each cen6 ter under paragraph (1) shall use the facilities of a 

7 single institution meeting such requirements as may 

8 be prescribed by the Director of NIH, be formed 

9 from a consortium or network of such institutions, 

10 or both. 

11 ‘‘(7) DURATION OF SUPPORT.— 

12 ‘‘(A) IN GENERAL.—Subject to subpara13 graph (B), the Director of NIH may not pro14 vide support to a center established under para15 graph (1) for a period of more than 5 years. 

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

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

18 more additional periods not exceeding 5 years 

19 if— 

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

21 been reviewed by an appropriate technical 

22 and scientific peer review group established 

23 by the Director of NIH; and 

24 ‘‘(ii) such group has recommended to 

25 the Director that such period be extended. 


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1 ‘‘(c) FACILITATION AND COORDINATION OF RE2 SEARCH.—The Director of NIH shall, in coordination of 

3 the National Down Syndrome Patient Registry and 

4 Biobank established under section 317U, provide for a 

5 program under subsection (a)(1) under which samples of 

6 tissues and genetic materials that are of use in research 

7 on Down syndrome are donated, collected, preserved, and 

8 made available for such research. The program shall— 

9 ‘‘(1) be carried out in accordance with accepted 

10 scientific and medical standards for the donation, 

11 collection, and preservation of such samples; and 

12 ‘‘(2) be linked with the National Down Syn13 drome Patient Registry and Biobank established 

14 under section 317U to allow for systematic searches 

15 of information. 

16 ‘‘(d) COORDINATING COMMITTEE.— 

17 ‘‘(1) IN GENERAL.—The Secretary shall estab18 lish the Down Syndrome Coordinating Committee 

19 (referred to in this section as the ‘Coordinating 

20 Committee’) to coordinate activities across the Na21 tional Institutes of Health and with other Federal 

22 health programs and activities relating to Down syn23 drome. 


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1 ‘‘(2) COMPOSITION.—The Coordinating Com2 mittee shall consist of not more than 15 members, 

3 of which— 

‘‘(A) 2 4 ⁄3 of such members shall represent 

5 governmental agencies, including— 

6 ‘‘(i) the directors or their designees of 

7 each of the national research institutes in8 volved in research with respect to Down 

9 syndrome; 

10 ‘‘(ii) representatives of all other Fed11 eral departments and agencies whose pro12 grams involve health functions or respon13 sibilities relevant to such diseases, includ14 ing the Centers for Disease Control and 

15 Prevention, the Health Resources and 

16 Services Administration, and the Food and 

17 Drug Administration; and 

18 ‘‘(iii) representatives of other govern19 mental agencies that serve children and 

20 adults with Down syndrome, such as the 

21 Department of Education, the Department 

22 of Labor, and the Department of Housing 

23 and Urban Development; and 

‘‘(B) 1 24 ⁄3 of such members shall be public 

25 members, including a broad cross section of 


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1 persons with Down syndrome, parents or legal 

2 guardians of persons with Down syndrome, re3 searchers, and clinicians. 

4 ‘‘(3) APPOINTMENT; TERMS.— 

5 ‘‘(A) IN GENERAL.—The Secretary, in con6 sultation with Down syndrome stakeholder or7 ganizations, shall appoint the members of the 

8 Coordinating Committee. 

9 ‘‘(B) PUBLIC MEMBERS.—Members of the 

10 Coordinating Committee appointed under para11 graph (2)(B) shall be appointed for a term of 

12 3 years, and may serve for an unlimited num13 ber of terms if reappointed. At least two such 

14 public members shall be persons who are ac15 tively engaged in research or clinical practice on 

16 Down syndrome. At least one such public mem17 ber shall be a person with Down syndrome, and 

18 an additional, non-voting member, whose sole 

19 role shall be to support the member with Down 

20 syndrome, shall be identified with direct input 

21 from the member with Down syndrome. 

22 ‘‘(4) CHAIR.— 

23 ‘‘(A) DUTIES.—With respect to Down syn24 drome, the Chair of the Coordinating Com25 mittee shall— 


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1 ‘‘(i) serve as the principal advisor to 

2 the Secretary, the Assistant Secretary for 

3 Health, and the Director of NIH; and 

4 ‘‘(ii) provide advice to the Director of 

5 the Centers for Disease Control and Pre6 vention, the Commissioner of Food and 

7 Drugs, and to the heads of other relevant 

8 agencies. 

9 ‘‘(B) APPOINTMENT; TERM.—The Chair of 

10 the Coordinating Committee— 

11 ‘‘(i) shall be selected by the Coordi12 nating Committee from among its mem13 bers; and 

14 ‘‘(ii) shall be selected to serve a term 

15 not to exceed 2 years. 

16 ‘‘(5) ADMINISTRATIVE SUPPORT.—The Sec17 retary of Health and Human Services shall provide, 

18 or arrange for an appropriate office or agency of the 

19 Department of Health and Human Services to pro20 vide, necessary and appropriate administrative sup21 port to the Coordinating Committee. 

22 ‘‘(6) MEETINGS.—The Coordinating Committee 

23 shall meet as appropriate, as determined by the Sec24 retary in consultation with the Chair of the Coordi25 nating Committee. 


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1 ‘‘(e) PLAN FOR HHS ACTIVITIES.— 

2 ‘‘(1) IN GENERAL.—Not later than 1 year after 

3 the date of enactment of this section, the Coordi4 nating Committee shall develop a plan for con5 ducting and supporting research and education on 

6 Down syndrome through the national research insti7 tutes and shall periodically review and revise the 

8 plan. The plan shall— 

9 ‘‘(A) provide for a broad range of research 

10 and education activities relating to biomedical, 

11 epidemiological, public perception, psychosocial, 

12 and rehabilitative issues, including studies of 

13 the impact of such conditions in rural and un14 derserved communities; 

15 ‘‘(B) identify priorities among the pro16 grams and activities of the National Institutes 

17 of Health regarding such conditions; and 

18 ‘‘(C) reflect input from a broad range of 

19 scientists, patients, and advocacy groups. 

20 ‘‘(2) CERTAIN ELEMENTS OF PLAN.—The plan 

21 under paragraph (1) shall, with respect to Down 

22 syndrome, provide for the following as appropriate: 

23 ‘‘(A) Basic research concerning the eti24 ology and genetic contributions to the potential 


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1 causes and consequences of the chromosomal 

2 disorder. 

3 ‘‘(B) Basic and clinical research for the de4 velopment and evaluation of new treatments, in5 cluding new biological agents. 

6 ‘‘(C) Specific programs for identifying po7 tential therapeutic agents and moving them into 

8 clinical trials in a timely manner. 

9 ‘‘(D) Research to determine the reasons 

10 underlying the incidence and prevalence of var11 ious forms of Down syndrome. 

12 ‘‘(E) Information and education programs 

13 for health care professionals and the public. 

14 ‘‘(f) REPORTS TO CONGRESS.—The Coordinating 

15 Committee shall biennially submit to the Committee on 

16 Energy and Commerce of the House of Representatives 

17 and the Committee on Health, Education, Labor, and 

18 Pensions of the Senate a report that describes the re19 search, education, and other activities on Down syndrome 

20 being conducted or supported through the Department of 

21 Health and Human Services. Each such report shall in22 clude the following: 

23 ‘‘(1) The plan under subsection (e)(1) (or revi24 sions to the plan, as the case may be). 


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1 ‘‘(2) Provisions specifying the amounts ex2 pended by the Department of Health and Human 

3 Services with respect to Down syndrome. 

4 ‘‘(3) Provisions identifying particular projects 

5 or types of projects that should in the future be con6 sidered by the national research institutes or other 

7 entities in the field of research on Down syndrome. 

8 ‘‘(g) PUBLIC INPUT.—The Secretary shall, under 

9 subsection (a)(1), provide for a means through which the 

10 public can obtain information on the existing and planned 

11 programs and activities of the Department of Health and 

12 Human Services with respect to Down syndrome and 

13 through which the Secretary can receive comments from 

14 the public regarding such programs and activities. 

15 ‘‘(h) DEFINITION.—The term ‘translational research’ 

16 means rigorous, evidence-based basic or clinical research 

17 with an emphasis on accelerating the development and de18 livery of effective new therapies to patients. 

19 ‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—For the 

20 purpose of carrying out this section, there are authorized 

21 to be appropriated such sums as may be necessary for 

22 each of fiscal years 2011 through 2015. The authorization 

23 of appropriations established in the preceding sentence is 

24 in addition to any other authorization of appropriations 

25 that is available for conducting or supporting through the 


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1 National Institutes of Health research and other activities 

2 with respect to Down syndrome.’’. 

3 SEC. 4. CDC DOWN SYNDROME SURVEILLANCE AND RE4 SEARCH PROGRAMS. 

5 Part B of title III of the Public Health Service Act 

6 (42 U.S.C. 243 et seq.) is amended by inserting after sec7 tion 317T the following: 

8 ‘‘SEC. 317U. DOWN SYNDROME SURVEILLANCE AND RE9 SEARCH PROGRAMS. 

10 ‘‘(a) IN GENERAL.—The Secretary, acting through 

11 the Director of the Centers for Disease Control and Pre12 vention, may award grants and cooperative agreements to 

13 public or nonprofit private entities (including State health 

14 departments, political subdivisions of States, universities, 

15 and other educational entities) for the collection, analysis, 

16 and reporting of data on Down syndrome. In making such 

17 awards, the Secretary may provide direct technical assist18 ance, including personnel support, in lieu of cash. 

19 ‘‘(b) NATIONAL DOWN SYNDROME EPIDEMIOLOGY

20 PROGRAM.— 

21 ‘‘(1) GRANTS.—The Secretary, acting through 

22 the Director of the Centers for Disease Control and 

23 Prevention, may award grants to public or nonprofit 

24 private entities (including State health departments, 

25 political subdivisions of States, universities, and 


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1 other educational entities) for the purpose of car2 rying out epidemiological activities regarding Down 

3 syndrome, including collecting and analyzing infor4 mation on the number, incidence, correlates, and 

5 symptoms of cases and the clinical utility (including 

6 costs and benefits) of specific practice patterns. In 

7 making such awards, the Secretary may provide di8 rect technical assistance, including personnel sup9 port, in lieu of cash. 

10 ‘‘(2) NATIONAL SURVEILLANCE PROGRAM.—In 

11 carrying out subsection (a), the Secretary shall— 

12 ‘‘(A) provide for a national surveillance 

13 program; and 

14 ‘‘(B) where possible, ensure that the sur15 veillance program is coordinated with the data 

16 and sample collection activities of the National 

17 Down Syndrome Patient Registry and Biobank. 

18 ‘‘(c) NATIONAL DOWN SYNDROME PATIENT REG19 ISTRY AND BIOBANK.— 

20 ‘‘(1) IN GENERAL.—The Secretary, acting 

21 through the Director of the Centers for Disease 

22 Control and Prevention and in collaboration with an 

23 eligible national organization and patient advocacy 

24 organization, shall establish a National Down Syn25 drome Patient Registry and Biobank. 


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1 ‘‘(2) REQUIREMENTS.—The National Down 

2 Syndrome Patient Registry and Biobank— 

3 ‘‘(A) shall be used, building upon the 

4 multi-disease bank of brain and other tissue of 

5 the National Institute of Child Health and 

6 Human Development— 

7 ‘‘(i) to establish a centralized or dis8 tributed brain, cell, tissue, DNA, and RNA 

9 bank; 

10 ‘‘(ii) to well-characterize a cohort of 

11 patients for genotype-phenotype investiga12 tions to inter-operate with the bank; and 

13 ‘‘(iii) to correlate the nature and se14 verity of cognitive deficits and age of onset 

15 and severity of dementia; 

16 ‘‘(B) shall be used as a resource to prepare 

17 therapies and treatments for clinical trials of 

18 ongoing treatments for individuals with Down 

19 syndrome, including the encouragement to in20 clude participants with Down syndrome in Na21 tional Institutes of Health-funded clinical trials; 

22 and 

23 ‘‘(C) shall include the collection and anal24 ysis of longitudinal data related to individuals 

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1 fants, young children, adolescents, and adults of 

2 all ages including older Americans. 

3 ‘‘(d) CENTERS OF EXCELLENCE.— 

4 ‘‘(1) COOPERATIVE AGREEMENTS.—In carrying 

5 out this section, the Secretary shall enter into coop6 erative agreements with an eligible national organi7 zation, a patient advocacy organization, and appro8 priate academic health institutions to develop, imple9 ment, and manage Down Syndrome Centers of Ex10 cellence for the purpose of— 

11 ‘‘(A) providing clinical care for patients 

12 with Down syndrome; 

13 ‘‘(B) coordinating research and clinical ac14 tivities with the activities of the National Down 

15 Syndrome Registry and Biobank; and 

16 ‘‘(C) participating in a system for Down 

17 syndrome patient data collection and analysis, 

18 including the creation and use of a common 

19 data entry and management system. 

20 ‘‘(2) ELIGIBLE NATIONAL ORGANIZATION.—In 

21 this subsection, the term ‘eligible national organiza22 tion’ means a national organization that— 

23 ‘‘(A) has expertise in the epidemiology of 

24 Down syndrome; and 


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1 ‘‘(B) has the capacity to maintain a pa2 tient registry or Biobank. 

3 ‘‘(e) ADVISORY COMMITTEE.— 

4 ‘‘(1) ESTABLISHMENT.—Not later than 90 days 

5 after the date of the enactment of this section, the 

6 Secretary, acting through the Director of the Cen7 ters for Disease Control and Prevention, shall estab8 lish a committee to be known as the Advisory Com9 mittee on the National Down Syndrome Registry 

10 and Biobank (referred to in this section as the ‘Ad11 visory Committee’). 

12 ‘‘(2) MEMBERSHIP.—The Advisory Committee 

13 shall be composed of at least one member, to be ap14 pointed by the Secretary, acting through the Direc15 tor of the Centers for Disease Control and Preven16 tion, representing each of the following: 

17 ‘‘(A) National voluntary health associa18 tions that focus solely on Down syndrome and 

19 have demonstrated experience in Down syn20 drome research, care, and patient services. 

21 ‘‘(B) The National Institutes of Health, to 

22 include, upon the recommendation of the Direc23 tor of the National Institutes of Health, rep24 resentatives from the Directors of the National 

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1 ment, National Heart, Lung, and Blood Insti2 tute, National Institute of Allergy and Infec3 tious Diseases, National Institute of Neuro4 logical Disorders and Stroke, National Cancer 

5 Institute, National Institute on Aging, and Na6 tional Institute of Mental Health. 

7 ‘‘(C) The Agency for Toxic Substances and 

8 Disease Registry. 

9 ‘‘(D) The Centers for Disease Control and 

10 Prevention. 

11 ‘‘(E) Down Syndrome Centers of Excel12 lence developed under subsection (d). 

13 ‘‘(F) Individuals with Down syndrome and, 

14 for the sole purpose of supporting such individ15 uals, their family members. 

16 ‘‘(G) Clinicians with expertise on Down 

17 syndrome. 

18 ‘‘(H) Epidemiologists with experience in 

19 data registries. 

20 ‘‘(I) Geneticists or experts in genetics who 

21 have experience with the genetics of Down syn22 drome. 

23 ‘‘(J) Statisticians. 

24 ‘‘(K) Ethicists. 

25 ‘‘(L) Attorneys. 


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1 ‘‘(M) Researchers with expertise on Down 

2 syndrome. 

3 ‘‘(N) Research scientists with experience 

4 conducting translational research or creating 

5 systems that support translating basic discov6 eries into treatments. 

7 ‘‘(O) Experts in additional neurological 

8 diseases, as appropriate, based on development 

9 and implementation of national surveillance sys10 tems for other neurological diseases and dis11 orders. 

12 ‘‘(P) Other individuals with an interest in 

13 developing and maintaining the National Down 

14 Syndrome Registry and Biobank. 

15 For purposes of this paragraph, the Secretary may 

16 appoint a member to represent more than one cat17 egory described in subparagraphs (A) through (P). 

18 ‘‘(3) DUTIES.—The Advisory Committee shall 

19 review and make recommendations to the Secretary 

20 concerning— 

21 ‘‘(A) the establishment, operation, and 

22 maintenance of the National Down Syndrome 

23 Registry and Biobank; 

24 ‘‘(B) the type of information to be col25 lected and stored in the Registry and Biobank; 


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1 ‘‘(C) the manner in which such data is to 

2 be collected; and 

3 ‘‘(D) the use and availability of such data 

4 including guidelines for such use. 

5 ‘‘(4) ADMINISTRATIVE SUPPORT.—The Director 

6 of the Centers for Disease Control and Prevention 

7 shall provide administrative support that is nec8 essary and appropriate, as determined by the Direc9 tor, to the Advisory Committee. 

10 ‘‘(5) MEETINGS.—The Advisory Committee 

11 shall meet as appropriate, as determined by the Di12 rector of the Centers for Disease Control and Pre13 vention. 

14 ‘‘(6) REPORT.—Not later than 2 years after the 

15 date on which the Advisory Committee is estab16 lished, the Advisory Committee shall submit a report 

17 concerning the review conducted under paragraph 

18 (3) that contains the recommendations of the Advi19 sory Committee with respect to the results of such 

20 review. 

21 ‘‘(f) COORDINATION WITH CENTERS OF EXCEL22 LENCE.—The Secretary shall ensure that epidemiological 

23 and registry information under subsections (a), (b), (c), 

24 and (d) are made available to centers of excellence sup25 ported under section 409C(b) by the Director of NIH. 


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1 ‘‘(g) DEFINITION.—The term ‘translational research’ 

2 means rigorous, evidence-based basic or clinical research 

3 with an emphasis on accelerating the development and de4 livery of effective new therapies to patients. 

5 ‘‘(h) AUTHORIZATION OF APPROPRIATIONS.—To 

6 carry out this section, there are authorized to be appro7 priated $3,000,000 for fiscal year 2010 and $500,000 for 

8 each of fiscal years 2011 through 2015.’’. 

9 SEC. 5. REPORT TO CONGRESS. 

10 Not later than January 1, 2011, and each January 

11 1 thereafter, the Secretary of Health and Human Services 

12 shall prepare and submit to the appropriate committees 

13 of Congress a report concerning the implementation of 

14 this Act and the amendments made by this Act. 

Æ 


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