[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3656 Introduced in House (IH)]

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.

    Be it enacted by the Senate and House of Representatives 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''.

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 genetic cause of 
        mild to moderate intellectual disabilities (mental retardation) 
        and associated medical problems and occurs in one out of 733 
        live births, in all races and economic groups. Intellectual 
        disability is a disability characterized by significant 
        limitations both in intellectual functioning and in adaptive 
        behavior, which covers many everyday social and practical 
        skills. This disability originates before 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 chromosome 21 and 
        a third hybrid copy of chromosome 21 and another chromosome), 
        mosaic Down syndrome (where some but not all, cells have three 
        copies of chromosome 21), and segmental trisomy Down syndrome 
        (where cells have an extra copy of a part of chromosome 21 
        either added to an otherwise normal 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 syndrome 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 contribute 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 surveillance needs of many disabilities such as autism, 
        traumatic brain injury, Fragile X, juvenile diabetes, asthma, 
        epilepsy, and others. However, this landmark legislation did 
        not address the significant research, surveillance, and 
        clinical care needs of Down syndrome and thus has been an 
        impediment to progress in the Down syndrome research community 
        over the last decade. This Act attempts to incorporate Down 
        syndrome as an area of permissible research 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 Coordination of Activities.--
            ``(1) In general.--The Director of NIH, in coordination 
        with the directors of the National Institute of Child Health 
        and Human Development, the National Heart, Lung, and Blood 
        Institute, the National 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 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 
        concerning Down syndrome.
            ``(2) Coordination.--The directors referred to in paragraph 
        (1) shall jointly coordinate the programs 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 appropriated 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 
        appropriations made in advance, the Director of NIH 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 comprehensive 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 syndrome, provide an optimal 
        venue and infrastructure for patient-oriented research, and 
        conduct basic, clinical, and translational research on Down 
        syndrome, including, but not limited to, research on the 
        following:
                    ``(A) Early detection, diagnosis, and treatment of 
                Down syndrome.
                    ``(B) The biological mechanisms responsible for 
                structural and functional anomalies in cells and 
                tissues affected by Down syndrome.
                    ``(C) The biological mechanisms responsible for 
                cognitive and behavioral dysfunction resulting from 
                Down syndrome.
                    ``(D) Novel biomedical and pharmacological 
                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 disorders.
                    ``(F) Developmental disorders, interventions 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 complex 
                phenotypes.
                    ``(I) Accessibility of health care, evidence-based 
                health practice research and support services, referral 
                patterns, and complications.
                    ``(J) Noninvasive imaging in support of efforts to 
                other genotype and phenotypes of Down syndrome.
                    ``(K) Pharmacological and other therapies for 
                common features of Down syndrome including Alzheimer's 
                disease and other Down syndrome-related disorders.
            ``(3) Services for patients.--
                    ``(A) In general.--A center 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 research 
                conducted by the centers.
                    ``(B) Referrals and costs.--A program under 
                subparagraph (A) shall, in accordance with such 
                criteria as the Director 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 Director of NIH shall require 
                the applicant to demonstrate, and shall take into 
                consideration, the availability of and access to health 
                and medical services described in subparagraph (B).
            ``(4) Training program for clinician and scientists.--Each 
        center under paragraph (1) shall establish or expand training 
        programs 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 information 
                sharing among the centers 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 center under paragraph 
        (1) shall use the facilities of a single institution meeting 
        such requirements as may be prescribed by the Director of NIH, 
        be formed from a consortium or network of such institutions, or 
        both.
            ``(7) Duration of support.--
                    ``(A) In general.--Subject to subparagraph (B), the 
                Director of NIH may not provide support to a center 
                established under 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) Facilitation and Coordination of Research.--The Director of 
NIH shall, in coordination of the National Down Syndrome Patient 
Registry and Biobank established under section 317U, provide for a 
program under subsection (a)(1) under which samples of tissues and 
genetic materials that are of use in research on Down syndrome are 
donated, collected, preserved, and made available for such research. 
The program shall--
            ``(1) be carried out in accordance with accepted scientific 
        and medical standards for the donation, collection, and 
        preservation of such samples; and
            ``(2) be linked with the National Down Syndrome Patient 
        Registry and Biobank established under section 317U to allow 
        for systematic searches of information.
    ``(d) Coordinating Committee.--
            ``(1) In general.--The Secretary shall establish the Down 
        Syndrome Coordinating Committee (referred to in this section as 
        the `Coordinating Committee') to coordinate activities across 
        the National Institutes of Health and with other Federal health 
        programs and activities relating to Down syndrome.
            ``(2) Composition.--The Coordinating Committee shall 
        consist of not more than 15 members, of which--
                    ``(A) \2/3\ of such members shall represent 
                governmental agencies, including--
                            ``(i) the directors or their designees of 
                        each of the national research institutes 
                        involved in research with respect to Down 
                        syndrome;
                            ``(ii) representatives of all other Federal 
                        departments and agencies whose programs involve 
                        health functions or responsibilities relevant 
                        to such diseases, including the Centers for 
                        Disease Control and Prevention, the Health 
                        Resources and Services Administration, and the 
                        Food and Drug Administration; and
                            ``(iii) representatives of other 
                        governmental agencies that serve children and 
                        adults with Down syndrome, such as the 
                        Department of Education, the Department of 
                        Labor, and the Department of Housing and Urban 
                        Development; and
                    ``(B) \1/3\ of such members shall be public 
                members, including a broad cross section of persons 
                with Down syndrome, parents or legal guardians of 
                persons with Down syndrome, researchers, and 
                clinicians.
            ``(3) Appointment; terms.--
                    ``(A) In general.--The Secretary, in consultation 
                with Down syndrome stakeholder organizations, shall 
                appoint the members of the Coordinating Committee.
                    ``(B) Public members.--Members of the Coordinating 
                Committee appointed under paragraph (2)(B) shall be 
                appointed for a term of 3 years, and may serve for an 
                unlimited number of terms if reappointed. At least two 
                such public members shall be persons who are actively 
                engaged in research or clinical practice on Down 
                syndrome. At least one such public member shall be a 
                person with Down syndrome, and an additional, non-
                voting member, whose sole role shall be to support the 
                member with Down syndrome, shall be identified with 
                direct input from the member with Down syndrome.
            ``(4) Chair.--
                    ``(A) Duties.--With respect to Down syndrome, the 
                Chair of the Coordinating Committee shall--
                            ``(i) serve as the principal advisor to the 
                        Secretary, the Assistant Secretary for Health, 
                        and the Director of NIH; and
                            ``(ii) provide advice to the Director of 
                        the Centers for Disease Control and Prevention, 
                        the Commissioner of Food and Drugs, and to the 
                        heads of other relevant agencies.
                    ``(B) Appointment; term.--The Chair of the 
                Coordinating Committee--
                            ``(i) shall be selected by the Coordinating 
                        Committee from among its members; and
                            ``(ii) shall be selected to serve a term 
                        not to exceed 2 years.
            ``(5) Administrative support.--The Secretary of Health and 
        Human Services shall provide, or arrange for an appropriate 
        office or agency of the Department of Health and Human Services 
        to provide, necessary and appropriate administrative support to 
        the Coordinating Committee.
            ``(6) Meetings.--The Coordinating Committee shall meet as 
        appropriate, as determined by the Secretary in consultation 
        with the Chair of the Coordinating Committee.
    ``(e) Plan for HHS Activities.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this section, the Coordinating Committee shall 
        develop a plan for conducting and supporting research and 
        education on Down syndrome through the national research 
        institutes and shall periodically review and revise the plan. 
        The plan shall--
                    ``(A) provide for a broad range of research and 
                education activities relating to biomedical, 
                epidemiological, public perception, psychosocial, and 
                rehabilitative issues, including studies of the impact 
                of such conditions in rural and underserved 
                communities;
                    ``(B) identify priorities among the programs and 
                activities of the National Institutes of Health 
                regarding such conditions; and
                    ``(C) reflect input from a broad range of 
                scientists, patients, and advocacy groups.
            ``(2) Certain elements of plan.--The plan under paragraph 
        (1) shall, with respect to Down syndrome, provide for the 
        following as appropriate:
                    ``(A) Basic research concerning the etiology and 
                genetic contributions to the potential causes and 
                consequences of the chromosomal disorder.
                    ``(B) Basic and clinical research for the 
                development and evaluation of new treatments, including 
                new biological agents.
                    ``(C) Specific programs for identifying potential 
                therapeutic agents and moving them into clinical trials 
                in a timely manner.
                    ``(D) Research to determine the reasons underlying 
                the incidence and prevalence of various forms of Down 
                syndrome.
                    ``(E) Information and education programs for health 
                care professionals and the public.
    ``(f) Reports to Congress.--The Coordinating Committee shall 
biennially submit to the Committee on Energy and Commerce of the House 
of Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report that describes the research, education, 
and other activities on Down syndrome being conducted or supported 
through the Department of Health and Human Services. Each such report 
shall include the following:
            ``(1) The plan under subsection (e)(1) (or revisions to the 
        plan, as the case may be).
            ``(2) Provisions specifying the amounts expended by the 
        Department of Health and Human Services with respect to Down 
        syndrome.
            ``(3) Provisions identifying particular projects or types 
        of projects that should in the future be considered by the 
        national research institutes or other entities in the field of 
        research on Down syndrome.
    ``(g) Public Input.--The Secretary shall, under subsection (a)(1), 
provide for a means through which the public can obtain information on 
the existing and planned programs and activities of the Department of 
Health and Human Services with respect to Down syndrome and through 
which the Secretary can receive comments from the public regarding such 
programs and activities.
    ``(h) Definition.--The term `translational research' means 
rigorous, evidence-based basic or clinical research with an emphasis on 
accelerating the development and delivery of effective new therapies to 
patients.
    ``(i) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each of fiscal years 2011 through 2015. The 
authorization of appropriations established in the preceding sentence 
is in addition to any other authorization of appropriations that is 
available for conducting or supporting through the National Institutes 
of Health research and other activities with respect to Down 
syndrome.''.

SEC. 4. CDC DOWN SYNDROME SURVEILLANCE AND RESEARCH PROGRAMS.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by inserting after section 317T the following:

``SEC. 317U. DOWN SYNDROME SURVEILLANCE AND RESEARCH PROGRAMS.

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, may award grants and 
cooperative agreements to public or nonprofit private entities 
(including State health departments, political subdivisions of States, 
universities, and other educational entities) for the collection, 
analysis, and reporting of data on Down syndrome. In making such 
awards, the Secretary may provide direct technical assistance, 
including personnel support, in lieu of cash.
    ``(b) National Down Syndrome Epidemiology Program.--
            ``(1) Grants.--The Secretary, acting through the Director 
        of the Centers for Disease Control and Prevention, may award 
        grants to public or nonprofit private entities (including State 
        health departments, political subdivisions of States, 
        universities, and other educational entities) for the purpose 
        of carrying out epidemiological activities regarding Down 
        syndrome, including collecting and analyzing information on the 
        number, incidence, correlates, and symptoms of cases and the 
        clinical utility (including costs and benefits) of specific 
        practice patterns. In making such awards, the Secretary may 
        provide direct technical assistance, including personnel 
        support, in lieu of cash.
            ``(2) National surveillance program.--In carrying out 
        subsection (a), the Secretary shall--
                    ``(A) provide for a national surveillance program; 
                and
                    ``(B) where possible, ensure that the surveillance 
                program is coordinated with the data and sample 
                collection activities of the National Down Syndrome 
                Patient Registry and Biobank.
    ``(c) National Down Syndrome Patient Registry and Biobank.--
            ``(1) In general.--The Secretary, acting through the 
        Director of the Centers for Disease Control and Prevention and 
        in collaboration with an eligible national organization and 
        patient advocacy organization, shall establish a National Down 
        Syndrome Patient Registry and Biobank.
            ``(2) Requirements.--The National Down Syndrome Patient 
        Registry and Biobank--
                    ``(A) shall be used, building upon the multi-
                disease bank of brain and other tissue of the National 
                Institute of Child Health and Human Development--
                            ``(i) to establish a centralized or 
                        distributed brain, cell, tissue, DNA, and RNA 
                        bank;
                            ``(ii) to well-characterize a cohort of 
                        patients for genotype-phenotype investigations 
                        to inter-operate with the bank; and
                            ``(iii) to correlate the nature and 
                        severity of cognitive deficits and age of onset 
                        and severity of dementia;
                    ``(B) shall be used as a resource to prepare 
                therapies and treatments for clinical trials of ongoing 
                treatments for individuals with Down syndrome, 
                including the encouragement to include participants 
                with Down syndrome in National Institutes of Health-
                funded clinical trials; and
                    ``(C) shall include the collection and analysis of 
                longitudinal data related to individuals of all ages 
                with Down syndrome, including infants, young children, 
                adolescents, and adults of all ages including older 
                Americans.
    ``(d) Centers of Excellence.--
            ``(1) Cooperative agreements.--In carrying out this 
        section, the Secretary shall enter into cooperative agreements 
        with an eligible national organization, a patient advocacy 
        organization, and appropriate academic health institutions to 
        develop, implement, and manage Down Syndrome Centers of 
        Excellence for the purpose of--
                    ``(A) providing clinical care for patients with 
                Down syndrome;
                    ``(B) coordinating research and clinical activities 
                with the activities of the National Down Syndrome 
                Registry and Biobank; and
                    ``(C) participating in a system for Down syndrome 
                patient data collection and analysis, including the 
                creation and use of a common data entry and management 
                system.
            ``(2) Eligible national organization.--In this subsection, 
        the term `eligible national organization' means a national 
        organization that--
                    ``(A) has expertise in the epidemiology of Down 
                syndrome; and
                    ``(B) has the capacity to maintain a patient 
                registry or Biobank.
    ``(e) Advisory Committee.--
            ``(1) Establishment.--Not later than 90 days after the date 
        of the enactment of this section, the Secretary, acting through 
        the Director of the Centers for Disease Control and Prevention, 
        shall establish a committee to be known as the Advisory 
        Committee on the National Down Syndrome Registry and Biobank 
        (referred to in this section as the `Advisory Committee').
            ``(2) Membership.--The Advisory Committee shall be composed 
        of at least one member, to be appointed by the Secretary, 
        acting through the Director of the Centers for Disease Control 
        and Prevention, representing each of the following:
                    ``(A) National voluntary health associations that 
                focus solely on Down syndrome and have demonstrated 
                experience in Down syndrome research, care, and patient 
                services.
                    ``(B) The National Institutes of Health, to 
                include, upon the recommendation of the Director of the 
                National Institutes of Health, representatives from the 
                Directors of the National Institute of Child Health and 
                Human Development, National Heart, Lung, and Blood 
                Institute, National Institute of Allergy and Infectious 
                Diseases, National Institute of Neurological Disorders 
                and Stroke, National Cancer Institute, National 
                Institute on Aging, and National Institute of Mental 
                Health.
                    ``(C) The Agency for Toxic Substances and Disease 
                Registry.
                    ``(D) The Centers for Disease Control and 
                Prevention.
                    ``(E) Down Syndrome Centers of Excellence developed 
                under subsection (d).
                    ``(F) Individuals with Down syndrome and, for the 
                sole purpose of supporting such individuals, their 
                family members.
                    ``(G) Clinicians with expertise on Down syndrome.
                    ``(H) Epidemiologists with experience in data 
                registries.
                    ``(I) Geneticists or experts in genetics who have 
                experience with the genetics of Down syndrome.
                    ``(J) Statisticians.
                    ``(K) Ethicists.
                    ``(L) Attorneys.
                    ``(M) Researchers with expertise on Down syndrome.
                    ``(N) Research scientists with experience 
                conducting translational research or creating systems 
                that support translating basic discoveries into 
                treatments.
                    ``(O) Experts in additional neurological diseases, 
                as appropriate, based on development and implementation 
                of national surveillance systems for other neurological 
                diseases and disorders.
                    ``(P) Other individuals with an interest in 
                developing and maintaining the National Down Syndrome 
                Registry and Biobank.
        For purposes of this paragraph, the Secretary may appoint a 
        member to represent more than one category described in 
        subparagraphs (A) through (P).
            ``(3) Duties.--The Advisory Committee shall review and make 
        recommendations to the Secretary concerning--
                    ``(A) the establishment, operation, and maintenance 
                of the National Down Syndrome Registry and Biobank;
                    ``(B) the type of information to be collected and 
                stored in the Registry and Biobank;
                    ``(C) the manner in which such data is to be 
                collected; and
                    ``(D) the use and availability of such data 
                including guidelines for such use.
            ``(4) Administrative support.--The Director of the Centers 
        for Disease Control and Prevention shall provide administrative 
        support that is necessary and appropriate, as determined by the 
        Director, to the Advisory Committee.
            ``(5) Meetings.--The Advisory Committee shall meet as 
        appropriate, as determined by the Director of the Centers for 
        Disease Control and Prevention.
            ``(6) Report.--Not later than 2 years after the date on 
        which the Advisory Committee is established, the Advisory 
        Committee shall submit a report concerning the review conducted 
        under paragraph (3) that contains the recommendations of the 
        Advisory Committee with respect to the results of such review.
    ``(f) Coordination With Centers of Excellence.--The Secretary shall 
ensure that epidemiological and registry information under subsections 
(a), (b), (c), and (d) are made available to centers of excellence 
supported under section 409C(b) by the Director of NIH.
    ``(g) Definition.--The term `translational research' means 
rigorous, evidence-based basic or clinical research with an emphasis on 
accelerating the development and delivery of effective new therapies to 
patients.
    ``(h) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $3,000,000 for fiscal year 2010 
and $500,000 for each of fiscal years 2011 through 2015.''.

SEC. 5. REPORT TO CONGRESS.

    Not later than January 1, 2011, and each January 1 thereafter, the 
Secretary of Health and Human Services shall prepare and submit to the 
appropriate committees of Congress a report concerning the 
implementation of this Act and the amendments made by this Act.
                                 <all>