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.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Trisomy 21 Research Resource Act of 
2011''.

SEC. 2. FINDINGS.

    The Congress makes the following findings:
            (1) The father of modern genetics, Dr. Jerome Lejeune, 
        discovered the extra chromosome 21 responsible for the 
        condition, known as Down syndrome, which he called Trisomy 21 
        in January 1959. His discovery has opened the doors of genetics 
        to new generations of researchers.
            (2) Down syndrome was named after Dr. John Langdon Down, 
        the first physician to describe the syndrome.
            (3) Down syndrome is the most frequent genetic cause of 
        intellectual and developmental disabilities and associated 
        medical problems and occurs in one out of 691 live births, in 
        all races and economic groups. Intellectual disability, 
        formerly mental retardation, 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 birth and 
        lasts a lifetime.
            (4) Chromosomes are cell structures that hold our genes. 
        Genes are the instructions that cells give that determine 
        things such as eye color, blood type, and susceptibility to 
        disease. Human cells normally contain 23 pairs of chromosomes, 
        one pair from the mother and one pair from the father.
            (5) Down syndrome occurs when, because of cell division 
        error, there are 3 partial or total copies of chromosome 21 
        rather than the normal 2. Because of the extra copy of 
        chromosome 21, people with Down syndrome are more susceptible 
        to diseases including Alzheimer's disease, leukemia, congenital 
        heart disease, seizures, and diabetes. However, people with 
        Down syndrome may be protected from other common diseases 
        including atherosclerosis, hypertension, and solid tumors such 
        as brain, gastrointestinal, and breast tumors. Therefore, the 
        study of Down syndrome may lead to novel treatments of common 
        diseases that affect millions of Americans. Lead researcher, 
        Dr. Bill Mobely is quoted as saying ``We're not just asking 
        what our country can do for people with Down syndrome, we're 
        asking what studies of people can do for our country and the 
        world.''.
            (6) There are more than 400,000 people living with Down 
        syndrome in the United States.
            (7) 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.
            (8) 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.
            (9) 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 syndrome, 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 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 the following:

``SEC. 409K. DOWN SYNDROME RESEARCH ACTIVITIES.

    ``(a) Expansion, Intensification, and Coordination of Activities.--
            ``(1) In general.--The Director of NIH, acting 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 institutes, centers, offices, and agencies of the 
        National Institutes of Health.
            ``(2) NIH research plan on down syndrome.--The Director of 
        NIH shall publish a Research Plan on Down Syndrome, and update 
        it every five years or as appropriate.
    ``(b) Activities.--In expanding and intensifying programs under 
subsection (a)(1):
            ``(1) Basic, translational, and clinical research.--
        Building on the comprehensive research plan set forth by the 
        NIH Research Plan for Down Syndrome published in October 2007, 
        the Director of NIH may conduct basic, clinical, and 
        translational research on Down syndrome, including 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) Noninvasive imaging in support of efforts to 
                identify other genotypes and phenotypes of Down 
                syndrome.
                    ``(J) Pharmacological and other therapies for 
                common features of Down syndrome including Alzheimer's 
                disease and other Down syndrome-related disorders.
                    ``(K) Research related to improving the quality of 
                life for individuals with Down syndrome and their 
                families.
                    ``(L) Research training programs aimed at 
                increasing the number of scientists who are trained to 
                carry out these research directions.
            ``(2) Facilitation of research resources.--
                    ``(A) Contact registry for individuals with down 
                syndrome.--
                            ``(i) In general.--The Director of NIH may 
                        award a grant or contract to an eligible entity 
                        for the purpose of--
                                    ``(I) identifying individuals with 
                                Down syndrome across the Nation;
                                    ``(II) collecting the names and 
                                contact information of such 
                                individuals; and
                                    ``(III) maintaining such names and 
                                contact information in a registry.
                            ``(ii) Consent required.--As a condition on 
                        the receipt of a grant or contract under this 
                        subparagraph, an entity shall agree that 
                        information about any individual will be 
                        collected or maintained pursuant to this 
                        subparagraph only if the individual has 
                        consented to such collection and maintenance.
                            ``(iii) Eligible entity defined.--In this 
                        subparagraph, the term `eligible entity' means 
                        a consortium including at least one national 
                        Down syndrome patient advocacy organization.
                    ``(B) Research database for down syndrome.--
                            ``(i) In general.--The Director of NIH may 
                        establish a database including the names, 
                        contact information, and each medical condition 
                        of individuals with Down syndrome.
                            ``(ii) Requirements.--The database under 
                        clause (i) shall--
                                    ``(I) be searchable by category of 
                                medical condition; and
                                    ``(II) be used exclusively to 
                                facilitate research.
                            ``(iii) Consent required.--The Director of 
                        NIH may include information about an individual 
                        in the Research Database for Down Syndrome only 
                        with the individual's consent.
                    ``(C) Biobank for down syndrome.--
                            ``(i) In general.--The Director of NIH may 
                        expand one or more tissue banks maintained or 
                        supported by the National Institutes of 
                        Health--
                                    ``(I) to identify any tissue 
                                harvested from a tissue donor with Down 
                                syndrome;
                                    ``(II) to include each medical 
                                condition of any such tissue donor; and
                                    ``(III) to allow searches specific 
                                to tissue identified under subclause 
                                (I) and by category of medical 
                                condition included under subclause 
                                (II).
                            ``(ii) Consent required.--The Director of 
                        NIH may collect and maintain information about 
                        an individual pursuant to this subparagraph 
                        only with the individual's consent.
                    ``(D) Research resources.--In carrying out this 
                paragraph, the Director of NIH may--
                            ``(i) subject to the consent requirements 
                        of subparagraphs (A)(ii), (B)(iii), and 
                        (C)(ii), use information collected by the 
                        National Institutes of Health pursuant to other 
                        provisions of law or prior to the date of the 
                        enactment of this section;
                            ``(ii) take into consideration the 
                        availability of other research resources;
                            ``(iii) encourage the use of research 
                        resources for research on, and development of, 
                        therapies and treatments for individuals with 
                        Down syndrome; and
                            ``(iv) encourage the inclusion of 
                        individuals with Down syndrome in clinical 
                        trials conducted or supported by the National 
                        Institutes of Health.
            ``(3) Down syndrome consortium.--The Director of NIH may 
        provide for the participation of agencies of the National 
        Institutes of Health in a consortium to facilitate the exchange 
        of information and to make the research effort on Down syndrome 
        more efficient and effective by ensuring consistent 
        communication, minimizing duplication of effort, and 
        integrating the varied perspectives of partner agencies, 
        organizations, and individuals. Such consortium shall include 
        at least one national Down syndrome patient advocacy 
        organization and may be the same consortium receiving a grant 
        or contract under paragraph (2)(A).''.

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 Institutes of 
                Health under section 409K.''.

SEC. 5. REPORT TO CONGRESS.

    Not later than January 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 Act and the amendments made by this Act.

Summary: Trisomy 21 Research Resource Act of 2011 - Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH), acting through the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, to expand and intensify NIH programs with respect to research and related activities concerning Down syndrome. Requires the Director of NIH to publish a research plan on Down syndrome and update it every five years or as appropriate.

Authorizes the Director of NIH to: (1) conduct basic, clinical, and translational research on Down syndrome; (2) award a grant or contract for a registry of individuals with Down syndrome; (3) establish a database including the names, contact information, and each medical condition of individuals with Down syndrome; and (4) expand one or more tissue banks maintained or supported by NIH to identify any tissue harvested from a tissue donor with Down syndrome. Requires consent before including an individual's information in the registry, the database, or the tissue bank.

Authorizes the Director of NIH to provide for the participation of NIH agencies in a consortium to facilitate the exchange of information and to make the research effort on Down syndrome more efficient and effective by ensuring consistent communication, minimizing duplication of effort, and integrating the varied perspectives of partner agencies, organizations, and individuals.

Authorizes the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to: (1) award grants and cooperative agreements for the collection, analysis, and reporting of data on Down syndrome; and (2) carry out epidemiological activities regarding Down syndrome.