S 1762 ISCommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

October 7, 2009CommentsClose CommentsPermalink

Mr. BROWNBACK (for himself and Mr. BROWN) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and PensionsCommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘Trisomy 21 Translational Research Parity Act of 2009’ or the ‘21 Act’.CommentsClose CommentsPermalink

SEC. 2. FINDINGS.

The Congress makes the following findings:CommentsClose CommentsPermalink





(1) Down syndrome was named after John Langdon Down, the first physician to identify the syndrome.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





(4) There are more than 400,000 people living with Down syndrome in the United States.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

‘SEC. 409J. DOWN SYNDROME TRANSLATIONAL RESEARCH AND SERVICE DEVELOPMENT ACTIVITIES.

‘(a) Expansion, Intensification, and Coordination of Activities-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(b) Centers of Excellence-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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:CommentsClose CommentsPermalink





‘(A) Early detection, diagnosis, and treatment of Down syndrome.CommentsClose CommentsPermalink





‘(B) The biological mechanisms responsible for structural and functional anomalies in cells and tissues affected by Down syndrome.CommentsClose CommentsPermalink





‘(C) The biological mechanisms responsible for cognitive and behavioral dysfunction resulting from Down syndrome.CommentsClose CommentsPermalink





‘(D) Novel biomedical and pharmacological interventions designed to promote or enhance cognition and related brain functions and activities of daily living (ADLs).CommentsClose CommentsPermalink





‘(E) Co-occurrence of and treatments for associated medical and neurobehavioral disorders.CommentsClose CommentsPermalink





‘(F) Developmental disorders, interventions for congenital heart disease, obstructive sleep apnea, coronary heart disease, obesity, and metabolism.CommentsClose CommentsPermalink





‘(G) Contributions of genetic variation to clinical presentation as targets for therapy.CommentsClose CommentsPermalink





‘(H) Identification of biomarkers for complex phenotypes.CommentsClose CommentsPermalink





‘(I) Accessibility of health care, evidence-based health practice research and support services, referral patterns, and complications.CommentsClose CommentsPermalink





‘(J) Noninvasive imaging in support of efforts to other genotype and phenotypes of Down syndrome.CommentsClose CommentsPermalink





‘(K) Pharmacological and other therapies for common features of Down syndrome including Alzheimer disease and other Down syndrome related disorders.CommentsClose CommentsPermalink





‘(3) SERVICES FOR PATIENTS-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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).CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(5) COORDINATION OF CENTERS; REPORTS- The Director of NIH shall--CommentsClose CommentsPermalink





‘(A) provide for the coordination of information sharing among the centers under paragraph (1) and ensure regular communication among such centers; andCommentsClose CommentsPermalink





‘(B) require the centers to submit periodic reports to the Director on their activities.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(7) DURATION OF SUPPORT-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) EXTENSION- The period referred to in subparagraph (A) may be extended for 1 or more additional periods not exceeding 5 years if--CommentsClose CommentsPermalink





‘(i) the operations of the center have been reviewed by an appropriate technical and scientific peer review group established by the Director of NIH; andCommentsClose CommentsPermalink





‘(ii) such group has recommended to the Director that such period be extended.CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(1) be carried out in accordance with accepted scientific and medical standards for the donation, collection, and preservation of such samples; andCommentsClose CommentsPermalink





‘(2) be linked with the National Down Syndrome Patient Registry and Biobank established under section 317U to allow for systematic searches of information.CommentsClose CommentsPermalink





‘(d) Coordinating Committee-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(2) COMPOSITION- The Coordinating Committee shall consist of not more than 15 members, of which--CommentsClose CommentsPermalink





‘(A) 2/3 of such members shall represent governmental agencies, including--CommentsClose CommentsPermalink





‘(i) the directors or their designees of each of the national research institutes involved in research with respect to Down syndrome;CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(3) APPOINTMENT; TERMS-CommentsClose CommentsPermalink





‘(A) IN GENERAL- The Secretary, in consultation with Down syndrome stakeholder organizations, shall appoint the members of the Coordinating Committee.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(4) CHAIR-CommentsClose CommentsPermalink





‘(A) DUTIES- With respect to Down syndrome, the Chair of the Coordinating Committee shall--CommentsClose CommentsPermalink





‘(i) serve as the principal advisor to the Secretary, the Assistant Secretary for Health, and the Director of NIH; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(B) APPOINTMENT; TERM- The Chair of the Coordinating Committee--CommentsClose CommentsPermalink





‘(i) shall be selected by the Coordinating Committee from among its members; andCommentsClose CommentsPermalink





‘(ii) shall be selected to serve a term not to exceed 2 years.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(6) MEETINGS- The Coordinating Committee shall meet as appropriate, as determined by the Secretary in consultation with the Chair of the Coordinating Committee.CommentsClose CommentsPermalink





‘(e) Plan for HHS Activities-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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;CommentsClose CommentsPermalink





‘(B) identify priorities among the programs and activities of the National Institutes of Health regarding such conditions; andCommentsClose CommentsPermalink





‘(C) reflect input from a broad range of scientists, patients, and advocacy groups.CommentsClose CommentsPermalink





‘(2) CERTAIN ELEMENTS OF PLAN- The plan under paragraph (1) shall, with respect to Down syndrome, provide for the following as appropriate:CommentsClose CommentsPermalink





‘(A) Basic research concerning the etiology and genetic contributions to the potential causes and consequences of the chromosomal disorder.CommentsClose CommentsPermalink





‘(B) Basic and clinical research for the development and evaluation of new treatments, including new biological agents.CommentsClose CommentsPermalink





‘(C) Specific programs for identifying potential therapeutic agents and moving them into clinical trials in a timely manner.CommentsClose CommentsPermalink





‘(D) Research to determine the reasons underlying the incidence and prevalence of various forms of Down syndrome.CommentsClose CommentsPermalink





‘(E) Information and education programs for health care professionals and the public.CommentsClose CommentsPermalink





‘(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:CommentsClose CommentsPermalink





‘(1) The plan under subsection (e)(1) (or revisions to the plan, as the case may be).CommentsClose CommentsPermalink





‘(2) Provisions specifying the amounts expended by the Department of Health and Human Services with respect to Down syndrome.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink

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:CommentsClose CommentsPermalink

‘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.CommentsClose CommentsPermalink





‘(b) National Down Syndrome Epidemiology Program-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(2) NATIONAL SURVEILLANCE PROGRAM- In carrying out subsection (a), the Secretary shall--CommentsClose CommentsPermalink





‘(A) provide for a national surveillance program; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(c) National Down Syndrome Patient Registry and Biobank-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(2) REQUIREMENTS- The National Down Syndrome Patient Registry and Biobank--CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(i) to establish a centralized or distributed brain, cell, tissue, DNA, and RNA bank;CommentsClose CommentsPermalink





‘(ii) to well-characterize a cohort of patients for genotype-phenotype investigations to inter-operate with the bank; andCommentsClose CommentsPermalink





‘(iii) to correlate the nature and severity of cognitive deficits and age of onset and severity of dementia;CommentsClose CommentsPermalink





‘(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; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(d) Centers of Excellence-CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(A) providing clinical care for patients with Down syndrome;CommentsClose CommentsPermalink





‘(B) coordinating research and clinical activities with the activities of the National Down Syndrome Registry and Biobank; andCommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(2) ELIGIBLE NATIONAL ORGANIZATION- In this subsection, the term ‘eligible national organization’ means a national organization that--CommentsClose CommentsPermalink





‘(A) has expertise in the epidemiology of Down syndrome; andCommentsClose CommentsPermalink





‘(B) has the capacity to maintain a patient registry or Biobank.CommentsClose CommentsPermalink





‘(e) Advisory Committee-CommentsClose CommentsPermalink





‘(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’).CommentsClose CommentsPermalink





‘(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:CommentsClose CommentsPermalink





‘(A) National voluntary health associations that focus solely on Down syndrome and have demonstrated experience in Down syndrome research, care, and patient services.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(C) The Agency for Toxic Substances and Disease Registry.CommentsClose CommentsPermalink





‘(D) The Centers for Disease Control and Prevention.CommentsClose CommentsPermalink





‘(E) Down Syndrome Centers of Excellence developed under subsection (d).CommentsClose CommentsPermalink





‘(F) Individuals with Down syndrome and, for the sole purpose of supporting such individuals, their family members.CommentsClose CommentsPermalink





‘(G) Clinicians with expertise on Down syndrome.CommentsClose CommentsPermalink





‘(H) Epidemiologists with experience in data registries.CommentsClose CommentsPermalink





‘(I) Geneticists or experts in genetics who have experience with the genetics of Down syndrome.CommentsClose CommentsPermalink





‘(J) Statisticians.CommentsClose CommentsPermalink





‘(K) Ethicists.CommentsClose CommentsPermalink





‘(L) Attorneys.CommentsClose CommentsPermalink





‘(M) Researchers with expertise on Down syndrome.CommentsClose CommentsPermalink





‘(N) Research scientists with experience conducting translational research or creating systems that support translating basic discoveries into treatments.CommentsClose CommentsPermalink





‘(O) Experts in additional neurological diseases, as appropriate, based on development and implementation of national surveillance systems for other neurological diseases and disorders.CommentsClose CommentsPermalink





‘(P) Other individuals with an interest in developing and maintaining the National Down Syndrome Registry and Biobank.CommentsClose CommentsPermalink





For purposes of this paragraph, the Secretary may appoint a member to represent more than one category described in subparagraphs (A) through (P).CommentsClose CommentsPermalink





‘(3) DUTIES- The Advisory Committee shall review and make recommendations to the Secretary concerning--CommentsClose CommentsPermalink





‘(A) the establishment, operation, and maintenance of the National Down Syndrome Registry and Biobank;CommentsClose CommentsPermalink





‘(B) the type of information to be collected and stored in the Registry and Biobank;CommentsClose CommentsPermalink





‘(C) the manner in which such data is to be collected; andCommentsClose CommentsPermalink





‘(D) the use and availability of such data including guidelines for such use.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(5) MEETINGS- The Advisory Committee shall meet as appropriate, as determined by the Director of the Centers for Disease Control and Prevention.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink