[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1362 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 1362

To amend the Public Health Service Act to provide for the establishment 
  of permanent national surveillance systems for multiple sclerosis, 
  Parkinson's disease, and other neurological diseases and disorders.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 5, 2009

Mr. Van Hollen (for himself, Mr. Burgess, Mrs. Maloney, Mr. Upton, Mr. 
  Carnahan, and Mr. King of New York) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Public Health Service Act to provide for the establishment 
  of permanent national surveillance systems for multiple sclerosis, 
  Parkinson's disease, and other neurological diseases and disorders.

    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 ``National MS and Parkinson's Disease 
Registries Act''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Multiple sclerosis (referred to in this section as 
        ``MS'') is a progressive, disabling disease that affects the 
        brain and the spinal cord causing loss of myelin, damage to 
        axons, and cerebral atrophy.
            (2) MS is a prime-of-life disease with an average age of 
        onset at 30 to 35 years of age.
            (3) More than 10,000 individuals in the United States are 
        diagnosed with MS annually, and it is thought that more than 
        400,000 individuals in the United States have MS.
            (4) Parkinson's disease is a chronic, progressive 
        neurological disease. The primary pathologic feature of 
        Parkinson's disease is degeneration and premature death of 
        dopamine-producing brain cells.
            (5) Parkinson's is the second-most common neurodegenerative 
        disease in the United States.
            (6) It is estimated that more than 1,000,000 Americans are 
        currently fighting Parkinson's disease, and 60,000 Americans 
        are newly diagnosed every year.
            (7) Although estimates exist, there is no confirmed data 
        regarding prevalence or diagnosed cases of Parkinson's disease 
        or MS.
            (8) The causes of Parkinson's disease and MS are not well 
        understood.
            (9) There is no known cure for Parkinson's disease or MS.
            (10) Studies have found relationships between both MS and 
        Parkinson's disease and environmental and genetic factors, but 
        those relationships are not well understood.
            (11) Better data are needed to understand the economic 
        impact of Parkinson's disease, MS, and other neurological 
        diseases.
            (12) There are several drugs currently approved by the Food 
        and Drug Administration for the treatment of MS, which have 
        shown modest success in reducing relapses, slowing progression 
        of disability, and limiting the accumulation of brain lesions.
            (13) Currently, state-of-the-art treatment for Parkinson's 
        disease is based on a 40-year-old pharmaceutical therapy, which 
        only treats some of the motor symptoms of Parkinson's disease. 
        Deep brain stimulation surgery is available for certain 
        patients and treats some symptoms of Parkinson's disease.
            (14) No therapies exist that will slow or stop progression 
        of Parkinson's disease. There is no effective, lasting therapy 
        for all features of Parkinson's disease.
            (15) Central nervous system drugs, including therapies for 
        MS, Parkinson's disease, and other neurological diseases, are 
        the slowest in the drug development pipeline, taking an average 
        of 15 years post discovery for new therapies to reach the 
        market.
            (16) Several small and uncoordinated MS and Parkinson's 
        disease registries, surveillance systems, and databases exist 
        in the United States and throughout the world.
            (17) A single national system to collect and store 
        information on the incidence and prevalence of MS, Parkinson's 
        disease, or other neurological diseases in the United States 
        does not exist.
            (18) The Agency for Toxic Substances and Disease Registry 
        (ATSDR) has established a series of small pilot studies, 
        beginning in fiscal year 2006, to evaluate the feasibility of 
        various methodologies to create an MS surveillance system at 
        the national level.
            (19) The national surveillance system methodology resulting 
        from the MS pilot studies should be expanded upon and developed 
        into a national surveillance system for Parkinson's disease.
            (20) The establishment of separate, coordinated national 
        surveillance systems for Parkinson's disease and MS will help--
                    (A) to identify the incidence and prevalence of 
                these diseases in the United States;
                    (B) to collect demographic and other data important 
                to the study of MS and Parkinson's disease;
                    (C) to produce epidemiologically sound data that 
                can be used to compare with cluster information, data 
                sets of the Department of Veterans Affairs, 
                environmental exposure data, and other information;
                    (D) to promote a better understanding of causes, 
                prevention, and treatment of disease;
                    (E) to better understand public and private 
                resource impact;
                    (F) to collect information that is important for 
                research into genetic and environmental risk factors;
                    (G) to enhance biomedical and clinical research by 
                providing a basis for population comparisons;
                    (H) to enhance efforts to develop better diagnosis 
                and progression biomarkers for MS and Parkinson's 
                disease; and
                    (I) to enhance efforts to find treatments and a 
                cure for MS and Parkinson's disease.

SEC. 3. SURVEILLANCE SYSTEMS.

    Part P of title III of the Public Health Service Act (42 U.S.C. 
280g et seq.) is amended--
            (1) by redesignating the second and third sections 399R 
        (added by section 2 of Public Law 110-373 and section 3 of 
        Public Law 110-374) as sections 399S and 399T, respectively; 
        and
            (2) by adding at the end the following:

``SEC. 399U. SURVEILLANCE OF NEUROLOGICAL DISEASES.

    ``(a) Multiple Sclerosis National Surveillance System.--
            ``(1) In general.--Not later than 1 year after receipt of 
        the report described in subsection (c)(3), the Secretary, 
        acting through the Director of the Agency for Toxic Substances 
        and Disease Registry and in consultation with a national 
        voluntary health organization with experience serving the 
        population of individuals with multiple sclerosis (referred to 
        in this section as `MS'), shall--
                    ``(A) develop a system to collect data on MS 
                including information with respect to the incidence and 
                prevalence of the disease in the United States;
                    ``(B) establish a national surveillance system for 
                the collection and storage of such data to include a 
                population-based registry of cases of MS in the United 
                States;
                    ``(C) assist in application of MS national 
                surveillance system methodologies for the development, 
                piloting, and implementation of a national Parkinson's 
                disease national surveillance system under subsection 
                (b); and
                    ``(D) provide analysis regarding expansion of 
                national disease surveillance systems for other 
                neurological diseases and disorders utilizing the MS 
                and Parkinson's disease national surveillance systems' 
                process and structure.
            ``(2) Purpose.--It is the purpose of the registry 
        established under paragraph (1)(B) to gather available data 
        concerning--
                    ``(A) MS, including the incidence and prevalence of 
                MS in the United States;
                    ``(B) the age, race or ethnicity, gender, military 
                service if applicable, and family history of 
                individuals who are diagnosed with the disease; and
                    ``(C) other matters as recommended by the Advisory 
                Committee established pursuant to subsection (c).
    ``(b) Parkinson's Disease National Surveillance System.--
            ``(1) In general.--Not later than 1 year after the receipt 
        of the report described in subsection (c)(3), the Secretary, 
        acting through the Director of the Agency for Toxic Substances 
        and Disease Registry and in consultation with a national 
        voluntary health organization with experience serving the 
        population of individuals with Parkinson's disease, shall--
                    ``(A) develop a system to collect data on 
                Parkinson's disease including information with respect 
                to the incidence and prevalence of the disease in the 
                United States;
                    ``(B) establish a national surveillance system for 
                the collection and storage of such data to include a 
                population-based registry of cases of Parkinson's 
                disease in the United States; and
                    ``(C) provide analysis regarding expansion of 
                national disease surveillance systems for other 
                neurological diseases utilizing the MS and Parkinson's 
                disease national surveillance systems' process and 
                structure.
            ``(2) Purpose.--It is the purpose of the registry 
        established under paragraph (1)(B) to gather available data 
        concerning--
                    ``(A) Parkinson's disease, including the incidence 
                and prevalence of Parkinson's disease in the United 
                States;
                    ``(B) the age, race or ethnicity, gender, military 
                service if applicable, and family history of 
                individuals who are diagnosed with the disease; and
                    ``(C) other matters as recommended by the Advisory 
                Committee established pursuant to subsection (c).
    ``(c) Advisory Committee.--
            ``(1) Establishment.--Not later than 180 days after the 
        date of the enactment of this section, the Secretary, acting 
        through the Director of the Agency for Toxic Substances and 
        Disease Registry, shall establish a committee to be known as 
        the Advisory Committee on Neurological Disease Registries 
        (referred to in this section as the `Advisory Committee'). The 
        Advisory Committee shall be composed of at least one member, to 
        be appointed by the Secretary, acting through the Director of 
        the Agency for Toxic Substances and Disease Registry, 
        representing each of the following:
                    ``(A) National voluntary health associations that 
                focus solely on MS and have demonstrated experience in 
                MS research, care, or patient services.
                    ``(B) National voluntary health associations that 
                focus solely on Parkinson's disease and have 
                demonstrated experience in Parkinson's disease public 
                policy, research, care, or patient services.
                    ``(C) The National Institutes of Health, to 
                include, upon the recommendation of the Director of the 
                National Institutes of Health, representatives from the 
                Office of Portfolio Analysis and Strategic Initiatives, 
                the National Institute of Neurological Disorders and 
                Stroke, the National Institute of Environmental Health 
                Sciences, the National Institute on Aging, and the 
                National Institute of Allergy and Infectious Diseases.
                    ``(D) The Department of Veterans Affairs, to 
                include representatives from the Parkinson's Disease 
                Research Education and Clinical Centers and the MS 
                Centers of Excellence.
                    ``(E) The Department of Defense, to include 
                representatives from the Parkinson's disease and MS 
                research programs.
                    ``(F) The Food and Drug Administration.
                    ``(G) The Centers for Disease Control and 
                Prevention, to include representatives from the Agency 
                for Toxic Substances and Disease Registry.
                    ``(H) Patients with MS and Parkinson's disease or 
                their family members.
                    ``(I) Clinicians with expertise on MS and 
                Parkinson's disease.
                    ``(J) Research scientists with experience 
                conducting translational research or creating systems 
                that support translating basic discoveries into 
                treatments.
                    ``(K) Epidemiologists with experience in data 
                registries.
                    ``(L) Geneticists or experts in genetics who have 
                experience with the genetics of MS and Parkinson's 
                disease.
                    ``(M) Statisticians.
                    ``(N) Bioethicists.
                    ``(O) Attorneys.
                    ``(P) Other individuals, organizations, or agencies 
                with an interest in developing and maintaining the MS 
                and Parkinson's disease national surveillance systems.
                    ``(Q) Experts in additional neurological diseases, 
                as appropriate, based on development and implementation 
                of national surveillance systems for other neurological 
                diseases and disorders.
            ``(2) Duties.--The Advisory Committee shall review 
        information and make recommendations to the Secretary 
        concerning--
                    ``(A) the development and maintenance of the MS and 
                Parkinson's disease national surveillance systems;
                    ``(B) the use and coordination of existing 
                databases that collect or maintain information on 
                neurological diseases and disorders;
                    ``(C) the type of information to be collected and 
                stored in the systems;
                    ``(D) the manner in which such data is to be 
                collected;
                    ``(E) the use and availability of such data 
                including guidelines for such use; and
                    ``(F) the application of MS and Parkinson's disease 
                registry methodologies to benefit other neurological 
                diseases and disorders, including analysis of how other 
                neurological disease surveillance systems or registries 
                can be developed, piloted, and implemented nationally 
                utilizing the MS and Parkinson's disease national 
                surveillance systems' process and structure.
            ``(3) Report.--Not later than 1 year after the date on 
        which the Advisory Committee is established, the Advisory 
        Committee shall submit a report to Congress concerning the 
        review conducted under paragraph (2) that contains the 
        recommendations of the Advisory Committee with respect to the 
        results of such review.
    ``(d) Grants.--Notwithstanding the recommendations of the Advisory 
Committee under subsection (c), the Secretary, acting through the 
Director of the Agency for Toxic Substances and Disease Registry, may 
award grants to, and enter into contracts and cooperative agreements 
with, public or private nonprofit entities for the collection, 
analysis, and reporting of data on MS and Parkinson's disease.
    ``(e) Coordination With State, Local, and Federal Registries.--
            ``(1) In general.--In establishing the MS and Parkinson's 
        disease national surveillance systems under subsections (a) and 
        (b), the Secretary, acting through the Director of the Agency 
        for Toxic Substances and Disease Registry, shall--
                    ``(A) identify, build upon, expand, and coordinate 
                existing data and surveillance systems, surveys, 
                registries, and other Federal public health and 
                environmental infrastructure wherever possible, 
                including--
                            ``(i) the 2 MS surveillance pilot studies 
                        initiated in fiscal year 2006 by the Centers 
                        for Disease Control and Prevention and the 
                        Agency for Toxic Substances and Disease 
                        Registry;
                            ``(ii) the Parkinson's disease and MS 
                        databases of the Department of Veterans 
                        Affairs;
                            ``(iii) current Parkinson's disease 
                        registries and surveillance systems, including 
                        the Nebraska and California State registries;
                            ``(iv) current MS registries, including the 
                        New York State MS Registry and the North 
                        American Research Committee on MS (NARCOMS) 
                        Registry; and
                            ``(v) any other existing or relevant 
                        databases that collect or maintain information 
                        on neurological diseases and disorders 
                        identified by researchers or recommended by the 
                        Advisory Committee pursuant to subsection (c); 
                        and
                    ``(B) provide for and conduct outreach in support 
                of research access to Parkinson's disease and MS data 
                as recommended by the Advisory Committee established 
                pursuant to subsection (c) to the extent permitted by 
                applicable statutes and regulations and in a manner 
                that protects personal privacy consistent with 
                applicable privacy statutes and regulations.
            ``(2) Coordination with other federal agencies.--
        Notwithstanding the recommendations of the Advisory Committee 
        established pursuant to subsection (c), and consistent with 
        applicable privacy statutes and regulations, the Secretary 
        shall ensure that epidemiological and other types of 
        information obtained under subsections (a) and (b) are made 
        available to agencies such as the National Institutes of 
        Health, the Food and Drug Administration, the Department of 
        Veterans Affairs, and the Department of Defense.
    ``(f) Definition.--For the purposes of this section, the term 
`national voluntary health association' means a national nonprofit 
organization with chapters, other affiliated organizations, or networks 
in States throughout the United States.
    ``(g) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $5,000,000 for each of fiscal 
years 2010 through 2014.''.
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