[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 2858 Introduced in Senate (IS)]

111th CONGRESS
  1st Session
                                S. 2858

   To amend the Public Health Service Act to establish an Office of 
  Mitochondrial Disease at the National Institutes of Health, and for 
                            other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            December 9, 2009

    Mrs. Boxer (for herself, Mr. Durbin, Mr. Kerry, and Mr. Casey) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To amend the Public Health Service Act to establish an Office of 
  Mitochondrial Disease at the National Institutes of Health, 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 ``Brittany Wilkinson Mitochondrial 
Disease Research and Treatment Enhancement Act''.

SEC. 2. FINDINGS AND PURPOSE.

    (a) Findings.--Congress finds the following:
            (1) Mitochondrial disease results when there is a defect 
        that reduces the ability of the mitochondria in a cell to 
        produce energy. As mitochondria fail to produce enough energy, 
        the cells will cease to function properly and will eventually 
        die. Organ systems will begin to fail, and the life of the 
        individual is compromised or ended.
            (2) There are more than 40 mitochondrial diseases.
            (3) Mitochondrial diseases are a relatively newly diagnosed 
        group of diseases, first recognized in the late 1960s. 
        Diagnosis of these diseases is extremely difficult.
            (4) Mitochondrial diseases can present themselves at any 
        age, with associated mortality rates that vary depending upon 
        the particular disease. The most severe diseases result in 
        progressive loss of neurological and liver function, and death 
        within several years.
            (5) According to the National Institute of Environmental 
        Health Sciences, half of those affected by mitochondrial 
        disease are children, who show symptoms before age five and 
        approximately 80 percent of whom will not survive beyond the 
        age of 20.
            (6) Mitochondrial dysfunction is also associated with 
        numerous other disorders, including many neurological diseases 
        (such as Parkinson's, Alzheimer's, ALS, and autism), and other 
        diseases associated with aging, diabetes, and cancer.
            (7) Mitochondrial diseases are most commonly the result of 
        genetic mutation, either in the nuclear DNA or in the 
        mitochondrial DNA. Some mitochondrial diseases have been 
        attributable to environmental factors that interfere with 
        mitochondrial function.
            (8) Researchers estimate that one in 4,000 children will 
        develop a mitochondrial disease related to an inherited 
        mutation by the age of 10 years, and that 1,000-2,000 children 
        are born each year in the United States who will develop 
        mitochondrial disease in their lifetimes. However, studies of 
        umbilical cord blood samples show that one in 200 children are 
        born with both normal and mutant mitochondrial DNA, and the 
        number of children with these mutations who actually develop a 
        disease is unknown.
            (9) There are no cures for any of the specifically 
        identified mitochondrial diseases, nor is there a specific 
        treatment for any of these diseases.
            (10) Improving our basic understanding of mitochondrial 
        function and dysfunction has potential application to numerous 
        areas of biomedical research. The National Institutes of Health 
        has taken an increased interest in mitochondrial disease and 
        dysfunction and has sponsored a number of activities in recent 
        years aimed at advancing mitochondrial medicine, including 
        incorporating research into functional variation in 
        mitochondria in the Transformative Research Grants Initiative.
    (b) Purpose.--It is the purpose of this Act to promote an enhanced 
research effort aimed at improved understanding of mitochondrial 
disease and dysfunction and the development of treatments and cures for 
mitochondrial disease.

SEC. 3. ENHANCEMENT OF RESEARCH AND TREATMENT ACTIVITIES RELATED TO 
              MITOCHONDRIAL DISEASE.

    (a) Mitochondrial Disease Research Enhancement.--Part A of title IV 
of the Public Health Service Act (42 U.S.C. 281 et seq.) is amended--
            (1) by redesignating section 404H as section 404I; and
            (2) inserting after section 404G the following new section:

``SEC. 404H. OFFICE OF MITOCHONDRIAL DISEASE.

    ``(a) Establishment.--There is established within the Office of the 
Director of NIH at the Division of Program Coordination, Planning and 
Strategic Initiatives, an office to be known as the Office of 
Mitochondrial Disease (in this section referred to as the `Office'), 
which shall be headed by a Director (in this section referred to as the 
`Director'), appointed by the Director of NIH.
    ``(b) Mitochondrial Disease Research Plan.--
            ``(1) In general.--The Director shall develop, make 
        publicly available, and implement a written plan to facilitate 
        and coordinate research into mitochondrial disease.
            ``(2) Contents.--The plan required under paragraph (1) 
        shall include the following objectives:
                    ``(A) Improving coordination of research related to 
                mitochondrial disease among the national research 
                institutes and between the National Institutes of 
                Health and outside researchers.
                    ``(B) Providing training to research scientists and 
                clinical researchers engaged in research related to 
                mitochondrial disease.
                    ``(C) Conducting programs to provide information 
                and continuing education to health care providers 
                regarding the diagnosis of mitochondrial disease.
                    ``(D) Ensuring relevant scientific review groups 
                contain individuals with expertise in mitochondrial 
                disease.
            ``(3) Consultation.--In developing the plan under paragraph 
        (1), the Director shall consult with--
                    ``(A) the Director of the National Cancer 
                Institute;
                    ``(B) the Director of the National Institute of 
                Child Health and Human Development;
                    ``(C) the Director of the National Institute of 
                Environmental Health Sciences;
                    ``(D) the Director of the National Heart, Lung, and 
                Blood Institute;
                    ``(E) the Director of the National Institute of 
                Neurological Disorders and Stroke;
                    ``(F) the Director of the National Institute of 
                Diabetes and Digestive and Kidney Diseases;
                    ``(G) the Director of the National Eye Institute;
                    ``(H) the Director of the National Institute of 
                Mental Health;
                    ``(I) the Director of the National Institute of 
                Arthritis and Muscoloskeletal and Skin Diseases;
                    ``(J) the Director of the National Human Genome 
                Research Institute; and
                    ``(K) the heads of such other institutes and 
                offices as the Director considers appropriate.
            ``(4) Updates.--The Director shall update the plan required 
        under paragraph (1) on a biennial basis.
    ``(c) Research Grants.--In addition to any grants otherwise awarded 
by the National Institutes of Health for research in mitochondrial 
disease, the Director may award competitive, peer-reviewed grants--
            ``(1) for integrated, multi-project research programs 
        related to mitochondrial disease; and
            ``(2) for planning activities associated with integrated, 
        multi-project research programs related to mitochondrial 
        disease.
    ``(d) Centers of Excellence.--
            ``(1) In general.--The Director may award grants to 
        institutions or consortiums of institutions to establish 
        Mitochondrial Disease Centers of Excellence to promote 
        interdisciplinary research and training related to 
        mitochondrial disease.
            ``(2) Use of funds awarded.--A grant awarded under 
        paragraph (1) may be used to--
                    ``(A) conduct basic and clinical research related 
                to mitochondrial disease;
                    ``(B) facilitate training programs for research 
                scientists and health professionals seeking to engage 
                in research related to mitochondrial disease; and
                    ``(C) develop and disseminate programs and 
                materials to provide continuing education to health 
                care professionals regarding the recognition, 
                diagnosis, and treatment of mitochondrial disease.
    ``(e) National Registry; Biorepository.--
            ``(1) National registry.--The Director of the Centers for 
        Disease Control and Prevention shall establish a national 
        registry for the maintenance and sharing for research purposes 
        of medical information collected from patients with 
        mitochondrial disease.
            ``(2) Biorepository.--The Director of the Centers for 
        Disease Control and Prevention shall establish a national 
        biorepository for the maintenance and sharing for research 
        purposes of tissues and DNA collected from patients with 
        mitochondrial disease.
    ``(f) Definition.--In this section, the term `mitochondrial 
disease' means mitochondrial diseases, mutations, dysfunctions and 
functions.
    ``(g) Authorization of Appropriations.--There is authorized to be 
appropriated, such sums as may be necessary to carry out this 
section.''.
    (b) Development of Mitochondrial Disease Research Plan.--The 
Director of the Office of Mitochondrial Disease shall develop and make 
publicly available the mitochondrial disease research plan required 
under section 404H(b)(1) of the Public Health Service Act, as added by 
subsection (a) of this section, not later than 180 days after the date 
of the enactment of this Act.
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