[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3502 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 3502

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 31, 2009

  Mr. McDermott (for himself, Mr. Connolly of Virginia, Ms. Wasserman 
 Schultz, Mr. Johnson of Georgia, Mr. Tim Murphy of Pennsylvania, Mr. 
Ellsworth, Ms. Eshoo, Mr. Kirk, Mr. Adler of New Jersey, Mr. McGovern, 
   Mr. Boswell, Mr. Thornberry, Mr. Van Hollen, and Mr. Thompson of 
 California) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Public Health Service Act to establish an Office of 
 Mitochondrial Medicine 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 ``Mitochondrial Medicine 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 the mitochondria fail to produce enough 
        energy, the cell 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 specifically identified 
        mitochondrial diseases, but the vast majority have not yet been 
        identified.
            (3) Mitochondrial diseases are a relatively newly diagnosed 
        group of diseases, first recognized in the late 1960s. 
        Diagnosis is extremely difficult for a number of reasons.
            (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 related disorders, including many common 
        neurological diseases (such as Parkinson's, Alzheimer's, ALS, 
        and autism), and other diseases associated with aging, 
        diabetes, cancer, and obesity.
            (7) Mitochondrial disease is most commonly the result of 
        genetic mutation, either in the nuclear DNA or in the 
        mitochondrial DNA. Some mitochondrial diseases also are 
        attributable to environmental factors, including prescription 
        medications, 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 for 
mitochondrial disease.

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

    (a) Mitochondrial Medicine 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 MEDICINE.

    ``(a) Establishment.--There is established within the Office of the 
Director of NIH an office to be known as the Office of Mitochondrial 
Medicine (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 Medicine Research Plan.--
            ``(1) In general.--The Director shall develop, make 
        publicly available, and implement a written plan to facilitate 
        research into mitochondrial medicine.
            ``(2) Contents.--The plan required under paragraph (1) 
        shall include the following objectives:
                    ``(A) Improving coordination of research related to 
                mitochondrial medicine among the national research 
                institutes and between the National Institutes of 
                Health and outside researchers.
                    ``(B) Providing training to research scientists and 
                health professionals engaged in research related to 
                mitochondrial medicine.
                    ``(C) Providing training to health care providers 
                regarding the diagnosis of mitochondrial disease and 
                dysfunction.
                    ``(D) Establishing scientific review groups with 
                expertise in mitochondrial medicine to oversee relevant 
                research projects in the National Institutes of Health.
            ``(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; 
                and
                    ``(H) 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 
medicine, the Director shall annually award--
            ``(1) at least five grants for integrated, multi-project 
        research programs related to mitochondrial medicine; and
            ``(2) at least five grants for planning activities 
        associated with integrated, multi-project research programs 
        related to mitochondrial medicine.
    ``(d) Centers of Excellence.--
            ``(1) In general.--The Director may award grants to 
        institutions or consortiums of institutions to establish 
        Mitochondrial Medicine Centers of Excellence to promote 
        interdisciplinary research and training related to 
        mitochondrial medicine.
            ``(2) Use of funds awarded.--A grant awarded under 
        paragraph (1) shall be used to--
                    ``(A) conduct basic and clinical research related 
                to mitochondrial medicine;
                    ``(B) facilitate training programs for research 
                scientists and health professionals seeking to engage 
                in research related to mitochondrial medicine;
                    ``(C) develop and disseminate programs and 
                materials to provide continuing education to health 
                care professionals regarding the recognition, 
                diagnosis, and treatment of mitochondrial disease and 
                dysfunction; and
                    ``(D) provide living stipends for research 
                scientists and health professionals enrolled in 
                mitochondrial research training programs.
    ``(e) National Registry; Biorepository.--
            ``(1) National registry.--The Director shall establish a 
        national registry for the maintenance and sharing for research 
        purposes of medical information collected from patients with 
        mitochondrial disease or dysfunction.
            ``(2) Biorepository.--The Director shall establish a 
        national biorepository for the maintenance and sharing for 
        research purposes of tissues and DNA collected from patients 
        with mitochondrial disease or dysfunction.
    ``(f) Definition.--In this section, the term `mitochondrial 
medicine' means medical treatment related to mitochondrial disease or 
dysfunction.''.
    (b) Development of Mitochondrial Medicine Research Plan.--The 
Director of the Office of Mitochondrial Medicine shall develop and make 
publicly available the mitochondrial medicine 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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