Muscular dystrophy; initiative through Director of National Institutes of Health

42 U.S.C. § 283g
in effect
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(a) Expansion, intensification, and coordination of activities(1) In generalThe Director of NIH, in coordination with the Directors of the National Institute of Neurological Disorders and Stroke, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Heart, Lung, and Blood Institute, and the other national research institutes as appropriate, shall expand and intensify programs of such Institutes with respect to research and related activities concerning various forms of muscular dystrophy, including Duchenne, Becker, congenital muscular dystrophy, limb-girdle muscular dystrophy, myotonic, facioscapulohumeral muscular dystrophy (referred to in this section as “FSHD”) and other forms of muscular dystrophy. (2) CoordinationThe Directors referred to in paragraph (1) shall jointly coordinate the programs referred to in such paragraph and consult with the Muscular Dystrophy Interagency Coordinating Committee established under section 6 of the MD–CARE Act.11 See References in Text note below. (3) Allocations by Director of NIHThe 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). (b) Centers of excellence(1) In generalThe 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 research on various forms of muscular dystrophy. Such centers of excellence shall be known as the “Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers”. (2) ResearchEach center under paragraph (1) shall supplement but not replace the establishment of a comprehensive research portfolio in all the muscular dystrophies. As a whole, the centers shall conduct basic and clinical research in all forms of muscular dystrophy including early detection, diagnosis, prevention, and treatment, including the fields of muscle biology, genetics, noninvasive imaging, cardiac and pulmonary function, and pharmacological and other therapies. (3) Coordination of centersThe Director of NIH shall, as appropriate, provide for the coordination of information among centers under paragraph (1) and ensure regular communication and sharing of data between such centers. (4) Organization of centersEach center under paragraph (1) shall use the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be prescribed by the Director of NIH. (5) Duration of supportSupport for a center established under paragraph (1) may be provided under this section for a period of not to exceed 5 years. Such period may be extended for 1 or more additional periods not exceeding 5 years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director of NIH and if such group has recommended to the Director that such period should be extended. (c) Facilitation of researchThe Director of NIH shall provide for a program under subsection (a)(1) under which samples of tissues and genetic materials that are of use in research on muscular dystrophy are donated, collected, preserved, and made available for such research. The program shall be carried out in accordance with accepted scientific and medical standards for the donation, collection, and preservation of such samples. (d) Coordinating Committee(1) In generalThe Secretary shall establish the Muscular Dystrophy Coordinating Committee (referred to in this section as the “Coordinating Committee”) to coordinate activities across the National Institutes and with other Federal health programs and activities relating to the various forms of muscular dystrophy. (2) CompositionThe Coordinating Committee shall consist of not more than 18 members to be appointed by the Secretary, of which—(A) ⅔ of such members shall represent governmental agencies, including the directors or their designees of each of the national research institutes involved in research with respect to muscular dystrophy and 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, the Food and Drug Administration, and the Administration for Community Living and representatives of other governmental agencies that serve children and adults with muscular dystrophy, including the Department of Education and the Social Security Administration; and (B) ⅓ of such members shall be public members, including a broad cross section of persons affected with muscular dystrophies including parents or legal guardians, affected individuals, researchers, and clinicians. Members appointed under subparagraph (B) shall serve for a term of 3 years, and may serve for an unlimited number of terms if reappointed. (3) Chair(A) In generalWith respect to muscular dystrophy, the Chair of the Coordinating Committee shall serve as the principal advisor to the Secretary, the Assistant Secretary for Health, and the Director of NIH, and shall 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. The Coordinating Committee shall select the Chair for a term not to exceed 2 years. (B) AppointmentThe Chair of the Committee shall be appointed by and be directly responsible to the Secretary. (4) Administrative support; terms of service; other provisionsThe following shall apply with respect to the Coordinating Committee:(A) The Coordinating Committee shall receive necessary and appropriate administrative support from the Department of Health and Human Services. (B) The Coordinating Committee shall meet as appropriate as determined by the Secretary, in consultation with the chair,22 So in original. Probably should be capitalized. but shall meet no fewer than two times per calendar year. (e) Plan for HHS activities(1) In generalNot later than 1 year after December 18, 2001, the Coordinating Committee shall develop a plan for conducting and supporting research and education on muscular dystrophy through the agencies represented on the Coordinating Committee pursuant to subsection (d)(2)(A) and shall periodically review and revise the plan. The plan shall—(A) provide for a broad range of research and education activities relating to biomedical, epidemiological, psychosocial, public services, and rehabilitative issues, including studies of the impact of such diseases in rural and underserved communities, studies to demonstrate the cost-effectiveness of providing independent living resources and support to patients with various forms of muscular dystrophy, and studies to determine optimal clinical care interventions for adults with various forms of muscular dystrophy; (B) identify priorities among the programs and activities of the National Institutes of Health regarding such diseases; and (C) reflect input from a broad range of scientists, patients, and advocacy groups. (2) Certain elements of planThe plan under paragraph (1) shall, with respect to each form of muscular dystrophy, provide for the following as appropriate:(A) Research to determine the reasons underlying the incidence and prevalence of various forms of muscular dystrophy. (B) Basic research concerning the etiology and genetic links of the disease and potential causes of mutations. (C) The development of improved screening techniques. (D) Basic and clinical research for the development and evaluation of new treatments, including new biological agents and new clinical interventions to improve the health of those with muscular dystrophy. (E) Information and education programs for health care professionals and the public. (f) Public inputThe 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 various forms of muscular dystrophy and through which the Secretary can receive comments from the public regarding such programs and activities. (g) Clinical researchThe Coordinating Committee may evaluate the potential need to enhance the clinical research infrastructure required to test emerging therapies for the various forms of muscular dystrophy by prioritizing the achievement of the goals related to this topic in the plan under subsection (e)(1).

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