42 U.S.C. § 283g — Muscular dystrophy; initiative through

Page 657 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 283g and Commerce of the House of Representatives, and to the Committee on Labor and Human Re- sources of the Senate, the plan required in sub- section (a) and shall begin implementation of the plan. (c) Periodic review and revision The Director of NIH shall periodically review, and as appropriate, make revisions in the plan required under subsection (a). A description of any revision made in the plan shall be included in the first biennial report under section 283 of this title that is submitted after the revision is made. (d) Dissemination of information The Director of NIH shall take such actions as may be appropriate to convey to scientists and others who use animals in biomedical or behav- ioral research or experimentation information respecting the methods found to be valid and re- liable under subsection (a)(2). (e) Interagency Coordinating Committee on the Use of Animals in Research (1) The Director of NIH shall establish within the National Institutes of Health a committee to be known as the Interagency Coordinating Committee on the Use of Animals in Research (in this subsection referred to as the ‘‘Com- mittee’’). (2) The Committee shall provide advice to the Director of NIH on the preparation of the plan required in subsection (a). (3) The Committee shall be composed of— (A) the Directors of each of the national re- search institutes (or the designees of such Di- rectors); and (B) representatives of the Environmental Protection Agency, the Food and Drug Admin- istration, the Consumer Product Safety Com- mission, the National Science Foundation, and such additional agencies as the Director of NIH determines to be appropriate, which rep- resentatives shall include not less than one veterinarian with expertise in laboratory-ani- mal medicine. (July 1, 1944, ch. 373, title IV, § 404C, as added Pub. L. 103–43, title II, § 205(a), June 10, 1993, 107 Stat. 146; amended Pub. L. 112–74, div. F, title II, § 221(d)(2), Dec. 23, 2011, 125 Stat. 1090.) Editorial Notes AMENDMENTS 2011—Subsec. (e)(3)(A). Pub. L. 112–74 struck out ‘‘and the Director of the Center for Research Resources’’ after ‘‘institutes’’. Statutory Notes and Related Subsidiaries CHANGE OF NAME Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999. Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of Pub. L. 104–14, set out as a note preceding section 21 of Title 2, The Congress. Committee on Commerce of House of Representatives changed to Committee on En- ergy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and ex- changes and insurance generally transferred to Com- mittee on Financial Services of House of Representa- tives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001. § 283f. Requirements regarding surveys of sexual behavior With respect to any survey of human sexual behavior proposed to be conducted or supported through the National Institutes of Health, the survey may not be carried out unless— (1) the proposal has undergone review in ac- cordance with any applicable requirements of sections 289 and 289a of this title; and (2) the Secretary, in accordance with section 289a–1 of this title, makes a determination that the information expected to be obtained through the survey will assist— (A) in reducing the incidence of sexually transmitted diseases, the incidence of infec- tion with the human immunodeficiency virus, or the incidence of any other infec- tious disease; or (B) in improving reproductive health or other conditions of health. (July 1, 1944, ch. 373, title IV, § 404D, as added Pub. L. 103–43, title II, § 207, June 10, 1993, 107 Stat. 148.) Statutory Notes and Related Subsidiaries PROHIBITION AGAINST SHARP ADULT SEX SURVEY AND AMERICAN TEENAGE SEX SURVEY Pub. L. 103–43, title XX, § 2015, June 10, 1993, 107 Stat. 217, provided that: ‘‘The Secretary of Health and Human Services may not during fiscal year 1993 or any subsequent fiscal year conduct or support the SHARP survey of adult sexual behavior or the American Teen- age Study of adolescent sexual behavior. This section becomes effective on the date of the enactment of this Act [June 10, 1993].’’ § 283g. Muscular dystrophy; initiative through Director of National Institutes of Health (a) Expansion, intensification, and coordination of activities (1) In general The Director of NIH, in coordination with the Directors of the National Institute of Neu- rological 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 re- search institutes as appropriate, shall expand and intensify programs of such Institutes with respect to research and related activities con- cerning various forms of muscular dystrophy, including Duchenne, Becker, congenital mus- cular dystrophy, limb-girdle muscular dys- trophy, myotonic, facioscapulohumeral mus- cular dystrophy (referred to in this section as ‘‘FSHD’’) and other forms of muscular dys- trophy. (2) Coordination The Directors referred to in paragraph (1) shall jointly coordinate the programs referred to in such paragraph and consult with the Page 658 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 283g 1 See References in Text note below. Muscular Dystrophy Interagency Coordinating Committee established under section 6 of the MD–CARE Act.1 (3) Allocations by Director of NIH The Director of NIH shall allocate the amounts appropriated to carry out this sec- tion for each fiscal year among the national research institutes referred to in paragraph (1). (b) Centers of excellence (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 cen- ters of excellence regarding research on var- ious forms of muscular dystrophy. Such cen- ters of excellence shall be known as the ‘‘Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers’’. (2) Research Each center under paragraph (1) shall sup- plement 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 treat- ment, including the fields of muscle biology, genetics, noninvasive imaging, cardiac and pulmonary function, and pharmacological and other therapies. (3) Coordination of centers The 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 centers Each center under paragraph (1) shall use the facilities of a single institution, or be formed from a consortium of cooperating in- stitutions, meeting such requirements as may be prescribed by the Director of NIH. (5) Duration of support Support for a center established under para- graph (1) may be provided under this section for a period of not to exceed 5 years. Such pe- riod may be extended for 1 or more additional periods not exceeding 5 years if the operations of such center have been reviewed by an appro- priate technical and scientific peer review group established by the Director of NIH and if such group has recommended to the Direc- tor that such period should be extended. (c) Facilitation of research The Director of NIH shall provide for a pro- gram under subsection (a)(1) under which sam- ples of tissues and genetic materials that are of use in research on muscular dystrophy are do- nated, 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 general The Secretary shall establish the Muscular Dystrophy Coordinating Committee (referred to in this section as the ‘‘Coordinating Com- mittee’’) to coordinate activities across the National Institutes and with other Federal health programs and activities relating to the various forms of muscular dystrophy. (2) Composition The Coordinating Committee shall consist of not more than 18 members to be appointed by the Secretary, of which— (A) 2⁄3 of such members shall represent gov- ernmental agencies, including the directors or their designees of each of the national re- search institutes involved in research with respect to muscular dystrophy and rep- resentatives of all other Federal depart- ments 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 Ad- ministration for Community Living and rep- resentatives of other governmental agencies that serve children and adults with muscular dystrophy, including the Department of Edu- cation and the Social Security Administra- tion; and (B) 1⁄3 of such members shall be public members, including a broad cross section of persons affected with muscular dystrophies including parents or legal guardians, af- fected individuals, researchers, and clini- cians. Members appointed under subparagraph (B) shall serve for a term of 3 years, and may serve for an unlimited number of terms if re- appointed. (3) Chair (A) In general With respect to muscular dystrophy, the Chair of the Coordinating Committee shall serve as the principal advisor to the Sec- retary, the Assistant Secretary for Health, and the Director of NIH, and shall provide advice to the Director of the Centers for Dis- ease Control and Prevention, the Commis- sioner 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) Appointment The Chair of the Committee shall be ap- pointed by and be directly responsible to the Secretary. (4) Administrative support; terms of service; other provisions The following shall apply with respect to the Coordinating Committee: (A) The Coordinating Committee shall re- ceive necessary and appropriate administra- tive support from the Department of Health and Human Services. Page 659 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 283g 2 So in original. Probably should be capitalized. (B) The Coordinating Committee shall meet as appropriate as determined by the Secretary, in consultation with the chair,2 but shall meet no fewer than two times per calendar year. (e) Plan for HHS activities (1) In general Not later than 1 year after December 18, 2001, the Coordinating Committee shall de- velop a plan for conducting and supporting re- search and education on muscular dystrophy through the agencies represented on the Co- ordinating Committee pursuant to subsection (d)(2)(A) and shall periodically review and re- vise the plan. The plan shall— (A) provide for a broad range of research and education activities relating to bio- medical, epidemiological, psychosocial, pub- lic services, and rehabilitative issues, in- cluding studies of the impact of such dis- eases in rural and underserved communities, studies to demonstrate the cost-effective- ness of providing independent living re- sources and support to patients with various forms of muscular dystrophy, and studies to determine optimal clinical care interven- tions for adults with various forms of mus- cular 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 sci- entists, patients, and advocacy groups. (2) Certain elements of plan The plan under paragraph (1) shall, with re- spect to each form of muscular dystrophy, pro- vide for the following as appropriate: (A) Research to determine the reasons un- derlying the incidence and prevalence of var- ious forms of muscular dystrophy. (B) Basic research concerning the etiology and genetic links of the disease and poten- tial causes of mutations. (C) The development of improved screening techniques. (D) Basic and clinical research for the de- velopment and evaluation of new treat- ments, 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 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 Depart- ment of Health and Human Services with re- spect to various forms of muscular dystrophy and through which the Secretary can receive comments from the public regarding such pro- grams and activities. (g) Clinical research The Coordinating Committee may evaluate the potential need to enhance the clinical re- search infrastructure required to test emerging therapies for the various forms of muscular dys- trophy by prioritizing the achievement of the goals related to this topic in the plan under sub- section (e)(1). (July 1, 1944, ch. 373, title IV, § 404E, as added Pub. L. 107–84, § 3, Dec. 18, 2001, 115 Stat. 824; amended Pub. L. 109–482, title I, §§ 103(b)(4), 104(b)(1)(A), Jan. 15, 2007, 120 Stat. 3687, 3692; Pub. L. 110–154, § 1(b)(3), Dec. 21, 2007, 121 Stat. 1827; Pub. L. 110–361, § 2, Oct. 8, 2008, 122 Stat. 4010; Pub. L. 113–166, § 2, Sept. 26, 2014, 128 Stat. 1879.) Editorial Notes REFERENCES IN TEXT Section 6 of the MD–CARE Act, referred to in subsec. (a)(2), is section 6 of Pub. L. 107–84, which was formerly set out as a note under section 247b–18 of this title and does not relate to establishment of a coordinating com- mittee. However, subsec. (d) of this section contains provisions relating to the establishment of the Mus- cular Dystrophy Coordinating Committee. PRIOR PROVISIONS A prior section 283g, act July 1, 1944, ch. 373, title IV, § 404E, as added Pub. L. 103–43, title II, § 209, June 10, 1993, 107 Stat. 149, related to Office of Alternative Medi- cine, prior to repeal by Pub. L. 105–277, div. A, § 101(f) [title VI, § 601(1)], Oct. 21, 1998, 112 Stat. 2681–337, 2681–387. AMENDMENTS 2014—Subsec. (a)(1). Pub. L. 113–166, § 2(1), substituted ‘‘Musculoskeletal’’ for ‘‘Muscoskeletal’’ and inserted ‘‘Becker, congenital muscular dystrophy, limb-girdle muscular dystrophy,’’ after ‘‘Duchenne,’’. Subsec. (b)(2). Pub. L. 113–166, § 2(2)(A), substituted ‘‘cardiac and pulmonary function, and pharma- cological’’ for ‘‘genetics, pharmacological’’. Subsec. (b)(3). Pub. L. 113–166, § 2(2)(B), inserted ‘‘and sharing of data’’ after ‘‘regular communication’’. Subsec. (d)(2). Pub. L. 113–166, § 2(3)(A)(i), substituted ‘‘18’’ for ‘‘15’’ in introductory provisions. Subsec. (d)(2)(A). Pub. L. 113–166, § 2(3)(A)(ii), sub- stituted ‘‘, the Food and Drug Administration, and the Administration for Community Living’’ for ‘‘and the Food and Drug Administration’’ and ‘‘including the De- partment of Education and the Social Security Admin- istration’’ for ‘‘such as the Department of Education’’ and inserted ‘‘and adults’’ after ‘‘children’’. Subsec. (d)(4)(B). Pub. L. 113–166, § 2(3)(B), inserted ‘‘, but shall meet no fewer than two times per calendar year’’ before period at end. Subsec. (e)(1). Pub. L. 113–166, § 2(4)(A)(i), substituted ‘‘through the agencies represented on the Coordinating Committee pursuant to subsection (d)(2)(A)’’ for ‘‘through the national research institutes’’ in introduc- tory provisions. Subsec. (e)(1)(A). Pub. L. 113–166, § 2(4)(A)(ii), inserted ‘‘public services,’’ after ‘‘psychosocial,’’ and ‘‘, studies to demonstrate the cost-effectiveness of providing inde- pendent living resources and support to patients with various forms of muscular dystrophy, and studies to de- termine optimal clinical care interventions for adults with various forms of muscular dystrophy’’ after ‘‘in- cluding studies of the impact of such diseases in rural and underserved communities’’. Subsec. (e)(2)(D). Pub. L. 113–166, § 2(4)(B), inserted ‘‘and new clinical interventions to improve the health of those with muscular dystrophy’’ after ‘‘including new biological agents’’. 2008—Subsec. (a)(1). Pub. L. 110–361, § 2(b)(1), inserted ‘‘the National Heart, Lung, and Blood Institute,’’ after ‘‘the Eunice Kennedy Shriver National Institute of Child Health and Human Development,’’. Subsec. (b)(1). Pub. L. 110–361, § 2(b)(2), inserted at end ‘‘Such centers of excellence shall be known as the ‘Paul Page 660 TITLE 42—THE PUBLIC HEALTH AND WELFARE §§ 283h, 283i D. Wellstone Muscular Dystrophy Cooperative Re- search Centers’.’’ Subsec. (f). Pub. L. 110–361, § 2(a), redesignated subsec. (g) as (f) and struck out former subsec. (f) which related to reports. Subsec. (g). Pub. L. 110–361, § 2(a), (b)(3), added subsec. (g) and redesignated former subsec. (g) as (f). 2007—Pub. L. 109–482, § 104(b)(1)(A)(ii), which directed amendment of subsec. (b) by striking subsec. (f) and re- designating subsec. (g) as (f), could not literally be exe- cuted and was not executed in view of amendments by Pub. L. 110–361. See 2008 Amendment notes above. Subsec. (a)(1). Pub. L. 110–154 substituted ‘‘Eunice Kennedy Shriver National Institute of Child Health and Human Development’’ for ‘‘National Institute of Child Health and Human Development’’. Subsec. (b)(3). Pub. L. 109–482, § 104(b)(1)(A)(i), amend- ed heading and text of par. (3) generally. Text read as follows: ‘‘The Director of NIH— ‘‘(A) shall, as appropriate, provide for the coordina- tion of information among centers under paragraph (1) and ensure regular communication between such centers; and ‘‘(B) shall require the periodic preparation of re- ports on the activities of the centers and the submis- sion of the reports to the Director.’’ Subsec. (h). Pub. L. 109–482, § 103(b)(4), struck out heading and text of subsec. (h). Text read as follows: ‘‘For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be nec- essary for each of fiscal years 2002 through 2006. The au- thorization of appropriations established in the pre- ceding sentence is in addition to any other authoriza- tion of appropriations that is available for conducting or supporting through the National Institutes of Health research and other activities with respect to muscular dystrophy.’’ Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2007 AMENDMENT Amendment by Pub. L. 109–482 applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of Pub. L. 109–482, set out as a note under section 281 of this title. §§ 283h, 283i. Transferred Editorial Notes CODIFICATION Section 283h, act July 1, 1944, ch. 373, title IV, § 404F, as added Pub. L. 107–280, § 3, Nov. 6, 2002, 116 Stat. 1989; amended Pub. L. 109–482, title I, §§ 103(b)(5), 104(b)(1)(B), Jan. 15, 2007, 120 Stat. 3687, 3693, which related to the Office of Rare Diseases, was renumbered section 481 of act July 1, 1944, by Pub. L. 112–74, div. F, title II, § 221(c)(2)(A)(i), Dec. 23, 2011, 125 Stat. 1089, and trans- ferred to section 287a–1 of this title. Section 283i, act July 1, 1944, ch. 373, title IV, § 404G, as added Pub. L. 107–280, § 4, Nov. 6, 2002, 116 Stat. 1990; amended Pub. L. 109–482, title I, § 103(b)(6), Jan. 15, 2007, 120 Stat. 3687, which related to rare disease regional centers of excellence, was renumbered section 481A of act July 1, 1944, by Pub. L. 112–74, div. F, title II, § 221(c)(3), Dec. 23, 2011, 125 Stat. 1089, and transferred to section 287a–2 of this title. § 283j. Repealed. Pub. L. 114–255, div. A, title II, § 2042(f)(1), Dec. 13, 2016, 130 Stat. 1073 Section, July 1, 1944, ch. 373, title IV, § 404H, as added Pub. L. 109–416, § 2(b), Dec. 19, 2006, 120 Stat. 2821, re- quired review and report on centers of excellence fund- ed under this subchapter. § 283k. Biomedical and behavioral research fa- cilities (a) Modernization and construction of facilities (1) In general The Director of NIH, acting through the Of- fice of the Director of NIH or the Director of the National Institute of Allergy and Infec- tious Diseases, may make grants or contracts to public and nonprofit private entities to ex- pand, remodel, renovate, or alter existing re- search facilities or construct new research fa- cilities, subject to the provisions of this sec- tion. (2) Construction and cost of construction For purposes of this section, the terms ‘‘con- struction’’ and ‘‘cost of construction’’ include the construction of new buildings and the ex- pansion, renovation, remodeling, and alter- ation of existing buildings, including archi- tects’ fees, but do not include the cost of ac- quisition of land or off-site improvements. (b) Scientific and technical review boards for merit-based review of proposals (1) In general: approval as precondition to grants (A) Establishment There is established a Scientific and Tech- nical Review Board on Biomedical and Be- havioral Research Facilities (referred to in this section as the ‘‘Board’’). (B) Requirement The Director of NIH, acting through the Office of the Director of NIH, may approve an application for a grant under subsection (a) only if the Board has under paragraph (2) recommended the application for approval. (2) Duties (A) Advice The Board shall provide advice to the Di- rector of NIH and the Council of Councils es- tablished under section 282(l) of this title (in this section referred to as the ‘‘Council’’) in carrying out this section. (B) Determination of merit In carrying out subparagraph (A), the Board shall make a determination of the merit of each application submitted for a grant under subsection (a), after consider- ation of the requirements established in sub- section (c), and shall report the results of the determination to the Director of NIH and the Council. Such determinations shall be conducted in a manner consistent with procedures established under section 289a of this title. (C) Amount In carrying out subparagraph (A), the Board shall, in the case of applications rec- ommended for approval, make recommenda- tions to the Director and the Council on the amount that should be provided under the grant. (D) Annual report In carrying out subparagraph (A), the Board shall prepare an annual report for the