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42 U.S.C. § 281 — Organization of National Institutes of

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42 U.S.C. § 281 — Organization of National Institutes of

Page 627 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 281 (C) Open meetings The meetings under subparagraphs (A) and (B) shall be open to the public. (4) Annual report Not later than 18 months after July 2, 2024, and every year thereafter, the Advisory Coun- cil shall provide to the Secretary and Congress a report containing— (A) a list of all federally-funded efforts in Parkinson’s research, prevention, diagnosis, treatment, clinical care, and institutional-, home-, and community-based programs and the outcomes of such efforts; (B) recommendations for priority actions to expand, eliminate, coordinate, refocus, streamline, or condense Federal programs based on each program’s performance, mis- sion, scope, and purpose; (C) recommendations to— (i) reduce the financial impact of Parkin- son’s on families living with Parkinson’s; (ii) improve health outcomes for, and the quality of life of, individuals living with Parkinson’s; (iii) prevent Parkinson’s, ameliorate symptoms, and slow or stop progression; (iv) improve the quality of care provided to beneficiaries with Parkinson’s who re- ceive coverage through a federally-funded health care program, such as the Medicare program under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] or the Medicaid program under title XIX of such Act [42 U.S.C. 1396 et seq.]; (v) research the association between en- vironmental triggers and Parkinson’s to help reduce exposure to potential triggers; and (vi) research and better understand the underlying factors contributing to Parkin- son’s; (D) priority actions to improve all feder- ally-funded efforts in Parkinson’s research, prevention, diagnosis, treatment, clinical care, and institutional-, home-, and commu- nity-based programs; (E) an evalu

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Page 627 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 281 (C) Open meetings The meetings under subparagraphs (A) and (B) shall be open to the public. (4) Annual report Not later than 18 months after July 2, 2024, and every year thereafter, the Advisory Coun- cil shall provide to the Secretary and Congress a report containing— (A) a list of all federally-funded efforts in Parkinson’s research, prevention, diagnosis, treatment, clinical care, and institutional-, home-, and community-based programs and the outcomes of such efforts; (B) recommendations for priority actions to expand, eliminate, coordinate, refocus, streamline, or condense Federal programs based on each program’s performance, mis- sion, scope, and purpose; (C) recommendations to— (i) reduce the financial impact of Parkin- son’s on families living with Parkinson’s; (ii) improve health outcomes for, and the quality of life of, individuals living with Parkinson’s; (iii) prevent Parkinson’s, ameliorate symptoms, and slow or stop progression; (iv) improve the quality of care provided to beneficiaries with Parkinson’s who re- ceive coverage through a federally-funded health care program, such as the Medicare program under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.] or the Medicaid program under title XIX of such Act [42 U.S.C. 1396 et seq.]; (v) research the association between en- vironmental triggers and Parkinson’s to help reduce exposure to potential triggers; and (vi) research and better understand the underlying factors contributing to Parkin- son’s; (D) priority actions to improve all feder- ally-funded efforts in Parkinson’s research, prevention, diagnosis, treatment, clinical care, and institutional-, home-, and commu- nity-based programs; (E) an evaluation of the implementation, including outcomes, of the national plan under subsection (c)(1); and (F) implementation steps to address the recommendations and priority actions under subparagraphs (B), (C), and (D), based in part on the evaluation under subparagraph (E). (5) Termination The Advisory Council shall terminate at the end of calendar year 2035. (f) Information sharing Each Federal department and agency that has information relating to Parkinson’s shall share such information with the Secretary consistent with the statutory obligations of such depart- ment or agency regarding disclosure of informa- tion, as necessary to enable the Secretary to complete a report under subsection (e)(4). (g) Sunset The section shall cease to be effective at the end of calendar year 2035. (July 1, 1944, ch. 373, title III, § 399OO, as added Pub. L. 118–66, § 2, July 2, 2024, 138 Stat. 1443.) Editorial Notes REFERENCES IN TEXT The Social Security Act, referred to in subsec. (e)(4)(C)(iv), is act Aug. 14, 1935, ch. 531, 49 Stat. 620. Ti- tles XVIII and XIX of the Act are classified generally to subchapters XVIII (§ 1395 et seq.) and XIX (§ 1396 et seq.), respectively, of chapter 7 of this title. For com- plete classification of this Act to the Code, see section 1305 of this title and Tables. SUBCHAPTER III—NATIONAL RESEARCH INSTITUTES Editorial Notes CODIFICATION Title IV of the Public Health Service Act, comprising this subchapter, was originally enacted by act July 1, 1944, ch. 373, 58 Stat. 707, at which time title IV related solely to the National Cancer Institute. Because of the extensive amendments, reorganization of the subject matter, and expansion of title IV by the acts listed below, title IV is shown herein as having been added by Pub. L. 99–158, without reference to intervening amend- ments. The provisions of title IV as originally enacted were subsequently redesignated as part A of title IV and amended, and parts B to I of title IV were added and amended by the following acts: June 16, 1948, ch. 481, 62 Stat. 464; June 24, 1948, ch. 621, 62 Stat. 598; Aug. 15, 1950, ch. 714, 64 Stat. 443; Oct. 5, 1961, Pub. L. 87–395, 75 Stat. 824; Oct. 17, 1962, Pub. L. 87–838, 76 Stat. 1072; Aug. 16, 1968, Pub. L. 90–489, 82 Stat. 771; Oct. 30, 1970, Pub. L. 91–515, 84 Stat. 1297; Dec. 23, 1971, Pub. L. 92–218, 85 Stat. 778; May 19, 1972, Pub. L. 92–305, 86 Stat. 162; Sept. 19, 1972, Pub. L. 92–423, 86 Stat. 679; Apr. 22, 1974, Pub. L. 93–270, 88 Stat. 90; May 14, 1974, Pub. L. 93–282, 88 Stat. 126; May 31, 1974, Pub. L. 93–296, 88 Stat. 184; July 12, 1974, Pub. L. 93–348, 88 Stat. 342; July 23, 1974, Pub. L. 93–352, 88 Stat. 358; July 23, 1974, Pub. L. 93–354, 88 Stat. 373; Jan. 4, 1975, Pub. L. 93–640, 88 Stat. 2217; July 29, 1975, Pub. L. 94–63, 89 Stat. 304; Nov. 28, 1975, Pub. L. 94–135, 89 Stat. 713; Apr. 21, 1976, Pub. L. 94–273, 90 Stat. 375; Apr. 22, 1976, Pub. L. 94–278, 90 Stat. 401; Oct. 19, 1976, Pub. L. 94–562, 90 Stat. 2645; Aug. 1, 1977, Pub. L. 95–83, 91 Stat. 383; Nov. 9, 1978, Pub. L. 95–622, 92 Stat. 3412; Nov. 9, 1978, Pub. L. 95–623, 92 Stat. 3443; July 10, 1979, Pub. L. 96–32, 93 Stat. 82; Oct. 7, 1980, Pub. L. 96–398, 94 Stat. 1564; Dec. 17, 1980, Pub. L. 96–538, 94 Stat. 3183; Aug. 13, 1981, Pub. L. 97–35, 95 Stat. 358; Apr. 26, 1984, Pub. L. 98–24, 97 Stat. 175. Title IV was subsequently amended generally and completely reorganized by Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 822. PART A—NATIONAL INSTITUTES OF HEALTH § 281. Organization of National Institutes of Health (a) Relation to Public Health Service The National Institutes of Health is an agency of the Service. (b) National research institutes and national cen- ters The following agencies of the National Insti- tutes of Health are national research institutes or national centers: (1) The National Cancer Institute. (2) The National Heart, Lung, and Blood In- stitute. (3) The National Institute of Diabetes and Digestive and Kidney Diseases. (4) The National Institute of Arthritis and Musculoskeletal and Skin Diseases. Page 628 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 281 (5) The National Institute on Aging. (6) The National Institute of Allergy and In- fectious Diseases. (7) The Eunice Kennedy Shriver National In- stitute of Child Health and Human Develop- ment. (8) The National Institute of Dental and Craniofacial Research. (9) The National Eye Institute. (10) The National Institute of Neurological Disorders and Stroke. (11) The National Institute on Deafness and Other Communication Disorders. (12) The National Institute on Alcohol Abuse and Alcoholism. (13) The National Institute on Drug Abuse. (14) The National Institute of Mental Health. (15) The National Institute of General Med- ical Sciences. (16) The National Institute of Environmental Health Sciences. (17) The National Institute of Nursing Re- search. (18) The National Institute of Biomedical Imaging and Bioengineering. (19) The National Human Genome Research Institute. (20) The National Library of Medicine. (21) The National Center for Advancing Translational Sciences. (22) The John E. Fogarty International Cen- ter for Advanced Study in the Health Sciences. (23) The National Center for Complementary and Integrative Health. (24) The National Institute on Minority Health and Health Disparities. (25) Any other national center that, as an agency separate from any national research institute, was established within the National Institutes of Health as of the day before Janu- ary 15, 2007. (c) Division of Program Coordination, Planning, and Strategic Initiatives (1) In general Within the Office of the Director of the Na- tional Institutes of Health, there shall be a Di- vision of Program Coordination, Planning, and Strategic Initiatives (referred to in this sub- section as the ‘‘Division’’). (2) Offices within Division (A) Offices The following offices are within the Divi- sion: The Office of AIDS Research, the Office of Research on Women’s Health, the Office of Behavioral and Social Sciences Research, the Office of Disease Prevention, the Office of Dietary Supplements, and any other office located within the Office of the Director of NIH as of the day before January 15, 2007. In addition to such offices, the Director of NIH may establish within the Division such addi- tional offices or other administrative units as the Director determines to be appro- priate. (B) Authorities Each office in the Division— (i) shall continue to carry out the au- thorities that were in effect for the office before January 15, 2007; and (ii) shall, as determined appropriate by the Director of NIH, support the Division with respect to the authorities described in section 282(b)(7) of this title. (d) Organization (1) Number of institutes and centers In the National Institutes of Health, the number of national research institutes and na- tional centers may not exceed a total of 27, in- cluding any such institutes or centers estab- lished under authority of paragraph (2) or under authority of this subchapter as in effect on the day before January 15, 2007. (2) Reorganization of institutes (A) In general The Secretary may establish in the Na- tional Institutes of Health one or more addi- tional national research institutes to con- duct and support research, training, health information, and other programs with re- spect to any particular disease or groups of diseases or any other aspect of human health if— (i) the Secretary determines that an ad- ditional institute is necessary to carry out such activities; and (ii) the additional institute is not estab- lished before the expiration of 180 days after the Secretary has provided the Com- mittee on Energy and Commerce of the House of Representatives and the Com- mittee on Health, Education, Labor, and Pensions of the Senate written notice of the determination made under clause (i) with respect to the institute. (B) Additional authority The Secretary may reorganize the func- tions of any national research institute and may abolish any national research institute if the Secretary determines that the insti- tute is no longer required. A reorganization or abolition may not take effect under this paragraph before the expiration of 180 days after the Secretary has provided the Com- mittee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate written notice of the reorga- nization or abolition. (3) Reorganization of Office of Director Notwithstanding subsection (c), the Director of NIH may, after a series of public hearings, and with the approval of the Secretary, reor- ganize the offices within the Office of the Di- rector, including the addition, removal, or transfer of functions of such offices, and the establishment or termination of such offices, if the Director determines that the overall management and operation of programs and activities conducted or supported by such of- fices would be more efficiently carried out under such a reorganization. (4) Internal reorganization of institutes and centers Notwithstanding any conflicting provisions of this subchapter, the director of a national research institute or a national center may, Page 629 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 281 after a series of public hearings and with the approval of the Director of NIH, reorganize the divisions, centers, or other administrative units within such institute or center, includ- ing the addition, removal, or transfer of func- tions of such units, and the establishment or termination of such units, if the director of such institute or center determines that the overall management and operation of pro- grams and activities conducted or supported by such divisions, centers, or other units would be more efficiently carried out under such a reorganization. (e) Scientific Management Review Board for periodic organizational reviews (1) In general Not later than 60 days after January 15, 2007, the Secretary shall establish an advisory council within the National Institutes of Health to be known as the Scientific Manage- ment Review Board (referred to in this sub- section as the ‘‘Board’’). (2) Duties (A) Reports on organizational issues The Board shall provide advice to the ap- propriate officials under subsection (d) re- garding the use of the authorities estab- lished in paragraphs (2), (3), and (4) of such subsection to reorganize the National Insti- tutes of Health (referred to in this sub- section as ‘‘organizational authorities’’). Not less frequently than once each 7 years, the Board shall— (i) determine whether and to what extent the organizational authorities should be used; and (ii) issue a report providing the rec- ommendations of the Board regarding the use of the authorities and the reasons un- derlying the recommendations. (B) Certain responsibilities regarding reports The activities of the Board with respect to a report under subparagraph (A) shall in- clude the following: (i) Reviewing the research portfolio of the National Institutes of Health (referred to in this subsection as ‘‘NIH’’) in order to determine the progress and effectiveness and value of the portfolio and the alloca- tion among the portfolio activities of the resources of NIH. (ii) Determining pending scientific op- portunities, and public health needs, with respect to research within the jurisdiction of NIH. (iii) For any proposal for organizational changes to which the Board gives signifi- cant consideration as a possible rec- ommendation in such report— (I) analyzing the budgetary and oper- ational consequences of the proposed changes; (II) taking into account historical funding and support for research activi- ties at national research institutes and centers that have been established re- cently relative to national research in- stitutes and centers that have been in existence for more than two decades; (III) estimating the level of resources needed to implement the proposed changes; (IV) assuming the proposed changes will be made and making a recommenda- tion for the allocation of the resources of NIH among the national research insti- tutes and national centers; and (V) analyzing the consequences for the progress of research in the areas affected by the proposed changes. (C) Consultation In carrying out subparagraph (A), the Board shall consult with— (i) the heads of national research insti- tutes and national centers whose directors are not members of the Board; (ii) other scientific leaders who are offi- cers or employees of NIH and are not mem- bers of the Board; (iii) advisory councils of the national re- search institutes and national centers; (iv) organizations representing the sci- entific community; and (v) organizations representing patients. (3) Composition of Board The Board shall consist of the Director of NIH, who shall be a permanent nonvoting member on an ex officio basis, and an odd number of additional members, not to exceed 21, all of whom shall be voting members. The voting members of the Board shall be the fol- lowing: (A) Not fewer than 9 officials who are di- rectors of national research institutes or na- tional centers. The Secretary shall designate such officials for membership and shall en- sure that the group of officials so designated includes directors of— (i) national research institutes whose budgets are substantial relative to a ma- jority of the other institutes; (ii) national research institutes whose budgets are small relative to a majority of the other institutes; (iii) national research institutes that have been in existence for a substantial pe- riod of time without significant organiza- tional change under subsection (d); (iv) as applicable, national research in- stitutes that have undergone significant organization changes under such sub- section, or that have been established under such subsection, other than national research institutes for which such changes have been in place for a substantial period of time; and (v) national centers. (B) Members appointed by the Secretary from among individuals who are not officers or employees of the United States. Such members shall include— (i) individuals representing the interests of public or private institutions of higher education that have historically received funds from NIH to conduct research; and (ii) individuals representing the interests of private entities that have received funds from NIH to conduct research or that have Page 630 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 281 broad expertise regarding how the Na- tional Institutes of Health functions, ex- clusive of private entities to which clause (i) applies. (4) Chair The Chair of the Board shall be selected by the Secretary from among the members of the Board appointed under paragraph (3)(B). The term of office of the Chair shall be 2 years. (5) Meetings (A) In general The Board shall meet at the call of the Chair or upon the request of the Director of NIH, but not fewer than 5 times with respect to issuing any particular report under para- graph (2)(A). The location of the meetings of the Board is subject to the approval of the Director of NIH. (B) Particular forums Of the meetings held under subparagraph (A) with respect to a report under paragraph (2)(A)— (i) one or more shall be directed toward the scientific community to address sci- entific needs and opportunities related to proposals for organizational changes under subsection (d), or as the case may be, re- lated to a proposal that no such changes be made; and (ii) one or more shall be directed toward consumer organizations to address the needs and opportunities of patients and their families with respect to proposals re- ferred to in clause (i). (C) Availability of information from forums For each meeting under subparagraph (B), the Director of NIH shall post on the Inter- net site of the National Institutes of Health a summary of the proceedings. (6) Compensation; term of office The provisions of subsections (b)(4) and (c) of section 284a of this title apply with respect to the Board to the same extent and in the same manner as such provisions apply with respect to an advisory council referred to in such sub- sections, except that the reference in such subsection (c) to 4 years regarding the term of an appointed member is deemed to be a ref- erence to 5 years. (7) Reports (A) Recommendations for changes Each report under paragraph (2)(A) shall be submitted to— (i) the Committee on Energy and Com- merce and the Committee on Appropria- tions of the House of Representatives; (ii) the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate; (iii) the Secretary; and (iv) officials with organizational authori- ties, other than any such official who served as a member of the Board with re- spect to the report involved. (B) Availability to public The Director of NIH shall post each report under paragraph (2) on the Internet site of the National Institutes of Health. (C) Report on Board activities Not later than 18 months after January 15, 2007, the Board shall submit to the commit- tees specified in subparagraph (A) a report describing the activities of the Board. (f) Organizational changes per recommendation of Scientific Management Review Board (1) In general With respect to an official who has organiza- tional authorities within the meaning of sub- section (e)(2)(A), if a recommendation to the official for an organizational change is made in a report under such subsection, the official shall, except as provided in paragraphs (2), (3), and (4) of this subsection, make the change in accordance with the following: (A) Not later than 100 days after the report is submitted under subsection (e)(7)(A), the official shall initiate the applicable public process required in subsection (d) toward making the change. (B) The change shall be fully implemented not later than the expiration of the 3-year period beginning on the date on which such process is initiated. (2) Inapplicability to certain reorganizations Paragraph (1) does not apply to a rec- ommendation made in a report under sub- section (e)(2)(A) if the recommendation is for— (A) an organizational change under sub- section (d)(2) that constitutes the establish- ment, termination, or consolidation of one or more national research institutes or na- tional centers; or (B) an organizational change under sub- section (d)(3). (3) Objection by Director of NIH (A) In general Paragraph (1) does not apply to a rec- ommendation for an organizational change made in a report under subsection (e)(2)(A) if, not later than 90 days after the report is submitted under subsection (e)(7)(A), the Di- rector of NIH submits to the committees specified in such subsection a report pro- viding that the Director objects to the change, which report includes the reasons underlying the objection. (B) Scope of objection For purposes of subparagraph (A), an ob- jection by the Director of NIH may be made to the entirety of a recommended organiza- tional change or to 1 or more aspects of the change. Any aspect of a change not objected to by the Director in a report under subpara- graph (A) shall be implemented in accord- ance with paragraph (1). (4) Congressional review An organizational change under subsection (d)(2) that is initiated pursuant to paragraph (1) shall be carried out by regulation in ac- cordance with the procedures for substantive rules under section 553 of title 5. A rule under the preceding sentence shall be considered a major rule for purposes of chapter 8 of such title (relating to congressional review of agen- cy rulemaking). Page 631 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 281 (g) Definitions For purposes of this subchapter: (1) The term ‘‘Director of NIH’’ means the Director of the National Institutes of Health. (2) The terms ‘‘national research institute’’ and ‘‘national center’’ mean an agency of the National Institutes of Health that is— (A) listed in subsection (b) and not termi- nated under subsection (d)(2)(A); or (B) established by the Director of NIH under such subsection. (h) References to NIH For purposes of this subchapter, a reference to the National Institutes of Health includes its agencies. (July 1, 1944, ch. 373, title IV, § 401, as added Pub. L. 99–158, § 2, Nov. 20, 1985, 99 Stat. 822; amended Pub. L. 100–553, § 2(1), Oct. 28, 1988, 102 Stat. 2769; Pub. L. 100–607, title I, § 101(1), Nov. 4, 1988, 102 Stat. 3048; Pub. L. 100–690, title II, § 2613(b)(2), Nov. 18, 1988, 102 Stat. 4238; Pub. L. 102–321, title I, § 121(a), July 10, 1992, 106 Stat. 358; Pub. L. 103–43, title XV, §§ 1501(1), 1511(b)(1), 1521(1), June 10, 1993, 107 Stat. 172, 179, 180; Pub. L. 103–417, § 13(b), Oct. 25, 1994, 108 Stat. 4335; Pub. L. 105–277, div. A, § 101(f) [title II, § 212, title VI, § 601(k)], Oct. 21, 1998, 112 Stat. 2681–337, 2681–359, 2681–388; Pub. L. 106–525, title I, § 101(b)(1), Nov. 22, 2000, 114 Stat. 2501; Pub. L. 106–580, § 3(e), Dec. 29, 2000, 114 Stat. 3091; Pub. L. 109–482, title I, §§ 101(a), (b), 108(a), Jan. 15, 2007, 120 Stat. 3675, 3676, 3697; Pub. L. 110–154, § 1(b)(1), Dec. 21, 2007, 121 Stat. 1827; Pub. L. 111–148, title X, § 10334(c)(3)(A), Mar. 23, 2010, 124 Stat. 974; Pub. L. 112–74, div. F, title II, § 221(a)(2), (c)(2)(B), Dec. 23, 2011, 125 Stat. 1087, 1089; Pub. L. 113–235, div. G, title II, § 224(1), Dec. 16, 2014, 128 Stat. 2490.) Editorial Notes AMENDMENTS 2014—Subsec. (b)(23). Pub. L. 113–235 substituted ‘‘Na- tional Center for Complementary and Integrative Health’’ for ‘‘National Center for Complementary and Alternative Medicine’’. 2011—Subsec. (b)(21). Pub. L. 112–74, § 221(a)(2), sub- stituted ‘‘National Center for Advancing Translational Sciences’’ for ‘‘National Center for Research Re- sources’’. Subsec. (c)(2)(A). Pub. L. 112–74, § 221(c)(2)(B), struck out ‘‘the Office of Rare Diseases,’’ after ‘‘the Office of Dietary Supplements,’’. 2010—Subsec. (b)(24). Pub. L. 111–148 substituted ‘‘In- stitute’’ for ‘‘Center’’. 2007—Subsec. (b)(7). Pub. L. 110–154 substituted ‘‘Eu- nice Kennedy Shriver National Institute of Child Health and Human Development’’ for ‘‘National Insti- tute of Child Health and Human Development’’. Pub. L. 109–482, § 101(a), reenacted section catchline without change and amended text generally, sub- stituting provisions consisting of subsecs. (a) to (d)(1) for former subsecs. (a) to (d) which related to: in sub- sec. (a), relationship to Public Health Service; in sub- sec. (b), list of national research institutes that were agencies; in subsec. (c), establishment of additional in- stitutes and reorganization or abolition of institutes; and, in subsec. (d), definition of ‘‘national research in- stitute’’. See below. Subsec. (d)(2). Pub. L. 109–482, § 108(a), added after subsec. (d)(1) provisions identical to text of subsec. (c) prior to amendment by Pub. L. 109–482, § 101(a), redesig- nated such provisions as par. (2), added par. heading, re- designated former pars. (1) and (2) as subpars. (A) and (B), respectively, added subpar. headings, in subpar. (A), redesignated former subpars. (A) and (B) as cls. (i) and (ii), respectively, in cl. (ii), substituted ‘‘Health, Education, Labor, and Pensions’’ for ‘‘Labor and Human Resources’’ and ‘‘clause (i)’’ for ‘‘subparagraph (A)’’, and, in subpar. (B), substituted ‘‘Health, Edu- cation, Labor, and Pensions’’ for ‘‘Labor and Human Resources’’. Subsec. (d)(3), (4). Pub. L. 109–482, § 101(b)(1), added pars. (3) and (4). Subsecs. (e) to (h). Pub. L. 109–482, § 101(b)(2), added subsecs. (e) to (h). 2000—Subsec. (b)(1)(R). Pub. L. 106–580 added subpar. (R). Subsec. (b)(2)(F). Pub. L. 106–525, § 101(b)(1)(A), re- aligned margins. Subsec. (b)(2)(G). Pub. L. 106–525, § 101(b)(1)(B), added subpar. (G). 1998—Subsec. (b)(1)(H). Pub. L. 105–277, § 101(f) [title II, § 212], substituted ‘‘National Institute of Dental and Craniofacial Research’’ for ‘‘National Institute of Den- tal Research’’. Subsec. (b)(2)(F). Pub. L. 105–277, § 101(f) [title VI, § 601(k)], added subpar. (F). 1994—Subsec. (b)(2)(E). Pub. L. 103–417 added subpar. (E). 1993—Subsec. (b)(1)(Q). Pub. L. 103–43, § 1511(b)(1)(A), added subpar. (Q). Subsec. (b)(2)(B). Pub. L. 103–43, § 1501(1), amended subpar. (B) generally, substituting ‘‘National Center for Research Resources’’ for ‘‘Division of Research Re- sources’’. Subsec. (b)(2)(D). Pub. L. 103–43, §§ 1511(b)(1)(B), 1521(1), added subpar. (D) and struck out former subpar. (D) which read as follows: ‘‘The National Center for Nursing Research.’’ 1992—Subsec. (b)(1)(N) to (P). Pub. L. 102–321 added subpars. (N) to (P). 1988—Subsec. (b)(1)(J), (M). Pub. L. 100–553 and Pub. L. 100–607 made identical amendments, striking out ‘‘and Communicative’’ after ‘‘Neurological’’ in subpar. (J), and adding subpar. (M). Pub. L. 100–690 amended subsec. (b)(1) to read as if the amendments by Pub. L. 100–607 had not been enacted. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2007 AMENDMENT Pub. L. 109–482, title I, § 109, Jan. 15, 2007, 120 Stat. 3697, provided that: ‘‘This title [see Tables for classi- fication] and the amendments made by this title apply only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years.’’ EFFECTIVE DATE OF 2000 AMENDMENT Pub. L. 106–525, title VI, § 603, Nov. 22, 2000, 114 Stat. 2511, provided that: ‘‘This Act [enacting subpart 6 (§ 287c–31 et seq.) of part E of this subchapter and sec- tions 293e, 296e–1, and 299a–1 of this title, amending sec- tions 281, 296f, 299a, 299c–6, and 300u–6 of this title, re- pealing section 283b of this title, and enacting provi- sions set out as notes under sections 201, 287c–31, 293e, and 3501 of this title] and the amendments made by this Act take effect October 1, 2000, or upon the date of the enactment of this Act [Nov. 22, 2000], whichever occurs later.’’ EFFECTIVE DATE OF 1992 AMENDMENT Amendment by Pub. L. 102–321 effective Oct. 1, 1992, with provision for programs providing financial assist- ance, see section 801(c), (d) of Pub. L. 102–321, set out as a note under section 236 of this title. EFFECTIVE DATE OF 1988 AMENDMENT For effective date of amendment by Pub. L. 100–690, see section 2613(b)(1) of Pub. L. 100–690, set out as an Ef- fect of Enactment of Similar Provisions note under sec- tion 285m of this title. CONSTRUCTION OF 2007 AMENDMENT Pub. L. 109–482, title I, § 102(g), Jan. 15, 2007, 120 Stat. 3685, provided that: ‘‘This Act [see Tables for classifica- Page 632 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 282 tion] and the amendments made by this Act may not be construed as affecting the authorities of the national research institutes and national centers that were in effect under the Public Health Service Act [42 U.S.C. 201 et seq.] on the day before the date of the enactment of this Act [Jan. 15, 2007], subject to the authorities of the Secretary of Health and Human Services and the Director of NIH under section 401 of the Public Health Service Act [42 U.S.C. 281] (as amended by section 101 of this Act). For purposes of the preceding sentence, the terms ‘national research institute’, ‘national cen- ter’, and ‘Director of NIH’ have the meanings given such terms in such section 401.’’ STUDY OF THE USE OF CENTERS OF EXCELLENCE AT THE NATIONAL INSTITUTES OF HEALTH Pub. L. 107–84, § 7, Dec. 18, 2001, 115 Stat. 829, required the Secretary of Health and Human Services to con- tract, not later than 60 days after Dec. 18, 2001, with the Institute of Medicine to conduct a study on the impact of, need for, and other issues associated with Centers of Excellence at the National Institutes of Health and complete the study and submit a report not later than one year after the date of the contract. REPORT ON MEDICAL USES OF BIOLOGICAL AGENTS IN DEVELOPMENT OF DEFENSES AGAINST BIOLOGICAL WARFARE Pub. L. 103–43, title XIX, § 1904, June 10, 1993, 107 Stat. 203, directed Secretary of Health and Human Services, in consultation with Secretary of Defense and with heads of other appropriate executive agencies, to report to Congress, not later than 12 months after June 10, 1993, on the appropriateness and impact of the National Institutes of Health assuming responsibility for the conduct of all Federal research, development, testing, and evaluation functions relating to medical counter- measures against biowarfare threat agents. RESEARCH ON LUPUS ERYTHEMATOSUS Pub. L. 99–158, § 5, Nov. 20, 1985, 99 Stat. 880, as amend- ed by Pub. L. 102–531, title III, § 312(f), Oct. 27, 1992, 106 Stat. 3506, directed Secretary of Health and Human Re- sources to establish a Lupus Erythematosus Coordi- nating Committee to plan, develop, coordinate, and im- plement comprehensive Federal initiatives in research on Lupus Erythematosus, provided for composition of committee and meetings, and directed Committee to prepare a report for Congress on its activities, to be submitted not later than 18 months after Nov. 20, 1985, with Committee to terminate one month after the re- port was submitted. INTERAGENCY COMMITTEE ON LEARNING DISABILITIES Pub. L. 99–158, § 9, Nov. 20, 1985, 99 Stat. 882, directed Director of the National Institutes of Health, not later than 90 days after Nov. 20, 1985, to establish an Inter- agency Committee on Learning Disabilities to review and assess Federal research priorities, activities, and findings regarding learning disabilities (including cen- tral nervous system dysfunction in children), provided for composition of the Committee, directed Committee to report to Congress on its activities not later than 18 months after Nov. 20, 1985, and provided that the Com- mittee terminate 90 days after submission of the re- port. § 282. Director of National Institutes of Health (a) Appointment The National Institutes of Health shall be headed by the Director of NIH who shall be ap- pointed by the President by and with the advice and consent of the Senate. The Director of NIH shall perform functions as provided under sub- section (b) and as the Secretary may otherwise prescribe. (b) Duties and authority In carrying out the purposes of section 241 of this title, the Secretary, acting through the Di- rector of NIH— (1) shall carry out this subchapter, including being responsible for the overall direction of the National Institutes of Health and for the establishment and implementation of general policies respecting the management and oper- ation of programs and activities within the National Institutes of Health; (2) shall coordinate and oversee the oper- ation of the national research institutes, na- tional centers, and administrative entities within the National Institutes of Health; (3) shall, in consultation with the heads of the national research institutes and national centers, be responsible for program coordina- tion across the national research institutes and national centers, including conducting priority-setting reviews, to ensure that the re- search portfolio of the National Institutes of Health is balanced and free of unnecessary du- plication, and takes advantage of collabo- rative, cross-cutting research; (4) shall assemble accurate data to be used to assess research priorities, including— (A) information to better evaluate sci- entific opportunity, public health burdens, and progress in reducing health disparities; and (B) data on study populations of clinical research, funded by or conducted at each na- tional research institute and national cen- ter, which— (i) specifies the inclusion of— (I) women; (II) members of minority groups; (III) relevant age categories, including pediatric subgroups; and (IV) other demographic variables as the Director of the National Institutes of Health determines appropriate; (ii) is disaggregated by research area, condition, and disease categories; and (iii) is to be made publicly available on the Internet website of the National Insti- tutes of Health; (5) shall ensure that scientifically based strategic planning is implemented in support of research priorities as determined by the agencies of the National Institutes of Health, and through the development, implementa- tion, and updating of the strategic plan devel- oped under subsection (m); (6) shall ensure that the resources of the Na- tional Institutes of Health are sufficiently al- located for research projects identified in stra- tegic plans; (7)(A) shall, through the Division of Program Coordination, Planning, and Strategic Initia- tives— (i) identify research that represents impor- tant areas of emerging scientific opportuni- ties, rising public health challenges, or knowledge gaps that deserve special empha- sis and would benefit from conducting or supporting additional research that involves collaboration between 2 or more national re- search institutes or national centers, or

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395 — Conditions of participation for home health agencies; home health quality

**(a) Conditions of participation; protection of individual rights; notification of State entities; use of home health aides; medical equipment; individual’s plan of care; compliance with Federal, State, and local laws and regulations** The conditions of participation that a home health agency is required to meet under this subsection are as follows: (1) The agency protects and promotes the rights of each individual under its care, including each of the following rights: (A) The right to be fully informed in advance about the care and treatment to be provided by the agency, to be fully informed in advance of any changes in the care or treatment to be provided by the agency that may affect the individual’s well-being, and (except with respect to an individual adjudged incompetent) to participate in planning care and treatment or changes in care or treatment. (B) The right to voice grievances with respect to treatment or care that is (or fails to be) furnished without discrimination or reprisal for voicing grievances. (C) The right to confidentiality of the clinical records described in section 1395x(o)(3) of this title. (D) The right to have one’s property treated with respect. (E) The right to be fully informed orally and in writing (in advance of coming under the care of the agency) of— (i) all items and services furnished by (or under arrangements with) the agency for which payment may be made under this subchapter, (ii) the coverage available for such items and services under this subchapter, subchapter XIX, and any other Federal program of which the agency is reasonably aware, (iii) any charges for items and services not covered under this subchapter and any charges the individual may have to pay with respect to items and services furn

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1395 — Prohibition against any Federal inter-

Page 2893 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1395a (i) shared savings and competitive bidding in FFS Medicare; (ii) use of MA-negotiated rates to set FFS Medicare rates; and (iii) novel approaches to information development and sharing that may enable markets to lower cost and improve quality for FFS Medicare beneficiaries. SEC. 10. Reducing Obstacles to Improved Patient Care. Within 1 year of the date of this order, the Secretary shall propose regulatory changes to the Medicare pro- gram to reduce the burden on providers and eliminate regulations that create inefficiencies or otherwise un- dermine patient outcomes. SEC. 11. Maximizing Freedom for Medicare Patients and Providers. (a) Within 180 days of the date of this order, the Secretary, in coordination with the Commissioner of Social Security, shall revise current rules or policies to preserve the Social Security retirement insurance benefits of seniors who choose not to receive benefits under Medicare Part A, and propose other administra- tive improvements to Medicare enrollment processes for beneficiaries. (b) Within 1 year of the date of this order, the Sec- retary shall identify and remove unnecessary barriers to private contracts that allow Medicare beneficiaries to obtain the care of their choice and facilitate the de- velopment of market-driven prices. SEC. 12. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect: (i) the authority granted by law to an executive de- partment or agency, or the head thereof; or (ii) the functions of the Director of the Office of Man- agement and Budget relating to budgetary, administra- tive, or legislative proposals. (b) This order shall be implemented consistent with applicable law and subject to the

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1396 — Medicaid and CHIP Payment and Access Commission

**(a) Establishment** There is hereby established the Medicaid and CHIP Payment and Access Commission (in this section referred to as “MACPAC”). **(b) Duties** (1) **Review of access policies for all States and annual reports** — MACPAC shall— (A) review policies of the Medicaid program established under this subchapter (in this section referred to as “Medicaid”) and the State Children’s Health Insurance Program established under subchapter XXI (in this section referred to as “CHIP”) affecting access to covered items and services, including topics described in paragraph (2); (B) make recommendations to Congress, the Secretary, and States concerning such access policies; (C) by not later than March 15 of each year (beginning with 2010), submit a report to Congress containing the results of such reviews and MACPAC’s recommendations concerning such policies; and (D) by not later than June 15 of each year (beginning with 2010), submit a report to Congress containing an examination of issues affecting Medicaid and CHIP, including the implications of changes in health care delivery in the United States and in the market for health care services on such programs. (2) **Specific topics to be reviewed** — Specifically, MACPAC shall review and assess the following: (A) *Medicaid and CHIP payment policies* — Payment policies under Medicaid and CHIP, including— (i) the factors affecting expenditures for the efficient provision of items and services in different sectors, including the process for updating payments to medical, dental, and health professionals, hospitals, residential and long-term care providers, providers of home and community based services, Federally-qualified health centers and rural health clinics, managed care entities, and providers of ot

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 1396 — Medicaid and CHIP Payment and Access

Page 4009 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1396 of the enactment of this Act [Oct. 6, 2014], the Sec- retary shall develop and report to Congress on a stra- tegic plan for collecting or otherwise accessing data on race and ethnicity for purposes of specifying quality measures and resource use and other measures under subsections (c) and (d) of section 1899B of the Social Se- curity Act, as added by subsection (a), and, as the Sec- retary determines appropriate, other similar provisions of, including payment adjustments under, title XVIII of such Act (42 U.S.C. 1395 et seq.).’’ SUBCHAPTER XIX—GRANTS TO STATES FOR MEDICAL ASSISTANCE PROGRAMS § 1396. Medicaid and CHIP Payment and Access Commission (a) Establishment There is hereby established the Medicaid and CHIP Payment and Access Commission (in this section referred to as ‘‘MACPAC’’). (b) Duties (1) Review of access policies for all States and annual reports MACPAC shall— (A) review policies of the Medicaid pro- gram established under this subchapter (in this section referred to as ‘‘Medicaid’’) and the State Children’s Health Insurance Pro- gram established under subchapter XXI (in this section referred to as ‘‘CHIP’’) affecting access to covered items and services, includ- ing topics described in paragraph (2); (B) make recommendations to Congress, the Secretary, and States concerning such access policies; (C) by not later than March 15 of each year (beginning with 2010), submit a report to Congress containing the results of such re- views and MACPAC’s recommendations con- cerning such policies; and (D) by not later than June 15 of each year (beginning with 2010), submit a report to Congress containing an examination of issues affecting Medicaid and CHIP, includ- ing the impli

Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 1396

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 201 — Funding

Beginning with fiscal year 2010, the Secretary shall transfer from the Public Health and Social Services Emergency Fund such sums as may be necessary to carry out this part.

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 201

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 201 — Definitions

Page 35 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 201 1 See References in Text note below. Sec. 300jj–34. Competitive grants to States and Indian tribes for the development of loan pro- grams to facilitate the widespread adoption of certified EHR technology. 300jj–35. Demonstration program to integrate in- formation technology into clinical education. 300jj–36. Information technology professionals in health care. 300jj–37. General grant and loan provisions. 300jj–38. Authorization for appropriations. PART C—OTHER PROVISIONS 300jj–51. Health information technology enroll- ment standards and protocols. 300jj–52. Information blocking. SUBCHAPTER XXIX—DATA COLLECTION, ANALYSIS, AND QUALITY 300kk. Data collection, analysis, and quality. SUBCHAPTER XXX—COMMUNITY LIVING ASSISTANCE SERVICES AND SUPPORTS 300ll to 300ll–9. Repealed. SUBCHAPTER XXXI—WORLD TRADE CENTER HEALTH PROGRAM PART A—ESTABLISHMENT OF PROGRAM; ADVISORY COMMITTEE 300mm. Establishment of World Trade Center Health Program. 300mm–1. WTC Health Program Scientific/Tech- nical Advisory Committee; WTC Health Program Steering Committees. 300mm–2. Education and outreach. 300mm–3. Uniform data collection and analysis. 300mm–4. Clinical Centers of Excellence and Data Centers. 300mm–5. Definitions. PART B—PROGRAM OF MONITORING, INITIAL HEALTH EVALUATIONS, AND TREATMENT SUBPART 1—WTC RESPONDERS 300mm–21. Identification of WTC responders and provision of WTC-related monitoring services. 300mm–22. Treatment of enrolled WTC responders for WTC-related health conditions. 300mm–23. National arrangement for benefits for el- igible individuals outside New York. SUBPART 2—WTC SURVIVORS 300mm–31. Identification and initial health evalua- tion of screening-eligible and

Source: Supplied 2024 U.S. Code historical extraction · 42 U.S.C. § 201

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 281 — Organization of National Institutes of Health

**(a) Relation to Public Health Service** The National Institutes of Health is an agency of the Service. **(b) National research institutes and national centers** The following agencies of the National Institutes of Health are national research institutes or national centers: (1) The National Cancer Institute. (2) The National Heart, Lung, and Blood Institute. (3) The National Institute of Diabetes and Digestive and Kidney Diseases. (4) The National Institute of Arthritis and Musculoskeletal and Skin Diseases. (5) The National Institute on Aging. (6) The National Institute of Allergy and Infectious Diseases. (7) The Eunice Kennedy Shriver National Institute of Child Health and Human Development. (8) The National Institute of Dental and Craniofacial Research. (9) The National Eye Institute. (10) The National Institute of Neurological Disorders and Stroke. (11) The National Institute on Deafness and Other Communication Disorders. (12) The National Institute on Alcohol Abuse and Alcoholism. (13) The National Institute on Drug Abuse. (14) The National Institute of Mental Health. (15) The National Institute of General Medical Sciences. (16) The National Institute of Environmental Health Sciences. (17) The National Institute of Nursing Research. (18) The National Institute of Biomedical Imaging and Bioengineering. (19) The National Human Genome Research Institute. (20) The National Library of Medicine. (21) The National Center for Advancing Translational Sciences. (22) The John E. Fogarty International Center for Advanced Study in the Health Sciences. (23) The National Center for Complementary and Integrative Health. (24) The National Institute on Minority Health and Health Disparities. (25) Any other national center that, as an agency separate from

Source: Supplied U.S. Code snapshot — release unconfirmed · 42 U.S.C. § 281

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