USC Subpart 2

USC Subpart 2
in effect

42 U.S.C. § 285b Purpose of Institute

The general purpose of the National Heart, Lung, and Blood Institute (hereafter in this subpart referred to as the “Institute”) is the conduct and support of research, training, health information dissemination, and other programs with respect to heart, blood vessel, lung, and blood diseases and with respect to the use of blood and blood products and the management of blood resources.

42 U.S.C. § 285b–1 Heart, blood vessel, lung, and blood disease prevention and control programs

(a) The Director of the Institute shall conduct and support programs for the prevention and control of heart, blood vessel, lung, and blood diseases. Such programs shall include community-based and population-based programs carried out in cooperation with other Federal agencies, with public health agencies of State or local governments, with nonprofit private entities that are community-based health agencies, or with other appropriate public or nonprofit private entities. (b) In carrying out programs under subsection (a), the Director of the Institute shall give special consideration to the prevention and control of heart, blood vessel, lung, and blood diseases in children, and in populations that are at increased risk with respect to such diseases.

42 U.S.C. § 285b–2 Information and education

The Director of the Institute shall collect, identify, analyze, and disseminate on a timely basis, through publications and other appropriate means, to patients, families of patients, physicians and other health professionals, and the general public, information on research, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases, the maintenance of health to reduce the incidence of such diseases, and on the use of blood and blood products and the management of blood resources. In carrying out this section, the Director of the Institute shall place special emphasis upon the utilization of collaborative efforts with both the public and private sectors to— (1) increase the awareness and knowledge of health care professionals and the public regarding the prevention of heart and blood vessel, lung, and blood diseases and the utilization of blood resources; and (2) develop and disseminate to health professionals, patients and patient families, and the public information designed to encourage adults and children to adopt healthful practices concerning the prevention of such diseases.

42 U.S.C. § 285b–3 National Heart, Blood Vessel, Lung, and Blood Diseases and Blood Resources Program; administrative provisions

(a)(1) The National Heart, Blood Vessel, Lung, and Blood Diseases and Blood Resources Program (hereafter in this subpart referred to as the “Program”) may provide for—(A) investigation into the epidemiology, etiology, and prevention of all forms and aspects of heart, blood vessel, lung, and blood diseases, including investigations into the social, environmental, behavioral, nutritional, biological, and genetic determinants and influences involved in the epidemiology, etiology, and prevention of such diseases; (B) studies and research into the basic biological processes and mechanisms involved in the underlying normal and abnormal heart, blood vessel, lung, and blood phenomena; (C) research into the development, trial, and evaluation of techniques, drugs, and devices (including computers) used in, and approaches to, the diagnosis, treatment (including the provision of emergency medical services), and prevention of heart, blood vessel, lung, and blood diseases and the rehabilitation of patients suffering from such diseases; (D) establishment of programs that will focus and apply scientific and technological efforts involving the biological, physical, and engineering sciences to all facets of heart, blood vessel, lung, and blood diseases with emphasis on the refinement, development, and evaluation of technological devices that will assist, replace, or monitor vital organs and improve instrumentation for detection, diagnosis, and treatment of and rehabilitation from such diseases; (E) establishment of programs for the conduct and direction of field studies, large-scale testing and evaluation, and demonstration of preventive, diagnostic, therapeutic, and rehabilitative approaches to, and emergency medical services for, such diseases; (F) studies and research into blood diseases and blood, and into the use of blood for clinical purposes and all aspects of the management of blood resources in the United States, including the collection, preservation, fractionation, and distribution of blood and blood products; (G) the education (including continuing education) and training of scientists, clinical investigators, and educators, in fields and specialties (including computer sciences) requisite to the conduct of clinical programs respecting heart, blood vessel, lung, and blood diseases and blood resources; (H) public and professional education relating to all aspects of such diseases, including the prevention of such diseases, and the use of blood and blood products and the management of blood resources; (I) establishment of programs for study and research into heart, blood vessel, lung, and blood diseases of children (including cystic fibrosis, hyaline membrane, hemolytic diseases such as sickle cell anemia and Cooley’s anemia, and hemophilic diseases) and for the development and demonstration of diagnostic, treatment, and preventive approaches to such diseases; and (J) establishment of programs for study, research, development, demonstrations and evaluation of emergency medical services for people who become critically ill in connection with heart, blood vessel, lung, or blood diseases. (2) The Program shall be coordinated with other national research institutes to the extent that they have responsibilities respecting such diseases and shall give special emphasis to the continued development in the Institute of programs related to the causes of stroke and to effective coordination of such programs with related stroke programs in the National Institute of Neurological and Communicative Disorders and Stroke. The Director of the Institute, with the advice of the advisory council for the Institute, shall revise annually the plan for the Program and shall carry out the Program in accordance with such plan. (b) In carrying out the Program, the Director of the Institute, under policies established by the Director of NIH—(1) may, after consultation with the advisory council for the Institute, obtain (in accordance with section 3109 of title 5, but without regard to the limitation in such section on the period of such service) the services of not more than one hundred experts or consultants who have scientific or professional qualifications; (2)(A) may, in consultation with the advisory council for the Institute, acquire and construct, improve, repair, operate, alter, renovate, and maintain, heart, blood vessel, lung, and blood disease and blood resource laboratories, research, training, and other facilities, equipment, and such other real or personal property as the Director determines necessary; (B) may, in consultation with the advisory council for the Institute, make grants for construction or renovation of facilities; and (C) may, in consultation with the advisory council for the Institute, acquire, without regard to section 8141 of title 40, by lease or otherwise, through the Administrator of General Services, buildings or parts of buildings in the District of Columbia or communities located adjacent to the District of Columbia for the use of the Institute for a period not to exceed ten years; (3) subject to section 284(b)(2) of this title and without regard to section 3324 of title 31 and section 6101 of title 41, may enter into such contracts, leases, cooperative agreements, or other transactions, as may be necessary in the conduct of the Director’s functions, with any public agency, or with any person, firm, association, corporation, or educational institutions; (4) may make grants to public and nonprofit private entities to assist in meeting the cost of the care of patients in hospitals, clinics, and related facilities who are participating in research projects; and (5) shall, in consultation with the advisory council for the Institute, conduct appropriate intramural training and education programs, including continuing education and laboratory and clinical research training programs. Except as otherwise provided, experts and consultants whose services are obtained under paragraph (1) shall be paid or reimbursed, in accordance with title 5, for their travel to and from their place of service and for other expenses associated with their assignment. Such expenses shall not be allowed in connection with the assignment of an expert or consultant whose services are obtained under paragraph (1) unless the expert or consultant has agreed in writing to complete the entire period of the assignment or one year of the assignment, whichever is shorter, unless separated or reassigned for reasons which are beyond the control of the expert or consultant and which are acceptable to the Director of the Institute. If the expert or consultant violates the agreement, the money spent by the United States for such expenses is recoverable from the expert or consultant as a debt due the United States. The Secretary may waive in whole or in part a right of recovery under the preceding sentence.

42 U.S.C. § 285b–4 National research and demonstration centers

(a) Heart, blood vessel, lung, blood diseases, and blood resources; utilization of centers for prevention programs(1) The Director of the Institute may provide, in accordance with subsection (c), for the development of—(A) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment and rehabilitation methods (including methods of providing emergency medical services) for heart and blood vessel diseases; (B) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment and rehabilitation methods (including methods of providing emergency medical services) for lung diseases (including bronchitis, emphysema, asthma, cystic fibrosis, and other lung diseases of children); (C) ten centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment methods (including methods of providing emergency medical services) for blood diseases and research into blood, in the use of blood products and in the management of blood resources; and (D) three centers for basic and clinical research into, training in, and demonstration of, advanced diagnostic, prevention, and treatment (including genetic studies, intrauterine environment studies, postnatal studies, heart arrhythmias, and acquired heart disease and preventive cardiology) for cardiovascular diseases in children. (2) The centers developed under paragraph (1) shall, in addition to being utilized for research, training, and demonstrations, be utilized for the following prevention programs for cardiovascular, pulmonary, and blood diseases:(A) Programs to develop improved methods of detecting individuals with a high risk of developing cardiovascular, pulmonary, and blood diseases. (B) Programs to develop improved methods of intervention against those factors which cause individuals to have a high risk of developing such diseases. (C) Programs to develop health professions and allied health professions personnel highly skilled in the prevention of such diseases. (D) Programs to develop improved methods of providing emergency medical services for persons with such diseases. (E) Programs of continuing education for health and allied health professionals in the diagnosis, prevention, and treatment of such diseases and the maintenance of health to reduce the incidence of such diseases and information programs for the public respecting the prevention and early diagnosis and treatment of such diseases and the maintenance of health. (3) The research, training, and demonstration activities carried out through any such center may relate to any one or more of the diseases referred to in paragraph (1) of this subsection. (b) Sickle cell anemiaThe Director of the Institute shall provide, in accordance with subsection (c), for the development of ten centers for basic and clinical research into the diagnosis, treatment, and control of sickle cell anemia. (c) Cooperative agreements and grants for establishing and supporting; uses for Federal payments; period of support, additional periods(1) The Director of the Institute may enter into cooperative agreements with and make grants to public or private nonprofit entities to pay all or part of the cost of planning, establishing, or strengthening, and providing basic operating support for centers for basic and clinical research into, training in, and demonstration of the management of blood resources and advanced diagnostic, prevention, and treatment methods for heart, blood vessel, lung, or blood diseases. (2) A cooperative agreement or grant under paragraph (1) shall be entered into in accordance with policies established by the Director of NIH and after consultation with the Institute’s advisory council. (3) Federal payments made under a cooperative agreement or grant under paragraph (1) may be used for—(A) construction (notwithstanding any limitation under section 289e of this title); (B) staffing and other basic operating costs, including such patient care costs as are required for research; (C) training, including training for allied health professionals; and (D) demonstration purposes. As used in this subsection, the term “construction” does not include the acquisition of land, and the term “training” does not include research training for which Ruth L. Kirschstein National Research Service Awards may be provided under section 288 of this title. (4) Support of a center under paragraph (1) may be for a period of not to exceed five years. Such period may be extended by the Director for additional periods of not more than five years each if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.

42 U.S.C. § 285b–6 Associate Director for Prevention; appointment; function

(a) There shall be in the Institute an Associate Director for Prevention to coordinate and promote the programs in the Institute concerning the prevention of heart, blood vessel, lung, and blood diseases. The Associate Director shall be appointed by the Director of the Institute from individuals who because of their professional training or experience are experts in public health or preventive medicine. (b) The Associate Director for Prevention shall prepare for inclusion in the biennial report made under section 284b 11 See References in Text note below. of this title a description of the prevention activities of the Institute, including a description of the staff and resources allocated to those activities.

42 U.S.C. § 285b–7 National Center on Sleep Disorders Research

(a) EstablishmentNot later than 1 year after June 10, 1993, the Director of the Institute shall establish the National Center on Sleep Disorders Research (in this section referred to as the “Center”). The Center shall be headed by a director, who shall be appointed by the Director of the Institute. (b) PurposeThe general purpose of the Center is—(1) the conduct and support of research, training, health information dissemination, and other activities with respect to sleep disorders, including biological and circadian rhythm research, basic understanding of sleep, chronobiological and other sleep related research; and (2) to coordinate the activities of the Center with similar activities of other Federal agencies, including the other agencies of the National Institutes of Health, and similar activities of other public entities and nonprofit entities. (c) Sleep Disorders Research Advisory Board(1) The Director of the National Institutes of Health shall establish a board to be known as the Sleep Disorders Research Advisory Board (in this section referred to as the “Advisory Board”). (2) The Advisory Board shall advise, assist, consult with, and make recommendations to the Director of the National Institutes of Health, through the Director of the Institute, and the Director of the Center concerning matters relating to the scientific activities carried out by and through the Center and the policies respecting such activities, including recommendations with respect to the plan required in subsection (c).11 So in original. Probably should be subsection “(d)”. (3)(A) The Director of the National Institutes of Health shall appoint to the Advisory Board 12 appropriately qualified representatives of the public who are not officers or employees of the Federal Government. Of such members, eight shall be representatives of health and scientific disciplines with respect to sleep disorders and four shall be individuals representing the interests of individuals with or undergoing treatment for sleep disorders. (B) The following officials shall serve as ex officio members of the Advisory Board:(i) The Director of the National Institutes of Health. (ii) The Director of the Center. (iii) The Director of the National Heart, Lung and Blood Institute. (iv) The Director of the National Institute of Mental Health. (v) The Director of the National Institute on Aging. (vi) The Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. (vii) The Director of the National Institute of Neurological Disorders and Stroke. (viii) The Assistant Secretary for Health. (ix) The Assistant Secretary of Defense (Health Affairs). (x) The Chief Medical Director of the Veterans’ Administration. (4) The members of the Advisory Board shall, from among the members of the Advisory Board, designate an individual to serve as the chair of the Advisory Board. (5) Except as inconsistent with, or inapplicable to, this section, the provisions of section 284a of this title shall apply to the advisory board 22 So in original. Probably should be capitalized. established under this section in the same manner as such provisions apply to any advisory council established under such section. (d) Development of comprehensive research plan; revision(1) After consultation with the Director of the Center and the advisory board 2 established under subsection (c), the Director of the National Institutes of Health shall develop a comprehensive plan for the conduct and support of sleep disorders research. (2) The plan developed under paragraph (1) shall identify priorities with respect to such research and shall provide for the coordination of such research conducted or supported by the agencies of the National Institutes of Health. (3) The Director of the National Institutes of Health (after consultation with the Director of the Center and the advisory board 2 established under subsection (c)) shall revise the plan developed under paragraph (1) as appropriate. (e) Collection and dissemination of informationThe Director of the Center, in cooperation with the Centers for Disease Control and Prevention, is authorized to coordinate activities with the Department of Transportation, the Department of Defense, the Department of Education, the Department of Labor, and the Department of Commerce to collect data, conduct studies, and disseminate public information concerning the impact of sleep disorders and sleep deprivation.

42 U.S.C. § 285b–7a Heart attack, stroke, and other cardiovascular diseases in women

(a) In generalThe Director of the Institute shall expand, intensify, and coordinate research and related activities of the Institute with respect to heart attack, stroke, and other cardiovascular diseases in women. (b) Coordination with other institutesThe Director of the Institute shall coordinate activities under subsection (a) with similar activities conducted by the other national research institutes and agencies of the National Institutes of Health to the extent that such Institutes and agencies have responsibilities that are related to heart attack, stroke, and other cardiovascular diseases in women. (c) Certain programsIn carrying out subsection (a), the Director of the Institute shall conduct or support research to expand the understanding of the causes of, and to develop methods for preventing, cardiovascular diseases in women. Activities under such subsection shall include conducting and supporting the following:(1) Research to determine the reasons underlying the prevalence of heart attack, stroke, and other cardiovascular diseases in women, including African-American women and other women who are members of racial or ethnic minority groups. (2) Basic research concerning the etiology and causes of cardiovascular diseases in women. (3) Epidemiological studies to address the frequency and natural history of such diseases and the differences among men and women, and among racial and ethnic groups, with respect to such diseases. (4) The development of safe, efficient, and cost-effective diagnostic approaches to evaluating women with suspected ischemic heart disease. (5) Clinical research for the development and evaluation of new treatments for women, including rehabilitation. (6) Studies to gain a better understanding of methods of preventing cardiovascular diseases in women, including applications of effective methods for the control of blood pressure, lipids, and obesity. (7) Information and education programs for patients and health care providers on risk factors associated with heart attack, stroke, and other cardiovascular diseases in women, and on the importance of the prevention or control of such risk factors and timely referral with appropriate diagnosis and treatment. Such programs shall include information and education on health-related behaviors that can improve such important risk factors as smoking, obesity, high blood cholesterol, and lack of exercise.

42 U.S.C. § 285b–7b Coordination of Federal asthma activities

(a) In generalThe Director of 11 So in original. Probably should be followed by “the”. Institute shall, through the National Asthma Education Prevention Program Coordinating Committee—(1) identify all Federal programs that carry out asthma-related activities; and (2) develop, in consultation with appropriate Federal agencies and professional and voluntary health organizations, a Federal plan for responding to asthma. (b) Representation of the Department of Housing and Urban DevelopmentA representative of the Department of Housing and Urban Development shall be included on the National Asthma Education Prevention Program Coordinating Committee for the purpose of performing the tasks described in subsection (a).

42 U.S.C. § 285b–7c Tuberculosis

(a) In generalThe Director of the National Institutes of Health may expand, intensify, and coordinate research and development and related activities of the Institutes with respect to tuberculosis including activities toward the goal of eliminating such disease. (b) Certain activitiesActivities under subsection (a) may include—(1) enhancing basic and clinical research on tuberculosis, including drug resistant tuberculosis; (2) expanding research on the relationship between such disease and the human immunodeficiency virus; and (3) developing new tools for the elimination of tuberculosis, including public health interventions and methods to enhance detection and response to outbreaks of tuberculosis, including multidrug resistant tuberculosis.

42 U.S.C. § 285b–8 Congenital heart disease

(a) In generalThe Director of the Institute may expand, intensify, and coordinate research and related activities of the Institute with respect to congenital heart disease, which may include congenital heart disease research with respect to—(1) causation of congenital heart disease, including genetic causes; (2) long-term outcomes in individuals with congenital heart disease, including infants, children, teenagers, adults, and elderly individuals; (3) diagnosis, treatment, and prevention; (4) studies using longitudinal data and retrospective analysis to identify effective treatments and outcomes for individuals with congenital heart disease; and (5) identifying barriers to life-long care for individuals with congenital heart disease. (b) Coordination of research activitiesThe Director of the Institute may coordinate research efforts related to congenital heart disease among multiple research institutions and may develop research networks. (c) Minority and medically underserved communitiesIn carrying out the activities described in this section, the Director of the Institute shall consider the application of such research and other activities to minority and medically underserved communities.

42 U.S.C. § 285b–9 HHS valvular heart disease activities

(a) In generalThe Secretary of Health and Human Services (referred to in this section as the “Secretary”) shall, as appropriate, continue activities related to research, education, and awareness of valvular heart diseases. (b) NIH research related to valvular heart diseases(1) In generalThe Director of the National Institutes of Health, in consultation with the Director of the National Heart, Lung, and Blood Institute, may support or conduct research regarding valvular heart diseases. (2) Support further researchIn order to improve information on, and understanding of, causation and risk factors for valvular heart diseases, research conducted or supported under this subsection for such diseases may include the following:(A) Use of advanced technological imaging and other relevant methods to generate data related to valvular heart diseases. (B) Assessing potential risk factors for sudden cardiac arrest or sudden cardiac death from valvular heart diseases. (C) Other activities, as appropriate, in order to improve the availability of information on, and advance research related to, valvular heart diseases. (3) Mitral valve prolapse workshopNot later than 2 years after December 20, 2022, the Director of the National Heart, Lung, and Blood Institute shall, as appropriate, convene a workshop composed of subject matter experts and stakeholders to identify research needs and opportunities to develop recommendations for the identification and treatment of individuals with mitral valve prolapse, including such individuals who may be at risk for sudden cardiac arrest or sudden cardiac death. (c) Prevention activities to improve awareness of sudden cardiac death as a result of valvular heart diseases(1) In generalThe Secretary may carry out activities to increase education and awareness of valvular heart diseases in order to reduce the incidence of sudden cardiac death caused by such diseases. The Secretary may—(A) award grants or contracts to public or nonprofit private entities to carry out activities under this subsection; and (B) directly, or through grants or contracts, provide technical assistance with respect to such activities. (2) Certain activitiesUpon availability of applicable data, projects carried out under paragraph (1) may include—(A) continuing activities at the Centers for Disease Control and Prevention related to valvular heart diseases; (B) improving the awareness of the public concerning any risk factors for, the symptoms of, and the public health impact of, valvular heart diseases; and (C) enhancing public health data collection and improving the quality of such data, as appropriate, regarding cardiac arrests, including cardiac arrests that occur outside of the hospital. (3) Grant prioritizationThe Secretary may, in awarding grants or entering into contracts pursuant to paragraph (1), give priority to entities seeking to carry out projects for populations most impacted by valvular heart diseases. (4) Coordination of activitiesThe Secretary shall, as appropriate, ensure that activities under this section are coordinated with other agencies and offices of the Department of Health and Human Services that carry out activities regarding valvular heart diseases. (5) Best practicesThe Secretary shall, as applicable and appropriate, identify and disseminate best practices for relevant health care providers related to valvular heart diseases. (d) Authorization of appropriationsFor purposes of carrying out this section, there are authorized to be appropriated $28,000,000 for each of fiscal years 2023 through 2027.

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