§241. Research and investigations generally — Inbound Citations
42 U.S.C. § 241
Cited by 19 provisions in release 119-102.
Citations to 42 U.S.C. § 241 as a whole
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(H) Programs of student assistance under titles IV, V, IX, and X of the Higher Education Act of 1965 [20 U.S.C. 1070 et seq., 1101 et seq., 1134 et seq., 1135 et seq.], and titles III, VII, and VIII of the Public Health Service Act [42 U.S.C. 241 et seq., 292 et seq., 296 et seq.].
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(4) In carrying out the responsibilities under this section, any employee designated pursuant to paragraph (1) or (2) shall coordinate with the Secretary of Health and Human Services to promote alignment, as appropriate, between CEPI and the strategic objectives and activities of the Secretary of Health and Human Services with respect to the research, development, and procurement of medical countermeasures, consistent with titles III and XXVIII of the Public Health Service Act (42 U.S.C. 241 et seq. and 300hh et seq.).
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(a) In carrying out the purposes of section 241 of this title with respect to drugs the use or misuse of which might result in drug abuse or dependency, the studies and investigations authorized therein shall include the use and misuse of narcotic drugs and other drugs. Such studies and investigations shall further include the quantities of crude opium, coca leaves, and their salts, derivatives, and preparations, and other drugs subject to control under the Controlled Substances Act [21 U.S.C. 801 et seq.] and Controlled Substances Import and Export Act [21 U.S.C. 951 et seq.], together with reserves thereof, necessary to supply the normal and emergency medicinal and scientific requirements of the United States. The results of studies and investigations of the quantities of narcotic drugs or other drugs subject to control under such Acts, together with reserves of such drugs, that are necessary to supply the normal and emergency medicinal and scientific requirements of the United States, shall be reported not later than the first day of April of each year to the Attorney General, to be used at his discretion in determining manufacturing quotas or importation requirements under such Acts.
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(c) The Secretary shall establish, under section 241 of this title, a small health care provider quality improvement grant program.
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(1) The rural health care services outreach, rural health network development, and small health care provider quality improvement grant programs established under section 241 of this title shall be administered by the Director of the Office of Rural Health Policy of the Health Resources and Services Administration, in consultation with State offices of rural health or other appropriate State government entities.
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(b) The Secretary shall establish, under section 241 of this title, telehealth network and telehealth resource centers grant programs.
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(2) For purposes of paragraph (1), the term “Healthy Start Initiative” is a reference to the program that, as an initiative to reduce the rate of infant mortality and improve perinatal outcomes, makes grants for project areas with high or increasing above the national average annual rates of infant mortality and that, prior to the effective date of this section, was a demonstration program carried out under section 241 of this title.
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(a) The Service may prepare for its own use any product described in section 262 of this title and any product necessary to carrying out any of the purposes of section 241 of this title.
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(b) In carrying out the purposes of section 241 of this title, the Secretary, acting through the Director 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 operation of programs and activities within the National Institutes of Health;(2) shall coordinate and oversee the operation of the national research institutes, national 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 coordination across the national research institutes and national centers, including conducting priority-setting reviews, to ensure that the research portfolio of the National Institutes of Health is balanced and free of unnecessary duplication, and takes advantage of collaborative, cross-cutting research;(4) shall assemble accurate data to be used to assess research priorities, including—(A) information to better evaluate scientific 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 national research institute and national center, 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 Institutes 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, implementation, and updating of the strategic plan developed under subsection (m);(6) shall ensure that the resources of the National Institutes of Health are sufficiently allocated for research projects identified in strategic plans;(A) shall, through the Division of Program Coordination, Planning, and Strategic Initiatives—(i) identify research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis and would benefit from conducting or supporting additional research that involves collaboration between 2 or more national research institutes or national centers, or would otherwise benefit from strategic coordination and planning;(ii) include information on such research in reports under section 283 of this title; and(iii) in the case of such research supported with funds referred to in subparagraph (B)—(I) require as appropriate that proposals include milestones and goals for the research;(II) require that the proposals include timeframes for funding of the research; and(III) ensure appropriate consideration of proposals for which the principal investigator is an individual who has not previously served as the principal investigator of research conducted or supported by the National Institutes of Health;(i) may, with respect to funds reserved under section 282a(c)(1) of this title for the Common Fund, allocate such funds to the national research institutes and national centers for conducting and supporting research that is identified under subparagraph (A); and(ii) shall, with respect to funds appropriated to the Division of Program Coordination, Planning, and Strategic Initiatives pursuant to section 282a(a)(2) of this title, allocate such funds to the national research institutes and national centers for making grants for pediatric research that is identified under subparagraph (A) and shall prioritize, as appropriate, such pediatric research that does not duplicate existing research activities of the National Institutes of Health; and(C) may assign additional functions to the Division in support of responsibilities identified in subparagraph (A), as determined appropriate by the Director;(8) shall, in coordination with the heads of the national research institutes and national centers, ensure that such institutes and centers—(A) preserve an emphasis on investigator-initiated research project grants, including with respect to research involving collaboration between 2 or more such institutes or centers;(B) when appropriate, maximize investigator-initiated research project grants in their annual research portfolios;(C) foster collaboration between clinical research projects funded by the respective national research institutes and national centers that—(i) conduct research involving human subjects; and(ii) collect similar data; and(D) encourage the collaboration described in subparagraph (C) to—(i) allow for an increase in the number of subjects studied; and(ii) utilize diverse study populations, with special consideration to biological, social, and other determinants of health that contribute to health disparities;(9) shall ensure that research conducted or supported by the National Institutes of Health is subject to review in accordance with section 289a of this title and that, after such review, the research is reviewed in accordance with section 289a–1(a)(2) of this title by the appropriate advisory council under section 284a of this title before the research proposals are approved for funding;(10) shall have authority to review and approve the establishment of all centers of excellence recommended by the national research institutes;(A) shall oversee research training for all of the national research institutes and National Research Service Awards in accordance with section 288 of this title; and(B) may conduct and support research training—(i) for which fellowship support is not provided under section 288 of this title; and(ii) that does not consist of residency training of physicians or other health professionals;(12) may, from funds appropriated under section 282a(b) of this title, reserve funds to provide for research on matters that have not received significant funding relative to other matters, to respond to new issues and scientific emergencies, and to act on research opportunities of high priority;(13) may, subject to appropriations Acts, collect and retain registration fees obtained from third parties to defray expenses for scientific, educational, and research-related conferences;(14) for the national research institutes and administrative entities within the National Institutes of Health—(A) may acquire, construct, improve, repair, operate, and maintain, at the site of such institutes and entities, laboratories, and other research facilities, other facilities, equipment, and other real or personal property, and(B) may 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 use for a period not to exceed ten years;(15) may secure resources for research conducted by or through the National Institutes of Health;(16) may, without regard to the provisions of title 5 governing appointments in the competitive service, and without regard to the provisions of chapter 51 and subchapter III of chapter 53 of such title relating to classification and General Schedule pay rates, establish such technical and scientific peer review groups and scientific program advisory committees as are needed to carry out the requirements of this subchapter and appoint and pay the members of such groups, except that officers and employees of the United States shall not receive additional compensation for service as members of such groups;(17) may secure for the National Institutes of Health consultation services and advice of persons from the United States or abroad;(18) may use, with their consent, the services, equipment, personnel, information, and facilities of other Federal, State, or local public agencies, with or without reimbursement therefor;(19) may, for purposes of study, admit and treat at facilities of the National Institutes of Health individuals not otherwise eligible for such treatment;(20) may accept voluntary and uncompensated services;(21) may perform such other administrative functions as the Secretary determines are needed to effectively carry out this subchapter;(22) may appoint physicians, dentists, and other health care professionals, subject to the provisions of title 5 relating to appointments and classifications in the competitive service, and may compensate such professionals subject to the provisions of chapter 74 of title 38;(23) shall designate a contact point or office to help innovators and physicians identify sources of funding available for pediatric medical device development;(24) implement the Cures Acceleration Network described in section 287a of this title;(25) may require recipients of National Institutes of Health awards to share scientific data, to the extent feasible, generated from such National Institutes of Health awards in a manner that is consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection of—(A) human research participants, including with respect to privacy, security, informed consent, and protected health information; and(B) proprietary interests, confidential commercial information, and the intellectual property rights of the funding recipient;(26) shall consult with the Assistant Secretary for Preparedness and Response, the Director of the Biomedical Advanced Research and Development Authority, the Director of the Centers for Disease Control and Prevention, and the heads of other Federal agencies and offices, as appropriate, regarding research needs to advance medical countermeasures to diagnose, mitigate, prevent, or treat harm from any biological agent or toxin, including emerging infectious diseases, chemical, radiological, or nuclear agent that may cause a public health emergency or other research needs related to emerging public health threats;(27) shall consult with the Director of the Office of National Security within the Department of Health and Human Services, the Assistant Secretary for Preparedness and Response, the Director of National Intelligence, the Director of the Federal Bureau of Investigation, and the heads of other appropriate agencies on a regular basis, regarding biomedical research conducted or supported by the National Institutes of Health that may affect or be affected by matters of national security;(28) shall ensure that recipients of awards from the National Institutes of Health, and, as appropriate and practicable, entities collaborating with such recipients, have in place and are adhering to appropriate technology practices and policies for the security of identifiable, sensitive information, including information collected, stored, managed, or analyzed by domestic and non-domestic entities; and(29) shall ensure that recipients of awards from the National Institutes of Health are in compliance with the terms and conditions of such award, which may include activities to support awareness of, and compliance with, such terms and conditions by any subrecipients of the award.Chapter 10 of title 5 shall not apply to the duration of a peer review group appointed under paragraph (16). The members of such a group shall be individuals who by virtue of their training or experience are eminently qualified to perform the review functions of such group. Not more than one-fourth of the members of any such group shall be officers or employees of the United States.
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(1) In carrying out the purposes of section 241 of this title with respect to human diseases or disorders or other aspects of human health for which the national research institutes were established, the Secretary, acting through the Director of each national research institute—(A) shall encourage and support research, investigations, experiments, demonstrations, and studies in the health sciences related to—(i) the maintenance of health,(ii) the detection, diagnosis, treatment, and prevention of human diseases and disorders,(iii) the rehabilitation of individuals with human diseases, disorders, and disabilities, and(iv) the expansion of knowledge of the processes underlying human diseases, disorders, and disabilities, the processes underlying the normal and pathological functioning of the body and its organ systems, and the processes underlying the interactions between the human organism and the environment;(B) may, subject to the peer review prescribed under section 289a(b) of this title and any advisory council review under section 284a(a)(3)(A)(i) of this title, conduct the research, investigations, experiments, demonstrations, and studies referred to in subparagraph (A);(C) shall, as appropriate, conduct and support research that has the potential to transform the scientific field, has inherently higher risk, and that seeks to address major current challenges;(D) may conduct and support research training (i) for which fellowship support is not provided under section 288 of this title, and (ii) which is not residency training of physicians or other health professionals;(E) may develop, implement, and support demonstrations and programs for the application of the results of the activities of the institute to clinical practice and disease prevention activities;(F) may develop, conduct, and support public and professional education and information programs;(G) may secure, develop and maintain, distribute, and support the development and maintenance of resources needed for research;(H) may make available the facilities of the institute to appropriate entities and individuals engaged in research activities and cooperate with and assist Federal and State agencies charged with protecting the public health;(I) may accept unconditional gifts made to the institute for its activities, and, in the case of gifts of a value in excess of $50,000, establish suitable memorials to the donor;(J) may secure for the institute consultation services and advice of persons from the United States or abroad;(K) may use, with their consent, the services, equipment, personnel, information, and facilities of other Federal, State, or local public agencies, with or without reimbursement therefor;(L) may accept voluntary and uncompensated services; and(M) may perform such other functions as the Secretary determines are needed to carry out effectively the purposes of the institute.The indemnification provisions of section 3861 of title 10 shall apply with respect to contracts entered into under this subsection and section 282(b) of this title.
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In carrying out section 241 of this title, the Secretary may make grants to public and nonprofit private entities, and may enter into contracts with public and private entities and individuals, for projects for (1) basic or applied research leading to the understanding, diagnosis, treatment, and control of genetic diseases, (2) planning, establishing, demonstrating, and developing special programs for the training of genetic counselors, social and behavioral scientists, and other health professionals, (3) the development of programs to educate practicing physicians, other health professionals, and the public regarding the nature of genetic processes, the inheritance patterns of genetic diseases, and the means, methods, and facilities available to diagnose, control, counsel, and treat genetic diseases, and (4) the development of counseling and testing programs and other programs for the diagnosis, control, and treatment of genetic diseases. In making grants and entering into contracts for projects described in clause (1) of the preceding sentence, the Secretary shall give priority to applications for such grants or contracts which are submitted for research on sickle cell anemia and for research on Cooley’s anemia.
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(b) In making grants and entering into contracts for any fiscal year under section 241 of this title for projects described in section 300b–1 of this title the Secretary shall give special consideration to applications from entities that received grants from, or entered into contracts with, the Secretary for the preceding fiscal year for the conduct of comprehensive sickle cell centers or sickle cell screening and education clinics.
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(A) be based on the radiation dose received by the employee (or a group of employees performing similar work) at such facility and the upper 99 percent confidence interval of the probability of causation in the radioepidemiological tables published under section 7(b) of the Orphan Drug Act (42 U.S.C. 241 note), as such tables may be updated under section 7(b)(3) of such Act from time to time;
Citations to §241(a)(3)
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(1) The Secretary may, as the Secretary determines necessary to respond to pressing qualified countermeasure research and development needs under this section, employ such expedited peer review procedures (including consultation with appropriate scientific experts) as the Secretary, in consultation with the Director of NIH, deems appropriate to obtain assessment of scientific and technical merit and likely contribution to the field of qualified countermeasure research, in place of the peer review and advisory council review procedures that would be required under sections 241(a)(3), 284(b)(1)(B), 284(b)(2), 284a(a)(3)(A), 289a, and 289c of this title, as applicable to a grant, contract, or cooperative agreement—(A) that is for performing, administering, or supporting qualified countermeasure research and development activities; and(B) the amount of which is not greater than $1,500,000.
Citations to §241(d)(4)
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(a) The Secretary of Health and Human Services, in consultation with the Director of National Intelligence, the Secretary of State, the Secretary of Defense, and other national security experts, as appropriate, shall ensure that biomedical research conducted or supported by the National Institutes of Health and other relevant agencies and offices within the Department of Health and Human Services is conducted or supported in a manner that appropriately considers national security risks, including national security implications related to research involving the sequencing of human genomic information, and collection, analysis, or storage of identifiable, sensitive information, as defined in section 241(d)(4) of this title, and the potential misuse of such data. Not later than 2 years after December 29, 2022, the Secretary shall ensure that the National Institutes of Health and other relevant agencies and offices within the Department of Health and Human Services, in consultation with the heads of agencies and national security experts, including the Office of the National Security within the Department of Health and Human Services—(1) develop a comprehensive framework and policies for assessing and managing such national security risks that includes, or review and update, as appropriate, the current (as of the date of review) such framework and policies to include—(A) criteria for how and when to conduct risk assessments for projects that may have national security implications;(B) security controls and training for researchers or entities, including peer reviewers, that manage or have access to such data that may present national security risks; and(C) methods to incorporate risk mitigation in the process for funding such projects that may have national security implications and monitor associated research activities following issuance of an award, including changes in the terms and conditions related to the use of such funds, as appropriate;(2) not later than 1 year after the framework and policies are developed or reviewed and updated, as applicable, under paragraph (1), develop and implement controls to ensure that—(A) researchers or entities involved in projects reviewed under the framework and relevant policies, including such projects that manage or have access to sensitive, identifiable information, have complied with the requirements of paragraph (1) and ongoing requirements with such paragraph;(B) consideration of funding for projects that may have national security implications takes into account the extent to which the country in which the proposed research will be conducted or supported poses a risk to the integrity of the United States biomedical research enterprise; and(C) data access committees reviewing data access requests for projects that may have national security risks, as appropriate, include members with expertise in current and emerging national security threats, in order to make appropriate decisions, including related to access to such identifiable, sensitive information; and(3) not later than 2 years after the framework and relevant policies are developed or reviewed and updated, as applicable, under paragraph (1), update data access and sharing policies related to human genomic data, as applicable, based on current and emerging national security threats.
Citations to §241(g)
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(d) The flexibilities provided to the National Institutes of Health under section 241(g) of this title shall apply to ARPA–H with respect to the functions described in subsection (b)(2).