SUBCHAPTER III—NATIONAL RESEARCH INSTITUTES
Codification
Title IV of the Public Health Service Act, comprising this subchapter, was originally enacted by act July 1, 1944, ch. 373,
The provisions of title IV as originally enacted were subsequently redesignated as part A of title IV and amended, and parts B to I of title IV were added and amended by the following acts: June 16, 1948, ch.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,
Title IV was subsequently amended generally and completely reorganized by
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 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 any national research institute, was established within the National Institutes of Health as of the day before January 15, 2007.
(c) Division of Program Coordination, Planning, and Strategic Initiatives
(1) In general
Within the Office of the Director of the National Institutes of Health, there shall be a Division of Program Coordination, Planning, and Strategic Initiatives (referred to in this subsection as the "Division").
(2) Offices within Division
(A) Offices
The following offices are within the Division: 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 additional offices or other administrative units as the Director determines to be appropriate.
(B) Authorities
Each office in the Division—
(i) shall continue to carry out the authorities 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
(d) Organization
(1) Number of institutes and centers
In the National Institutes of Health, the number of national research institutes and national centers may not exceed a total of 27, including any such institutes or centers established 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 National Institutes of Health one or more additional national research institutes to conduct and support research, training, health information, and other programs with respect to any particular disease or groups of diseases or any other aspect of human health if—
(i) the Secretary determines that an additional institute is necessary to carry out such activities; and
(ii) the additional institute is not established before the expiration of 180 days after the Secretary has provided the Committee 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 determination made under clause (i) with respect to the institute.
(B) Additional authority
The Secretary may reorganize the functions of any national research institute and may abolish any national research institute if the Secretary determines that the institute 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 Committee 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 reorganization 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, reorganize the offices within the Office of the Director, 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 offices 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, 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, including the addition, removal, or transfer of functions 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 programs 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 Management Review Board (referred to in this subsection as the "Board").
(2) Duties
(A) Reports on organizational issues
The Board shall provide advice to the appropriate officials under subsection (d) regarding the use of the authorities established in paragraphs (2), (3), and (4) of such subsection to reorganize the National Institutes of Health (referred to in this subsection 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 recommendations of the Board regarding the use of the authorities and the reasons underlying the recommendations.
(B) Certain responsibilities regarding reports
The activities of the Board with respect to a report under subparagraph (A) shall include 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 allocation among the portfolio activities of the resources of NIH.
(ii) Determining pending scientific opportunities, 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 significant consideration as a possible recommendation in such report—
(I) analyzing the budgetary and operational consequences of the proposed changes;
(II) taking into account historical funding and support for research activities at national research institutes and centers that have been established recently relative to national research institutes 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 recommendation for the allocation of the resources of NIH among the national research institutes 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 institutes and national centers whose directors are not members of the Board;
(ii) other scientific leaders who are officers or employees of NIH and are not members of the Board;
(iii) advisory councils of the national research institutes and national centers;
(iv) organizations representing the scientific 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 following:
(A) Not fewer than 9 officials who are directors of national research institutes or national centers. The Secretary shall designate such officials for membership and shall ensure that the group of officials so designated includes directors of—
(i) national research institutes whose budgets are substantial relative to a majority 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 period of time without significant organizational change under subsection (d);
(iv) as applicable, national research institutes that have undergone significant organization changes under such subsection, 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 broad expertise regarding how the National Institutes of Health functions, exclusive 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 paragraph (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 scientific needs and opportunities related to proposals for organizational changes under subsection (d), or as the case may be, related 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 referred to in clause (i).
(C) Availability of information from forums
For each meeting under subparagraph (B), the Director of NIH shall post on the Internet 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
(7) Reports
(A) Recommendations for changes
Each report under paragraph (2)(A) shall be submitted to—
(i) the Committee on Energy and Commerce and the Committee on Appropriations 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 authorities, other than any such official who served as a member of the Board with respect 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 committees 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 organizational authorities within the meaning of subsection (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 recommendation made in a report under subsection (e)(2)(A) if the recommendation is for—
(A) an organizational change under subsection (d)(2) that constitutes the establishment, termination, or consolidation of one or more national research institutes or national centers; or
(B) an organizational change under subsection (d)(3).
(3) Objection by Director of NIH
(A) In general
Paragraph (1) does not apply to a recommendation 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 Director of NIH submits to the committees specified in such subsection a report providing 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 objection by the Director of NIH may be made to the entirety of a recommended organizational 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 subparagraph (A) shall be implemented in accordance 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 accordance with the procedures for substantive rules under
(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 terminated 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
Amendments
2014—Subsec. (b)(23).
2011—Subsec. (b)(21).
Subsec. (c)(2)(A).
2010—Subsec. (b)(24).
2007—Subsec. (b)(7).
Subsec. (d)(2).
Subsec. (d)(3), (4).
Subsecs. (e) to (h).
2000—Subsec. (b)(1)(R).
Subsec. (b)(2)(F).
Subsec. (b)(2)(G).
1998—Subsec. (b)(1)(H).
Subsec. (b)(2)(F).
1994—Subsec. (b)(2)(E).
1993—Subsec. (b)(1)(Q).
Subsec. (b)(2)(B).
Subsec. (b)(2)(D).
1992—Subsec. (b)(1)(N) to (P).
1988—Subsec. (b)(1)(J), (M).
Effective Date of 2007 Amendment
Effective Date of 2000 Amendment
Effective Date of 1992 Amendment
Amendment by
Effective Date of 1988 Amendment
For effective date of amendment by
Construction of 2007 Amendment
Study of the Use of Centers of Excellence at the National Institutes of Health
Report on Medical Uses of Biological Agents in Development of Defenses Against Biological Warfare
Research on Lupus Erythematosus
Interagency Committee on Learning Disabilities
§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 appointed by the President by and with the advice and consent of the Senate. The Director of NIH shall perform functions as provided under subsection (b) and as the Secretary may otherwise prescribe.
(b) Duties and authority
In carrying out the purposes of
(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;
(7)(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
(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;
(B)(i) may, with respect to funds reserved under
(ii) shall, with respect to funds appropriated to the Common Fund pursuant to
(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
(10) shall have authority to review and approve the establishment of all centers of excellence recommended by the national research institutes;
(11)(A) shall oversee research training for all of the national research institutes and National Research Service Awards in accordance with
(B) may conduct and support research training—
(i) for which fellowship support is not provided under
(ii) that does not consist of residency training of physicians or other health professionals;
(12) may, from funds appropriated under
(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
(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
(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
(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
(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.
The Federal Advisory Committee Act 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.
(c) Availability of substances and organisms for research
The Director of NIH may make available to individuals and entities, for biomedical and behavioral research, substances and living organisms. Such substances and organisms shall be made available under such terms and conditions (including payment for them) as the Secretary determines appropriate.
(d) Services of experts or consultants; number; payment of expenses, conditions, recovery
(1) The Director of NIH may obtain (in accordance with
(2)(A) Except as provided in subparagraph (B), 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.
(B) Expenses specified in subparagraph (A) 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 Secretary. 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 this subparagraph.
(e) Dissemination of research information
The Director of NIH shall—
(1) advise the agencies of the National Institutes of Health on medical applications of research;
(2) coordinate, review, and facilitate the systematic identification and evaluation of, clinically relevant information from research conducted by or through the national research institutes;
(3) promote the effective transfer of the information described in paragraph (2) to the health care community and to entities that require such information;
(4) monitor the effectiveness of the activities described in paragraph (3); and
(5) ensure that, after January 1, 1994, all new or revised health education and promotion materials developed or funded by the National Institutes of Health and intended for the general public are in a form that does not exceed a level of functional literacy, as defined in the National Literacy Act of 1991 (
(f) Associate Director for Prevention; functions
There shall be in the National Institutes of Health an Associate Director for Prevention. The Director of NIH shall delegate to the Associate Director for Prevention the functions of the Director relating to the promotion of the disease prevention research programs of the national research institutes and the coordination of such programs among the national research institutes and between the national research institutes and other public and private entities, including elementary, secondary, and post-secondary schools. The Associate Director shall—
(1) annually review the efficacy of existing policies and techniques used by the national research institutes to disseminate the results of disease prevention and behavioral research programs; and
(2) recommend, coordinate, and oversee the modification or reconstruction of such policies and techniques to ensure maximum dissemination, using advanced technologies to the maximum extent practicable, of research results to such entities.
(g) Transferred
(h) Increased participation of women and disadvantaged individuals in biomedical and behavioral research
The Secretary, acting through the Director of NIH and the Directors of the agencies of the National Institutes of Health, shall, in conducting and supporting programs for research, research training, recruitment, and other activities, provide for an increase in the number of women and individuals from disadvantaged backgrounds (including racial and ethnic minorities) in the fields of biomedical and behavioral research.
(i) Data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions
(1)(A) The Secretary, acting through the Director of NIH, shall establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions (in this subsection referred to as the "data bank"). The activities of the data bank shall be integrated and coordinated with related activities of other agencies of the Department of Health and Human Services, and to the extent practicable, coordinated with other data banks containing similar information.
(B) The Secretary shall establish the data bank after consultation with the Commissioner of Food and Drugs, the directors of the appropriate agencies of the National Institutes of Health (including the National Library of Medicine), and the Director of the Centers for Disease Control and Prevention.
(2) In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the information described in such paragraph. The Secretary shall disseminate such information through information systems, which shall include toll-free telephone communications, available to individuals with serious or life-threatening diseases and conditions, to other members of the public, to health care providers, and to researchers.
(3) The data bank shall include the following:
(A) A registry of clinical trials (whether federally or privately funded) of experimental treatments for serious or life-threatening diseases and conditions under regulations promulgated pursuant to
(B) Information pertaining to experimental treatments for serious or life-threatening diseases and conditions that may be available—
(i) under a treatment investigational new drug application that has been submitted to the Secretary under
(ii) as a Group C cancer drug (as defined by the National Cancer Institute).
The data bank may also include information pertaining to the results of clinical trials of such treatments, with the consent of the sponsor, including information concerning potential toxicities or adverse effects associated with the use or administration of such experimental treatments.
(4) The data bank shall not include information relating to an investigation if the sponsor has provided a detailed certification to the Secretary that disclosure of such information would substantially interfere with the timely enrollment of subjects in the investigation, unless the Secretary, after the receipt of the certification, provides the sponsor with a detailed written determination that such disclosure would not substantially interfere with such enrollment.
(5) Fees collected under
(j) Expanded clinical trial registry data bank
(1) Definitions; requirement
(A) Definitions
In this subsection:
(i) Applicable clinical trial
The term "applicable clinical trial" means an applicable device clinical trial or an applicable drug clinical trial.
(ii) Applicable device clinical trial
The term "applicable device clinical trial" means—
(I) a prospective clinical study of health outcomes comparing an intervention with a device subject to
(II) a pediatric postmarket surveillance as required under
(iii) Applicable drug clinical trial
(I) In general
The term "applicable drug clinical trial" means a controlled clinical investigation, other than a phase I clinical investigation, of a drug subject to
(II) Clinical investigation
For purposes of subclause (I), the term "clinical investigation" has the meaning given that term in section 312.3 of title 21, Code of Federal Regulations (or any successor regulation).
(III) Phase I
For purposes of subclause (I), the term "phase I" has the meaning given that term in section 312.21 of title 21, Code of Federal Regulations (or any successor regulation).
(iv) Clinical trial information
The term "clinical trial information" means, with respect to an applicable clinical trial, those data elements that the responsible party is required to submit under paragraph (2) or under paragraph (3).
(v) Completion date
The term "completion date" means, with respect to an applicable clinical trial, the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated.
(vi) Device
The term "device" means a device as defined in
(vii) Drug
The term "drug" means a drug as defined in
(viii) Ongoing
The term "ongoing" means, with respect to a clinical trial of a drug or a device and to a date, that—
(I) 1 or more patients is enrolled in the clinical trial; and
(II) the date is before the completion date of the clinical trial.
(ix) Responsible party
The term "responsible party", with respect to a clinical trial of a drug or device, means—
(I) the sponsor of the clinical trial (as defined in section 50.3 of title 21, Code of Federal Regulations (or any successor regulation)); or
(II) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this subsection for the submission of clinical trial information.
(B) Requirement
The Secretary shall develop a mechanism by which the responsible party for each applicable clinical trial shall submit the identity and contact information of such responsible party to the Secretary at the time of submission of clinical trial information under paragraph (2).
(2) Expansion of clinical trial registry data bank with respect to clinical trial information
(A) In general
(i) Expansion of data bank
To enhance patient enrollment and provide a mechanism to track subsequent progress of clinical trials, the Secretary, acting through the Director of NIH, shall expand, in accordance with this subsection, the clinical trials registry of the data bank described under subsection (i)(1) (referred to in this subsection as the "registry data bank"). The Director of NIH shall ensure that the registry data bank is made publicly available through the Internet.
(ii) Content
The clinical trial information required to be submitted under this paragraph for an applicable clinical trial shall include—
(I) descriptive information, including—
(aa) a brief title, intended for the lay public;
(bb) a brief summary, intended for the lay public;
(cc) the primary purpose;
(dd) the study design;
(ee) for an applicable drug clinical trial, the study phase;
(ff) study type;
(gg) the primary disease or condition being studied, or the focus of the study;
(hh) the intervention name and intervention type;
(ii) the study start date;
(jj) the expected completion date;
(kk) the target number of subjects; and
(ll) outcomes, including primary and secondary outcome measures;
(II) recruitment information, including—
(aa) eligibility criteria;
(bb) gender;
(cc) age limits;
(dd) whether the trial accepts healthy volunteers;
(ee) overall recruitment status;
(ff) individual site status; and
(gg) in the case of an applicable drug clinical trial, if the drug is not approved under
(III) location and contact information, including—
(aa) the name of the sponsor;
(bb) the responsible party, by official title; and
(cc) the facility name and facility contact information (including the city, State, and zip code for each clinical trial location, or a toll-free number through which such location information may be accessed); and
(IV) administrative data (which the Secretary may make publicly available as necessary), including—
(aa) the unique protocol identification number;
(bb) other protocol identification numbers, if any; and
(cc) the Food and Drug Administration IND/IDE protocol number and the record verification date.
(iii) Modifications
The Secretary may by regulation modify the requirements for clinical trial information under this paragraph, if the Secretary provides a rationale for why such a modification improves and does not reduce such clinical trial information.
(B) Format and structure
(i) Searchable categories
The Director of NIH shall ensure that the public may, in addition to keyword searching, search the entries in the registry data bank by 1 or more of the following criteria:
(I) The disease or condition being studied in the clinical trial, using Medical Subject Headers (MeSH) descriptors.
(II) The name of the intervention, including any drug or device being studied in the clinical trial.
(III) The location of the clinical trial.
(IV) The age group studied in the clinical trial, including pediatric subpopulations.
(V) The study phase of the clinical trial.
(VI) The sponsor of the clinical trial, which may be the National Institutes of Health or another Federal agency, a private industry source, or a university or other organization.
(VII) The recruitment status of the clinical trial.
(VIII) The National Clinical Trial number or other study identification for the clinical trial.
(ii) Additional searchable category
Not later than 18 months after September 27, 2007, the Director of NIH shall ensure that the public may search the entries of the registry data bank by the safety issue, if any, being studied in the clinical trial as a primary or secondary outcome.
(iii) Other elements
The Director of NIH shall also ensure that the public may search the entries of the registry data bank by such other elements as the Director deems necessary on an ongoing basis.
(iv) Format
The Director of the NIH shall ensure that the registry data bank is easily used by the public, and that entries are easily compared.
(C) Data submission
The responsible party for an applicable clinical trial, including an applicable drug clinical trial for a serious or life-threatening disease or condition, that is initiated after, or is ongoing on the date that is 90 days after, September 27, 2007, shall submit to the Director of NIH for inclusion in the registry data bank the clinical trial information described in of 1 subparagraph (A)(ii) not later than the later of—
(i) 90 days after September 27, 2007;
(ii) 21 days after the first patient is enrolled in such clinical trial; or
(iii) in the case of a clinical trial that is not for a serious or life-threatening disease or condition and that is ongoing on September 27, 2007, 1 year after September 27, 2007.
(D) Posting of data
(i) Applicable drug clinical trial
The Director of NIH shall ensure that clinical trial information for an applicable drug clinical trial submitted in accordance with this paragraph is posted in the registry data bank not later than 30 days after such submission.
(ii) Applicable device clinical trial
The Director of NIH shall ensure that clinical trial information for an applicable device clinical trial submitted in accordance with this paragraph is posted publicly in the registry data bank—
(I) not earlier than the date of clearance under
(II) for a device that was previously cleared or approved, not later than 30 days after the clinical trial information under paragraph (3)(C) is required to be posted by the Secretary.
(iii) Option to make certain clinical trial information available earlier
The Director of the National Institutes of Health shall inform responsible parties of the option to request that clinical trial information for an applicable device clinical trial be publicly posted prior to the date of clearance or approval, in accordance with clause (ii)(I).
(iv) Combination products
An applicable clinical trial for a product that is a combination of drug, device, or biological product shall be considered—
(I) an applicable drug clinical trial, if the Secretary determines under
(II) an applicable device clinical trial, if the Secretary determines under such section that the primary mode of action of such product is that of a device.
(3) Expansion of registry data bank to include results of clinical trials
(A) Linking registry data bank to existing results
(i) In general
Beginning not later than 90 days after September 27, 2007, for those clinical trials that form the primary basis of an efficacy claim or are conducted after the drug involved is approved or after the device involved is cleared or approved, the Secretary shall ensure that the registry data bank includes links to results information as described in clause (ii) for such clinical trial—
(I) not earlier than 30 days after the date of the approval of the drug involved or clearance or approval of the device involved; or
(II) not later than 30 days after the results information described in clause (ii) becomes publicly available.
(ii) Required information
(I) FDA information
The Secretary shall ensure that the registry data bank includes links to the following information:
(aa) If an advisory committee considered at a meeting an applicable clinical trial, any posted Food and Drug Administration summary document regarding such applicable clinical trial.
(bb) If an applicable drug clinical trial was conducted under
(cc) Food and Drug Administration public health advisories regarding the drug or device that is the subject of the applicable clinical trial, if any.
(dd) For an applicable drug clinical trial, the Food and Drug Administration action package for approval document required under
(ee) For an applicable device clinical trial, in the case of a premarket application under
(II) NIH information
The Secretary shall ensure that the registry data bank includes links to the following information:
(aa) Medline citations to any publications focused on the results of an applicable clinical trial.
(bb) The entry for the drug that is the subject of an applicable drug clinical trial in the National Library of Medicine database of structured product labels, if available.
(iii) Results for existing data bank entries
The Secretary may include the links described in clause (ii) for data bank entries for clinical trials submitted to the data bank prior to September 27, 2007, as available.
(B) Inclusion of results
The Secretary, acting through the Director of NIH, shall—
(i) expand the registry data bank to include the results of applicable clinical trials (referred to in this subsection as the "registry and results data bank");
(ii) ensure that such results are made publicly available through the Internet;
(iii) post publicly a glossary for the lay public explaining technical terms related to the results of clinical trials; and
(iv) in consultation with experts on risk communication, provide information with the information included under subparagraph (C) in the registry and results data bank to help ensure that such information does not mislead the patients or the public.
(C) Basic results
Not later than 1 year after September 27, 2007, the Secretary shall include in the registry and results data bank for each applicable clinical trial for a drug that is approved under
(i) Demographic and baseline characteristics of patient sample
A table of the demographic and baseline data collected overall and for each arm of the clinical trial to describe the patients who participated in the clinical trial, including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any.
(ii) Primary and secondary outcomes
The primary and secondary outcome measures as submitted under paragraph (2)(A)(ii)(I)(ll), and a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial, including the results of scientifically appropriate tests of the statistical significance of such outcome measures.
(iii) Point of contact
A point of contact for scientific information about the clinical trial results.
(iv) Certain agreements
Whether there exists an agreement (other than an agreement solely to comply with applicable provisions of law protecting the privacy of participants) between the sponsor or its agent and the principal investigator (unless the sponsor is an employer of the principal investigator) that restricts in any manner the ability of the principal investigator, after the completion date of the trial, to discuss the results of the trial at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the trial.
(D) Expanded registry and results data bank
(i) Expansion by rulemaking
To provide more complete results information and to enhance patient access to and understanding of the results of clinical trials, not later than 3 years after September 27, 2007, the Secretary shall by regulation expand the registry and results data bank as provided under this subparagraph.
(ii) Clinical trials
(I) Approved products
The regulations under this subparagraph shall require the inclusion of the results information described in clause (iii) for—
(aa) each applicable drug clinical trial for a drug that is approved under
(bb) each applicable device clinical trial for a device that is cleared under
(II) Unapproved products
The regulations under this subparagraph shall establish whether or not the results information described in clause (iii) shall be required for—
(aa) an applicable drug clinical trial for a drug that is not approved under
(bb) an applicable device clinical trial for a device that is not cleared under
(iii) Required elements
The regulations under this subparagraph shall require, in addition to the elements described in subparagraph (C), information within each of the following categories:
(I) A summary of the clinical trial and its results that is written in non-technical, understandable language for patients, if the Secretary determines that such types of summary can be included without being misleading or promotional.
(II) A summary of the clinical trial and its results that is technical in nature, if the Secretary determines that such types of summary can be included without being misleading or promotional.
(III) The full protocol or such information on the protocol for the trial as may be necessary to help to evaluate the results of the trial.
(IV) Such other categories as the Secretary determines appropriate.
(iv) Results submission
The results information described in clause (iii) shall be submitted to the Director of NIH for inclusion in the registry and results data bank as provided by subparagraph (E), except that the Secretary shall by regulation determine—
(I) whether the 1-year period for submission of clinical trial information described in subparagraph (E)(i) should be increased from 1 year to a period not to exceed 18 months;
(II) whether the clinical trial information described in clause (iii) should be required to be submitted for an applicable clinical trial for which the clinical trial information described in subparagraph (C) is submitted to the registry and results data bank before the effective date of the regulations issued under this subparagraph; and
(III) in the case when the clinical trial information described in clause (iii) is required to be submitted for the applicable clinical trials described in clause (ii)(II), the date by which such clinical trial information shall be required to be submitted, taking into account—
(aa) the certification process under subparagraph (E)(iii) when approval, licensure, or clearance is sought; and
(bb) whether there should be a delay of submission when approval, licensure, or clearance will not be sought.
(v) Additional provisions
The regulations under this subparagraph shall also establish—
(I) a standard format for the submission of clinical trial information under this paragraph to the registry and results data bank;
(II) additional information on clinical trials and results that is written in nontechnical, understandable language for patients;
(III) considering the experience under the pilot quality control project described in paragraph (5)(C), procedures for quality control, including using representative samples, with respect to completeness and content of clinical trial information under this subsection, to help ensure that data elements are not false or misleading and are non-promotional;
(IV) the appropriate timing and requirements for updates of clinical trial information, and whether and, if so, how such updates should be tracked;
(V) a statement to accompany the entry for an applicable clinical trial when the primary and secondary outcome measures for such clinical trial are submitted under paragraph (4)(A) after the date specified for the submission of such information in paragraph (2)(C); and
(VI) additions or modifications to the manner of reporting of the data elements established under subparagraph (C).
(vi) Consideration of World Health Organization data set
The Secretary shall consider the status of the consensus data elements set for reporting clinical trial results of the World Health Organization when issuing the regulations under this subparagraph.
(vii) Public meeting
The Secretary shall hold a public meeting no later than 18 months after September 27, 2007, to provide an opportunity for input from interested parties with regard to the regulations to be issued under this subparagraph.
(E) Submission of results information
(i) In general
Except as provided in clauses (iii), (iv), (v), and (vi) the responsible party for an applicable clinical trial that is described in clause (ii) shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraph (C) not later than 1 year, or such other period as may be provided by regulation under subparagraph (D), after the earlier of—
(I) the estimated completion date of the trial as described in paragraph (2)(A)(ii)(I)(jj)); 2 or
(II) the actual date of completion.
(ii) Clinical trials described
An applicable clinical trial described in this clause is an applicable clinical trial subject to—
(I) paragraph (2)(C); and
(II)(aa) subparagraph (C); or
(bb) the regulations issued under subparagraph (D).
(iii) Delayed submission of results with certification
If the responsible party for an applicable clinical trial submits a certification that clause (iv) or (v) applies to such clinical trial, the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) as required under the applicable clause.
(iv) Seeking initial approval of a drug or device
With respect to an applicable clinical trial that is completed before the drug is initially approved under
(v) Seeking approval of a new use for the drug or device
(I) In general
With respect to an applicable clinical trial where the manufacturer of the drug or device is the sponsor of an applicable clinical trial, and such manufacturer has filed, or will file within 1 year, an application seeking approval under
(aa) the new use of the drug or device is approved under such section 355, licensed under such section 262, cleared under such section 360(k), or approved under such section 360e or 360j(m);
(bb) the Secretary issues a letter, such as a complete response letter, not approving the submission or not clearing the submission, a not approvable letter, or a not substantially equivalent letter for the new use of the drug or device under such section 355, 262, 360(k), 360e, or 360j(m); or
(cc) except as provided in subclause (III), the application or premarket notification under such section 355, 262, 360(k), 360e, or 360j(m) is withdrawn without resubmission for no less than 210 days.
(II) Requirement that each clinical trial in application be treated the same
If a manufacturer makes a certification under clause (iii) that this clause applies with respect to a clinical trial, the manufacturer shall make such a certification with respect to each applicable clinical trial that is required to be submitted in an application or report for licensure, approval, or clearance (under
(III) Two-year limitation
The responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information subject to subclause (I) on the date that is 2 years after the date a certification under clause (iii) was made to the Director of NIH, if an action referred to in item (aa), (bb), or (cc) of subclause (I) has not occurred by such date.
(vi) Extensions
The Director of NIH may provide an extension of the deadline for submission of clinical trial information under clause (i) if the responsible party for the trial submits to the Director a written request that demonstrates good cause for the extension and provides an estimate of the date on which the information will be submitted. The Director of NIH may grant more than one such extension for a clinical trial.
(F) Notice to Director of NIH
The Commissioner of Food and Drugs shall notify the Director of NIH when there is an action described in subparagraph (E)(iv) or item (aa), (bb), or (cc) of subparagraph (E)(v)(I) with respect to an application or a report that includes a certification required under paragraph (5)(B) of such action not later than 30 days after such action.
(G) Posting of data
The Director of NIH shall ensure that the clinical trial information described in subparagraphs (C) and (D) for an applicable clinical trial submitted in accordance with this paragraph is posted publicly in the registry and results database not later than 30 days after such submission.
(H) Waivers regarding certain clinical trial results
The Secretary may waive any applicable requirements of this paragraph for an applicable clinical trial, upon a written request from the responsible party, if the Secretary determines that extraordinary circumstances justify the waiver and that providing the waiver is consistent with the protection of public health, or in the interest of national security. Not later than 30 days after any part of a waiver is granted, the Secretary shall notify, in writing, the appropriate committees of Congress of the waiver and provide an explanation for why the waiver was granted.
(I) Adverse events
(i) Regulations
Not later than 18 months after September 27, 2007, the Secretary shall by regulation determine the best method for including in the registry and results data bank appropriate results information on serious adverse and frequent adverse events for applicable clinical trials described in subparagraph (C) in a manner and form that is useful and not misleading to patients, physicians, and scientists.
(ii) Default
If the Secretary fails to issue the regulation required by clause (i) by the date that is 24 months after September 27, 2007, clause (iii) shall take effect.
(iii) Additional elements
Upon the application of clause (ii), the Secretary shall include in the registry and results data bank for applicable clinical trials described in subparagraph (C), in addition to the clinical trial information described in subparagraph (C), the following elements:
(I) Serious adverse events
A table of anticipated and unanticipated serious adverse events grouped by organ system, with number and frequency of such event in each arm of the clinical trial.
(II) Frequent adverse events
A table of anticipated and unanticipated adverse events that are not included in the table described in subclause (I) that exceed a frequency of 5 percent within any arm of the clinical trial, grouped by organ system, with number and frequency of such event in each arm of the clinical trial.
(iv) Posting of other information
In carrying out clause (iii), the Secretary shall, in consultation with experts in risk communication, post with the tables information to enhance patient understanding and to ensure such tables do not mislead patients or the lay public.
(v) Relation to subparagraph (C)
Clinical trial information included in the registry and results data bank pursuant to this subparagraph is deemed to be clinical trial information included in such data bank pursuant to subparagraph (C).
(4) Additional submissions of clinical trial information
(A) Voluntary submissions
A responsible party for a clinical trial that is not an applicable clinical trial, or that is an applicable clinical trial that is not subject to paragraph (2)(C), may submit complete clinical trial information described in paragraph (2) or paragraph (3) provided the responsible party submits clinical trial information for each applicable clinical trial that is required to be submitted under
(B) Required submissions
(i) In general
Notwithstanding paragraphs (2) and (3) and subparagraph (A), in any case in which the Secretary determines for a specific clinical trial described in clause (ii) that posting in the registry and results data bank of clinical trial information for such clinical trial is necessary to protect the public health—
(I) the Secretary may require by notification that such information be submitted to the Secretary in accordance with paragraphs (2) and (3) except with regard to timing of submission;
(II) unless the responsible party submits a certification under paragraph (3)(E)(iii), such information shall be submitted not later than 30 days after the date specified by the Secretary in the notification; and
(III) failure to comply with the requirements under subclauses (I) and (II) shall be treated as a violation of the corresponding requirement of such paragraphs.
(ii) Clinical trials described
A clinical trial described in this clause is—
(I) an applicable clinical trial for a drug that is approved under
(II) an applicable clinical trial that is described by both by 3 paragraph (2)(C) and paragraph (3)(D)(ii)(II)).4
(C) Updates to clinical trial data bank
(i) Submission of updates
The responsible party for an applicable clinical trial shall submit to the Director of NIH for inclusion in the registry and results data bank updates to reflect changes to the clinical trial information submitted under paragraph (2). Such updates—
(I) shall be provided not less than once every 12 months, unless there were no changes to the clinical trial information during the preceding 12-month period;
(II) shall include identification of the dates of any such changes;
(III) not later than 30 days after the recruitment status of such clinical trial changes, shall include an update of the recruitment status; and
(IV) not later than 30 days after the completion date of the clinical trial, shall include notification to the Director that such clinical trial is complete.
(ii) Public availability of updates
The Director of NIH shall make updates submitted under clause (i) publicly available in the registry data bank. Except with regard to overall recruitment status, individual site status, location, and contact information, the Director of NIH shall ensure that updates to elements required under subclauses (I) to (V) of paragraph (2)(A)(ii) do not result in the removal of any information from the original submissions or any preceding updates, and information in such databases is presented in a manner that enables users to readily access each original element submission and to track the changes made by the updates. The Director of NIH shall provide a link from the table of primary and secondary outcomes required under paragraph (3)(C)(ii) to the tracked history required under this clause of the primary and secondary outcome measures submitted under paragraph (2)(A)(ii)(I)(ll).
(5) Coordination and compliance
(A) Clinical trials supported by grants from Federal agencies
(i) Grants from certain Federal agencies
If an applicable clinical trial is funded in whole or in part by a grant from any agency of the Department of Health and Human Services, including the Food and Drug Administration, the National Institutes of Health, or the Agency for Healthcare Research and Quality, any grant or progress report forms required under such grant shall include a certification that the responsible party has made all required submissions to the Director of NIH under paragraphs (2) and (3).
(ii) Verification by Federal agencies
The heads of the agencies referred to in clause (i), as applicable, shall verify that the clinical trial information for each applicable clinical trial for which a grantee is the responsible party has been submitted under paragraphs (2) and (3) before releasing any remaining funding for a grant or funding for a future grant to such grantee.
(iii) Notice and opportunity to remedy
If the head of an agency referred to in clause (i), as applicable, verifies that a grantee has not submitted clinical trial information as described in clause (ii), such agency head shall provide notice to such grantee of such non-compliance and allow such grantee 30 days to correct such non-compliance and submit the required clinical trial information.
(iv) Consultation with other Federal agencies
The Secretary shall—
(I) consult with other agencies that conduct research involving human subjects in accordance with any section of part 46 of title 45, Code of Federal Regulations (or any successor regulations), to determine if any such research is an applicable clinical trial; and
(II) develop with such agencies procedures comparable to those described in clauses (i), (ii), and (iii) to ensure that clinical trial information for such applicable clinical trial is submitted under paragraphs (2) and (3).
(B) Certification to accompany drug, biological product, and device submissions
At the time of submission of an application under
(C) Quality control
(i) Pilot quality control project
Until the effective date of the regulations issued under paragraph (3)(D), the Secretary, acting through the Director of NIH and the Commissioner of Food and Drugs, shall conduct a pilot project to determine the optimal method of verification to help to ensure that the clinical trial information submitted under paragraph (3)(C) is non-promotional and is not false or misleading in any particular under subparagraph (D). The Secretary shall use the publicly available information described in paragraph (3)(A) and any other information available to the Secretary about applicable clinical trials to verify the accuracy of the clinical trial information submitted under paragraph (3)(C).
(ii) Notice of compliance
If the Secretary determines that any clinical trial information was not submitted as required under this subsection, or was submitted but is false or misleading in any particular, the Secretary shall notify the responsible party and give such party an opportunity to remedy such noncompliance by submitting the required revised clinical trial information not later than 30 days after such notification.
(D) Truthful clinical trial information
(i) In general
The clinical trial information submitted by a responsible party under this subsection shall not be false or misleading in any particular.
(ii) Effect
Clause (i) shall not have the effect of—
(I) requiring clinical trial information with respect to an applicable clinical trial to include information from any source other than such clinical trial involved; or
(II) requiring clinical trial information described in paragraph (3)(D) to be submitted for purposes of paragraph (3)(C).
(E) Public notices
(i) Notice of violations
If the responsible party for an applicable clinical trial fails to submit clinical trial information for such clinical trial as required under paragraphs (2) or (3), the Director of NIH shall include in the registry and results data bank entry for such clinical trial a notice—
(I) that the responsible party is not in compliance with this chapter by—
(aa) failing to submit required clinical trial information; or
(bb) submitting false or misleading clinical trial information;
(II) of the penalties imposed for the violation, if any; and
(III) whether the responsible party has corrected the clinical trial information in the registry and results data bank.
(ii) Notice of failure to submit primary and secondary outcomes
If the responsible party for an applicable clinical trial fails to submit the primary and secondary outcomes as required under section 2(A)(ii)(I)(ll),5 the Director of NIH shall include in the registry and results data bank entry for such clinical trial a notice that the responsible party is not in compliance by failing to register the primary and secondary outcomes in accordance with this chapter, and that the primary and secondary outcomes were not publicly disclosed in the database before conducting the clinical trial.
(iii) Failure to submit statement
The notice under clause (i) for a violation described in clause (i)(I)(aa) shall include the following statement: "The entry for this clinical trial was not complete at the time of submission, as required by law. This may or may not have any bearing on the accuracy of the information in the entry.".
(iv) Submission of false information statement
The notice under clause (i) for a violation described in clause (i)(I)(bb) shall include the following statement: "The entry for this clinical trial was found to be false or misleading and therefore not in compliance with the law.".
(v) Non-submission of statement
The notice under clause (ii) for a violation described in clause (ii) shall include the following statement: "The entry for this clinical trial did not contain information on the primary and secondary outcomes at the time of submission, as required by law. This may or may not have any bearing on the accuracy of the information in the entry.".
(vi) Compliance searches
The Director of NIH shall provide that the public may easily search the registry and results data bank for entries that include notices required under this subparagraph.
(6) Limitation on disclosure of clinical trial information
(A) In general
Nothing in this subsection (or under
(B) Information described
Information described in this subparagraph is—
(i) information submitted to the Director of NIH under this subsection, or information of the same general nature as (or integrally associated with) the information so submitted; and
(ii) information not otherwise publicly available, including because it is protected from disclosure under
(7) Authorization of appropriations
There are authorized to be appropriated to carry out this subsection $10,000,000 for each fiscal year.
(k) Day care for children of employees
(1) The Director of NIH may establish a program to provide day care services for the employees of the National Institutes of Health similar to those services provided by other Federal agencies (including the availability of day care service on a 24-hour-a-day basis).
(2) Any day care provider at the National Institutes of Health shall establish a sliding scale of fees that takes into consideration the income and needs of the employee.
(3) For purposes regarding the provision of day care services, the Director of NIH may enter into rental or lease purchase agreements.
(l) Council of Councils
(1) Establishment
Not later than 90 days after January 15, 2007, the Director of NIH shall establish within the Office of the Director an advisory council to be known as the "Council of Councils" (referred to in this subsection as the "Council") for the purpose of advising the Director on matters related to the policies and activities of the Division of Program Coordination, Planning, and Strategic Initiatives, including making recommendations with respect to the conduct and support of research described in subsection (b)(7).
(2) Membership
(A) In general
The Council shall be composed of 27 members selected by the Director of NIH with approval from the Secretary from among the list of nominees under subparagraph (C).
(B) Certain requirements
In selecting the members of the Council, the Director of NIH shall ensure—
(i) the representation of a broad range of disciplines and perspectives; and
(ii) the ongoing inclusion of at least 1 representative from each national research institute whose budget is substantial relative to a majority of the other institutes.
(C) Nomination
The Director of NIH shall maintain an updated list of individuals who have been nominated to serve on the Council, which list shall consist of the following:
(i) For each national research institute and national center, 3 individuals nominated by the head of such institute or center from among the members of the advisory council of the institute or center, of which—
(I) two shall be scientists; and
(II) one shall be from the general public or shall be a leader in the field of public policy, law, health policy, economics, or management.
(ii) For each office within the Division of Program Coordination, Planning, and Strategic Initiatives, 1 individual nominated by the head of such office.
(iii) Members of the Council of Public Representatives.
(3) Terms
(A) In general
The term of service for a member of the Council shall be 6 years, except as provided in subparagraphs (B) and (C).
(B) Terms of initial appointees
Of the initial members selected for the Council, the Director of NIH shall designate—
(i) nine for a term of 6 years;
(ii) nine for a term of 4 years; and
(iii) nine for a term of 2 years.
(C) Vacancies
Any member appointed to fill a vacancy occurring before the expiration of the term for which the member's predecessor was appointed shall be appointed only for the remainder of that term. A member may serve after the expiration of that member's term until a successor has taken office.
(m) National Institutes of Health Strategic Plan
(1) In general
Not later than 2 years after December 13, 2016, and at least every 6 years thereafter, the Director of the National Institutes of Health shall develop and submit to the appropriate committees of Congress and post on the Internet website of the National Institutes of Health, a coordinated strategy (to be known as the "National Institutes of Health Strategic Plan") to provide direction to the biomedical research investments made by the National Institutes of Health, to facilitate collaboration across the institutes and centers, to leverage scientific opportunity, and to advance biomedicine.
(2) Requirements
The strategy under paragraph (1) shall—
(A) identify strategic research priorities and objectives across biomedical research, including—
(i) an assessment of the state of biomedical and behavioral research, including areas of opportunity with respect to basic, clinical, and translational research;
(ii) priorities and objectives to advance the treatment, cure, and prevention of health conditions;
(iii) emerging scientific opportunities, rising public health challenges, and scientific knowledge gaps; and
(iv) the identification of near-, mid-, and long-term scientific needs;
(B) consider, in carrying out subparagraph (A)—
(i) disease burden in the United States and the potential for return on investment to the United States;
(ii) rare diseases and conditions;
(iii) biological, social, and other determinants of health that contribute to health disparities; and
(iv) other factors the Director of National Institutes of Health determines appropriate;
(C) include multi-institute priorities, including coordination of research among institutes and centers;
(D) include strategic priorities for funding research through the Common Fund, in accordance with
(E) address the National Institutes of Health's proposed and ongoing activities related to training and the biomedical workforce; and
(F) describe opportunities for collaboration with other agencies and departments, as appropriate.
(3) Use of plans
Strategic plans developed and updated by the national research institutes and national centers of the National Institutes of Health shall be prepared regularly and in such a manner that such plans will be informed by the strategic plans developed and updated under this subsection. Such plans developed by and updated by the national research institutes and national centers shall have a common template.
(4) Consultation
The Director of National Institutes of Health shall develop the strategic plan under paragraph (1) in consultation with the directors of the national research institutes and national centers, researchers, patient advocacy groups, and industry leaders.
(n) Unique research initiatives
(1) In general
The Director of NIH may approve, after consideration of a proposal under paragraph (2)(A), requests by the national research institutes and centers, or program officers within the Office of the Director to engage in transactions other than a contract, grant, or cooperative agreement with respect to projects that carry out—
(A) the Precision Medicine Initiative under
(B) subsection (b)(7), except that not more than 50 percent of the funds available for a fiscal year through the Common Fund under
(C) high impact cutting-edge research that fosters scientific creativity and increases fundamental biological understanding leading to the prevention, diagnosis, or treatment of diseases and disorders, or research urgently required to respond to a public health threat.
(2) Requirements
The authority provided under this subsection may be used to conduct or support high impact cutting-edge research described in paragraph (1) using the other transactions authority described in such paragraph if the institute, center, or office—
(A) submits a proposal to the Director of NIH for the use of such authority before conducting or supporting the research, including why the use of such authority is essential to promoting the success of the project;
(B) receives approval for the use of such authority from the Director of NIH; and
(C) for each year in which the institute, center, or office has used such authority in accordance with this subsection, submits a report to the Director of NIH on the activities of the institute, center, or office relating to such research.
(July 1, 1944, ch. 373, title IV, §402, as added
References in Text
The Federal Advisory Committee Act, referred to in subsec. (b), is
The General Schedule, referred to in subsec. (b)(16), is set out under
The National Literacy Act of 1991, referred to in subsec. (e)(5), is
Codification
In subsec. (b)(14)(B), "
Amendments
2018—Subsec. (n)(1)(C).
2016—Subsec. (b)(4).
Subsec. (b)(5).
Subsec. (b)(8)(C), (D).
Subsec. (b)(25).
Subsec. (j)(2)(D)(ii)(I).
Subsec. (j)(2)(D)(iii), (iv).
Subsec. (m).
Subsec. (n).
2014—Subsec. (b)(7).
2011—Subsec. (b)(24).
Subsec. (g).
2010—Subsec. (b)(24).
2008—Subsec. (j)(3)(C).
Subsec. (j)(3)(I)(i), (iii).
2007—Subsec. (a).
Subsec. (b).
Subsec. (b)(1).
Subsec. (b)(2), (3).
"(2) shall coordinate and oversee the operation of the national research institutes and administrative entities within the National Institutes of Health;
"(3) shall assure that research at or supported by the National Institutes of Health is subject to review in accordance with
Subsec. (b)(4).
Subsec. (b)(5) to (22).
"(12) after consultation with the Director of the Office of Research on Women's Health, shall ensure that resources of the National Institutes of Health are sufficiently allocated for projects of research on women's health that are identified under
"(13) may conduct and support research training—
"(A) for which fellowship support is not provided under
"(B) which does not consist of residency training of physicians or other health professionals; and".
Subsec. (b)(23).
Subsec. (i).
Subsec. (i)(5).
Subsecs. (j), (k).
Subsec. (l).
2002—Subsec. (j)(3)(A).
1998—Subsec. (b)(13), (14).
Subsec. (f).
"(A) a summary of the Associate Director's review of existing dissemination policies and techniques together with a detailed statement concerning any modification or restructuring, or recommendations for modification or restructuring, of such policies and techniques; and
"(B) a detailed statement of the expenditures made for the prevention and dissemination activities reported on and the personnel used in connection with such activities."
1997—Subsecs. (j) to (l).
1993—Subsec. (b)(12).
Subsec. (e)(5).
Subsec. (f).
Subsec. (g).
Subsec. (h).
Subsec. (i).
Subsec. (j).
Subsec. (k).
1992—Subsec. (d)(1).
1988—Subsec. (b)(6).
Effective Date of 2007 Amendment
Amendment by
Effective Date of 1997 Amendment
Amendment by
Effective Date of 1992 Amendment
Amendment by
Rule of Construction Regarding Continuation of Programs
Confidentiality
Appropriate Age Groupings in Clinical Research
"(1)
"(A) appropriate age groups to be included in research studies involving human subjects; and
"(B) acceptable justifications for excluding participants from a range of age groups from human subjects research studies.
"(2)
"(A) address the consideration of age as an inclusion variable in research involving human subjects; and
"(B) identify the criteria for justification for any age-related exclusions in such research.
"(3)
"(A) make the findings and conclusions resulting from the workshop under paragraph (1) and updates to policies in accordance with paragraph (2), as applicable, available to the public on the Internet website of the National Institutes of Health; and
"(B) ensure that age-related data reported in the triennial report under section 403 of the Public Health Service Act (
Enhancing the Rigor and Reproducibility of Scientific Research
"(a)
"(b)
"(1) preclinical experiment design, including analysis of sex as a biological variable;
"(2) clinical experiment design, including—
"(A) the diversity of populations studied for clinical research, with respect to biological, social, and other determinants of health that contribute to health disparities;
"(B) the circumstances under which summary information regarding biological, social, and other factors that contribute to health disparities should be reported; and
"(C) the circumstances under which clinical studies, including clinical trials, should conduct an analysis of the data collected during the study on the basis of biological, social, and other factors that contribute to health disparities;
"(3) applicable levels of rigor in statistical methods, methodology, and analysis;
"(4) data and information sharing in accordance with applicable privacy laws and regulations; and
"(5) any other matter the working group determines relevant.
"(c)
"(d)
"(e)
Demonstration Grants for Improving Pediatric Device Availability
"(a)
"(1)
"(2)
"(b)
"(c)
"(1) encouraging innovation and connecting qualified individuals with pediatric device ideas with potential manufacturers;
"(2) mentoring and managing pediatric device projects through the development process, including product identification, prototype design, device development, and marketing;
"(3) connecting innovators and physicians to existing Federal and non-Federal resources, including resources from the Food and Drug Administration, the National Institutes of Health, the Small Business Administration, the Department of Energy, the Department of Education, the National Science Foundation, the Department of Veterans Affairs, the Agency for Healthcare Research and Quality, and the National Institute of Standards and Technology;
"(4) assessing the scientific and medical merit of proposed pediatric device projects;
"(5) providing assistance and advice as needed on business development, personnel training, prototype development, postmarket needs, and other activities consistent with the purposes of this section; and
"(6) providing regulatory consultation to device sponsors in support of the submission of an application for a pediatric device, where appropriate.
"(d)
"(1)
"(A) coordinate with the National Institutes of Health's pediatric device contact point or office, designated under section 402(b)(23) of the Public Health Service Act [
"(B) provide to the National Institutes of Health any identified pediatric device needs that the consortium lacks sufficient capacity to address or those needs in which the consortium has been unable to stimulate manufacturer interest.
"(2)
"(3)
"(e)
Surveillances
Preemption
"(1)
"(2)
Collaboration and Report
Chronic Fatigue Syndrome; Experts and Research Representatives on Advisory Committees and Boards
Third-Party Payments Regarding Certain Clinical Trials and Certain Life-Threatening Illnesses
"(1) determining the policies of third-party payors regarding the payment of the costs of appropriate health services that are provided incident to the participation of individuals as subjects in clinical trials conducted in the development of drugs with respect to acquired immune deficiency syndrome, cancer, and other life-threatening illnesses; and
"(2) developing recommendations regarding such policies."
Personnel Study of Recruitment, Retention and Turnover
Chronic Pain Conditions
Support for Bioengineering Research
Master Plan for Physical Infrastructure for Research
1 So in original. The word "of" probably should not appear.
2 So in original. The second closing parenthesis probably should not appear.
4 So in original. The second closing parenthesis probably should not appear.
5 So in original. Probably should be "paragraph (2)(A)(ii)(I)(ll),".
§282a. Authorization of appropriations
(a) In general
(1) This subchapter
For purposes of carrying out this subchapter, there are authorized to be appropriated—
(A) $30,331,309,000 for fiscal year 2007;
(B) $32,831,309,000 for fiscal year 2008;
(C) such sums as may be necessary for fiscal year 2009;
(D) $34,851,000,000 for fiscal year 2018;
(E) $35,585,871,000 for fiscal year 2019; and
(F) $36,472,442,775 for fiscal year 2020.
(2) Funding for 10-year pediatric research initiative through Common Fund
For the purpose of carrying out
(b) Office of the Director
Of the amount authorized to be appropriated under subsection (a) for a fiscal year, there are authorized to be appropriated for programs and activities under this subchapter carried out through the Office of the Director of NIH such sums as may be necessary for each of the fiscal years 2007 through 2009.
(c) Trans-NIH research
(1) Common Fund
(A) Account
For the purpose of allocations under
(B) Reservation
(i) In general
Of the total amount appropriated under subsection (a)(1) for fiscal year 2007 or any subsequent fiscal year, the Director of NIH shall reserve an amount for the Common Fund, subject to any applicable provisions in appropriations Acts.
(ii) Minimum amount
For each fiscal year, the percentage constituted by the amount reserved under clause (i) relative to the total amount appropriated under subsection (a)(1) for such year may not be less than the percentage constituted by the amount so reserved for the preceding fiscal year relative to the total amount appropriated under subsection (a)(1) for such preceding fiscal year, subject to any applicable provisions in appropriations Acts.
(C) Common Fund strategic planning report
As part of the National Institutes of Health Strategic Plan required under
(i) An estimate of the amounts determined by the Director of NIH to be appropriate for maximizing the potential of such research.
(ii) An estimate of the amounts determined by the Director of NIH to be sufficient only for continuing to fund research activities previously identified by the Division of Program Coordination, Planning, and Strategic Initiatives.
(iii) An estimate of the amounts determined by the Director of NIH to be necessary to fund research described in
(I) that is in addition to the research activities described in clause (ii); and
(II) for which there is the most substantial need.
(D) Evaluation
During the 6-month period following the end of the first fiscal year for which the total amount reserved under subparagraph (B) is equal to 5 percent of the total amount appropriated under subsection (a)(1) for such fiscal year, the Secretary, acting through the Director of NIH, in consultation with the advisory council established under
(2) Trans-NIH research reporting
(A) Limitation
With respect to the total amount appropriated under subsection (a) for fiscal year 2008 or any subsequent fiscal year, if the head of a national research institute or national center fails to submit the report required by subparagraph (B) for the preceding fiscal year, the amount made available for the institute or center for the fiscal year involved may not exceed the amount made available for the institute or center for fiscal year 2006.
(B) Reporting
Not later than 2 years after December 13, 2016, the head of each national research institute or national center shall submit to the Director of the National Institutes of Health a report, to be included in the triennial report under
(C) Determination
For purposes of determining the amount or percentage of funds to be reported under subparagraph (B), any amounts made available to an institute or center under
(D) Verification of amounts
Upon receipt of each report submitted under subparagraph (B), the Director of NIH shall review and, in cases of discrepancy, verify the accuracy of the amounts specified in the report.
(E) Waiver
At the request of any national research institute or national center, the Director of NIH may waive the application of this paragraph to such institute or center if the Director finds that the conduct or support of research described in subparagraph (B) is inconsistent with the mission of such institute or center.
(d) Transfer authority
Of the total amount appropriated under subsection (a)(1) for a fiscal year, the Director of NIH may (in addition to the reservation under subsection (c)(1) for such year) transfer not more than 1 percent for programs or activities that are authorized in this subchapter and identified by the Director to receive funds pursuant to this subsection. In making such transfers, the Director may not decrease any appropriation account under subsection (a)(1) by more than 1 percent.
(e) Rule of construction
This section may not be construed as affecting the authorities of the Director of NIH under
(July 1, 1944, ch. 373, title IV, §402A, as added
Amendments
2016—Subsec. (a)(1)(D) to (F).
Subsec. (c)(1)(C).
Subsec. (c)(2)(B).
"(i) the head of each national research institute or national center shall submit to the Director of NIH a report on the amount made available by the institute or center for conducting or supporting research that involves collaboration between the institute or center and 1 or more other national research institutes or national centers; and
"(ii) the Secretary shall submit a report to the Congress identifying the percentage of funds made available by each national research institute and national center with respect to such fiscal year for conducting or supporting research described in clause (i)."
Subsec. (c)(2)(D), (E).
2014—Subsec. (a).
Subsec. (a)(2).
Subsecs. (c)(1)(B), (D), (d).
Effective Date
Section applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of
Supplement, Not Supplant; Prohibition Against Transfer
"(1) shall be used to supplement, not supplant, the funds otherwise allocated by the National Institutes of Health for pediatric research; and
"(2) notwithstanding any transfer authority in any appropriation Act, shall not be used for any purpose other than allocating funds for making grants as described in section 402(b)(7)(B)(ii) of the Public Health Service Act [
§282b. Electronic coding of grants and activities
The Secretary, acting through the Director of NIH, shall establish an electronic system to uniformly code research grants and activities of the Office of the Director and of all the national research institutes and national centers. The electronic system shall be searchable by a variety of codes, such as the type of research grant, the research entity managing the grant, and the public health area of interest. When permissible, the Secretary, acting through the Director of NIH, shall provide information on relevant literature and patents that are associated with research activities of the National Institutes of Health.
(July 1, 1944, ch. 373, title IV, §402B, as added
Effective Date
Section applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of
§282c. Public access to funded investigators' final manuscripts
The Director of the National Institutes of Health ("NIH") shall require in the current fiscal year and thereafter that all investigators funded by the NIH submit or have submitted for them to the National Library of Medicine's PubMed Central an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication: Provided, That the NIH shall implement the public access policy in a manner consistent with copyright law.
(
Codification
Section was enacted as part of the Department of Health and Human Services Appropriations Act, 2009, and also as part of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2009, and the Omnibus Appropriations Act, 2009, and not as part of the Public Health Service Act which comprises this chapter.
§282d. Transferred
Codification
Section, act July 1, 1944, ch. 373, title IV, §402C, as added
§283. Triennial reports of Director of NIH
(a) In general
The Director of NIH shall submit to the Congress on a triennial basis a report in accordance with this section. The first report shall be submitted not later than 1 year after January 15, 2007. Each such report shall include the following information:
(1) An assessment of the state of biomedical and behavioral research.
(2) A description of the activities conducted or supported by the agencies of the National Institutes of Health and policies respecting the programs of such agencies.
(3) A description of intra-National Institutes of Health activities, including—
(A) identification of the percentage of funds made available by each national research institute and national center with respect to each applicable fiscal year for conducting or supporting research that involves collaboration between the institute or center and 1 or more other national research institutes or national centers; and
(B) recommendations for promoting coordination of information among the centers of excellence.
(4) A catalog of all the research activities of the agencies, prepared in accordance with the following:
(A) The catalog shall, for each such activity—
(i) identify the agency or agencies involved;
(ii) state whether the activity was carried out directly by the agencies or was supported by the agencies and describe to what extent the agency was involved; and
(iii) identify whether the activity was carried out through a center of excellence.
(B) In the case of clinical research, the catalog shall, as appropriate, identify study populations by demographic variables, including biological and social variables and relevant age categories (such as pediatric subgroups), and determinants of health, that contribute to research on minority health and health disparities.
(C) Research activities listed in the catalog shall include, where applicable, the following:
(i) Epidemiological studies and longitudinal studies.
(ii) Disease registries, information clearinghouses, and other data systems.
(iii) Public education and information campaigns.
(iv) Training activities, including—
(I) National Research Service Awards and Clinical Transformation Science Awards;
(II) graduate medical education programs, including information on the number and type of graduate degrees awarded during the period in which the programs received funding under this subchapter;
(III) investigator-initiated awards for postdoctoral training and postdoctoral training funded through research grants;
(IV) a breakdown by demographic variables and other appropriate categories; and
(V) an evaluation and comparison of outcomes and effectiveness of various training programs.
(v) Clinical trials, including a breakdown of participation by study populations and demographic variables, including relevant age categories (such as pediatric subgroups), information submitted by each national research institute and national center to the Director of National Institutes of Health under
(vi) Translational research activities with other agencies of the Public Health Service.
(5) A summary of the research activities throughout the agencies, which summary shall be organized by the following categories, where applicable:
(A) Cancer.
(B) Neurosciences.
(C) Life stages, human development, and rehabilitation.
(D) Organ systems.
(E) Autoimmune diseases.
(F) Genomics.
(G) Molecular biology and basic science.
(H) Technology development.
(I) Chronic diseases, including pain and palliative care.
(J) Infectious diseases and bioterrorism.
(K) Minority health and health disparities.
(L) Such additional categories as the Director determines to be appropriate.
(6) A review of each entity receiving funding under this subchapter in its capacity as a center of excellence (in this paragraph referred to as a "center of excellence"), including the following—
(A) an evaluation of the performance and research outcomes of each center of excellence; and
(B) recommendations for improving the effectiveness, efficiency, and outcomes of the centers of excellence.
(b) Requirement regarding disease-specific research activities
In a report under subsection (a), the Director of NIH, when reporting on research activities relating to a specific disease, disorder, or other adverse health condition, shall—
(1) present information in a standardized format;
(2) identify the actual dollar amounts obligated for such activities; and
(3) include a plan for research on the specific disease, disorder, or other adverse health condition, including a statement of objectives regarding the research, the means for achieving the objectives, a date by which the objectives are expected to be achieved, and justifications for revisions to the plan.
(c) Additional reports
In addition to reports required by subsections (a) and (b), the Director of NIH or the head of a national research institute or national center may submit to the Congress such additional reports as the Director or the head of such institute or center determines to be appropriate.
(July 1, 1944, ch. 373, title IV, §403, as added
Prior Provisions
A prior section 283, act July 1, 1944, ch. 373, title IV, §403, as added
Amendments
2016—
Subsec. (a).
Subsec. (a)(3).
Subsec. (a)(4)(B).
Subsec. (a)(4)(C)(v).
Subsec. (a)(6).
"(B) Recommendations for promoting coordination of information among the centers of excellence.
"(D) If no additional centers of excellence have been funded under this subchapter since the previous report under this section, an explanation of the reasons for not funding any additional centers."
2007—Subsec. (a)(4)(C)(iv)(III).
Effective Date
Section applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of
§283a. Annual reporting to increase interagency collaboration and coordination
(a) Collaboration with other HHS agencies
On an annual basis, the Director of NIH shall submit to the Secretary a report on the activities of the National Institutes of Health involving collaboration with other agencies of the Department of Health and Human Services.
(b) Clinical trials
Each calendar year, the Director of NIH shall submit to the Commissioner of Food and Drugs a report that identifies each clinical trial that is registered during such calendar year in the databank of information established under
(c) Human tissue samples
On an annual basis, the Director of NIH shall submit to the Congress a report that describes how the National Institutes of Health and its agencies store and track human tissue samples.
(d) First report
The first report under subsections (a), (b), and (c) shall be submitted not later than 1 year after January 15, 2007.
(July 1, 1944, ch. 373, title IV, §403A, as added
Prior Provisions
A prior section 403A of act July 1, 1944, was renumbered section 403D and is classified to
Effective Date
Section applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of
§283a–1. Annual reporting to prevent fraud and abuse
(a) Whistleblower complaints
(1) In general
On an annual basis, the Director of NIH shall submit to the Inspector General of the Department of Health and Human Services, the Secretary, the Committee on Energy and Commerce and the Committee on Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate a report summarizing the activities of the National Institutes of Health relating to whistleblower complaints.
(2) Contents
For each whistleblower complaint pending during the year for which a report is submitted under this subsection, the report shall identify the following:
(A) Each agency of the National Institutes of Health involved.
(B) The status of the complaint.
(C) The resolution of the complaint to date.
(b) First report
The first report under subsection (a) shall be submitted not later than 1 year after January 15, 2007.
(July 1, 1944, ch. 373, title IV, §403B, as added
Amendments
2016—Subsecs. (b), (c).
Effective Date
Section applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of
§283a–2. Annual reporting regarding training of graduate students for doctoral degrees
(a) In general
Each institution receiving an award under this subchapter for the training of graduate students for doctoral degrees shall annually report to the Director of NIH, with respect to graduate students supported by the National Institutes of Health at such institution—
(1) the percentage of such students admitted for study who successfully attain a doctoral degree; and
(2) for students described in paragraph (1), the average time between the beginning of graduate study and the receipt of a doctoral degree.
(3) 1 Provision of information to applicants
Each institution described in subsection (a) shall provide to each student submitting an application for a program of graduate study at such institution the information described in paragraphs (1) and (2) of such subsection with respect to the program or programs to which such student has applied.
(July 1, 1944, ch. 373, title IV, §403C, as added
Prior Provisions
A prior section 403C of act July 1, 1944, was renumbered section 403D and is classified to
Amendments
2016—Subsec. (a)(2).
2007—Subsec. (a).
Subsec. (a)(1).
Subsec. (a)(2).
Effective Date
Section applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of
1 So in original. Probably should be "(b)".
§283a–3. Establishment of program regarding DES
(a) In general
The Director of NIH shall establish a program for the conduct and support of research and training, the dissemination of health information, and other programs with respect to the diagnosis and treatment of conditions associated with exposure to the drug diethylstilbestrol (in this section referred to as "DES").
(b) Education programs
In carrying out subsection (a), the Director of NIH, after consultation with nonprofit private entities representing individuals who have been exposed to DES, shall conduct or support programs to educate health professionals and the public on the drug, including the importance of identifying and treating individuals who have been exposed to the drug.
(c) Longitudinal studies
After consultation with the Office of Research on Women's Health, the Director of NIH, acting through the appropriate national research institutes, shall in carrying out subsection (a) conduct or support one or more longitudinal studies to determine the incidence of the following diseases or disorders in the indicated populations and the relationship of DES to the diseases or disorders:
(1) In the case of women to whom (on or after January 1, 1938) DES was administered while the women were pregnant, the incidence of all diseases and disorders (including breast cancer, gynecological cancers, and impairments of the immune system, including autoimmune disease).
(2) In the case of women exposed to DES in utero, the incidence of clear cell cancer (including recurrences), the long-term health effects of such cancer, and the effects of treatments for such cancer.
(3) In the case of men and women exposed to DES in utero, the incidence of all diseases and disorders (including impairments of the reproductive and autoimmune systems).
(4) In the case of children of men or women exposed to DES in utero, the incidence of all diseases and disorders.
(d) Exposure to DES in utero
For purposes of this section, an individual shall be considered to have been exposed to DES in utero if, during the pregnancy that resulted in the birth of such individual, DES was (on or after January 1, 1938) administered to the biological mother of the individual.
(July 1, 1944, ch. 373, title IV, §403D, formerly §403A, as added
Codification
Section was formerly classified to
Amendments
2007—Subsec. (e).
1998—Subsec. (e).
Effective Date of 2007 Amendment
Amendment by
§283b. Repealed. Pub. L. 106–525, title I, §101(b)(2), Nov. 22, 2000, 114 Stat. 2501
Section, act July 1, 1944, ch. 373, title IV, §404, as added
§283c. Office of Behavioral and Social Sciences Research
(a) There is established within the Office of the Director of NIH an office to be known as the Office of Behavioral and Social Sciences Research (in this section referred to as the "Office"). The Office shall be headed by a director, who shall be appointed by the Director of NIH.
(b)(1) With respect to research on the relationship between human behavior and the development, treatment, and prevention of medical conditions, the Director of the Office shall—
(A) coordinate research conducted or supported by the agencies of the National Institutes of Health; and
(B) identify projects of behavioral and social sciences research that should be conducted or supported by the national research institutes, and develop such projects in cooperation with such institutes.
(2) Research authorized under paragraph (1) includes research on teen pregnancy, infant mortality, violent behavior, suicide, and homelessness. Such research does not include neurobiological research, or research in which the behavior of an organism is observed for the purpose of determining activity at the cellular or molecular level.
(July 1, 1944, ch. 373, title IV, §404A, as added
Effective Date
§283d. Children's Vaccine Initiative
The Secretary, in consultation with the Director of the National Vaccine Program under subchapter XIX and acting through the Directors of the National Institute for Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institute for Aging, and other public and private programs, shall carry out activities, which shall be consistent with the global Children's Vaccine Initiative, to develop affordable new and improved vaccines to be used in the United States and in the developing world that will increase the efficacy and efficiency of the prevention of infectious diseases. In carrying out such activities, the Secretary shall, to the extent practicable, develop and make available vaccines that require fewer contacts to deliver, that can be given early in life, that provide long lasting protection, that obviate refrigeration, needles and syringes, and that protect against a larger number of diseases.
(July 1, 1944, ch. 373, title IV, §404B, as added
Amendments
2016—
2007—Subsec. (a).
Subsec. (c).
Effective Date of 2007 Amendment
Amendment by
§283e. Plan for use of animals in research
(a) Preparation
The Director of NIH, after consultation with the committee established under subsection (e), shall prepare a plan—
(1) for the National Institutes of Health to conduct or support research into—
(A) methods of biomedical research and experimentation that do not require the use of animals;
(B) methods of such research and experimentation that reduce the number of animals used in such research;
(C) methods of such research and experimentation that produce less pain and distress in such animals; and
(D) methods of such research and experimentation that involve the use of marine life (other than marine mammals);
(2) for establishing the validity and reliability of the methods described in paragraph (1);
(3) for encouraging the acceptance by the scientific community of such methods that have been found to be valid and reliable; and
(4) for training scientists in the use of such methods that have been found to be valid and reliable.
(b) Submission to Congressional committees
Not later than October 1, 1993, the Director of NIH shall submit to the Committee on Energy and Commerce of the House of Representatives, and to the Committee on Labor and Human Resources of the Senate, the plan required in subsection (a) and shall begin implementation of the plan.
(c) Periodic review and revision
The Director of NIH shall periodically review, and as appropriate, make revisions in the plan required under subsection (a). A description of any revision made in the plan shall be included in the first biennial report under
(d) Dissemination of information
The Director of NIH shall take such actions as may be appropriate to convey to scientists and others who use animals in biomedical or behavioral research or experimentation information respecting the methods found to be valid and reliable under subsection (a)(2).
(e) Interagency Coordinating Committee on the Use of Animals in Research
(1) The Director of NIH shall establish within the National Institutes of Health a committee to be known as the Interagency Coordinating Committee on the Use of Animals in Research (in this subsection referred to as the "Committee").
(2) The Committee shall provide advice to the Director of NIH on the preparation of the plan required in subsection (a).
(3) The Committee shall be composed of—
(A) the Directors of each of the national research institutes (or the designees of such Directors); and
(B) representatives of the Environmental Protection Agency, the Food and Drug Administration, the Consumer Product Safety Commission, the National Science Foundation, and such additional agencies as the Director of NIH determines to be appropriate, which representatives shall include not less than one veterinarian with expertise in laboratory-animal medicine.
(July 1, 1944, ch. 373, title IV, §404C, as added
Amendments
2011—Subsec. (e)(3)(A).
Change of Name
Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of
§283f. Requirements regarding surveys of sexual behavior
With respect to any survey of human sexual behavior proposed to be conducted or supported through the National Institutes of Health, the survey may not be carried out unless—
(1) the proposal has undergone review in accordance with any applicable requirements of
(2) the Secretary, in accordance with
(A) in reducing the incidence of sexually transmitted diseases, the incidence of infection with the human immunodeficiency virus, or the incidence of any other infectious disease; or
(B) in improving reproductive health or other conditions of health.
(July 1, 1944, ch. 373, title IV, §404D, as added
Prohibition Against SHARP Adult Sex Survey and American Teenage Sex Survey
§283g. Muscular dystrophy; initiative through Director of National Institutes of Health
(a) Expansion, intensification, and coordination of activities
(1) In general
The Director of NIH, in coordination with the Directors of the National Institute of Neurological Disorders and Stroke, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Heart, Lung, and Blood Institute, and the other national research institutes as appropriate, shall expand and intensify programs of such Institutes with respect to research and related activities concerning various forms of muscular dystrophy, including Duchenne, Becker, congenital muscular dystrophy, limb-girdle muscular dystrophy, myotonic, facioscapulohumeral muscular dystrophy (referred to in this section as "FSHD") and other forms of muscular dystrophy.
(2) Coordination
The Directors referred to in paragraph (1) shall jointly coordinate the programs referred to in such paragraph and consult with the Muscular Dystrophy Interagency Coordinating Committee established under section 6 of the MD–CARE Act.1
(3) Allocations by Director of NIH
The Director of NIH shall allocate the amounts appropriated to carry out this section for each fiscal year among the national research institutes referred to in paragraph (1).
(b) Centers of excellence
(1) In general
The Director of NIH shall award grants and contracts under subsection (a)(1) to public or nonprofit private entities to pay all or part of the cost of planning, establishing, improving, and providing basic operating support for centers of excellence regarding research on various forms of muscular dystrophy. Such centers of excellence shall be known as the "Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers".
(2) Research
Each center under paragraph (1) shall supplement but not replace the establishment of a comprehensive research portfolio in all the muscular dystrophies. As a whole, the centers shall conduct basic and clinical research in all forms of muscular dystrophy including early detection, diagnosis, prevention, and treatment, including the fields of muscle biology, genetics, noninvasive imaging, cardiac and pulmonary function, and pharmacological and other therapies.
(3) Coordination of centers
The Director of NIH shall, as appropriate, provide for the coordination of information among centers under paragraph (1) and ensure regular communication and sharing of data between such centers.
(4) Organization of centers
Each center under paragraph (1) shall use the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be prescribed by the Director of NIH.
(5) Duration of support
Support for a center established under paragraph (1) may be provided under this section for a period of not to exceed 5 years. Such period may be extended for 1 or more additional periods not exceeding 5 years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director of NIH and if such group has recommended to the Director that such period should be extended.
(c) Facilitation of research
The Director of NIH shall provide for a program under subsection (a)(1) under which samples of tissues and genetic materials that are of use in research on muscular dystrophy are donated, collected, preserved, and made available for such research. The program shall be carried out in accordance with accepted scientific and medical standards for the donation, collection, and preservation of such samples.
(d) Coordinating Committee
(1) In general
The Secretary shall establish the Muscular Dystrophy Coordinating Committee (referred to in this section as the "Coordinating Committee") to coordinate activities across the National Institutes and with other Federal health programs and activities relating to the various forms of muscular dystrophy.
(2) Composition
The Coordinating Committee shall consist of not more than 18 members to be appointed by the Secretary, of which—
(A) 2/3 of such members shall represent governmental agencies, including the directors or their designees of each of the national research institutes involved in research with respect to muscular dystrophy and representatives of all other Federal departments and agencies whose programs involve health functions or responsibilities relevant to such diseases, including the Centers for Disease Control and Prevention, the Health Resources and Services Administration, the Food and Drug Administration, and the Administration for Community Living and representatives of other governmental agencies that serve children and adults with muscular dystrophy, including the Department of Education and the Social Security Administration; and
(B) 1/3 of such members shall be public members, including a broad cross section of persons affected with muscular dystrophies including parents or legal guardians, affected individuals, researchers, and clinicians.
Members appointed under subparagraph (B) shall serve for a term of 3 years, and may serve for an unlimited number of terms if reappointed.
(3) Chair
(A) In general
With respect to muscular dystrophy, the Chair of the Coordinating Committee shall serve as the principal advisor to the Secretary, the Assistant Secretary for Health, and the Director of NIH, and shall provide advice to the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, and to the heads of other relevant agencies. The Coordinating Committee shall select the Chair for a term not to exceed 2 years.
(B) Appointment
The Chair of the Committee shall be appointed by and be directly responsible to the Secretary.
(4) Administrative support; terms of service; other provisions
The following shall apply with respect to the Coordinating Committee:
(A) The Coordinating Committee shall receive necessary and appropriate administrative support from the Department of Health and Human Services.
(B) The Coordinating Committee shall meet as appropriate as determined by the Secretary, in consultation with the chair,2 but shall meet no fewer than two times per calendar year.
(e) Plan for HHS activities
(1) In general
Not later than 1 year after December 18, 2001, the Coordinating Committee shall develop a plan for conducting and supporting research and education on muscular dystrophy through the agencies represented on the Coordinating Committee pursuant to subsection (d)(2)(A) and shall periodically review and revise the plan. The plan shall—
(A) provide for a broad range of research and education activities relating to biomedical, epidemiological, psychosocial, public services, and rehabilitative issues, including studies of the impact of such diseases in rural and underserved communities, studies to demonstrate the cost-effectiveness of providing independent living resources and support to patients with various forms of muscular dystrophy, and studies to determine optimal clinical care interventions for adults with various forms of muscular dystrophy;
(B) identify priorities among the programs and activities of the National Institutes of Health regarding such diseases; and
(C) reflect input from a broad range of scientists, patients, and advocacy groups.
(2) Certain elements of plan
The plan under paragraph (1) shall, with respect to each form of muscular dystrophy, provide for the following as appropriate:
(A) Research to determine the reasons underlying the incidence and prevalence of various forms of muscular dystrophy.
(B) Basic research concerning the etiology and genetic links of the disease and potential causes of mutations.
(C) The development of improved screening techniques.
(D) Basic and clinical research for the development and evaluation of new treatments, including new biological agents and new clinical interventions to improve the health of those with muscular dystrophy.
(E) Information and education programs for health care professionals and the public.
(f) Public input
The Secretary shall, under subsection (a)(1), provide for a means through which the public can obtain information on the existing and planned programs and activities of the Department of Health and Human Services with respect to various forms of muscular dystrophy and through which the Secretary can receive comments from the public regarding such programs and activities.
(g) Clinical research
The Coordinating Committee may evaluate the potential need to enhance the clinical research infrastructure required to test emerging therapies for the various forms of muscular dystrophy by prioritizing the achievement of the goals related to this topic in the plan under subsection (e)(1).
(July 1, 1944, ch. 373, title IV, §404E, as added
References in Text
Section 6 of the MD–CARE Act, referred to in subsec. (a)(2), is section 6 of
Prior Provisions
A prior section 283g, act July 1, 1944, ch. 373, title IV, §404E, as added
Amendments
2014—Subsec. (a)(1).
Subsec. (b)(2).
Subsec. (b)(3).
Subsec. (d)(2).
Subsec. (d)(2)(A).
Subsec. (d)(4)(B).
Subsec. (e)(1).
Subsec. (e)(1)(A).
Subsec. (e)(2)(D).
2008—Subsec. (a)(1).
Subsec. (b)(1).
Subsec. (f).
Subsec. (g).
2007—
Subsec. (a)(1).
Subsec. (b)(3).
"(A) shall, as appropriate, provide for the coordination of information among centers under paragraph (1) and ensure regular communication between such centers; and
"(B) shall require the periodic preparation of reports on the activities of the centers and the submission of the reports to the Director."
Subsec. (h).
Effective Date of 2007 Amendment
Amendment by
1 See References in Text note below.
2 So in original. Probably should be capitalized.
§§283h, 283i. Transferred
Codification
Section 283h, act July 1, 1944, ch. 373, title IV, §404F, as added
Section 283i, act July 1, 1944, ch. 373, title IV, §404G, as added
§283j. Repealed. Pub. L. 114–255, div. A, title II, §2042(f)(1), Dec. 13, 2016, 130 Stat. 1073
Section, July 1, 1944, ch. 373, title IV, §404H, as added
§283k. Biomedical and behavioral research facilities
(a) Modernization and construction of facilities
(1) In general
The Director of NIH, acting through the Office of the Director of NIH or the Director of the National Institute of Allergy and Infectious Diseases, may make grants or contracts to public and nonprofit private entities to expand, remodel, renovate, or alter existing research facilities or construct new research facilities, subject to the provisions of this section.
(2) Construction and cost of construction
For purposes of this section, the terms "construction" and "cost of construction" include the construction of new buildings and the expansion, renovation, remodeling, and alteration of existing buildings, including architects' fees, but do not include the cost of acquisition of land or off-site improvements.
(b) Scientific and technical review boards for merit-based review of proposals
(1) In general: approval as precondition to grants
(A) Establishment
There is established a Scientific and Technical Review Board on Biomedical and Behavioral Research Facilities (referred to in this section as the "Board").
(B) Requirement
The Director of NIH, acting through the Office of the Director of NIH, may approve an application for a grant under subsection (a) only if the Board has under paragraph (2) recommended the application for approval.
(2) Duties
(A) Advice
The Board shall provide advice to the Director of NIH and the Council of Councils established under
(B) Determination of merit
In carrying out subparagraph (A), the Board shall make a determination of the merit of each application submitted for a grant under subsection (a), after consideration of the requirements established in subsection (c), and shall report the results of the determination to the Director of NIH and the Council. Such determinations shall be conducted in a manner consistent with procedures established under
(C) Amount
In carrying out subparagraph (A), the Board shall, in the case of applications recommended for approval, make recommendations to the Director and the Council on the amount that should be provided under the grant.
(D) Annual report
In carrying out subparagraph (A), the Board shall prepare an annual report for the Director of NIH and the Council describing the activities of the Board in the fiscal year for which the report is made. Each such report shall be available to the public, and shall—
(i) summarize and analyze expenditures made under this section;
(ii) provide a summary of the types, numbers, and amounts of applications that were recommended for grants under subsection (a) but that were not approved by the Director of NIH; and
(iii) contain the recommendations of the Board for any changes in the administration of this section.
(3) Membership
(A) In general
Subject to subparagraph (B), the Board shall be composed of 15 members to be appointed by the Director of NIH, acting through the Office of the Director of NIH, and such ad-hoc or temporary members as the Director of NIH, acting through the Office of the Director of NIH, determines to be appropriate. All members of the Board, including temporary and ad-hoc members, shall be voting members.
(B) Limitation
Not more than three individuals who are officers or employees of the Federal Government may serve as members of the Board.
(4) Certain requirements regarding membership
In selecting individuals for membership on the Board, the Director of NIH, acting through the Office of the Director of NIH, shall ensure that the members are individuals who, by virtue of their training or experience, are eminently qualified to perform peer review functions. In selecting such individuals for such membership, the Director of NIH, acting through the Office of the Director of NIH, shall ensure that the members of the Board collectively—
(A) are experienced in the planning, construction, financing, and administration of entities that conduct biomedical or behavioral research sciences;
(B) are knowledgeable in making determinations of the need of entities for biomedical or behavioral research facilities, including such facilities for the dentistry, nursing, pharmacy, and allied health professions;
(C) are knowledgeable in evaluating the relative priorities for applications for grants under subsection (a) in view of the overall research needs of the United States; and
(D) are experienced with emerging centers of excellence, as described in subsection (c)(2).
(5) Certain authorities
(A) Workshops and conferences
In carrying out paragraph (2), the Board may convene workshops and conferences, and collect data as the Board considers appropriate.
(B) Subcommittees
In carrying out paragraph (2), the Board may establish subcommittees within the Board. Such subcommittees may hold meetings as determined necessary to enable the subcommittee to carry out its duties.
(6) Terms
(A) In general
Except as provided in subparagraph (B), each appointed member of the Board shall hold office for a term of 4 years. Any member appointed to fill a vacancy occurring prior to the expiration of the term for which such member's predecessor was appointed shall be appointed for the remainder of the term of the predecessor.
(B) Staggered terms
Members appointed to the Board shall serve staggered terms as specified by the Director of NIH, acting through the Office of the Director of NIH, when making the appointments.
(C) Reappointment
No member of the Board shall be eligible for reappointment to the Board until 1 year has elapsed after the end of the most recent term of the member.
(7) Compensation
Members of the Board who are not officers or employees of the United States shall receive for each day the members are engaged in the performance of the functions of the Board compensation at the same rate received by members of other national advisory councils established under this subchapter.
(c) Requirements for grants
(1) In general
The Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases, may make a grant under subsection (a) only if the applicant for the grant meets the following conditions:
(A) The applicant is determined by such Director to be competent to engage in the type of research for which the proposed facility is to be constructed.
(B) The applicant provides assurances satisfactory to the Director that—
(i) for not less than 20 years after completion of the construction involved, the facility will be used for the purposes of the research for which it is to be constructed;
(ii) sufficient funds will be available to meet the non-Federal share of the cost of constructing the facility;
(iii) sufficient funds will be available, when construction is completed, for the effective use of the facility for the research for which it is being constructed; and
(iv) the proposed construction will expand the applicant's capacity for research, or is necessary to improve or maintain the quality of the applicant's research.
(C) The applicant meets reasonable qualifications established by the Director with respect to—
(i) the relative scientific and technical merit of the applications, and the relative effectiveness of the proposed facilities, in expanding the capacity for biomedical or behavioral research and in improving the quality of such research;
(ii) the quality of the research or training, or both, to be carried out in the facilities involved;
(iii) the congruence of the research activities to be carried out within the facility with the research and investigator manpower needs of the United States; and
(iv) the age and condition of existing research facilities.
(D) The applicant has demonstrated a commitment to enhancing and expanding the research productivity of the applicant.
(2) Institutions of emerging excellence
From the amount appropriated to carry out this section for a fiscal year up to $50,000,000, the Director of NIH, acting through the Office of the Director of NIH, shall make available 25 percent of such amount, and from the amount appropriated to carry out this section for a fiscal year that is over $50,000,000, the Director of NIH, acting through the Office of the Director of NIH, shall make available up to 25 percent of such amount, for grants under subsection (a) to applicants that in addition to meeting the requirements established in paragraph (1), have demonstrated emerging excellence in biomedical or behavioral research, as follows:
(A) The applicant has a plan for research or training advancement and possesses the ability to carry out the plan.
(B) The applicant carries out research and research training programs that have a special relevance to a problem, concern, or unmet health need of the United States.
(C) The applicant has been productive in research or research development and training.
(D) The applicant—
(i) has been designated as a center of excellence under section 293c 1 of this title;
(ii) is located in a geographic area whose population includes a significant number of individuals with health status deficit, and the applicant provides health services to such individuals; or
(iii) is located in a geographic area in which a deficit in health care technology, services, or research resources may adversely affect the health status of the population of the area in the future, and the applicant is carrying out activities with respect to protecting the health status of such population.
(d) Requirement of application
The Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases, may make a grant under subsection (a) only if an application for the grant is submitted to the Director and the application is in such form, is made in such manner, and contains such agreements, assurances, and information as the Director determines to be necessary to carry out this section.
(e) Amount of grant; payments
(1) Amount
The amount of any grant awarded under subsection (a) shall be determined by the Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases,,2 except that such amount shall not exceed—
(A) 50 percent (or, in the case of the Institute, 75 percent) of the necessary cost of the construction of a proposed facility as determined by the Director; or
(B) in the case of a multipurpose facility, 40 percent (or, in the case of the Institute, 75 percent) of that part of the necessary cost of construction that the Director determines to be proportionate to the contemplated use of the facility.
(2) Reservation of amounts
On the approval of any application for a grant under subsection (a), the Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases, shall reserve, from any appropriation available for such grants, the amount of such grant, and shall pay such amount, in advance or by way of reimbursement, and in such installments consistent with the construction progress, as the Director may determine appropriate. The reservation of any amount by the Director under this paragraph may be amended by the Director, either on the approval of an amendment of the application or on the revision of the estimated cost of construction of the facility.
(3) Exclusion of certain costs
In determining the amount of any grant under subsection (a), there shall be excluded from the cost of construction an amount equal to the sum of—
(A) the amount of any other Federal grant that the applicant has obtained, or is assured of obtaining, with respect to construction that is to be financed in part by a grant authorized under this section; and
(B) the amount of any non-Federal funds required to be expended as a condition of such other Federal grant.
(4) Waiver of limitations
The limitations imposed under paragraph (1) may be waived at the discretion of the Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases, for applicants meeting the conditions described in subsection (c).
(f) Recapture of payments
If, not later than 20 years after the completion of construction for which a grant has been awarded under subsection (a)—
(1) in the case of an award by the Director of NIH, acting through the Office of the Director of NIH, the applicant or other owner of the facility shall cease to be a public or non profit 3 private entity; or
(2) the facility shall cease to be used for the research purposes for which it was constructed (unless the Director of NIH, acting through the Office of the Director of NIH or the National Institute of Allergy and Infectious Diseases, determines, in accordance with regulations, that there is good cause for releasing the applicant or other owner from obligation to do so),
the United States shall be entitled to recover from the applicant or other owner of the facility the amount bearing the same ratio to the current value (as determined by an agreement between the parties or by action brought in the United States District Court for the district in which such facility is situated) of the facility as the amount of the Federal participation bore to the cost of the construction of such facility.
(g) Guidelines
Not later than 6 months after June 10, 1993, the Director of NIH, acting through the Office of the Director of NIH, after consultation with the Council, shall issue guidelines with respect to grants under subsection (a).
(July 1, 1944, ch. 373, title IV, §404I, formerly §481A, as added
References in Text
Codification
Section was formerly classified to
Amendments
2011—Subsec. (a)(1).
Subsec. (b)(1)(A).
Subsec. (b)(1)(B).
Subsec. (b)(2)(A).
Subsec. (b)(2)(B).
Subsec. (b)(2)(C).
Subsec. (b)(2)(D).
Subsec. (b)(3)(A).
Subsec. (b)(4).
Subsec. (b)(6)(B).
Subsec. (c)(1).
Subsec. (c)(2).
Subsec. (d).
Subsec. (e).
Subsec. (f)(1).
Subsec. (f)(2).
Subsec. (g).
2007—Subsec. (c)(2).
Subsec. (h).
Subsec. (i).
2004—Subsec. (a)(1).
Subsec. (c)(1).
Subsec. (c)(2).
Subsec. (d).
Subsec. (e)(1).
Subsec. (e)(1)(A).
Subsec. (e)(1)(B).
Subsec. (e)(2).
Subsec. (e)(4).
Subsec. (f)(1).
Subsec. (f)(2).
Subsec. (i).
2000—
1998—Subsec. (c)(3)(D)(i).
Effective Date of 2007 Amendment
Amendment by
Findings
"(1) the National Institutes of Health is the principal source of Federal funding for medical research at universities and other research institutions in the United States;
"(2) the National Institutes of Health has received a substantial increase in research funding from Congress for the purpose of expanding the national investment of the United States in behavioral and biomedical research;
"(3) the infrastructure of our research institutions is central to the continued leadership of the United States in medical research;
"(4) as Congress increases the investment in cutting-edge basic and clinical research, it is critical that Congress also examine the current quality of the laboratories and buildings where research is being conducted, as well as the quality of laboratory equipment used in research;
"(5) many of the research facilities and laboratories in the United States are outdated and inadequate;
"(6) the National Science Foundation found, in a 1998 report on the status of biomedical research facilities, that over 60 percent of research-performing institutions indicated that they had an inadequate amount of medical research space;
"(7) the National Science Foundation reports that academic institutions have deferred nearly $11,000,000,000 in renovation and construction projects because of a lack of funds; and
"(8) future increases in Federal funding for the National Institutes of Health must include increased support for the renovation and construction of extramural research facilities in the United States and the purchase of state-of-the-art laboratory instrumentation."
1 See References in Text note below.
3 So in original. Probably should be "nonprofit".
§283l. Construction of regional centers for research on primates
(a) With respect to activities carried out by the Director of NIH, acting through the Office of the Director of NIH, to support regional centers for research on primates, the Director of NIH may, for each of the fiscal years 2000 through 2002, reserve from the amounts appropriated to carry out
(b) The Director of NIH may not make a grant or enter into a contract under subsection (a) unless the applicant for such assistance agrees, with respect to the costs to be incurred by the applicant in carrying out the purpose described in such subsection, to make available (directly or through donations from public or private entities) non-Federal contributions in cash toward such costs in an amount equal to not less than $1 for each $4 of Federal funds provided in such assistance.
(July 1, 1944, ch. 373, title IV, §404J, formerly §481B, as added
Codification
Section was formerly classified to
Amendments
2011—Subsec. (a).
2007—Subsec. (a).
2000—Subsec. (a).
1998—Subsec. (a).
Effective Date of 2007 Amendment
Amendment by
§283m. Sanctuary system for surplus chimpanzees
(a) In general
The Secretary shall provide for the establishment and operation in accordance with this section of a system to provide for the lifetime care of chimpanzees that have been used, or were bred or purchased for use, in research conducted or supported by the National Institutes of Health, the Food and Drug Administration, or other agencies of the Federal Government, and with respect to which it has been determined by the Secretary that the chimpanzees are not needed for such research (in this section referred to as "surplus chimpanzees").
(b) Administration of sanctuary system
The Secretary shall carry out this section, including the establishment of regulations under subsection (d), in consultation with the board of directors of the nonprofit private entity that receives the contract under subsection (e) (relating to the operation of the sanctuary system).
(c) Acceptance of chimpanzees into system
All surplus chimpanzees owned by the Federal Government shall be accepted into the sanctuary system. Subject to standards under subsection (d)(4), any chimpanzee that is not owned by the Federal Government can be accepted into the system if the owner transfers to the sanctuary system title to the chimpanzee.
(d) Standards for permanent retirement of surplus chimpanzees
(1) In general
Not later than 180 days after December 20, 2000, the Secretary shall by regulation establish standards for operating the sanctuary system to provide for the permanent retirement of surplus chimpanzees. In establishing the standards, the Secretary shall consider the recommendations of the board of directors of the nonprofit private entity that receives the contract under subsection (e), and shall consider the recommendations of the National Research Council applicable to surplus chimpanzees that are made in the report published in 1997 and entitled "Chimpanzees in Research—Strategies for Their Ethical Care, Management, and Use".
(2) Chimpanzees accepted into system
With respect to chimpanzees that are accepted into the sanctuary system, standards under paragraph (1) shall include the following:
(A) A prohibition that the chimpanzees may not be used for research, except as authorized under paragraph (3).
(B) Provisions regarding the housing of the chimpanzees.
(C) Provisions regarding the behavioral well-being of the chimpanzees.
(D) A requirement that the chimpanzees be cared for in accordance with the Animal Welfare Act [
(E) A requirement that the chimpanzees be prevented from breeding.
(F) A requirement that complete histories be maintained on the health and use in research of the chimpanzees.
(G) A requirement that the chimpanzees be monitored for the purpose of promptly detecting the presence in the chimpanzees of any condition that may be a threat to the public health or the health of other chimpanzees.
(H) A requirement that chimpanzees posing such a threat be contained in accordance with applicable recommendations of the Director of the Centers for Disease Control and Prevention.
(I) A prohibition that none of the chimpanzees may be subjected to euthanasia, except as in the best interests of the chimpanzee involved, as determined by the system and an attending veterinarian.
(J) A prohibition that the chimpanzees may not be discharged from the system.
(K) A provision that the Secretary may, in the discretion of the Secretary, accept into the system chimpanzees that are not surplus chimpanzees.
(L) Such additional standards as the Secretary determines to be appropriate.
(3) Restrictions regarding research
(A) In general
For purposes of paragraph (2)(A), standards under paragraph (1) shall provide that a chimpanzee accepted into the sanctuary system may not be used for studies or research, except that the chimpanzee may be used for noninvasive behavioral studies or medical studies based on information collected during the course of normal veterinary care that is provided for the benefit of the chimpanzee, provided that any such study involves minimal physical and mental harm, pain, distress, and disturbance to the chimpanzee and the social group in which the chimpanzee lives.
(B) Additional restriction
For purposes of paragraph (2)(A), a condition for the use in studies or research of a chimpanzee accepted into the sanctuary system is (in addition to conditions under subparagraph (A) of this paragraph) that the applicant for such use has not been fined for, or signed a consent decree for, any violation of the Animal Welfare Act [
(4) Non-Federal chimpanzees offered for acceptance into system
With respect to a chimpanzee that is not owned by the Federal Government and is offered for acceptance into the sanctuary system, standards under paragraph (1) shall include the following:
(A) A provision that the Secretary may authorize the imposition of a fee for accepting such chimpanzee into the system, except as follows:
(i) Such a fee may not be imposed for accepting the chimpanzee if, on the day before December 20, 2000, the chimpanzee was owned by the nonprofit private entity that receives the contract under subsection (e) or by any individual sanctuary facility receiving a subcontract or grant under subsection (e)(1).
(ii) Such a fee may not be imposed for accepting the chimpanzee if the chimpanzee is owned by an entity that operates a primate center, and if the chimpanzee is housed in the primate center pursuant to the program for regional centers for research on primates that is carried out by the Director of NIH, acting through the Office of the Director of NIH,.1
Any fees collected under this subparagraph are available to the Secretary for the costs of operating the system. Any other fees received by the Secretary for the long-term care of chimpanzees (including any Federal fees that are collected for such purpose and are identified in the report under section 3 of the Chimpanzee Health Improvement, Maintenance, and Protection Act) are available for operating the system, in addition to availability for such other purposes as may be authorized for the use of the fees.
(B) A provision that the Secretary may deny such chimpanzee acceptance into the system if the capacity of the system is not sufficient to accept the chimpanzee, taking into account the physical capacity of the system; the financial resources of the system; the number of individuals serving as the staff of the system, including the number of professional staff; the necessity of providing for the safety of the staff and of the public; the necessity of caring for accepted chimpanzees in accordance with the standards under paragraph (1); and such other factors as may be appropriate.
(C) A provision that the Secretary may deny such chimpanzee acceptance into the system if a complete history of the health and use in research of the chimpanzee is not available to the Secretary.
(D) Such additional standards as the Secretary determines to be appropriate.
(e) Award of contract for operation of system
(1) In general
Subject to the availability of funds pursuant to subsection (g), the Secretary shall make an award of a contract to a nonprofit private entity under which the entity has the responsibility of operating (and establishing, as applicable) the sanctuary system and awarding subcontracts or grants to individual sanctuary facilities that meet the standards under subsection (d).
(2) Requirements
The Secretary may make an award under paragraph (1) to a nonprofit private entity only if the entity meets the following requirements:
(A) The entity has a governing board of directors that is composed and appointed in accordance with paragraph (3) and is satisfactory to the Secretary.
(B) The terms of service for members of such board are in accordance with paragraph (3).
(C) The members of the board serve without compensation. The members may be reimbursed for travel, subsistence, and other necessary expenses incurred in carrying out the duties of the board.
(D) The entity has an executive director meeting such requirements as the Secretary determines to be appropriate.
(E) The entity makes the agreement described in paragraph (4) (relating to non-Federal contributions).
(F) The entity agrees to comply with standards under subsection (d).
(G) The entity agrees to make necropsy reports on chimpanzees in the sanctuary system available on a reasonable basis to persons who conduct biomedical or behavioral research, with priority given to such persons who are Federal employees or who receive financial support from the Federal Government for research.
(H) Such other requirements as the Secretary determines to be appropriate.
(3) Board of directors
For purposes of subparagraphs (A) and (B) of paragraph (2):
(A) The governing board of directors of the nonprofit private entity involved is composed and appointed in accordance with this paragraph if the following conditions are met:
(i) Such board is composed of not more than 13 voting members.
(ii) Such members include individuals with expertise and experience in the science of managing captive chimpanzees (including primate veterinary care), appointed from among individuals endorsed by organizations that represent individuals in such field.
(iii) Such members include individuals with expertise and experience in the field of animal protection, appointed from among individuals endorsed by organizations that represent individuals in such field.
(iv) Such members include individuals with expertise and experience in the zoological field (including behavioral primatology), appointed from among individuals endorsed by organizations that represent individuals in such field.
(v) Such members include individuals with expertise and experience in the field of the business and management of nonprofit organizations, appointed from among individuals endorsed by organizations that represent individuals in such field.
(vi) Such members include representatives from entities that provide accreditation in the field of laboratory animal medicine.
(vii) Such members include individuals with expertise and experience in the field of containing biohazards.
(viii) Such members include an additional member who serves as the chair of the board, appointed from among individuals who have been endorsed for purposes of clause (ii), (iii), (iv), or (v).
(ix) None of the members of the board has been fined for, or signed a consent decree for, any violation of the Animal Welfare Act [
(B) The terms of service for members of the board of directors are in accordance with this paragraph if the following conditions are met:
(i) The term of the chair of the board is 3 years.
(ii) The initial members of the board select, by a random method, one member from each of the six fields specified in subparagraph (A) to serve a term of 2 years and (in addition to the chair) one member from each of such fields to serve a term of 3 years.
(iii) After the initial terms under clause (ii) expire, each member of the board (other than the chair) is appointed to serve a term of 2 years.
(iv) An individual whose term of service expires may be reappointed to the board.
(v) A vacancy in the membership of the board is filled in the manner in which the original appointment was made.
(vi) If a member of the board does not serve the full term applicable to the member, the individual appointed to fill the resulting vacancy is appointed for the remainder of the term of the predecessor member.
(4) Requirement of matching funds
The agreement required in paragraph (2)(E) for a nonprofit private entity (relating to the award of the contract under paragraph (1)) is an agreement that, with respect to the costs to be incurred by the entity in establishing and operating the sanctuary system, the entity will make available (directly or through donations from public or private entities) non-Federal contributions toward such costs, in cash or in kind, in an amount not less than the following, as applicable:
(A) For expenses associated with establishing the sanctuary system (as determined by the Secretary), 10 percent of such costs ($1 for each $9 of Federal funds provided under the contract under paragraph (1)).
(B) For expenses associated with operating the sanctuary system (as determined by the Secretary), 25 percent of such costs ($1 for each $3 of Federal funds provided under such contract).
(5) Establishment of contract entity
If the Secretary determines that an entity meeting the requirements of paragraph (2) does not exist, not later than 60 days after December 20, 2000, the Secretary shall, for purposes of paragraph (1), make a grant for the establishment of such an entity, including paying the cost of incorporating the entity under the law of one of the States.
(f) Definitions
For purposes of this section:
(1) Permanent retirement
The term "permanent retirement", with respect to a chimpanzee that has been accepted into the sanctuary system, means that under subsection (a) the system provides for the lifetime care of the chimpanzee, that under subsection (d)(2) the system does not permit the chimpanzee to be used in research (except as authorized under subsection (d)(3)) or to be euthanized (except as provided in subsection (d)(2)(I)), that under subsection (d)(2) the system will not discharge the chimpanzee from the system, and that under such subsection the system otherwise cares for the chimpanzee.
(2) Sanctuary system
The term "sanctuary system" means the system described in subsection (a).
(3) Secretary
The term "Secretary" means the Secretary of Health and Human Services.
(4) Surplus chimpanzees
The term "surplus chimpanzees" has the meaning given that term in subsection (a).
(g) Funding
(1) In general
Of the amount appropriated for the National Institutes of Health, there are authorized to be appropriated to carry out this section and for the care, maintenance, and transportation of all chimpanzees otherwise under the ownership or control of the National Institutes of Health, and to enable the National Institutes of Health to operate more efficiently and economically by decreasing the overall Federal cost of providing for the care, maintenance, and transportation of chimpanzees—
(A) for fiscal year 2014, $12,400,000;
(B) for fiscal year 2015, $11,650,000;
(C) for fiscal year 2016, $10,900,000;
(D) for fiscal year 2017, $10,150,000; and
(E) for fiscal year 2018, $9,400,000.
(2) Use of funds for other compliant facilities
With respect to amounts authorized to be appropriated by paragraph (1) for a fiscal year, the Secretary may use a portion of such amounts to make awards of grants or contracts to public or private entities operating facilities that, as determined by the Secretary in consultation with the board of directors of the nonprofit private entity that receives the contract under subsection (e), provide for the retirement of chimpanzees in accordance with the same standards that apply to the sanctuary system pursuant to regulations under subsection (d). Such an award may be expended for the expenses of operating the facilities involved.
(3) Biennial report
Not later than 180 days after November 27, 2013, the Director of the National Institutes of Health shall submit to the Committee on Health, Education, Labor, and Pensions and the Committee on Appropriations of the Senate and the Committee on Energy and Commerce and the Committee on Appropriations in the House of Representatives a report, to be updated biennially, regarding—
(A) the care, maintenance, and transportation of the chimpanzees under the ownership or control of the National Institutes of Health;
(B) costs related to such care, maintenance, and transportation, and any other related costs; and
(C) the research status of such chimpanzees.
(July 1, 1944, ch. 373, title IV, §404K, formerly §481C, as added
References in Text
The Animal Welfare Act, referred to in subsecs. (d)(2)(D), (3)(B) and (e)(3)(A)(ix), is
Section 3 of the Chimpanzee Health Improvement, Maintenance, and Protection Act, referred to in subsec. (d)(4)(A), is section 3 of
Codification
Section was formerly classified to
November 27, 2013, referred to in subsec. (g)(3), was in the original "the date enactment of this Act" (sic), which was translated as meaning the date of enactment of
Amendments
2013—Subsec. (g)(1).
Subsec. (g)(2).
Subsec. (g)(3).
2011—Subsec. (d)(4)(A)(ii).
2007—Subsec. (d)(2)(J).
Subsec. (d)(3)(A).
"(i) The chimpanzee may be used for noninvasive behavioral studies"
and struck out cl. (ii) which related to findings necessary before a chimpanzee may be used in research.
Subsec. (d)(3)(B), (C).
Report to Congress Regarding Number of Chimpanzees and Funding for Care of Chimpanzees
1 So in original. Comma probably should not appear.
§283n. Shared Instrumentation Grant Program
(a) Requirements for grants
In determining whether to award a grant to an applicant under the Shared Instrumentation Grant Program, the Director of NIH, acting through the Office of the Director of NIH, shall consider—
(1) the extent to which an award for the specific instrument involved would meet the scientific needs and enhance the planned research endeavors of the major users by providing an instrument that is unavailable or to which availability is highly limited;
(2) with respect to the instrument involved, the availability and commitment of the appropriate technical expertise within the major user group or the applicant institution for use of the instrumentation;
(3) the adequacy of the organizational plan for the use of the instrument involved and the internal advisory committee for oversight of the applicant, including sharing arrangements if any;
(4) the applicant's commitment for continued support of the utilization and maintenance of the instrument; and
(5) the extent to which the specified instrument will be shared and the benefit of the proposed instrument to the overall research community to be served.
(b) Peer review
In awarding grants under the program described in subsection (a), the Director of NIH, acting through the Office of the Director of NIH, shall comply with the peer review requirements in
(July 1, 1944, ch. 373, title IV, §404L, formerly
Codification
Section was formerly set out as a note under
Amendments
2011—
Subsec. (a).
Subsec. (b).
Subsec. (c).
§283o. Next generation of researchers
(a) Next generation of researchers initiative
There shall be established within the Office of the Director of the National Institutes of Health, the Next Generation of Researchers Initiative (referred to in this section as the "Initiative"), through which the Director shall coordinate all policies and programs within the National Institutes of Health that are focused on promoting and providing opportunities for new researchers and earlier research independence.
(b) Activities
The Director of the National Institutes of Health, through the Initiative shall—
(1) promote policies and programs within the National Institutes of Health that are focused on improving opportunities for new researchers and promoting earlier research independence, including existing policies and programs, as appropriate;
(2) develop, modify, or prioritize policies, as needed, within the National Institutes of Health to promote opportunities for new researchers and earlier research independence, such as policies to increase opportunities for new researchers to receive funding, enhance training and mentorship programs for researchers, and enhance workforce diversity;
(3) coordinate, as appropriate, with relevant agencies, professional and academic associations, academic institutions, and others, to improve and update existing information on the biomedical research workforce in order to inform programs related to the training, recruitment, and retention of biomedical researchers; and
(4) carry out other activities, including evaluation and oversight of existing programs, as appropriate, to promote the development of the next generation of researchers and earlier research independence.
(July 1, 1944, ch. 373, title IV, §404M, as added
§283p. Population focused research
The Director of the National Institutes of Health shall, as appropriate, encourage efforts to improve research related to the health of sexual and gender minority populations, including by—
(1) facilitating increased participation of sexual and gender minority populations in clinical research supported by the National Institutes of Health, and reporting on such participation, as applicable;
(2) facilitating the development of valid and reliable methods for research relevant to sexual and gender minority populations; and
(3) addressing methodological challenges.
(July 1, 1944, ch. 373, title IV, §404N, as added
Reporting
"(1)
"(A) continue to support research for the development of appropriate measures related to reporting health information about sexual and gender minority populations; and
"(B) not later than 2 years after the date of enactment of this Act [Dec. 13, 2016], disseminate and make public such measures.
"(2)
§283q. Eureka prize competitions
(a) In general
Pursuant to the authorities and processes established under
(1) Identifying and funding areas of biomedical science that could realize significant advancements through a prize competition.
(2) Improving health outcomes, particularly with respect to human diseases and conditions—
(A) for which public and private investment in research is disproportionately small relative to Federal Government expenditures on prevention and treatment activities with respect to such diseases and conditions, such that Federal expenditures on health programs would be reduced;
(B) that are serious and represent a significant disease burden in the United States; or
(C) for which there is potential for significant return on investment to the United States.
(b) Tracking; reporting
The Director of the National Institutes of Health shall—
(1) collect information on—
(A) the effect of innovations funded through the prize competitions under this section in advancing biomedical science or improving health outcomes pursuant to subsection (a); and
(B) the effect of the innovations on Federal expenditures; and
(2) include the information collected under paragraph (1) in the triennial report under
(
References in Text
Section 2032, referred to in subsec. (b)(2), means section 2032 of
Codification
Section was enacted as part of the 21st Century Cures Act, and not as part of the Public Health Service Act which comprises this chapter.
Part B—General Provisions Respecting National Research Institutes
§284. Directors of national research institutes
(a) Appointment
(1) In general
The Director of the National Cancer Institute shall be appointed by the President, and the Directors of the other national research institutes and national centers shall be appointed by the Secretary, acting through the Director of National Institutes of Health. Each Director of a national research institute or national center shall report directly to the Director of National Institutes of Health.
(2) Appointment
(A) Term
A Director of a national research institute or national center who is appointed by the Secretary, acting through the Director of National Institutes of Health, shall be appointed for 5 years.
(B) Reappointment
At the end of the term of a Director of a national research institute or national center, the Director may be reappointed in accordance with standards applicable to the relevant appointment mechanism. There shall be no limit on the number of terms that a Director may serve.
(C) Vacancies
If the office of a Director of a national research institute or national center becomes vacant before the end of such Director's term, the Director appointed to fill the vacancy shall be appointed for a 5-year term starting on the date of such appointment.
(D) Current directors
Each Director of a national research institute or national center who is serving on December 13, 2016, shall be deemed to be appointed for a 5-year term under this subsection beginning on such date.
(E) Rule of construction
Nothing in this subsection shall be construed to limit the authority of the Secretary or the Director of National Institutes of Health to terminate the appointment of a director referred to in subparagraph (A) before the expiration of such director's 5-year term.
(F) Nature of appointment
Appointments and reappointments under this subsection shall be made on the basis of ability and experience as it relates to the mission of the National Institutes of Health and its components, including compliance with any legal requirement that the Secretary or Director of National Institutes of Health determines relevant.
(3) Nonapplication of certain provision
The restrictions contained in section 202 of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1993 (
(b) Duties and authority; grants, contracts, and cooperative agreements
(1) In carrying out the purposes of
(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
(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
(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
(2) Support for an activity or program under this subsection may be provided through grants, contracts, and cooperative agreements. The Secretary, acting through the Director of each national research institute—
(A) may enter into a contract for research, training, or demonstrations only if the contract has been recommended after technical and scientific peer review required by regulations under
(B) may make grants and cooperative agreements under paragraph (1) for research, training, or demonstrations, except that—
(i) if the direct cost of the grant or cooperative agreement to be made does not exceed $50,000, such grant or cooperative agreement may be made only if such grant or cooperative agreement has been recommended after technical and scientific peer review required by regulations under
(ii) if the direct cost of the grant or cooperative agreement to be made exceeds $50,000, such grant or cooperative agreement may be made only if such grant or cooperative agreement has been recommended after technical and scientific peer review required by regulations under
(C) shall, subject to
(3) Before an award is made by a national research institute or by a national center for a grant for a research program or project (commonly referred to as an "R-series grant"), other than an award constituting a noncompetitive renewal of such a grant, or a noncompetitive administrative supplement to such a grant, the Director of such national research institute or national center shall, consistent with the peer review process—
(A) review and make the final decision with respect to making the award; and
(B) take into consideration, as appropriate—
(i) the mission of the national research institute or national center and the scientific priorities identified in the strategic plan under
(ii) programs or projects funded by other agencies on similar research topics; and
(iii) advice by staff and the advisory council or board of such national research institute or national center.
(c) Coordination with other public and private entities; cooperation with other national research institutes; appointment of additional peer review groups
In carrying out subsection (b), each Director of a national research institute—
(1) shall coordinate, as appropriate, the activities of the institute with similar programs of other public and private entities;
(2) shall cooperate with the Directors of the other national research institutes in the development and support of multidisciplinary research and research that involves more than one institute;
(3) may, in consultation with the advisory council for the Institute and with the approval of the Director of NIH—
(A) establish technical and scientific peer review groups in addition to those appointed under
(B) appoint the members of peer review groups established under subparagraph (A); and
(4) may publish, or arrange for the publication of, information with respect to the purpose of the Institute without regard to
The Federal Advisory Committee Act shall not apply to the duration of a peer review group appointed under paragraph (3).
(July 1, 1944, ch. 373, title IV, §405, as added
References in Text
The Federal Advisory Committee Act, referred to in subsec. (c), is
Amendments
2016—Subsec. (a).
Subsec. (b)(1)(C) to (M).
Subsec. (b)(3).
2007—Subsec. (c)(3)(A).
1993—Subsec. (b)(2)(C).
Subsec. (c).
Subsec. (c)(3).
1988—Subsec. (b)(1).
Subsec. (c)(3).
Subsec. (c)(4).
Effective Date of 2007 Amendment
Amendment by
Effective Date of 1988 Amendment
Amendment by
Enhancing the Clinical and Translational Science Award
"(a)
"(1) allowing the appointment of a secondary principal investigator under a single Clinical and Translational Science Award, such that a pediatric principal investigator may be appointed with direct authority over a separate budget and infrastructure for pediatric clinical research; or
"(2) otherwise securing institutional independence of pediatric clinical research centers with respect to finances, infrastructure, resources, and research agenda.
"(b)
"(c)
§284a. Advisory councils
(a) Establishment; acceptance of conditional gifts; functions
(1) Except as provided in subsection (h), the Secretary shall appoint an advisory council for each national research institute which (A) shall advise, assist, consult with, and make recommendations to the Secretary and the Director of such institute on matters related to the activities carried out by and through the institute and the policies respecting such activities, and (B) shall carry out the special functions prescribed by part C.
(2) Each advisory council for a national research institute may recommend to the Secretary acceptance, in accordance with
(3) Each advisory council for a national research institute—
(A)(i) may on the basis of the materials provided under
(ii) may review applications for grants and cooperative agreements for research or training and for which advisory council approval is required under
(iii) may review any grant, contract, or cooperative agreement proposed to be made or entered into by the institute;
(B) may collect, by correspondence or by personal investigation, information as to studies which are being carried on in the United States or any other country as to the diseases, disorders, or other aspect of human health with respect to which the institute was established and with the approval of the Director of the institute make available such information through appropriate publications for the benefit of public and private health entities and health professions personnel and scientists and for the information of the general public; and
(C) may appoint subcommittees and convene workshops and conferences.
(b) Membership; compensation
(1) Each advisory council shall consist of ex officio members and not more than eighteen members appointed by the Secretary. The ex officio members shall be nonvoting members.
(2) The ex officio members of an advisory council shall consist of—
(A) the Secretary, the Director of NIH, the Director of the national research institute for which the council is established, the Under Secretary for Health of the Department of Veterans Affairs or the Chief Dental Director of the Department of Veterans Affairs, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers), and
(B) such additional officers or employees of the United States as the Secretary determines necessary for the advisory council to effectively carry out its functions.
(3) The members of an advisory council who are not ex officio members shall be appointed as follows:
(A) Two-thirds of the members shall be appointed by the Secretary from among the leading representatives of the health and scientific disciplines (including not less than two individuals who are leaders in the fields of public health and the behavioral or social sciences) relevant to the activities of the national research institute for which the advisory council is established.
(B) One-third of the members shall be appointed by the Secretary from the general public and shall include leaders in fields of public policy, law, health policy, economics, and management.
(4) Members of an advisory council who are officers or employees of the United States shall not receive any compensation for service on the advisory council. The other members of an advisory council shall receive, for each day (including traveltime) they are engaged in the performance of the functions of the advisory council, compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS–18 of the General Schedule.
(c) Term of office; reappointment; vacancy
The term of office of an appointed member of an advisory council is four years, except that any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term and the Secretary shall make appointments to an advisory council in such a manner as to ensure that the terms of the members do not all expire in the same year. A member may serve after the expiration of the member's term for 180 days after the date of such expiration. A member who has been appointed for a term of four years may not be reappointed to an advisory council before two years from the date of expiration of such term of office. If a vacancy occurs in the advisory council among the appointed members, the Secretary shall make an appointment to fill the vacancy within 90 days from the date the vacancy occurs.
(d) Chairman; term of office
The chairman of an advisory council shall be selected by the Secretary from among the appointed members, except that the Secretary may select the Director of the national research institute for which the advisory council is established to be the chairman of the advisory council. The term of office of the chairman shall be two years.
(e) Meetings
The advisory council shall meet at the call of the chairman or upon the request of the Director of the national research institute for which it was established, but at least three times each fiscal year. The location of the meetings of each advisory council is subject to the approval of the Director of the national research institute for which the advisory council was established.
(f) Appointment of executive secretary; training and orientation for new members
The Director of the national research institute for which an advisory council is established shall designate a member of the staff of the institute to serve as the executive secretary of the advisory council. The Director of such institute shall make available to the advisory council such staff, information, and other assistance as it may require to carry out its functions. The Director of such institute shall provide orientation and training for new members of the advisory council to provide them with such information and training as may be appropriate for their effective participation in the functions of the advisory council.
(g) Comments and recommendations for inclusion in biennial report; additional reports
Each advisory council may prepare, for inclusion in the biennial report made under section 284b 1 of this title, (1) comments respecting the activities of the advisory council in the fiscal years respecting which the report is prepared, (2) comments on the progress of the national research institute for which it was established in meeting its objectives, and (3) recommendations respecting the future directions and program and policy emphasis of the institute. Each advisory council may prepare such additional reports as it may determine appropriate.
(h) Advisory councils in existence; application of section to National Cancer Advisory Board and advisory council to National Heart, Lung, and Blood Institute
(1) Except as provided in paragraph (2), this section does not terminate the membership of any advisory council for a national research institute which was in existence on November 20, 1985. After November 20, 1985—
(A) the Secretary shall make appointments to each such advisory council in such a manner as to bring about as soon as practicable the composition for such council prescribed by this section;
(B) each advisory council shall organize itself in accordance with this section and exercise the functions prescribed by this section; and
(C) the Director of each national research institute shall perform for such advisory council the functions prescribed by this section.
(2)(A) The National Cancer Advisory Board shall be the advisory council for the National Cancer Institute. This section applies to the National Cancer Advisory Board, except that—
(i) appointments to such Board shall be made by the President;
(ii) the term of office of an appointed member shall be 6 years;
(iii) of the members appointed to the Board—
(I) not less than 5 members shall be individuals knowledgeable in environmental carcinogenesis (including carcinogenesis involving occupational and dietary factors); and
(II) not less than one member shall be an individual knowledgeable in pediatric oncology;
(iv) the chairman of the Board shall be selected by the President from the appointed members and shall serve as chairman for a term of two years;
(v) the ex officio members of the Board shall be nonvoting members and shall be the Secretary, the Director of the Office of Science and Technology Policy, the Director of NIH, the Under Secretary for Health of the Department of Veterans Affairs, the Director of the National Institute for Occupational Safety and Health, the Director of the National Institute of Environmental Health Sciences, the Secretary of Labor, the Commissioner of the Food and Drug Administration, the Administrator of the Environmental Protection Agency, the Chairman of the Consumer Product Safety Commission, the Assistant Secretary of Defense for Health Affairs, and the Director of the Office of Science of the Department of Energy (or the designees of such officers); and
(vi) the Board shall meet at least four times each fiscal year.
(B) This section applies to the advisory council to the National Heart, Lung, and Blood Institute, except that the advisory council shall meet at least four times each fiscal year.
(July 1, 1944, ch. 373, title IV, §406, as added
References in Text
Amendments
2018—Subsec. (h)(2)(A)(iii).
1998—Subsec. (h)(2)(A)(v).
1993—Subsec. (a)(2).
Subsec. (b)(2)(A).
Subsec. (c).
Subsec. (h)(2)(A)(v).
1992—Subsecs. (b)(2)(A), (h)(2)(A)(v).
1990—Subsec. (a)(2).
1988—Subsec. (b)(1).
Subsec. (b)(3)(A).
Subsec. (h)(2)(A)(v).
Termination of Advisory Councils
Advisory councils established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a council established by the President or an officer of the Federal Government, such council is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a council established by the Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of
References in Other Laws to GS–16, 17, or 18 Pay Rates
References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of
1 See References in Text note below.
§284b. Repealed. Pub. L. 109–482, title I, §104(b)(1)(C), Jan. 15, 2007, 120 Stat. 3693
Section, act July 1, 1944, ch. 373, title IV, §407, as added
Effective Date of Repeal
Repeal applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of
§284c. Certain uses of funds
(a)(1) Except as provided in paragraph (2), the sum of the amounts obligated in any fiscal year for administrative expenses of the National Institutes of Health may not exceed an amount which is 5.5 percent of the total amount appropriated for such fiscal year for the National Institutes of Health.
(2) Paragraph (1) does not apply to the National Library of Medicine, the National Center for Nursing Research, the John E. Fogarty International Center for Advanced Study in the Health Sciences, the Warren G. Magnuson Clinical Center, and the Office of Medical Applications of Research.
(3) For purposes of paragraph (1), the term "administrative expenses" means expenses incurred for the support of activities relevant to the award of grants, contracts, and cooperative agreements and expenses incurred for general administration of the scientific programs and activities of the National Institutes of Health.
(b) For fiscal year 1989 and subsequent fiscal years, amounts made available to the National Institutes of Health shall be available for payment of nurses and allied health professionals in accordance with payment authorities, scheduling options, benefits, and other authorities provided under
(July 1, 1944, ch. 373, title IV, §408, as added
Amendments
1998—Subsec. (a)(4).
1996—Subsec. (a)(3).
1993—
1988—Subsec. (a)(1), (2).
"(1)(A) For the National Cancer Institute (other than its programs under
"(B) For the programs under
"(2)(A) For the National Heart, Lung, and Blood Institute (other than its programs under
"(B) For the programs under
Subsec. (a)(2)(B).
Subsec. (b)(5).
Change of Name
National Center for Nursing Research changed to National Institute of Nursing Research by
Effective Date of 1988 Amendment
Amendment by
Warren G. Magnuson Clinical Center; Availability of Funds for Payment of Nurses; Rate of Pay and Options and Benefits
§284d. Definitions
(a) Health service research
For purposes of this subchapter, the term "health services research" means research endeavors that study the impact of the organization, financing and management of health services on the quality, cost, access to and outcomes of care. Such term does not include research on the efficacy of services to prevent, diagnose, or treat medical conditions.
(b) Clinical research
As used in this subchapter, the term "clinical research" means patient oriented clinical research conducted with human subjects, or research on the causes and consequences of disease in human populations involving material of human origin (such as tissue specimens and cognitive phenomena) for which an investigator or colleague directly interacts with human subjects in an outpatient or inpatient setting to clarify a problem in human physiology, pathophysiology or disease, or epidemiologic or behavioral studies, outcomes research or health services research, or developing new technologies, therapeutic interventions, or clinical trials.
(July 1, 1944, ch. 373, title IV, §409, as added
Amendments
2000—
1993—
Effective Date
Section effective Oct. 1, 1992, with provision for programs providing financial assistance, see section 801(c), (d) of
§284e. Research on osteoporosis, Paget's disease, and related bone disorders
(a) Establishment
The Directors of the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging, the National Institute of Dental Research, and the National Institute of Diabetes and Digestive and Kidney Diseases, shall expand and intensify the programs of such Institutes with respect to research and related activities concerning osteoporosis, Paget's disease, and related bone disorders.
(b) Coordination
The Directors referred to in subsection (a) shall jointly coordinate the programs referred to in such subsection and consult with the Arthritis and Musculoskeletal Diseases Interagency Coordinating Committee and the Interagency Task Force on Aging Research.
(c) Information clearinghouse
(1) In general
In order to assist in carrying out the purpose described in subsection (a), the Director of NIH shall provide for the establishment of an information clearinghouse on osteoporosis and related bone disorders to facilitate and enhance knowledge and understanding on the part of health professionals, patients, and the public through the effective dissemination of information.
(2) Establishment through grant or contract
For the purpose of carrying out paragraph (1), the Director of NIH shall enter into a grant, cooperative agreement, or contract with a nonprofit private entity involved in activities regarding the prevention and control of osteoporosis and related bone disorders.
(July 1, 1944, ch. 373, title IV, §409A, as added
Amendments
2007—Subsec. (d).
1998—Subsec. (d).
Effective Date of 2007 Amendment
Amendment by
§284f. Parkinson's disease
(a) In general
The Director of NIH shall establish a program for the conduct and support of research and training with respect to Parkinson's disease (subject to the extent of amounts appropriated to carry out this section).
(b) Inter-institute coordination
(1) In general
The Director of NIH shall provide for the coordination of the program established under subsection (a) among all of the national research institutes conducting Parkinson's disease research.
(2) Conference
Coordination under paragraph (1) shall include the convening of a research planning conference not less frequently than once every 2 years. Each such conference shall prepare and submit to the Committee on Appropriations and the Committee on Labor and Human Resources of the Senate and the Committee on Appropriations and the Committee on Commerce of the House of Representatives a report concerning the conference.
(c) Morris K. Udall research centers
(1) In general
The Director of NIH is authorized to award Core Center Grants to encourage the development of innovative multidisciplinary research and provide training concerning Parkinson's disease. The Director is authorized to award not more than 10 Core Center Grants and designate each center funded under such grants as a Morris K. Udall Center for Research on Parkinson's Disease.
(2) Requirements
(A) In general
With respect to Parkinson's disease, each center assisted under this subsection shall—
(i) use the facilities of a single institution or a consortium of cooperating institutions, and meet such qualifications as may be prescribed by the Director of the NIH; and
(ii) conduct basic and clinical research.
(B) Discretionary requirements
With respect to Parkinson's disease, each center assisted under this subsection may—
(i) conduct training programs for scientists and health professionals;
(ii) conduct programs to provide information and continuing education to health professionals;
(iii) conduct programs for the dissemination of information to the public;
(iv) separately or in collaboration with other centers, establish a nationwide data system derived from patient populations with Parkinson's disease, and where possible, comparing relevant data involving general populations;
(v) separately or in collaboration with other centers, establish a Parkinson's Disease Information Clearinghouse to facilitate and enhance knowledge and understanding of Parkinson's disease; and
(vi) separately or in collaboration with other centers, establish a national education program that fosters a national focus on Parkinson's disease and the care of those with Parkinson's disease.
(3) Stipends regarding training programs
A center may use funds provided under paragraph (1) to provide stipends for scientists and health professionals enrolled in training programs under paragraph (2)(B).
(4) Duration of support
Support of a center under this subsection may be for a period not exceeding five years. Such period may be extended by the Director of NIH for one or more additional periods of not more than five years 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.
(d) Morris K. Udall Awards for Excellence in Parkinson's Disease Research
The Director of NIH is authorized to establish a grant program to support investigators with a proven record of excellence and innovation in Parkinson's disease research and who demonstrate potential for significant future breakthroughs in the understanding of the pathogensis,1 diagnosis, and treatment of Parkinson's disease. Grants under this subsection shall be available for a period of not to exceed 5 years.
(July 1, 1944, ch. 373, title IV, §409B, as added
Amendments
2007—Subsec. (a).
Subsec. (e).
Change of Name
Committee on Commerce of House of Representatives changed to Committee on Energy and Commerce of House of Representatives, and jurisdiction over matters relating to securities and exchanges and insurance generally transferred to Committee on Financial Services of House of Representatives by House Resolution No. 5, One Hundred Seventh Congress, Jan. 3, 2001.
Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.
Effective Date of 2007 Amendment
Amendment by
Additional Grants
Similar provisions were contained in
Finding and Purpose
"(1)
"(2)
1 So in original. Probably should be "pathogenesis,".
§284g. Expansion, intensification, and coordination of activities of National Institutes of Health with respect to research on autism spectrum disorder
(a) In general
(1) Expansion of activities
The Director of NIH (in this section referred to as the "Director") shall, subject to the availability of appropriations, expand, intensify, and coordinate the activities of the National Institutes of Health with respect to research on autism spectrum disorder, including basic and clinical research in fields including pathology, developmental neurobiology, genetics, epigenetics, pharmacology, nutrition, immunology, neuroimmunology, neurobehavioral development, endocrinology, gastroenterology, toxicology, and interventions to maximize outcomes for individuals with autism spectrum disorder. Such research shall investigate the causes (including possible environmental causes), diagnosis or ruling out, early and ongoing detection, prevention, services across the lifespan, supports, intervention, and treatment of autism spectrum disorder, including dissemination and implementation of clinical care, supports, interventions, and treatments.
(2) Consolidation
The Director may consolidate program activities under this section if such consolidation would improve program efficiencies and outcomes.
(3) Administration of program; collaboration among agencies
The Director shall carry out this section acting through the Director of the National Institute of Mental Health and in collaboration with any other agencies that the Director determines appropriate.
(b) Centers of excellence
(1) In general
The Director shall under subsection (a)(1) make awards of grants and contracts to public or nonprofit private entities to pay all or part of the cost of planning, establishing, improving, and providing basic operating support for centers of excellence regarding research on autism spectrum disorder.
(2) Research
Each center under paragraph (1) shall conduct basic and clinical research into autism spectrum disorder. Such research should include investigations into the causes, diagnosis, early and ongoing detection, prevention, and treatment of autism spectrum disorder across the lifespan. The centers, as a group, shall conduct research including the fields of developmental neurobiology, genetics, genomics, psychopharmacology, developmental psychology, behavioral psychology, and clinical psychology.
(3) Services for patients
(A) In general
A center under paragraph (1) may expend amounts provided under such paragraph to carry out a program to make individuals aware of opportunities to participate as subjects in research conducted by the centers.
(B) Referrals and costs
A program under subparagraph (A) may, in accordance with such criteria as the Director may establish, provide to the subjects described in such subparagraph, referrals for health and other services, and such patient care costs as are required for research.
(C) Availability and access
The extent to which a center can demonstrate availability and access to clinical services shall be considered by the Director in decisions about awarding grants to applicants which meet the scientific criteria for funding under this section.
(D) Reducing disparities
The Director may consider, as appropriate, the extent to which a center can demonstrate availability and access to clinical services for youth and adults from diverse racial, ethnic, geographic, or linguistic backgrounds in decisions about awarding grants to applicants which meet the scientific criteria for funding under this section.
(4) Organization of centers
Each center under paragraph (1) shall use the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be prescribed by the Director.
(5) Number of centers; duration of support
(A) In general
The Director shall provide for the establishment of not less than five centers under paragraph (1).
(B) Duration
Support for a center established under paragraph (1) may be provided under this section for a period of not to exceed 5 years. Such period may be extended for one or more additional periods not exceeding 5 years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director and if such group has recommended to the Director that such period should be extended.
(c) Facilitation of research
The Director shall under subsection (a)(1) provide for a program under which samples of tissues and genetic materials that are of use in research on autism spectrum disorder are donated, collected, preserved, and made available for such research. The program shall be carried out in accordance with accepted scientific and medical standards for the donation, collection, and preservation of such samples.
(d) Public input
The Director shall under subsection (a)(1) provide for means through which the public can obtain information on the existing and planned programs and activities of the National Institutes of Health with respect to autism spectrum disorder and through which the Director can receive comments from the public regarding such programs and activities.
(July 1, 1944, ch. 373, title IV, §409C, as added
Codification
Another section 409C of act July 1, 1944, was renumbered section 409G and is classified to
Amendments
2019—Subsec. (a)(1).
Subsec. (b)(2).
Subsec. (b)(3)(D).
2007—Subsec. (b)(4) to (6).
Subsec. (e).
2006—
Subsec. (a).
Subsec. (b)(1), (2).
Subsecs. (c), (d).
Subsec. (e).
Effective Date of 2007 Amendment
Amendment by
§284h. Pediatric Research Initiative
(a) Establishment
The Secretary shall establish within the Office of the Director of NIH a Pediatric Research Initiative (referred to in this section as the "Initiative") to conduct and support research that is directly related to diseases, disorders, and other conditions in children. The Initiative shall be headed by the Director of NIH.
(b) Purpose
The purpose of the Initiative is to provide funds to enable the Director of NIH—
(1) to increase support for pediatric biomedical research within the National Institutes of Health to realize the expanding opportunities for advancement in scientific investigations and care for children;
(2) to enhance collaborative efforts among the Institutes to conduct and support multidisciplinary research in the areas that the Director deems most promising; and
(3) in coordination with the Food and Drug Administration, to increase the development of adequate pediatric clinical trials and pediatric use information to promote the safer and more effective use of prescription drugs in the pediatric population.
(c) Duties
In carrying out subsection (b), the Director of NIH shall—
(1) consult with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the other national research institutes, in considering their requests for new or expanded pediatric research efforts, and consult with the Administrator of the Health Resources and Services Administration and other advisors as the Director determines to be appropriate;
(2) have broad discretion in the allocation of any Initiative assistance among the Institutes, among types of grants, and between basic and clinical research so long as the assistance is directly related to the illnesses and conditions of children; and
(3) be responsible for the oversight of any newly appropriated Initiative funds and annually report to Congress and the public on the extent of the total funds obligated to conduct or support pediatric research across the National Institutes of Health, including the specific support and research awards allocated through the Initiative.
(d) National Pediatric Research Network
(1) Network
In carrying out the Initiative, the Director of NIH, in collaboration with the national research institutes and national centers that carry out activities involving pediatric research, shall support a National Pediatric Research Network in order to more effectively support pediatric research and optimize the use of Federal resources. Such National Pediatric Research Network may be comprised of, as appropriate—
(A) the pediatric research consortia receiving awards under paragraph (2); or
(B) other consortia, centers, or networks focused on pediatric research that are recognized by the Director of NIH and established pursuant to the authorities vested in the National Institutes of Health by other sections of this chapter.
(2) Pediatric research consortia
(A) In general
The Director of NIH shall award funding, including through grants, contracts, or other mechanisms, to public or private nonprofit entities for providing support for pediatric research consortia, including with respect to—
(i) basic, clinical, behavioral, or translational research to meet unmet needs for pediatric research; and
(ii) training researchers in pediatric research techniques in order to address unmet pediatric research needs.
(B) Research
The Director of NIH shall, as appropriate, ensure that—
(i) each consortium receiving an award under subparagraph (A) conducts or supports at least one category of research described in subparagraph (A)(i) and collectively such consortia conduct or support such categories of research; and
(ii) one or more such consortia provide training described in subparagraph (A)(ii).
(C) Organization of consortium
Each consortium receiving an award under subparagraph (A) shall—
(i) be formed from a collaboration of cooperating institutions;
(ii) be coordinated by a lead institution or institutions;
(iii) agree to disseminate scientific findings, including from clinical trials, rapidly and efficiently, as appropriate, to—
(I) other consortia;
(II) the National Institutes of Health;
(III) the Food and Drug Administration;
(IV) and 1 other relevant agencies; and
(iv) meet such requirements as may be prescribed by the Director of NIH.
(D) Supplement, not supplant
Any support received by a consortium under subparagraph (A) shall be used to supplement, and not supplant, other public or private support for activities authorized to be supported under this paragraph.
(E) Duration of support
Support of a consortium under subparagraph (A) shall be for a period of not to exceed 5 years. Such period may be extended at the discretion of the Director of NIH.
(3) Coordination of consortia activities
The Director of NIH shall, as appropriate—
(A) provide for the coordination of activities (including the exchange of information and regular communication) among the consortia established pursuant to paragraph (2); and
(B) require the periodic preparation and submission to the Director of reports on the activities of each such consortium.
(4) Assistance with registries
Each consortium receiving an award under paragraph (2)(A) may provide assistance, as appropriate, to the Centers for Disease Control and Prevention for activities related to patient registries and other surveillance systems upon request by the Director of the Centers for Disease Control and Prevention.
(e) Research on pediatric rare diseases or conditions
In making awards under subsection (d)(2) for pediatric research consortia, the Director of NIH shall ensure that an appropriate number of such awards are awarded to such consortia that agree to—
(1) consider pediatric rare diseases or conditions, or those related to birth defects; and
(2) conduct or coordinate one or more multisite clinical trials of therapies for, or approaches to, the prevention, diagnosis, or treatment of one or more pediatric rare diseases or conditions.
(f) Transfer of funds
The Director of NIH may transfer amounts appropriated under this section to any of the Institutes for a fiscal year to carry out the purposes of the Initiative under this section.
(July 1, 1944, ch. 373, title IV, §409D, as added
Codification
Another section 409D of act July 1, 1944, was renumbered section 409H and is classified to
Amendments
2016—Subsec. (d)(1).
Subsec. (d)(2)(A), (E).
2013—Subsecs. (d) to (f).
2007—Subsec. (c)(1).
Subsecs. (d), (e).
Effective Date of 2007 Amendment
Amendment by
1 So in original. The word "and" probably should appear at end of subcl. (III).
§284i. Autoimmune diseases
(a) Expansion, intensification, and coordination of activities
(1) In general
The Director of NIH shall expand, intensify, and coordinate research and other activities of the National Institutes of Health with respect to autoimmune diseases.
(2) Allocations by Director of NIH
With respect to amounts appropriated to carry out this section for a fiscal year, the Director of NIH shall allocate the amounts among the national research institutes that are carrying out paragraph (1).
(3) Definition
The term "autoimmune disease" includes, for purposes of this section such diseases or disorders with evidence of autoimmune pathogensis 1 as the Secretary determines to be appropriate.
(b) Coordinating Committee
(1) In general
The Secretary shall ensure that the Autoimmune Diseases Coordinating Committee (referred to in this section as the "Coordinating Committee") coordinates activities across the National Institutes and with other Federal health programs and activities relating to such diseases.
(2) Composition
The Coordinating Committee shall be composed of the directors or their designees of each of the national research institutes involved in research with respect to autoimmune diseases and representatives of all other Federal departments and agencies whose programs involve health functions or responsibilities relevant to such diseases, including the Centers for Disease Control and Prevention and the Food and Drug Administration.
(3) Chair
(A) In general
With respect to autoimmune diseases, the Chair of the Committee shall serve as the principal advisor to the Secretary, the Assistant Secretary for Health, and the Director of NIH, and shall provide advice to the Director of the Centers for Disease Control and Prevention, the Commissioner of Food and Drugs, and other relevant agencies.
(B) Director of NIH
The Chair of the Committee shall be directly responsible to the Director of NIH.
(c) Plan for NIH activities
(1) In general
Not later than 1 year after October 17, 2000, the Coordinating Committee shall develop a plan for conducting and supporting research and education on autoimmune diseases through the national research institutes and shall periodically review and revise the plan. The plan shall—
(A) provide for a broad range of research and education activities relating to biomedical, psychosocial, and rehabilitative issues, including studies of the disproportionate impact of such diseases on women;
(B) identify priorities among the programs and activities of the National Institutes of Health regarding such diseases; and
(C) reflect input from a broad range of scientists, patients, and advocacy groups.
(2) Certain elements of plan
The plan under paragraph (1) shall, with respect to autoimmune diseases, provide for the following as appropriate:
(A) Research to determine the reasons underlying the incidence and prevalence of the diseases.
(B) Basic research concerning the etiology and causes of the diseases.
(C) Epidemiological studies to address the frequency and natural history of the diseases, including any differences among the sexes and among racial and ethnic groups.
(D) The development of improved screening techniques.
(E) Clinical research for the development and evaluation of new treatments, including new biological agents.
(F) Information and education programs for health care professionals and the public.
(3) Implementation of plan
The Director of NIH shall ensure that programs and activities of the National Institutes of Health regarding autoimmune diseases are implemented in accordance with the plan under paragraph (1).
(July 1, 1944, ch. 373, title IV, §409E, as added
Amendments
2007—Subsec. (d).
"(1) The plan under subsection (c)(1) of this section (or revisions to the plan, as the case may be).
"(2) Provisions specifying the amounts expended by the National Institutes of Health with respect to each of the autoimmune diseases included in the plan.
"(3) Provisions identifying particular projects or types of projects that should in the future be considered by the national research institutes or other entities in the field of research on autoimmune diseases."
Subsec. (e).
Effective Date of 2007 Amendment
Amendment by
1 So in original. Probably should be "pathogenesis".
§284j. Muscular dystrophy research
(a) Coordination of activities
The Director of NIH shall expand and increase coordination in the activities of the National Institutes of Health with respect to research on muscular dystrophies, including Duchenne muscular dystrophy.
(b) Administration of program; collaboration among agencies
The Director of NIH shall carry out this section through the appropriate institutes, including the National Institute of Neurological Disorders and Stroke and in collaboration with any other agencies that the Director determines appropriate.
(July 1, 1944, ch. 373, title IV, §409F, as added
Amendments
2007—Subsec. (c).
Effective Date of 2007 Amendment
Amendment by
§284k. Clinical research
(a) In general
The Director of National Institutes of Health shall undertake activities to support and expand the involvement of the National Institutes of Health in clinical research.
(b) Requirements
In carrying out subsection (a), the Director of National Institutes of Health shall—
(1) consider the recommendations of the Division of Research Grants Clinical Research Study Group and other recommendations for enhancing clinical research; and
(2) establish intramural and extramural clinical research fellowship programs directed specifically at medical and dental students and a continuing education clinical research training program at the National Institutes of Health.
(c) Support for the diverse needs of clinical research
The Director of National Institutes of Health, in cooperation with the Directors of the Institutes, Centers, and Divisions of the National Institutes of Health, shall support and expand the resources available for the diverse needs of the clinical research community, including inpatient, outpatient, and critical care clinical research.
(d) Peer review
The Director of National Institutes of Health shall establish peer review mechanisms to evaluate applications for the awards and fellowships provided for in subsection (b)(2) and
(July 1, 1944, ch. 373, title IV, §409G, formerly §409C, as added
References in Text
Findings and Purpose
"(a)
"(1) Clinical research is critical to the advancement of scientific knowledge and to the development of cures and improved treatment for disease.
"(2) Tremendous advances in biology are opening doors to new insights into human physiology, pathophysiology and disease, creating extraordinary opportunities for clinical research.
"(3) Clinical research includes translational research which is an integral part of the research process leading to general human applications. It is the bridge between the laboratory and new methods of diagnosis, treatment, and prevention and is thus essential to progress against cancer and other diseases.
"(4) The United States will spend more than $1,200,000,000,000 on health care in 1999, but the Federal budget for health research at the National Institutes of Health was $15,600,000,000 only 1 percent of that total.
"(5) Studies at the Institute of Medicine, the National Research Council, and the National Academy of Sciences have all addressed the current problems in clinical research.
"(6) The Director of the National Institutes of Health has recognized the current problems in clinical research and appointed a special panel, which recommended expanded support for existing National Institutes of Health clinical research programs and the creation of new initiatives to recruit and retain clinical investigators.
"(7) The current level of training and support for health professionals in clinical research is fragmented, undervalued, and underfunded.
"(8) Young investigators are not only apprentices for future positions but a crucial source of energy, enthusiasm, and ideas in the day-to-day research that constitutes the scientific enterprise. Serious questions about the future of life-science research are raised by the following:
"(A) The number of young investigators applying for grants dropped by 54 percent between 1985 and 1993.
"(B) The number of physicians applying for first-time National Institutes of Health research project grants fell from 1226 in 1994 to 963 in 1998, a 21 percent reduction.
"(C) Newly independent life-scientists are expected to raise funds to support their new research programs and a substantial proportion of their own salaries.
"(9) The following have been cited as reasons for the decline in the number of active clinical researchers, and those choosing this career path:
"(A) A medical school graduate incurs an average debt of $85,619, as reported in the Medical School Graduation Questionnaire by the Association of American Medical Colleges (AAMC).
"(B) The prolonged period of clinical training required increases the accumulated debt burden.
"(C) The decreasing number of mentors and role models.
"(D) The perceived instability of funding from the National Institutes of Health and other Federal agencies.
"(E) The almost complete absence of clinical research training in the curriculum of training grant awardees.
"(F) Academic Medical Centers are experiencing difficulties in maintaining a proper environment for research in a highly competitive health care marketplace, which are compounded by the decreased willingness of third party payers to cover health care costs for patients engaged in research studies and research procedures.
"(10) In 1960, general clinical research centers were established under the Office of the Director of the National Institutes of Health with an initial appropriation of $3,000,000.
"(11) Appropriations for general clinical research centers in fiscal year 1999 equaled $200,500,000.
"(12) Since the late 1960s, spending for general clinical research centers has declined from approximately 3 percent to 1 percent of the National Institutes of Health budget.
"(13) In fiscal year 1999, there were 77 general clinical research centers in operation, supplying patients in the areas in which such centers operate with access to the most modern clinical research and clinical research facilities and technologies.
"(b)
Oversight by GAO
§284l. Enhancement awards
(a) Mentored Patient-Oriented Research Career Development Awards
(1) Grants
(A) In general
The Director of the National Institutes of Health shall make grants (to be referred to as "Mentored Patient-Oriented Research Career Development Awards") to support individual careers in clinical research at general clinical research centers or at other institutions that have the infrastructure and resources deemed appropriate for conducting patient-oriented clinical research.
(B) Use
Grants under subparagraph (A) shall be used to support clinical investigators in the early phases of their independent careers by providing salary and such other support for a period of supervised study.
(2) Applications
An application for a grant under this subsection shall be submitted by an individual scientist at such time as the Director may require.
(b) Mid-Career Investigator Awards in Patient-Oriented Research
(1) Grants
(A) In general
The Director of the National Institutes of Health shall make grants (to be referred to as "Mid-Career Investigator Awards in Patient-Oriented Research") to support individual clinical research projects at general clinical research centers or at other institutions that have the infrastructure and resources deemed appropriate for conducting patient-oriented clinical research.
(B) Use
Grants under subparagraph (A) shall be used to provide support for mid-career level clinicians to allow such clinicians to devote time to clinical research and to act as mentors for beginning clinical investigators.
(2) Applications
An application for a grant under this subsection shall be submitted by an individual scientist at such time as the Director requires.
(c) Graduate Training in Clinical Investigation Award
(1) In general
The Director of the National Institutes of Health shall make grants (to be referred to as "Graduate Training in Clinical Investigation Awards") to support individuals pursuing master's or doctoral degrees in clinical investigation.
(2) Applications
An application for a grant under this subsection shall be submitted by an individual scientist at such time as the Director may require.
(3) Limitations
Grants under this subsection shall be for terms of 2 years or more and shall provide stipend, tuition, and institutional support for individual advanced degree programs in clinical investigation.
(4) Definition
As used in this subsection, the term "advanced degree programs in clinical investigation" means programs that award a master's or Ph.D. degree in clinical investigation after 2 or more years of training in areas such as the following:
(A) Analytical methods, biostatistics, and study design.
(B) Principles of clinical pharmacology and pharmacokinetics.
(C) Clinical epidemiology.
(D) Computer data management and medical informatics.
(E) Ethical and regulatory issues.
(F) Biomedical writing.
(d) Clinical Research Curriculum Awards
(1) In general
The Director of the National Institutes of Health shall make grants (to be referred to as "Clinical Research Curriculum Awards") to institutions for the development and support of programs of core curricula for training clinical investigators, including medical students. Such core curricula may include training in areas such as the following:
(A) Analytical methods, biostatistics, and study design.
(B) Principles of clinical pharmacology and pharmacokinetics.
(C) Clinical epidemiology.
(D) Computer data management and medical informatics.
(E) Ethical and regulatory issues.
(F) Biomedical writing.
(2) Applications
An application for a grant under this subsection shall be submitted by an individual institution or a consortium of institutions at such time as the Director may require. An institution may submit only one such application.
(3) Limitations
Grants under this subsection shall be for terms of up to 5 years and may be renewable.
(July 1, 1944, ch. 373, title IV, §409H, formerly §409D, as added
Amendments
2007—Subsec. (a)(3).
Subsec. (b)(3).
Subsec. (c)(5).
Subsec. (d)(4).
Effective Date of 2007 Amendment
Amendment by
§284m. Program for pediatric studies of drugs
(a) List of priority issues in pediatric therapeutics
(1) In general
Not later than one year after September 27, 2007, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs and experts in pediatric research, shall develop and publish a priority list of needs in pediatric therapeutics, including drugs, biological products, or indications that require study. The list shall be revised every three years.
(2) Consideration of available information
In developing and prioritizing the list under paragraph (1), the Secretary—
(A) shall consider—
(i) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials;
(ii) particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, and identification of biomarkers for such diseases, disorders, or conditions, may be beneficial in pediatric populations; and
(iii) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators; and
(B) may consider the availability of qualified countermeasures (as defined in
(b) Pediatric studies and research
The Secretary, acting through the National Institutes of Health, shall award funds to entities that have the expertise to conduct pediatric clinical trials or other research (including qualified universities, hospitals, laboratories, contract research organizations, practice groups, federally funded programs such as pediatric pharmacology research units, other public or private institutions, or individuals) to enable the entities to conduct the drug studies or other research on the issues described in paragraphs (1) and (2)(A) of subsection (a). The Secretary may use contracts, grants, or other appropriate funding mechanisms to award funds under this subsection.
(c) Process for proposed pediatric study requests and labeling changes
(1) Submission of proposed pediatric study request
The Director of the National Institutes of Health shall, as appropriate, submit proposed pediatric study requests for consideration by the Commissioner of Food and Drugs for pediatric studies of a specific pediatric indication identified under subsection (a). Such a proposed pediatric study request shall be made in a manner equivalent to a written request made under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act [
(A)(i) there is an approved application under section 505(j) of the Federal Food, Drug, and Cosmetic Act [
(ii) there is a submitted application that could be approved under the criteria of such section; and
(B) there remains no patent listed pursuant to section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act [
(C) additional studies are needed to assess the safety and effectiveness of the use of the drug in the pediatric population.
(2) Written request to holders of approved applications
The Commissioner of Food and Drugs, in consultation with the Director of the National Institutes of Health, may issue a written request based on the proposed pediatric study request for the indication or indications submitted pursuant to paragraph (1) (which shall include a timeframe for negotiations for an agreement) for pediatric studies concerning a drug identified under subsection (a) to all holders of an approved application for the drug. Such a written request shall be made in a manner equivalent to the manner in which a written request is made under subsection (b) or (c) of section 505A of the Federal Food, Drug, and Cosmetic Act [
(3) Requests for proposals
If the Commissioner of Food and Drugs does not receive a response to a written request issued under paragraph (2) not later than 30 days after the date on which a request was issued, the Secretary, acting through the Director of the National Institutes of Health and in consultation with the Commissioner of Food and Drugs, shall publish a request for proposals to conduct the pediatric studies described in the written request in accordance with subsection (b).
(4) Disqualification
A holder that receives a first right of refusal shall not be entitled to respond to a request for proposals under paragraph (3).
(5) Contracts, grants, or other funding mechanisms
A contract, grant, or other funding may be awarded under this section only if a proposal is submitted to the Secretary in such form and manner, and containing such agreements, assurances, and information as the Secretary determines to be necessary to carry out this section.
(6) Reporting of studies
(A) In general
On completion of a pediatric study in accordance with an award under this section, a report concerning the study shall be submitted to the Director of the National Institutes of Health and the Commissioner of Food and Drugs. The report shall include all data generated in connection with the study, including a written request if issued.
(B) Availability of reports
(i) In general
Each report submitted under subparagraph (A) shall be considered to be in the public domain (subject to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic Act [
(I) posted on the internet website of the National Institutes of Health in a manner that is accessible and consistent with all applicable Federal laws and regulations, including such laws and regulations for the protection of—
(aa) human research participants, including with respect to privacy, security, informed consent, and protected health information; and
(bb) proprietary interests, confidential commercial information, and intellectual property rights; and
(II) assigned a docket number by the Commissioner of Food and Drugs and made available for the submission of public comments.
(ii) Submission of comments
An interested person may submit written comments concerning such pediatric studies to the Commissioner of Food and Drugs, and the submitted comments shall become part of the docket file with respect to each of the drugs.
(C) Action by Commissioner
The Commissioner of Food and Drugs shall take action in a timely and appropriate manner in response to the reports submitted under subparagraph (A), and shall begin such action upon receipt of the report under subparagraph (A), in accordance with paragraph (7).
(7) Requests for labeling change
Within the 180-day period after the date on which a report is submitted under paragraph (6)(A), the Commissioner of Food and Drugs shall—
(A) review the report and such other data as are available concerning the safe and effective use in the pediatric population of the drug studied;
(B) negotiate with the holders of approved applications for the drug studied for any labeling changes that the Commissioner of Food and Drugs determines to be appropriate and requests the holders to make; and
(C)(i) include in the public docket file a reference to the location of the report on the internet website of the National Institutes of Health and a copy of any requested labeling changes; and
(ii) publish through a posting on the Web site of the Food and Drug Administration a summary of the report and a copy of any requested labeling changes.
(8) Dispute resolution
(A) Referral to Pediatric Advisory Committee
If, not later than the end of the 180-day period specified in paragraph (7), the holder of an approved application for the drug involved does not agree to any labeling change requested by the Commissioner of Food and Drugs under that paragraph, the Commissioner of Food and Drugs shall refer the request to the Pediatric Advisory Committee.
(B) Action by the Pediatric Advisory Committee
Not later than 90 days after receiving a referral under subparagraph (A), the Pediatric Advisory Committee shall—
(i) review the available information on the safe and effective use of the drug in the pediatric population, including study reports submitted under this section; and
(ii) make a recommendation to the Commissioner of Food and Drugs as to appropriate labeling changes, if any.
(9) FDA determination
Not later than 30 days after receiving a recommendation from the Pediatric Advisory Committee under paragraph (8)(B)(ii) with respect to a drug, the Commissioner of Food and Drugs shall consider the recommendation and, if appropriate, make a request to the holders of approved applications for the drug to make any labeling change that the Commissioner of Food and Drugs determines to be appropriate.
(10) Failure to agree
If a holder of an approved application for a drug, within 30 days after receiving a request to make a labeling change under paragraph (9), does not agree to make a requested labeling change, the Commissioner of Food and Drugs may deem the drug to be misbranded under the Federal Food, Drug, and Cosmetic Act [
(11) No effect on authority
Nothing in this subsection limits the authority of the United States to bring an enforcement action under the Federal Food, Drug, and Cosmetic Act [
(d) Authorization of appropriations
(1) In general
There are authorized to be appropriated to carry out this section, $25,000,000 for each of fiscal years 2018 through 2022.
(2) Availability
Any amount appropriated under paragraph (1) shall remain available to carry out this section until expended.
(July 1, 1944, ch. 373, title IV, §409I, as added
References in Text
The Federal Food, Drug, and Cosmetic Act, referred to in subsec. (c)(10), (11), is act June 25, 1938, ch. 675,
Amendments
2017—Subsec. (a)(2)(A)(ii).
Subsec. (c)(6)(B).
Subsec. (c)(6)(C).
Subsec. (c)(7).
Subsec. (c)(7)(C)(i).
Subsec. (c)(7)(C)(ii).
Subsec. (d).
Subsec. (d)(1).
Subsec. (e).
2013—Subsec. (a)(2).
"(A) therapeutic gaps in pediatrics that may include developmental pharmacology, pharmacogenetic determinants of drug response, metabolism of drugs and biologics in children, and pediatric clinical trials;
"(B) particular pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics, including drugs and biologics, may be beneficial in pediatric populations; and
"(C) the adequacy of necessary infrastructure to conduct pediatric pharmacological research, including research networks and trained pediatric investigators."
Subsec. (b).
2012—Subsec. (c)(1).
Subsec. (c)(1)(A)(i).
Subsec. (c)(1)(B).
Subsec. (c)(2).
Subsec. (e)(1).
"(A) $200,000,000 for fiscal year 2008; and
"(B) such sums as are necessary for each of the four succeeding fiscal years."
2010—Subsec. (a)(1).
2007—
Subsec. (d).
2003—Subsec. (c)(8), (9), (11).
Effective Date of 2007 Amendment
Amendment by
Effective Date of 2003 Amendment
Amendment by
§284m–1. Pediatric Advisory Committee
(a) In general
The Secretary of Health and Human Services shall, under
(b) Purpose
(1) In general
The advisory committee shall advise and make recommendations to the Secretary, through the Commissioner of Food and Drugs, on matters relating to pediatric therapeutics (including drugs and biological products) and medical devices.
(2) Matters included
The matters referred to in paragraph (1) include—
(A) pediatric research conducted under
(B) identification of research priorities related to therapeutics (including drugs and biological products) and medical devices for pediatric populations and the need for additional diagnostics and treatments for specific pediatric diseases or conditions;
(C) the ethics, design, and analysis of clinical trials related to pediatric therapeutics (including drugs and biological products) and medical devices; and
(D) the development of countermeasures (as defined in
(c) Composition
The advisory committee shall include representatives of pediatric health organizations, pediatric researchers, relevant patient and patient-family organizations, and other experts selected by the Secretary.
(d) Continuation of Operation of Committee
Notwithstanding section 14 of the Federal Advisory Committee Act, the advisory committee shall continue to operate to carry out the advisory committee's responsibilities under
(
References in Text
Section 14 of the Federal Advisory Committee Act, referred to in subsec. (d), is section 14 of
Codification
Section was formerly set out as a note under
Section was enacted as part of the Best Pharmaceuticals for Children Act, and not as part of the Public Health Service Act which comprises this chapter.
Amendments
2013—Subsec. (b)(2)(D).
2012—Subsec. (d).
2007—Subsec. (a).
Subsec. (b)(1).
Subsec. (b)(2)(A).
Subsec. (b)(2)(B).
Subsec. (b)(2)(C).
Subsec. (d).
2003—
Subsec. (a).
Subsec. (b)(1).
Subsec. (b)(2).
Subsec. (b)(2)(B), (C).
Effective Date of 2003 Amendment
Amendment by
§284n. Certain demonstration projects
(a) Bridging the sciences
(1) In general
From amounts to be appropriated under
(2) Goals, priorities, and methods; interagency collaboration
The Secretary shall establish goals, priorities, and methods of evaluation for research under paragraph (1), and shall provide for interagency collaboration with respect to such research. In developing such goals, priorities, and methods, the Secretary shall ensure that—
(A) the research reflects the vision of innovation and higher risk with long-term payoffs; and
(B) the research includes a wide spectrum of projects, funded at various levels, with varying timeframes.
(3) Peer review
A grant may be made under paragraph (1) only if the application for the grant has undergone technical and scientific peer review under
(b) High-risk, high-reward research
(1) In general
From amounts to be appropriated under
(2) Special consideration
In carrying out the program under paragraph (1), the Director of NIH shall give special consideration to coordinating activities with national research institutes whose budgets are substantial relative to a majority of the other institutes.
(3) Administration of program
Activities relating to research described in paragraph (1) shall be designed by the Director of NIH or the head of a national research institute or national center, as applicable, to enable such research to be carried out with maximum flexibility and speed.
(4) Public-private partnerships
In providing for research described in paragraph (1), the Director of NIH or the head of a national research institute or national center, as applicable, shall seek to facilitate partnerships between public and private entities and shall coordinate when appropriate with the Foundation for the National Institutes of Health.
(5) Peer review
A grant for research described in paragraph (1) may be made only if the application for the grant has undergone technical and scientific peer review under
(c) Report to Congress
Not later than the end of fiscal year 2009, the Secretary, acting through the Director of NIH, shall conduct an evaluation of the activities under this section and submit a report to the Congress on the results of such evaluation.
(d) Definitions
For purposes of this section, the terms "Director of NIH", "national research institute", and "national center" have the meanings given such terms in
(
Codification
Section was enacted as part of the National Institutes of Health Reform Act of 2006, and not as part of the Public Health Service Act which comprises this chapter.
Effective Date
Section applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of
§284o. Activities of the National Institutes of Health with respect to research on paralysis
(a) Coordination
The Director of the National Institutes of Health (referred to in this section and
(b) Christopher and Dana Reeve Paralysis Research Consortia
(1) In general
The Director may make awards of grants to public or private entities to pay all or part of the cost of planning, establishing, improving, and providing basic operating support for consortia in paralysis research. The Director shall designate each consortium funded through such grants as a Christopher and Dana Reeve Paralysis Research Consortium.
(2) Research
Each consortium under paragraph (1)—
(A) may conduct basic, translational, and clinical paralysis research;
(B) may focus on advancing treatments and developing therapies in paralysis research;
(C) may focus on one or more forms of paralysis that result from central nervous system trauma or stroke;
(D) may facilitate and enhance the dissemination of clinical and scientific findings; and
(E) may replicate the findings of consortia members or other researchers for scientific and translational purposes.
(3) Coordination of consortia; reports
The Director may, as appropriate, provide for the coordination of information among consortia under paragraph (1) and ensure regular communication among members of the consortia, and may require the periodic preparation of reports on the activities of the consortia and the submission of the reports to the Director.
(4) Organization of consortia
Each consortium under paragraph (1) may use the facilities of a single lead institution, or be formed from several cooperating institutions, meeting such requirements as may be prescribed by the Director.
(c) Public input
The Director may provide for a mechanism to educate and disseminate information on the existing and planned programs and research activities of the National Institutes of Health with respect to paralysis and through which the Director can receive comments from the public regarding such programs and activities.
(
Codification
Section was enacted as part of the Christopher and Dana Reeve Paralysis Act, and also as part of the Omnibus Public Land Management Act of 2009, and not as part of the Public Health Service Act which comprises this chapter.
§284p. Activities of the National Institutes of Health with respect to research with implications for enhancing daily function for persons with paralysis
(a) In general
The Director, pursuant to the general authority of the Director, may make awards of grants to public or private entities to pay all or part of the costs of planning, establishing, improving, and providing basic operating support to multicenter networks of clinical sites that will collaborate to design clinical rehabilitation intervention protocols and measures of outcomes on one or more forms of paralysis that result from central nervous system trauma, disorders, or stroke, or any combination of such conditions.
(b) Research
A multicenter network of clinical sites funded through this section may—
(1) focus on areas of key scientific concern, including—
(A) improving functional mobility;
(B) promoting behavioral adaptation to functional losses, especially to prevent secondary complications;
(C) assessing the efficacy and outcomes of medical rehabilitation therapies and practices and assisting technologies;
(D) developing improved assistive technology to improve function and independence; and
(E) understanding whole body system responses to physical impairments, disabilities, and societal and functional limitations; and
(2) replicate the findings of network members or other researchers for scientific and translation purposes.
(c) Coordination of clinical trials networks; reports
The Director may, as appropriate, provide for the coordination of information among networks funded through this section and ensure regular communication among members of the networks, and may require the periodic preparation of reports on the activities of the networks and submission of reports to the Director.
(
Codification
Section was enacted as part of the Christopher and Dana Reeve Paralysis Act, and also as part of the Omnibus Public Land Management Act of 2009, and not as part of the Public Health Service Act which comprises this chapter.
Definition of "Director"
"Director" as meaning the Director of the National Institutes of Health, see
§284q. Pain research
(a) Research initiatives
(1) In general
The Director of NIH is encouraged to continue and expand, through the Pain Consortium, an aggressive program of basic and clinical research on the causes of and potential treatments for pain.
(2) Annual recommendations
Not less than annually, the Pain Consortium, in consultation with the Division of Program Coordination, Planning, and Strategic Initiatives, shall develop and submit to the Director of NIH recommendations on appropriate pain research initiatives that could be undertaken with funds reserved under
(3) Definition
In this subsection, the term "Pain Consortium" means the Pain Consortium of the National Institutes of Health or a similar trans-National Institutes of Health coordinating entity designated by the Secretary for purposes of this subsection.
(b) Interagency Pain Research Coordinating Committee
(1) Establishment
The Secretary shall establish not later than 1 year after March 23, 2010, and as necessary maintain a committee, to be known as the Interagency Pain Research Coordinating Committee (in this section referred to as the "Committee"), to coordinate all efforts within the Department of Health and Human Services and other Federal agencies that relate to pain research.
(2) Membership
(A) In general
The Committee shall be composed of the following voting members:
(i) Not more than 7 voting Federal representatives appoint 1 by the Secretary from agencies that conduct pain care research and treatment.
(ii) 12 additional voting members appointed under subparagraph (B).
(B) Additional members
The Committee shall include additional voting members appointed by the Secretary as follows:
(i) 6 non-Federal members shall be appointed from among scientists, physicians, and other health professionals.
(ii) 6 members shall be appointed from members of the general public, who are representatives of leading research, advocacy, and service organizations for individuals with pain-related conditions.
(C) Nonvoting members
The Committee shall include such nonvoting members as the Secretary determines to be appropriate.
(3) Chairperson
The voting members of the Committee shall select a chairperson from among such members. The selection of a chairperson shall be subject to the approval of the Director of NIH.
(4) Meetings
The Committee shall meet at the call of the chairperson of the Committee or upon the request of the Director of NIH, but in no case less often than once each year.
(5) Duties
The Committee shall—
(A) develop a summary of advances in pain care research supported or conducted by the Federal agencies relevant to the diagnosis, prevention, treatment, and management of pain and diseases and disorders associated with pain, including information on best practices for the utilization of non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration;
(B) identify critical gaps in basic and clinical research on—
(i) the symptoms and causes of pain, including the identification of relevant biomarkers and screening models and the epidemiology of acute and chronic pain;
(ii) the diagnosis, prevention, treatment, and management of acute and chronic pain, including with respect to non-pharmacologic treatments, non-addictive medical products, and other drugs or devices approved or cleared by the Food and Drug Administration; and
(iii) risk factors for, and early warning signs of, substance use disorders in populations with acute and chronic pain; and
(C) make recommendations to the Director of NIH—
(i) to ensure that the activities of the National Institutes of Health and other Federal agencies are free of unnecessary duplication of effort;
(ii) on how best to disseminate information on pain care and epidemiological data related to acute and chronic pain; and
(iii) on how to expand partnerships between public entities and private entities to expand collaborative, cross-cutting research.
(6) Report
The Secretary shall ensure that recommendations and actions taken by the Director with respect to the topics discussed at the meetings described in paragraph (4) are included in appropriate reports to Congress.
(7) Review
The Secretary shall review the necessity of the Committee at least once every 2 years.
(July 1, 1944, ch. 373, title IV, §409J, as added
Amendments
2018—Subsec. (b)(5)(A).
Subsec. (b)(5)(B).
Subsec. (b)(5)(C) to (E).
"(C) make recommendations to ensure that the activities of the National Institutes of Health and other Federal agencies are free of unnecessary duplication of effort;
"(D) make recommendations on how best to disseminate information on pain care; and
"(E) make recommendations on how to expand partnerships between public entities and private entities to expand collaborative, cross-cutting research."
Subsec. (b)(6), (7).
1 So in original. Probably should be "appointed".
§284q–1. NIH opioid research
(a) In general
The Director of the National Institutes of Health (referred to in this section as the "NIH") may intensify and coordinate fundamental, translational, and clinical research of the NIH with respect to—
(1) the understanding of pain;
(2) the discovery and development of therapies for chronic pain; and
(3) the development of alternatives to opioids for effective pain treatments.
(b) Priority and direction
The prioritization and direction of the Federally funded portfolio of pain research studies shall consider recommendations made by the Interagency Pain Research Coordinating Committee in concert with the Pain Management Best Practices Inter-Agency Task Force, and in accordance with the National Pain Strategy, the Federal Pain Research Strategy, and the NIH-Wide Strategic Plan for Fiscal Years 2016–2020, the latter of which calls for the relative burdens of individual diseases and medical disorders to be regarded as crucial considerations in balancing the priorities of the Federal research portfolio.
(
Codification
Section was enacted as part of the Comprehensive Addiction and Recovery Act of 2016, and not as part of the Public Health Service Act which comprises this chapter.
§284r. Basic research
(1) Developing policies
Not later than 2 years after December 13, 2016, the Director of the National Institutes of Health (referred to in this section as the "Director of the National Institutes of Health"), taking into consideration the recommendations developed under section 2039,1 shall develop policies for projects of basic research funded by National Institutes of Health to assess—
(A) relevant biological variables including sex, as appropriate; and
(B) how differences between male and female cells, tissues, or animals may be examined and analyzed.
(2) Revising policies
The Director of the National Institutes of Health may update or revise the policies developed under paragraph (1) as appropriate.
(3) Consultation and outreach
In developing, updating, or revising the policies under this section, the Director of the National Institutes of Health shall—
(A) consult with—
(i) the Office of Research on Women's Health;
(ii) the Office of Laboratory Animal Welfare; and
(iii) appropriate members of the scientific and academic communities; and
(B) conduct outreach to solicit feedback from members of the scientific and academic communities on the influence of sex as a variable in basic research, including feedback on when it is appropriate for projects of basic research involving cells, tissues, or animals to include both male and female cells, tissues, or animals.
(4) Additional requirements
The Director of the National Institutes of Health shall—
(A) ensure that projects of basic research funded by the National Institutes of Health are conducted in accordance with the policies developed, updated, or revised under this section, as applicable; and
(B) encourage that the results of such research, when published or reported, be disaggregated as appropriate with respect to the analysis of any sex differences.
(
References in Text
Section 2039, referred to in par. (1), is section 2039 of
Codification
Section was enacted as part of the 21st Century Cures Act, and not as part of the Public Health Service Act which comprises this chapter.
1 See References in Text note below.
§284s. Tick-borne diseases
(a) In general
The Secretary of Health and Human Services (referred to in this section as "the Secretary") shall continue to conduct or support epidemiological, basic, translational, and clinical research related to vector-borne diseases, including tick-borne diseases.
(b) Reports
The Secretary shall ensure that each triennial report under
(c) Tick-Borne Diseases Working Group
(1) Establishment
The Secretary shall establish a working group, to be known as the Tick-Borne Disease Working Group (referred to in this section as the "Working Group"), comprised of representatives of appropriate Federal agencies and other non-Federal entities, to provide expertise and to review all efforts within the Department of Health and Human Services related to all tick-borne diseases, to help ensure interagency coordination and minimize overlap, and to examine research priorities.
(2) Responsibilities
The working group shall—
(A) not later than 2 years after December 13, 2016, develop or update a summary of—
(i) ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for individuals with tick-borne diseases;
(ii) advances made pursuant to such research;
(iii) Federal activities related to tick-borne diseases, including—
(I) epidemiological activities related to tick-borne diseases; and
(II) basic, clinical, and translational tick-borne disease research related to the pathogenesis, prevention, diagnosis, and treatment of tick-borne diseases;
(iv) gaps in tick-borne disease research described in clause (iii)(II);
(v) the Working Group's meetings required under paragraph (4); and
(vi) the comments received by the Working Group;
(B) make recommendations to the Secretary regarding any appropriate changes or improvements to such activities and research; and
(C) solicit input from States, localities, and nongovernmental entities, including organizations representing patients, health care providers, researchers, and industry regarding scientific advances, research questions, surveillance activities, and emerging strains in species of pathogenic organisms.
(3) Membership
The members of the working group shall represent a diversity of scientific disciplines and views and shall be composed of the following members:
(A) Federal members
Seven Federal members, consisting of one or more representatives of each of the following:
(i) The Office of the Assistant Secretary for Health.
(ii) The Food and Drug Administration.
(iii) The Centers for Disease Control and Prevention.
(iv) The National Institutes of Health.
(v) Such other agencies and offices of the Department of Health and Human Services as the Secretary determines appropriate.
(B) Non–Federal public members
Seven non–Federal public members, consisting of representatives of the following categories:
(i) Physicians and other medical providers with experience in diagnosing and treating tick-borne diseases.
(ii) Scientists or researchers with expertise.
(iii) Patients and their family members.
(iv) Nonprofit organizations that advocate for patients with respect to tick-borne diseases.
(v) Other individuals whose expertise is determined by the Secretary to be beneficial to the functioning of the Working Group.
(4) Meetings
The Working Group shall meet not less than twice each year.
(5) Reporting
Not later than 2 years after December 13, 2016, and every 2 years thereafter until termination of the Working Group pursuant to paragraph (7), the Working Group shall—
(A) submit a report on its activities under paragraph (2)(A) and any recommendations under paragraph (2)(B) to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions of the Senate; and
(B) make such report publicly available on the Internet website of the Department of Health and Human Services.
(6) Applicability of FACA
The Working Group shall be treated as an advisory committee subject to the Federal Advisory Committee Act (5 U.S.C. App.).
(7) Sunset
The Working Group under this section shall terminate 6 years after December 13, 2016.
(
References in Text
Section 2032, referred to in subsec. (b), means section 2032 of
The Federal Advisory Committee Act, referred to in subsec. (c)(6), is
Codification
Section was enacted as part of the 21st Century Cures Act, and not as part of the Public Health Service Act which comprises this chapter.
Part C—Specific Provisions Respecting National Research Institutes
subpart 1—national cancer institute
§285. Purpose of Institute
The general purpose of the National Cancer 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 the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.
(July 1, 1944, ch. 373, title IV, §410, as added
Amendments
1988—
White House Cancer Moonshot Task Force
Memorandum of President of the United States, Jan. 28, 2016, 81 F.R. 5361, provided:
Memorandum for the Heads of Executive Departments and Agencies
Cancer is a leading cause of death, and cancer incidence is expected to increase worldwide in the coming decades. But today, cancer research is on the cusp of major breakthroughs. It is of critical national importance that we accelerate progress towards prevention, treatment, and a cure—to double the rate of progress in the fight against cancer—and put ourselves on a path to achieve in just 5 years research and treatment gains that otherwise might take a decade or more. To that end, I hereby direct the following:
(a) Membership of the Task Force. In addition to the Vice President, the Task Force shall consist of the heads of the executive branch departments, agencies, and offices listed below:
(i) the Department of Defense;
(ii) the Department of Commerce;
(iii) the Department of Health and Human Services;
(iv) the Department of Energy;
(v) the Department of Veterans Affairs;
(vi) the Office of Management and Budget;
(vii) the National Economic Council;
(viii) the Domestic Policy Council;
(ix) the Office of Science and Technology Policy;
(x) the Food and Drug Administration;
(xi) the National Cancer Institute (NCI);
(xii) the National Institutes of Health (NIH);
(xiii) the National Science Foundation; and
(xiv) such other executive branch departments, agencies, or offices as the President may designate.
A member of the Task Force may designate, to perform the Task Force functions of the member, any person who is a part of the member's department, agency, or office, and who is a full time officer or employee of the Federal Government. At the direction of the Chair, the Task Force may establish subgroups consisting exclusively of Task Force members or their designees under this section, as appropriate.
(b) Administration of the Task Force. The NIH shall provide funding and administrative support for the Task Force to the extent permitted by law and within existing appropriations. The Vice President shall designate an officer or employee of the executive branch as the Executive Director of the Task Force, who shall coordinate the work of the Task Force.
(a) accelerate our understanding of cancer, and its prevention, early detection, treatment, and cure;
(b) improve patient access and care;
(c) support greater access to new research, data, and computational capabilities;
(d) encourage development of cancer treatments;
(e) identify and address any unnecessary regulatory barriers and consider ways to expedite administrative reforms;
(f) ensure optimal investment of Federal resources; and
(g) identify opportunities to develop public-private partnerships and increase coordination of the Federal Government's efforts with the private sector, as appropriate.
(b) Nothing in this memorandum shall be construed to impair or otherwise affect:
(i) authority granted by law to an executive department, agency, or the head thereof; or
(ii) functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(c) This memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations.
(d) This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
Barack Obama.
§285a. National Cancer Program
The National Cancer Program shall consist of (1) an expanded, intensified, and coordinated cancer research program encompassing the research programs conducted and supported by the Institute and the related research programs of the other national research institutes, including an expanded and intensified research program for the prevention of cancer caused by occupational or environmental exposure to carcinogens, and (2) the other programs and activities of the Institute.
(July 1, 1944, ch. 373, title IV, §411, as added
§285a–1. Cancer control programs
The Director of the Institute shall establish and support demonstration, education, and other programs for the detection, diagnosis, prevention, and treatment of cancer and for rehabilitation and counseling respecting cancer. Programs established and supported under this section shall include—
(1) locally initiated education and demonstration programs (and regional networks of such programs) to transmit research results and to disseminate information respecting—
(A) the detection, diagnosis, prevention, and treatment of cancer,
(B) the continuing care of cancer patients and the families of cancer patients, and
(C) rehabilitation and counseling respecting cancer,
to physicians and other health professionals who provide care to individuals who have cancer;
(2) the demonstration of and the education of students of the health professions and health professionals in—
(A) effective methods for the prevention and early detection of cancer and the identification of individuals with a high risk of developing cancer, and
(B) improved methods of patient referral to appropriate centers for early diagnosis and treatment of cancer; and
(3) the demonstration of new methods for the dissemination of information to the general public concerning the prevention, early detection, diagnosis, and treatment and control of cancer and information concerning unapproved and ineffective methods, drugs, and devices for the diagnosis, prevention, treatment, and control of cancer.
(July 1, 1944, ch. 373, title IV, §412, as added
§285a–2. Special authorities of Director
(a) Information and education program
(1) The Director of the Institute shall establish an information and education program to collect, identify, analyze, and disseminate on a timely basis, through publications and other appropriate means, to cancer patients and their families, physicians and other health professionals, and the general public, information on cancer research, diagnosis, prevention, and treatment (including information respecting nutrition programs for cancer patients and the relationship between nutrition and cancer). The Director of the Institute may take such action as may be necessary to insure that all channels for the dissemination and exchange of scientific knowledge and information are maintained between the Institute and the public and between the Institute and other scientific, medical, and biomedical disciplines and organizations nationally and internationally.
(2) In carrying out paragraph (1), the Director of the Institute shall—
(A) provide public and patient information and education programs, providing information that will help individuals take personal steps to reduce their risk of cancer, to make them aware of early detection techniques and to motivate appropriate utilization of those techniques, to help individuals deal with cancer if it strikes, and to provide information to improve long-term survival;
(B) continue and expand programs to provide physicians and the public with state-of-the-art information on the treatment of particular forms of cancers, and to identify those clinical trials that might benefit patients while advancing knowledge of cancer treatment;
(C) assess the incorporation of state-of-the-art cancer treatments into clinical practice and the extent to which cancer patients receive such treatments and include the results of such assessments in the biennial reports required under section 284b 1 of this title;
(D) maintain and operate the International Cancer Research Data Bank, which shall collect, catalog, store, and disseminate insofar as feasible the results of cancer research and treatment undertaken in any country for the use of any person involved in cancer research and treatment in any country; and
(E) to the extent practicable, in disseminating the results of such cancer research and treatment, utilize information systems available to the public.
(b) National Cancer Program
The Director of the Institute in carrying out the National Cancer Program—
(1) shall establish or support the large-scale production or distribution of specialized biological materials and other therapeutic substances for cancer research and set standards of safety and care for persons using such materials;
(2) shall, in consultation with the advisory council for the Institute, support (A) research in the cancer field outside the United States by highly qualified foreign nationals which can be expected to benefit the American people, (B) collaborative research involving American and foreign participants, and (C) the training of American scientists abroad and foreign scientists in the United States;
(3) shall, in consultation with the advisory council for the Institute, support appropriate programs of education and training (including continuing education and laboratory and clinical research training);
(4) shall encourage and coordinate cancer research by industrial concerns where such concerns evidence a particular capability for such research;
(5) may obtain (after consultation with the advisory council for the Institute and in accordance with
(6)(A) may, in consultation with the advisory council for the Institute, acquire, construct, improve, repair, operate, and maintain laboratories, other research 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
(7) may, in consultation with the advisory council for the Institute, appoint one or more advisory committees composed of such private citizens and officials of Federal, State, and local governments to advise the Director with respect to the Director's functions;
(8) may, subject to
(9) shall, notwithstanding
Except as otherwise provided, experts and consultants whose services are obtained under paragraph (5) 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 (5) 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.
(c) Pre-clinical models to evaluate promising pediatric cancer therapies
(1) Expansion and coordination of activities
The Director of the National Cancer Institute shall expand, intensify, and coordinate the activities of the Institute with respect to research on the development of preclinical models to evaluate which therapies are likely to be effective for treating pediatric cancer.
(2) Coordination with other institutes
The Director of the Institute shall coordinate the activities under paragraph (1) with similar activities conducted by other national research institutes and agencies of the National Institutes of Health to the extent that those Institutes and agencies have responsibilities that are related to pediatric cancer.
(July 1, 1944, ch. 373, title IV, §413, as added
References in Text
Codification
In subsec. (b)(6)(C), "
In subsec. (b)(8), "
Amendments
2002—Subsec. (c).
1993—Subsec. (b)(9).
1989—Subsec. (a)(1).
1988—Subsec. (a).
Subsec. (b)(5).
Subsec. (b)(8) to (10).
1 See References in Text note below.
§285a–3. National cancer research and demonstration centers
(a) Cooperative agreements and grants for establishing and supporting
(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 advanced diagnostic, prevention, control, and treatment methods for cancer.
(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.
(b) Uses for Federal payments under cooperative agreements or grants
Federal payments made under a cooperative agreement or grant under subsection (a) may be used for—
(1) construction (notwithstanding any limitation under
(2) staffing and other basic operating costs, including such patient care costs as are required for research;
(3) clinical training, including training for allied health professionals, continuing education for health professionals and allied health professions personnel, and information programs for the public respecting cancer; and
(4) demonstration purposes.
As used in this paragraph, 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
(c) Period of support; additional periods
Support of a center under subsection (a) 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.
(d) Construction
Research centers under this section may not be considered centers of excellence for purposes of
(July 1, 1944, ch. 373, title IV, §414, as added
Amendments
2007—Subsec. (d).
2002—Subsec. (b).
1988—Subsec. (a)(1).
Effective Date of 2007 Amendment
Amendment by
§285a–4. President's Cancer Panel; establishment, membership, etc., functions
(a)(1) The President's Cancer Panel (hereafter in this section referred to as the "Panel") shall be composed of three persons appointed by the President who by virtue of their training, experience, and background are exceptionally qualified to appraise the National Cancer Program. At least two members of the Panel shall be distinguished scientists or physicians.
(2)(A) Members of the Panel shall be appointed for three-year terms, except that (i) any member appointed to fill a vacancy occurring prior to the expiration of the term for which the member's predecessor was appointed shall be appointed only for the remainder of such term, and (ii) a member may serve until the member's successor has taken office. If a vacancy occurs in the Panel, the President shall make an appointment to fill the vacancy not later than 90 days after the date the vacancy occurred.
(B) The President shall designate one of the members to serve as the chairman of the Panel for a term of one year.
(C) Members of the Panel shall each be entitled to receive the daily equivalent of the annual rate of basic pay in effect for grade GS–18 of the General Schedule for each day (including traveltime) during which they are engaged in the actual performance of duties as members of the Panel and 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.
(3) The Panel shall meet at the call of the chairman, but not less often than four times a year. A transcript shall be kept of the proceedings of each meeting of the Panel, and the chairman shall make such transcript available to the public.
(b) The Panel shall monitor the development and execution of the activities of the National Cancer Program, and shall report directly to the President. Any delays or blockages in rapid execution of the Program shall immediately be brought to the attention of the President. The Panel shall submit to the President periodic progress reports on the National Cancer Program and shall submit to the President, the Secretary, and the Congress an annual evaluation of the efficacy of the Program and suggestions for improvements, and shall submit such other reports as the President shall direct.
(July 1, 1944, ch. 373, title IV, §415, as added
Termination of Reporting Requirements
For termination, effective May 15, 2000, of provisions in subsec. (b) of this section relating to the requirement that the Panel submit to Congress an annual evaluation of the efficacy of the Program and suggestions for improvements, see section 3003 of
Termination of Advisory Panels
Advisory panels established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a panel established by the President or an officer of the Federal Government, such panel is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a panel established by the Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of
References in Other Laws to GS–16, 17, or 18 Pay Rates
References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under the General Schedule, to be considered references to rates payable under specified sections of Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of
§285a–5. 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 cancer. 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 1 of this title a description of the prevention activities of the Institute, including a description of the staff and resources allocated to those activities.
(July 1, 1944, ch. 373, title IV, §416, as added
References in Text
1 See References in Text note below.
§285a–6. Breast and gynecological cancers
(a) Expansion and coordination of activities
The Director of the Institute, in consultation with the National Cancer Advisory Board, shall expand, intensify, and coordinate the activities of the Institute with respect to research on breast cancer, ovarian cancer, and other cancers of the reproductive system of women.
(b) Coordination with other institutes
The Director of the Institute shall coordinate the activities of the Director under subsection (a) with similar activities conducted by other national research institutes and agencies of the National Institutes of Health to the extent that such Institutes 1 and agencies have responsibilities that are related to breast cancer and other cancers of the reproductive system of women.
(c) Programs for breast cancer
(1) In general
In carrying out subsection (a), the Director of the Institute shall conduct or support research to expand the understanding of the cause of, and to find a cure for, breast cancer. Activities under such subsection shall provide for an expansion and intensification of the conduct and support of—
(A) basic research concerning the etiology and causes of breast cancer;
(B) clinical research and related activities concerning the causes, prevention, detection and treatment of breast cancer;
(C) control programs with respect to breast cancer in accordance with
(D) information and education programs with respect to breast cancer in accordance with
(E) research and demonstration centers with respect to breast cancer in accordance with
Not less than six centers shall be operated under subparagraph (E). Activities of such centers should include supporting new and innovative research and training programs for new researchers. Such centers shall give priority to expediting the transfer of research advances to clinical applications.
(2) Implementation of plan for programs
(A) The Director of the Institute shall ensure that the research programs described in paragraph (1) are implemented in accordance with a plan for the programs. Such plan shall include comments and recommendations that the Director of the Institute considers appropriate, with due consideration provided to the professional judgment needs of the Institute as expressed in the annual budget estimate prepared in accordance with section 285a–2(9) 2 of this title. The Director of the Institute, in consultation with the National Cancer Advisory Board, shall periodically review and revise such plan.
(B) Not later than October 1, 1993, the Director of the Institute shall submit a copy of the plan to the President's Cancer Panel, the Secretary and the Director of NIH.
(C) The Director of the Institute shall submit any revisions of the plan to the President's Cancer Panel, the Secretary, and the Director of NIH.
(D) The Secretary shall provide a copy of the plan submitted under subparagraph (A), and any revisions submitted under subparagraph (C), to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate.
(d) Other cancers
In carrying out subsection (a), the Director of the Institute shall conduct or support research on ovarian cancer and other cancers of the reproductive system of women. Activities under such subsection shall provide for the conduct and support of—
(1) basic research concerning the etiology and causes of ovarian cancer and other cancers of the reproductive system of women;
(2) clinical research and related activities into the causes, prevention, detection and treatment of ovarian cancer and other cancers of the reproductive system of women;
(3) control programs with respect to ovarian cancer and other cancers of the reproductive system of women in accordance with
(4) information and education programs with respect to ovarian cancer and other cancers of the reproductive system of women in accordance with
(5) research and demonstration centers with respect to ovarian cancer and cancers of the reproductive system in accordance with
(e) Report
The Director of the Institute shall prepare, for inclusion in the biennial report submitted under section 284b 3 of this title, a report that describes the activities of the National Cancer Institute under the research programs referred to in subsection (a), that shall include—
(1) a description of the research plan with respect to breast cancer prepared under subsection (c);
(2) an assessment of the development, revision, and implementation of such plan;
(3) a description and evaluation of the progress made, during the period for which such report is prepared, in the research programs on breast cancer and cancers of the reproductive system of women;
(4) a summary and analysis of expenditures made, during the period for which such report is made, for activities with respect to breast cancer and cancers of the reproductive system of women conducted and supported by the National Institutes of Health; and
(5) such comments and recommendations as the Director considers appropriate.
(July 1, 1944, ch. 373, title IV, §417, as added
References in Text
Change of Name
Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of
1 So in original. Probably should not be capitalized.
2 So in original. Probably should be section "285a–2(b)(9)".
3 See References in Text note below.
§285a–7. Prostate cancer
(a) Expansion and coordination of activities
The Director of the Institute, in consultation with the National Cancer Advisory Board, shall expand, intensify, and coordinate the activities of the Institute with respect to research on prostate cancer.
(b) Coordination with other institutes
The Director of the Institute shall coordinate the activities of the Director under subsection (a) with similar activities conducted by other national research institutes and agencies of the National Institutes of Health to the extent that such Institutes 1 and agencies have responsibilities that are related to prostate cancer.
(c) Programs
(1) In general
In carrying out subsection (a), the Director of the Institute shall conduct or support research to expand the understanding of the cause of, and to find a cure for, prostate cancer. Activities under such subsection shall provide for an expansion and intensification of the conduct and support of—
(A) basic research concerning the etiology and causes of prostate cancer;
(B) clinical research and related activities concerning the causes, prevention, detection and treatment of prostate cancer;
(C) prevention and control and early detection programs with respect to prostate cancer in accordance with
(D) an Inter-Institute Task Force, under the direction of the Director of the Institute, to provide coordination between relevant National Institutes of Health components of research efforts on prostate cancer;
(E) control programs with respect to prostate cancer in accordance with
(F) information and education programs with respect to prostate cancer in accordance with
(G) research and demonstration centers with respect to prostate cancer in accordance with
Not less than six centers shall be operated under subparagraph (G). Activities of such centers should include supporting new and innovative research and training programs for new researchers. Such centers shall give priority to expediting the transfer of research advances to clinical applications.
(2) Implementation of plan for programs
(A) The Director of the Institute shall ensure that the research programs described in paragraph (1) are implemented in accordance with a plan for the programs. Such plan shall include comments and recommendations that the Director of the Institute considers appropriate, with due consideration provided to the professional judgment needs of the Institute as expressed in the annual budget estimate prepared in accordance with section 285a–2(9) 2 of this title. The Director of the Institute, in consultation with the National Cancer Advisory Board, shall periodically review and revise such plan.
(B) Not later than October 1, 1993, the Director of the Institute shall submit a copy of the plan to the President's Cancer Panel, the Secretary, and the Director of NIH.
(C) The Director of the Institute shall submit any revisions of the plan to the President's Cancer Panel, the Secretary, and the Director of NIH.
(D) The Secretary shall provide a copy of the plan submitted under subparagraph (A), and any revisions submitted under subparagraph (C), to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate.
(July 1, 1944, ch. 373, title IV, §417A, as added
Change of Name
Committee on Labor and Human Resources of Senate changed to Committee on Health, Education, Labor, and Pensions of Senate by Senate Resolution No. 20, One Hundred Sixth Congress, Jan. 19, 1999.
Committee on Energy and Commerce of House of Representatives treated as referring to Committee on Commerce of House of Representatives by section 1(a) of
1 So in original. Probably should not be capitalized.
2 So in original. Probably should be section "285a–2(b)(9)".
§285a–8. Repealed. Pub. L. 109–482, title I, §103(b)(15), Jan. 15, 2007, 120 Stat. 3687
Section, act July 1, 1944, ch. 373, title IV, §417B, as added
Effective Date of Repeal
Repeal applicable only with respect to amounts appropriated for fiscal year 2007 or subsequent fiscal years, see section 109 of
§285a–9. Grants for education, prevention, and early detection of radiogenic cancers and diseases
(a) Definition
In this section the term "entity" means any—
(1) National Cancer Institute-designated cancer center;
(2) Department of Veterans Affairs hospital or medical center;
(3) Federally Qualified Health Center, community health center, or hospital;
(4) agency of any State or local government, including any State department of health; or
(5) nonprofit organization.
(b) In general
The Secretary, acting through the Administrator of the Health Resources and Services Administration in consultation with the Director of the National Institutes of Health and the Director of the Indian Health Service, may make competitive grants to any entity for the purpose of carrying out programs to—
(1) screen individuals described under section 4(a)(1)(A)(i) or 5(a)(1)(A) of the Radiation Exposure Compensation Act (
(2) provide appropriate referrals for medical treatment of individuals screened under paragraph (1) and to ensure, to the extent practicable, the provision of appropriate follow-up services;
(3) develop and disseminate public information and education programs for the detection, prevention, and treatment of radiogenic cancers and diseases; and
(4) facilitate putative applicants in the documentation of claims as described in section 5(a) of the Radiation Exposure Compensation Act (
(c) Indian Health Service
The programs under subsection (a) shall include programs provided through the Indian Health Service or through tribal contracts, compacts, grants, or cooperative agreements with the Indian Health Service and which are determined appropriate to raising the health status of Indians.
(d) Grant and contract authority
Entities receiving a grant under subsection (b) may expend the grant to carry out the purpose described in such subsection.
(e) Health coverage unaffected
Nothing in this section shall be construed to affect any coverage obligation of a governmental or private health plan or program relating to an individual referred to under subsection (b)(1).
(July 1, 1944, ch. 373, title IV, §417C, as added
References in Text
Sections 4 and 5 of the Radiation Exposure Compensation Act, referred to in subsec. (b)(1) and (4), are sections 4 and 5 of
Amendments
2007—Subsec. (f).
Subsec. (g).
Effective Date of 2007 Amendment
Amendment by
§285a–10. Research, information, and education with respect to blood cancer
(a) Joe Moakley Research Excellence Program
(1) In general
The Director of NIH shall expand, intensify, and coordinate programs for the conduct and support of research with respect to blood cancer, and particularly with respect to leukemia, lymphoma, and multiple myeloma.
(2) Administration
The Director of NIH shall carry out this subsection through the Director of the National Cancer Institute and in collaboration with any other agencies that the Director determines to be appropriate.
(b) Geraldine Ferraro Cancer Education Program
(1) In general
The Secretary shall direct the appropriate agency within the Department of Health and Human Services, in collaboration with the Director of NIH, to establish and carry out a program to provide information and education for patients and the general public with respect to blood cancer, and particularly with respect to the treatment of leukemia, lymphoma, and multiple myeloma.
(2) Administration
The Agency determined by the Secretary under paragraph (1) shall carry out this subsection in collaboration with private health organizations that have national education and patient assistance programs on blood-related cancers.
(July 1, 1944, ch. 373, title IV, §417D, as added
Amendments
2018—
2007—Subsec. (a)(3).
Subsec. (b)(3).
Effective Date of 2018 Amendment
Effective Date of 2007 Amendment
Amendment by
Congressional Findings
"(1) An estimated 109,500 people in the United States will be diagnosed with leukemia, lymphoma, and multiple myeloma in 2001.
"(2) New cases of the blood cancers described in paragraph (1) account for 8.6 percent of new cancer cases.
"(3) Those devastating blood cancers will cause the deaths of an estimated 60,300 persons in the United States in 2001. Every 9 minutes, a person in the United States dies from leukemia, lymphoma, or multiple myeloma.
"(4) While less than 5 percent of Federal funds for cancer research are spent on those blood cancers, those blood cancers cause 11 percent of all cancer deaths in the United States.
"(5) Increased Federal support of research into leukemia, lymphoma, and multiple myeloma has resulted and will continue to result in significant advances in the treatment, and ultimately the cure, of those blood cancers as well as other cancers."
§285a–11. Pediatric cancer research, awareness, and survivorship
(a) Children's cancer biorepositories
(1) Award
The Secretary, acting through the Director of NIH, may make awards to an entity or entities described in paragraph (4) to build upon existing research efforts to collect biospecimens and clinical and demographic information of children, adolescents, and young adults with selected cancer subtypes (and their recurrences) for which current treatments are least effective, in order to achieve a better understanding of the causes of such cancer subtypes (and their recurrences), and the effects and outcomes of treatments for such cancers.
(2) Use of funds
Amounts received under an award under paragraph (1) may be used to carry out the following:
(A) Collect and store high-quality, donated biospecimens and associated clinical and demographic information on children, adolescents, and young adults diagnosed with cancer in the United States, focusing on children, adolescents, and young adults with cancer enrolled in clinical trials for whom current treatments are least effective. Activities under this subparagraph may include storage of biospecimens and associated clinical and demographic data at existing biorepositories supported by the National Cancer Institute.
(B) Maintain an interoperable, secure, and searchable database on stored biospecimens and associated clinical and demographic data from children, adolescents, and young adults with cancer for the purposes of research by scientists and qualified health care professionals.
(C) Establish and implement procedures for evaluating applications for access to such biospecimens and clinical and demographic data from researchers and other qualified health care professionals.
(D) Provide access to biospecimens and clinical and demographic data from children, adolescents, and young adults with cancer to researchers and qualified health care professionals for peer-reviewed research—
(i) consistent with the procedures established pursuant to subparagraph (C);
(ii) only to the extent permitted by applicable Federal and State law; and
(iii) in a manner that protects personal privacy to the extent required by applicable Federal and State privacy law, at minimum.
(3) No requirement
No child, adolescent, or young adult with cancer shall be required under this subsection to contribute a specimen to a biorepository or share clinical or demographic data.
(4) Application; considerations
(A) Application
To be eligible to receive an award under paragraph (1) an entity shall submit an application to the Secretary at such a time, in such manner, and containing such information as the Secretary may reasonably require.
(B) Considerations
In evaluating applications submitted under subparagraph (A), the Secretary shall consider the existing infrastructure of the entity that would allow for the timely capture of biospecimens and related clinical and demographic information for children, adolescents, and young adults with cancer for whom current treatments are least effective.
(5) Privacy protections and informed consent
(A) In general
The Secretary may not make an award under paragraph (1) to an entity unless the Secretary ensures that such entity—
(i) collects biospecimens and associated clinical and demographic information only from participants who have given their informed consent in accordance with Federal and State law; and
(ii) protects personal privacy to the extent required by applicable Federal and State law, at minimum.
(B) Informed consent
The Secretary shall ensure biospecimens and associated clinical and demographic information are collected with informed consent, as described in subparagraph (A)(i).
(6) Guidelines and oversight
The Secretary shall develop and disseminate appropriate guidelines for the development and maintenance of the biorepositories supported under this subsection, including appropriate oversight, to facilitate further research on select cancer subtypes (and their recurrences) in children, adolescents, and young adults with such cancers (and their recurrences).
(7) Coordination
To encourage the greatest possible efficiency and effectiveness of federally supported efforts with respect to the activities described in this subsection, the Secretary shall ensure the appropriate coordination of programs supported under this section with existing federally supported cancer registry programs and the activities under
(8) Supplement not supplant
Funds provided under this subsection shall be used to supplement, and not supplant, Federal and non-Federal funds available for carrying out the activities described in this subsection.
(9) Report
Not later than 4 years after June 5, 2018, the Secretary shall submit to Congress a report on—
(A) the number of biospecimens and corresponding clinical demographic data collected through the biospecimen research efforts supported under paragraph (1);
(B) the number of biospecimens and corresponding clinical demographic data requested for use by researchers;
(C) barriers to the collection of biospecimens and corresponding clinical demographic data;
(D) barriers experienced by researchers or health care professionals in accessing the biospecimens and corresponding clinical demographic data necessary for use in research; and
(E) recommendations with respect to improving the biospecimen and biorepository research efforts under this subsection.
(10) Definitions
For purposes of this subsection:
(A) Award
The term "award" includes a grant, contract, or cooperative agreement determined by the Secretary.
(B) Biospecimen
The term "biospecimen" includes—
(i) solid tumor tissue or bone marrow;
(ii) normal or control tissue;
(iii) blood and plasma;
(iv) DNA and RNA extractions;
(v) familial DNA; and
(vi) any other sample relevant to cancer research, as required by the Secretary.
(C) Clinical and demographic information
The term "clinical and demographic information" includes—
(i) date of diagnosis;
(ii) age at diagnosis;
(iii) the patient's sex, race, ethnicity, and environmental exposures;
(iv) extent of disease at enrollment;
(v) site of metastases;
(vi) location of primary tumor coded;
(vii) histologic diagnosis;
(viii) tumor marker data when available;
(ix) treatment and outcome data;
(x) information related to specimen quality; and
(xi) any other applicable information required by the Secretary.
(b) Improving care for pediatric cancer survivors
(1) Research on pediatric cancer survivorship
The Director of NIH, in coordination with ongoing research activities, may continue to conduct or support pediatric cancer survivorship research including in any of the following areas:
(A) Outcomes of pediatric cancer survivors, including within minority or other medically underserved populations and with respect to health disparities of such outcomes.
(B) Barriers to follow-up care for pediatric cancer survivors, including within minority or other medically underserved populations.
(C) The impact of relevant factors, which may include familial, socioeconomic, and other environmental factors, on treatment outcomes and survivorship.
(D) The development of indicators used for long-term follow-up and analysis of the late effects of cancer treatment for pediatric cancer survivors.
(E) The identification of, as applicable—
(i) risk factors associated with the late effects of cancer treatment;
(ii) predictors of adverse neurocognitive and psychosocial outcomes; and
(iii) the molecular basis of long-term complications.
(F) The development of targeted interventions to reduce the burden of morbidity borne by cancer survivors in order to protect such cancer survivors from the late effects of cancer.
(2) Balanced approach
In conducting or supporting research under paragraph (1)(A)(i) on pediatric cancer survivors within minority or other medically underserved populations, the Director of NIH shall ensure that such research addresses both the physical and the psychological needs of such survivors, as appropriate.
(c) Rule of construction
Nothing in this section shall be construed as being inconsistent with the goals and purposes of the Minority Health and Health Disparities Research and Education Act of 2000.
(d) Authorization of appropriations
For purposes of carrying out this section and
(July 1, 1944, ch. 373, title IV, §417E, as added
References in Text
The Minority Health and Health Disparities Research and Education Act of 2000, referred to in subsec. (c), is
Amendments
2018—
Subsec. (a).
"(1)
"(2)
Subsec. (b).
Subsec. (c).
Subsec. (d).
Reporting on Childhood Cancer Research Projects
§285a–11a. Cancer survivorship programs
(a) Pilot programs to explore model systems of care for pediatric cancer survivors
(1) In general
The Secretary of Health and Human Services (referred to in this section as the "Secretary") may make awards to eligible entities to establish pilot programs to develop, study, or evaluate model systems for monitoring and caring for childhood cancer survivors throughout their lifespan, including evaluation of models for transition to adult care and care coordination.
(2) Awards
(A) Types of entities
In making awards under this subsection, the Secretary shall, to the extent practicable, include—
(i) small, medium, and large-sized eligible entities; and
(ii) sites located in different geographic areas, including rural and urban areas.
(B) Eligible entities
In this subsection, the term "eligible entity" means—
(i) a medical school;
(ii) a children's hospital;
(iii) a cancer center;
(iv) a community-based medical facility; or
(v) any other entity with significant experience and expertise in treating survivors of childhood cancers.
(3) Use of funds
Funds awarded under this subsection may be used—
(A) to develop, study, or evaluate one or more models for monitoring and caring for cancer survivors; and
(B) in developing, studying, and evaluating such models, to give special emphasis to—
(i) design of models of follow-up care, monitoring, and other survivorship programs (including peer support and mentoring programs);
(ii) development of models for providing multidisciplinary care;
(iii) dissemination of information to health care providers about culturally and linguistically appropriate follow-up care for cancer survivors and their families, as appropriate and practicable;
(iv) development of psychosocial and support programs to improve the quality of life of cancer survivors and their families, which may include peer support and mentoring programs;
(v) design of systems for the effective transfer of treatment information and care summaries from cancer care providers to other health care providers (including risk factors and a plan for recommended follow-up care);
(vi) dissemination of the information and programs described in clauses (i) through (v) to other health care providers (including primary care physicians and internists) and to cancer survivors and their families, where appropriate and in accordance with Federal and State law; and
(vii) development of initiatives that promote the coordination and effective transition of care between cancer care providers, primary care physicians, mental health professionals, and other health care professionals, as appropriate, including models that use a team-based or multi-disciplinary approach to care.
(b) Workforce development for health care providers on medical and psychosocial care for childhood cancer survivors
(1) In general
The Secretary shall, not later than 1 year after June 5, 2018, conduct a review of the activities of the Department of Health and Human Services related to workforce development for health care providers who treat pediatric cancer patients and survivors. Such review shall include—
(A) an assessment of the effectiveness of supportive psychosocial care services for pediatric cancer patients and survivors, including pediatric cancer survivorship care patient navigators and peer support programs;
(B) identification of existing models relevant to providing medical and psychosocial services to individuals surviving pediatric cancers, and programs related to training for health professionals who provide such services to individuals surviving pediatric cancers; and
(C) recommendations for improving the provision of psychosocial care for pediatric cancer survivors and patients.
(2) Report
Not later than 2 years after June 5, 2018, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and Committee on Energy and Commerce of the House of Representatives, a report concerning the findings and recommendations from the review conducted under paragraph (1).
(
Codification
Section was enacted as part of the Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2018, also known as the Childhood Cancer STAR Act, and not as part of the Public Health Service Act which comprises this chapter.
§285a–11b. Best practices for long-term follow-up services for pediatric cancer survivors
The Secretary of Health and Human Services may facilitate the identification of best practices for childhood and adolescent cancer survivorship care, and, as appropriate, may consult with individuals who have expertise in late effects of disease and treatment of childhood and adolescent cancers, which may include—
(1) oncologists, which may include pediatric oncologists;
(2) primary care providers engaged in survivorship care;
(3) survivors of childhood and adolescent cancer;
(4) parents of children and adolescents who have been diagnosed with and treated for cancer and parents of long-term survivors;
(5) nurses and social workers;
(6) mental health professionals;
(7) allied health professionals, including physical therapists and occupational therapists; and
(8) others, as the Secretary determines appropriate.
(
Codification
Section was enacted as part of the Childhood Cancer Survivorship, Treatment, Access, and Research Act of 2018, also known as the Childhood Cancer STAR Act, and not as part of the Public Health Service Act which comprises this chapter.
§285a–12. Interagency Breast Cancer and Environmental Research Coordinating Committee
(a) Interagency Breast Cancer and Environmental Research Coordinating Committee
(1) Establishment
Not later than 6 months after October 8, 2008, the Secretary shall establish a committee, to be known as the Interagency Breast Cancer and Environmental Research Coordinating Committee (in this section referred to as the "Committee").
(2) Duties
The Committee shall—
(A) share and coordinate information on existing research activities, and make recommendations to the National Institutes of Health and other Federal agencies regarding how to improve existing research programs, that are related to breast cancer research;
(B) develop a comprehensive strategy and advise the National Institutes of Health and other Federal agencies in the solicitation of proposals for collaborative, multidisciplinary research, including proposals to evaluate environmental and genomic factors that may be related to the etiology of breast cancer that would—
(i) result in innovative approaches to study emerging scientific opportunities or eliminate knowledge gaps in research to improve the research portfolio;
(ii) outline key research questions, methodologies, and knowledge gaps;
(iii) expand the number of research proposals that involve collaboration between 2 or more national research institutes or national centers, including proposals for Common Fund research described in
(iv) expand the number of collaborative, multidisciplinary, and multi-institutional research grants;
(C) develop a summary of advances in breast cancer research supported or conducted by Federal agencies relevant to the diagnosis, prevention, and treatment of cancer and other diseases and disorders; and
(D) not later than 2 years after the date of the establishment of the Committee, make recommendations to the Secretary—
(i) regarding any appropriate changes to research activities, including recommendations to improve the research portfolio of the National Institutes of Health to ensure that scientifically-based strategic planning is implemented in support of research priorities that impact breast cancer research activities;
(ii) to ensure that the activities of the National Institutes of Health and other Federal agencies, including the Department of Defense, are free of unnecessary duplication of effort;
(iii) regarding public participation in decisions relating to breast cancer research to increase the involvement of patient advocacy and community organizations representing a broad geographical area;
(iv) on how best to disseminate information on breast cancer research progress; and
(v) on how to expand partnerships between public entities, including Federal agencies, and private entities to expand collaborative, cross-cutting research.
(3) Rule of construction
For the purposes of the Committee, when focusing on research to evaluate environmental and genomic factors that may be related to the etiology of breast cancer, nothing in this section shall be construed to restrict the Secretary from including other forms of cancer, as appropriate, when doing so may advance research in breast cancer or advance research in other forms of cancer.
(4) Membership
(A) In general
The Committee shall be composed of the following voting members:
(i) Not more than 7 voting Federal representatives as follows:
(I) The Director of the Centers for Disease Control and Prevention.
(II) The Director of the National Institutes of Health and the directors of such national research institutes and national centers (which may include the National Institute of Environmental Health Sciences) as the Secretary determines appropriate.
(III) One representative from the National Cancer Institute Board of Scientific Advisors, appointed by the Director of the National Cancer Institute.
(IV) The heads of such other agencies of the Department of Health and Human Services as the Secretary determines appropriate.
(V) Representatives of other Federal agencies that conduct or support cancer research, including the Department of Defense.
(ii) 12 additional voting members appointed under subparagraph (B).
(B) Additional members
The Committee shall include additional voting members appointed by the Secretary as follows:
(i) 6 members shall be appointed from among scientists, physicians, and other health professionals, who—
(I) are not officers or employees of the United States;
(II) represent multiple disciplines, including clinical, basic, and public health sciences;
(III) represent different geographical regions of the United States;
(IV) are from practice settings, academia, or other research settings; and
(V) are experienced in scientific peer review process.
(ii) 6 members shall be appointed from members of the general public, who represent individuals with breast cancer.
(C) Nonvoting members
The Committee shall include such nonvoting members as the Secretary determines to be appropriate.
(5) Chairperson
The voting members of the Committee shall select a chairperson from among such members. The selection of a chairperson shall be subject to the approval of the Director of NIH.
(6) Meetings
The Committee shall meet at the call of the chairperson of the Committee or upon the request of the Director of NIH, but in no case less often than once each year.
(b) Review
The Secretary shall review the necessity of the Committee in calendar year 2011 and, thereafter, at least once every 2 years.
(July 1, 1944, ch. 373, title IV, §417F, as added
§285a–13. Scientific framework for recalcitrant cancers
(a) Development of scientific framework
(1) In general
For each recalcitrant cancer identified under subsection (b), the Director of the Institute shall develop (in accordance with subsection (c)) a scientific framework for the conduct or support of research on such cancer.
(2) Contents
The scientific framework with respect to a recalcitrant cancer shall include the following:
(A) Current status
(i) Review of literature
A summary of findings from the current literature in the areas of—
(I) the prevention, diagnosis, and treatment of such cancer;
(II) the fundamental biologic processes that regulate such cancer (including similarities and differences of such processes from the biological processes that regulate other cancers); and
(III) the epidemiology of such cancer.
(ii) Scientific advances
The identification of relevant emerging scientific areas and promising scientific advances in basic, translational, and clinical science relating to the areas described in subclauses (I) and (II) of clause (i).
(iii) Researchers
A description of the availability of qualified individuals to conduct scientific research in the areas described in clause (i).
(iv) Coordinated research initiatives
The identification of the types of initiatives and partnerships for the coordination of intramural and extramural research of the Institute in the areas described in clause (i) with research of the relevant national research institutes, Federal agencies, and non-Federal public and private entities in such areas.
(v) Research resources
The identification of public and private resources, such as patient registries and tissue banks, that are available to facilitate research relating to each of the areas described in clause (i).
(B) Identification of research questions
The identification of research questions relating to basic, translational, and clinical science in the areas described in subclauses (I) and (II) of subparagraph (A)(i) that have not been adequately addressed with respect to such recalcitrant cancer.
(C) Recommendations
Recommendations for appropriate actions that should be taken to advance research in the areas described in subparagraph (A)(i) and to address the research questions identified in subparagraph (B), as well as for appropriate benchmarks to measure progress on achieving such actions, including the following:
(i) Researchers
Ensuring adequate availability of qualified individuals described in subparagraph (A)(iii).
(ii) Coordinated research initiatives
Promoting and developing initiatives and partnerships described in subparagraph (A)(iv).
(iii) Research resources
Developing additional public and private resources described in subparagraph (A)(v) and strengthening existing resources.
(3) Timing
(A) Initial development and subsequent update
For each recalcitrant cancer identified under subsection (b)(1), the Director of the Institute shall—
(i) develop a scientific framework under this subsection not later than 18 months after January 2, 2013; and
(ii) review and update the scientific framework not later than 5 years after its initial development.
(B) Other updates
The Director of the Institute may review and update each scientific framework developed under this subsection as necessary.
(4) Public notice
With respect to each scientific framework developed under subsection (a), not later than 30 days after the date of completion of the framework, the Director of the Institute shall—
(A) submit such framework to the Committee on Energy and Commerce and Committee on Appropriations of the House of Representatives, and the Committee on Health, Education, Labor, and Pensions and Committee on Appropriations of the Senate; and
(B) make such framework publically available on the Internet website of the Department of Health and Human Services.
(b) Identification of recalcitrant cancer
(1) In general
Not later than 6 months after January 2, 2013, the Director of the Institute shall identify two or more recalcitrant cancers that each—
(A) have a 5-year relative survival rate of less than 20 percent; and
(B) are estimated to cause the death of at least 30,000 individuals in the United States per year.
(2) Additional cancers
The Director of the Institute may, at any time, identify other recalcitrant cancers for purposes of this section. In identifying a recalcitrant cancer pursuant to the previous sentence, the Director may consider additional metrics of progress (such as incidence and mortality rates) against such type of cancer.
(c) Working groups
For each recalcitrant cancer identified under subsection (b), the Director of the Institute shall convene a working group comprised of representatives of appropriate Federal agencies and other non-Federal entities to provide expertise on, and assist in developing, a scientific framework under subsection (a). The Director of the Institute (or the Director's designee) shall participate in the meetings of each such working group.
(d) Reporting
(1) Biennial reports
The Director of NIH shall ensure that each biennial report under
(A) Information on research grants awarded by the National Institutes of Health for research relating to such cancer.
(B) An assessment of the progress made in improving outcomes (including relative survival rates) for individuals diagnosed with such cancer.
(C) An update on activities pertaining to such cancer under the authority of
(2) Additional one-time report for certain frameworks
For each recalcitrant cancer identified under subsection (b)(1), the Director of the Institute shall, not later than 6 years after the initial development of a scientific framework under subsection (a), submit a report to the Congress on the effectiveness of the framework (including the update required by subsection (a)(3)(A)(ii)) in improving the prevention, detection, diagnosis, and treatment of such cancer.
(e) Recommendations for exception funding
The Director of the Institute shall consider each relevant scientific framework developed under subsection (a) when making recommendations for exception funding for grant applications.
(f) Definition
In this section, the term "recalcitrant cancer" means a cancer for which the five-year relative survival rate is below 50 percent.
(July 1, 1944, ch. 373, title IV, §417G, as added
subpart 2—national heart, lung, and blood institute
§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.
(July 1, 1944, ch. 373, title IV, §418, as added
§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.
(July 1, 1944, ch. 373, title IV, §419, as added
Amendments
1993—
§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.
(July 1, 1944, ch. 373, title IV, §420, as added
Amendments
1988—
"(1) the dissemination of information regarding diet and nutrition, environmental pollutants, exercise, stress, hypertension, cigarette smoking, weight control, and other factors affecting the prevention of arteriosclerosis and other cardiovascular diseases and of pulmonary and blood diseases; and
"(2) the dissemination of information designed to encourage children to adopt healthful habits respecting the risk factors related to the prevention of such diseases."
§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
(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
(3) subject to
(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.
(July 1, 1944, ch. 373, title IV, §421, as added
Codification
In subsec. (b)(2)(C), "
In subsec. (b)(3), "
Amendments
1993—Subsec. (b)(1).
Subsec. (b)(5).
1988—Subsec. (a)(1)(D).
Subsec. (b)(1).
§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 anemia
The 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
(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
(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.
(July 1, 1944, ch. 373, title IV, §422, as added
Amendments
2002—Subsec. (c)(3).
1993—Subsec. (a)(1)(D).
1988—Subsec. (a)(1)(A), (B).
§285b–5. Repealed. Pub. L. 100–607, title I, §129, Nov. 4, 1988, 102 Stat. 3055
Section, act July 1, 1944, ch. 373, title IV, §423, as added Nov. 20, 1985,
§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 1 of this title a description of the prevention activities of the Institute, including a description of the staff and resources allocated to those activities.
(July 1, 1944, ch. 373, title IV, §423, formerly §424, as added
References in Text
Prior Provisions
A prior section 423 of act July 1, 1944, was classified to
1 See References in Text note below.
§285b–7. National Center on Sleep Disorders Research
(a) Establishment
Not 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) Purpose
The 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).1
(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
(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 information
The 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.
(July 1, 1944, ch. 373, title IV, §424, as added
Amendments
2007—Subsec. (c)(3)(B)(vi).
Change of Name
Reference to Chief Medical Director of Department of Veterans Affairs deemed to refer to Under Secretary for Health of Department of Veterans Affairs pursuant to section 302(e) of
Reference to Chief Medical Director of Veterans' Administration deemed to refer to Chief Medical Director of Department of Veterans Affairs pursuant to section 10 of
Termination of Advisory Boards
Advisory boards established after Jan. 5, 1973, to terminate not later than the expiration of the 2-year period beginning on the date of their establishment, unless, in the case of a board established by the President or an officer of the Federal Government, such board is renewed by appropriate action prior to the expiration of such 2-year period, or in the case of a board established by Congress, its duration is otherwise provided by law. See sections 3(2) and 14 of
1 So in original. Probably should be subsection "(d)".
2 So in original. Probably should be capitalized.
§285b–7a. Heart attack, stroke, and other cardiovascular diseases in women
(a) In general
The 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 institutes
The 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 programs
In 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.
(July 1, 1944, ch. 373, title IV, §424A, as added
Amendments
2007—Subsec. (d).
Effective Date of 2007 Amendment
Amendment by
§285b–7b. Coordination of Federal asthma activities
(a) In general
The Director of 1 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 Development
A 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).
(July 1, 1944, ch. 373, title IV, §424B, as added
Amendments
2007—Subsec. (a).
Subsec. (c).
Effective Date of 2007 Amendment
Amendment by
1 So in original. Probably should be followed by "the".
§285b–7c. Tuberculosis
(a) In general
The 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 activities
Activities 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.
(July 1, 1944, ch. 373, title IV, §424C, as added
§285b–8. Congenital heart disease
(a) In general
The 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 activities
The 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 communities
In 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.
(July 1, 1944, ch. 373, title IV, §425, as added
Prior Provisions
A prior section 285b–8, act July 1, 1944, ch. 373, title IV, §425, as added
subpart 3—national institute of diabetes and digestive and kidney diseases
§285c. Purpose of Institute
The general purpose of the National Institute of Diabetes and Digestive and Kidney Diseases (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 diabetes mellitus and endocrine and metabolic diseases, digestive diseases and nutritional disorders, and kidney, urologic, and hematologic diseases.
(July 1, 1944, ch. 373, title IV, §426, as added
Study on Metabolic Disorders
"(a)
"(b)
"(c)
Review of Disease Research Programs of the National Institute of Diabetes and Digestive and Kidney Diseases
§285c–1. Data systems and information clearinghouses
(a) National Diabetes Data System and National Diabetes Clearinghouse
The Director of the Institute shall (1) establish the National Diabetes Data System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient populations with diabetes, including, where possible, data involving general populations for the purpose of detection of individuals with a risk of developing diabetes, and (2) establish the National Diabetes Information Clearinghouse to facilitate and enhance knowledge and understanding of diabetes on the part of health professionals, patients, and the public through the effective dissemination of information.
(b) National Digestive Diseases Data System and National Digestive Diseases Information Clearinghouse
The Director of the Institute shall (1) establish the National Digestive Diseases Data System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient populations with digestive diseases, including, where possible, data involving general populations for the purpose of detection of individuals with a risk of developing digestive diseases, and (2) establish the National Digestive Diseases Information Clearinghouse to facilitate and enhance knowledge and understanding of digestive diseases on the part of health professionals, patients, and the public through the effective dissemination of information.
(c) National Kidney and Urologic Diseases Data System and National Kidney and Urologic Diseases Information Clearinghouse
The Director of the Institute shall (1) establish the National Kidney and Urologic Diseases Data System for the collection, storage, analysis, retrieval, and dissemination of data derived from patient populations with kidney and urologic diseases, including, where possible, data involving general populations for the purpose of detection of individuals with a risk of developing kidney and urologic diseases, and (2) establish the National Kidney and Urologic Diseases Information Clearinghouse to facilitate and enhance knowledge and understanding of kidney and urologic diseases on the part of health professionals, patients, and the public through the effective dissemination of information.
(July 1, 1944, ch. 373, title IV, §427, as added
§285c–2. Division Directors for Diabetes, Endocrinology, and Metabolic Diseases, Digestive Diseases and Nutrition, and Kidney, Urologic, and Hematologic Diseases; functions
(a)(1) In the Institute there shall be a Division Director for Diabetes, Endocrinology, and Metabolic Diseases, a Division Director for Digestive Diseases and Nutrition, and a Division Director for Kidney, Urologic, and Hematologic Diseases. Such Division Directors, under the supervision of the Director of the Institute, shall be responsible for—
(A) developing a coordinated plan (including recommendations for expenditures) for each of the national research institutes within the National Institutes of Health with respect to research and training concerning diabetes, endocrine and metabolic diseases, digestive diseases and nutrition, and kidney, urologic, and hematologic diseases;
(B) assessing the adequacy of management approaches for the activities within such institutes concerning such diseases and nutrition and developing improved approaches if needed;
(C) monitoring and reviewing expenditures by such institutes concerning such diseases and nutrition; and
(D) identifying research opportunities concerning such diseases and nutrition and recommending ways to utilize such opportunities.
(2) The Director of the Institute shall transmit to the Director of NIH the plans, recommendations, and reviews of the Division Directors under subparagraphs (A) through (D) of paragraph (1) together with such comments and recommendations as the Director of the Institute determines appropriate.
(b) The Director of the Institute, acting through the Division Director for Diabetes, Endocrinology, and Metabolic Diseases, the Division Director for Digestive Diseases and Nutrition, and the Division Director for Kidney, Urologic, and Hematologic Diseases, shall—
(1) carry out programs of support for research and training (other than training for which Ruth L. Kirschstein National Research Service Awards may be made under
(2) establish programs of evaluation, planning, and dissemination of knowledge related to such research and training.
(July 1, 1944, ch. 373, title IV, §428, as added
Amendments
2002—Subsec. (b)(1).
1993—Subsec. (b).
§285c–3. Interagency coordinating committees
(a) Establishment and purpose
For the purpose of—
(1) better coordination of the research activities of all the national research institutes relating to diabetes mellitus, digestive diseases, and kidney, urologic, and hematologic diseases; and
(2) coordinating those aspects of all Federal health programs and activities relating to such diseases to assure the adequacy and technical soundness of such programs and activities and to provide for the full communication and exchange of information necessary to maintain adequate coordination of such programs and activities;
the Secretary shall establish a Diabetes Mellitus Interagency Coordinating Committee, a Digestive Diseases Interagency Coordinating Committee, and a Kidney, Urologic, and Hematologic Diseases Coordinating Committee (hereafter in this section individually referred to as a "Committee").
(b) Membership; chairman; meetings
Each Committee shall be composed of the Directors of each of the national research institutes and divisions involved in research with respect to the diseases for which the Committee is established, the Division Director of the Institute for the diseases for which the Committee is established, the Under Secretary for Health of the Department of Veterans Affairs, and the Assistant Secretary of Defense for Health Affairs (or the designees of such officers) and shall include representation from all other Federal departments and agencies whose programs involve health functions or responsibilities relevant to such diseases, as determined by the Secretary. Each Committee shall be chaired by the Director of NIH (or the designee of the Director). Each Committee shall meet at the call of the chairman, but not less often than four times a year.
(July 1, 1944, ch. 373, title IV, §429, as added
Amendments
2007—Subsecs. (c), (d).
2004—Subsec. (d).
1992—Subsec. (b).
1988—Subsec. (b).
Effective Date of 2007 Amendment
Amendment by
Effective Date of 1988 Amendment
Amendment by
§285c–4. Advisory boards
(a) Establishment
The Secretary shall establish in the Institute the National Diabetes Advisory Board, the National Digestive Diseases Advisory Board, and the National Kidney and Urologic Diseases Advisory Board (hereafter in this section individually referred to as an "Advisory Board").
(b) Membership; ex officio members
Each Advisory Board shall be composed of eighteen appointed members and nonvoting ex officio members as follows:
(1) The Secretary shall appoint—
(A) twelve members from individuals who are scientists, physicians, and other health professionals, who are not officers or employees of the United States, and who represent the specialties and disciplines relevant to the diseases with respect to which the Advisory Board is established; and
(B) six members from the general public who are knowledgeable with respect to such diseases, including at least one member who is a person who has such a disease and one member who is a parent of a person who has such a disease.
Of the appointed members at least five shall by virtue of training or experience be knowledgeable in the fields of health education, nursing, data systems, public information, and community program development.
(2)(A) The following shall be ex officio members of each Advisory Board:
(i) The Assistant Secretary for Health, the Director of NIH, the Director of the National Institute of Diabetes and Digestive and Kidney Diseases, the Director of the Centers for Disease Control and Prevention, the Under Secretary for Health of the Department of Veterans Affairs, the Assistant Secretary of Defense for Health Affairs, and the Division Director of the National Institute of Diabetes and Digestive and Kidney Diseases for the diseases for which the Board is established (or the designees of such officers).
(ii) Such other officers and employees of the United States as the Secretary determines necessary for the Advisory Board to carry out its functions.
(B) In the case of the National Diabetes Advisory Board, the following shall also be ex officio members: The Director of the National Heart, Lung, and Blood Institute, the Director of the National Eye Institute, the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the Administrator of the Health Resources and Services Administration (or the designees of such officers).
(c) Compensation
Members of an Advisory Board who are officers or employees of the Federal Government shall serve as members of the Advisory Board without compensation in addition to that received in their regular public employment. Other members of the Board shall receive compensation at rates not to exceed the daily equivalent of the annual rate in effect for grade GS–18 of the General Schedule for each day (including traveltime) they are engaged in the performance of their duties as members of the Board.
(d) Term of office; vacancy
The term of office of an appointed member of an Advisory Board is four years, except that no term of office may extend beyond the expiration of the Advisory Board. Any member appointed to fill a vacancy for an unexpired term shall be appointed for the remainder of such term. A member may serve after the expiration of the member's term until a successor has taken office. If a vacancy occurs in an Advisory Board, the Secretary shall make an appointment to fill the vacancy not later than 90 days from the date the vacancy occurred.
(e) Chairman
The members of each Advisory Board shall select a chairman from among the appointed members.
(f) Executive director; professional and clerical staff; administrative support services and facilities
The Secretary shall, after consultation with and consideration of the recommendations of an Advisory Board, provide the Advisory Board with an executive director and one other professional staff member. In addition, the Secretary shall, after consultation with and consideration of the recommendations of the Advisory Board, provide the Advisory Board with such additional professional staff members, such clerical staff members, such services of consultants, such information, and (through contracts or other arrangements) such administrative support services and facilities, as the Secretary determines are necessary for the Advisory Board to carry out its functions.
(g) Meetings
Each Advisory Board shall meet at the call of the chairman or upon request of the Director of the Institute, but not less often than four times a year.
(h) Functions of National Diabetes Advisory Board and National Digestive Diseases Advisory Board
The National Diabetes Advisory Board and the National Digestive Diseases Advisory Board shall—
(1) review and evaluate the implementation of the plan (referred to in
(2) for the purpose of assuring the most effective use and organization of resources respecting such diseases, advise and make recommendations to the Congress, the Secretary, the Director of NIH, the Director of the Institute, and the heads of other appropriate Federal agencies for the implementation and revision of such plan; and
(3) maintain liaison with other advisory bodies related to Federal agencies involved in the implementation of such plan, the coordinating committee for such diseases, and with key non-Federal entities involved in activities affecting the control of such diseases.
(i) Subcommittees; establishment and membership
In carrying out its functions, each Advisory Board may establish subcommittees, convene workshops and conferences, and collect data. Such subcommittees may be composed of Advisory Board members and nonmember consultants with expertise in the particular area addressed by such subcommittees. The subcommittees may hold such meetings as are necessary to enable them to carry out their activities.
(j) Termination of predecessor boards; time within which to appoint members
The National Diabetes Advisory Board and the National Digestive Diseases Advisory Board in existence on November 20, 1985, shall terminate upon the appointment of a successor Board under subsection (a). The Secretary shall make appointments to the Advisory Boards established under subsection (a) before the expiration of 90 days after November 20, 1985. The members of the Boards in existence on November 20, 1985, may be appointed, in accordance with subsections (b) and (d), to the Boards established under subsection (a) for diabetes and digestive diseases, except that at least one-half of the members of the National Diabetes Advisory Board in existence on November 20, 1985, shall be appointed to the National Diabetes Advisory Board first established under subsection (a).
(July 1, 1944, ch. 373, title IV, §430, as added