
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document affected by Public Law 107-109 Section 15(c)(2)]
[CITE: 42USC282]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
              SUBCHAPTER III--NATIONAL RESEARCH INSTITUTES
 
                  Part A--National Institutes of Health
 
Sec. 282. Director of National Institutes of Health


(a) Appointment

    The National Institutes of Health shall be headed by the Director of 
the National Institutes of Health (hereafter in this subchapter referred 
to as 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) of this section 
and as the Secretary may otherwise prescribe.

(b) Duties and authority

    In carrying out the purposes of section 241 of this title, the 
Secretary, acting through the Director of NIH--
        (1) shall be 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 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 section 
    289a of this title;
        (4) for the national research institutes and administrative 
    entities within the National Institutes of Health--
            (A) may acquire, construct, improve, repair, operate, and 
        maintain, at the site of such institutes and entities, 
        laboratories, and other research facilities, other facilities, 
        equipment, and other real or personal property, and
            (B) may acquire, without regard to section 34 of title 40, 
        by lease or otherwise through the Administrator of General 
        Services, buildings or parts of buildings in the District of 
        Columbia or communities located adjacent to the District of 
        Columbia for use for a period not to exceed ten years;

        (5) may secure resources for research conducted by or through 
    the National Institutes of Health;
        (6) may, without regard to the provisions of title 5 governing 
    appointments in the competitive service, and without regard to the 
    provisions of chapter 51 and subchapter III of chapter 53 of such 
    title relating to classification and General Schedule pay rates, 
    establish such technical and scientific peer review groups and 
    scientific program advisory committees as are needed to carry out 
    the requirements of this subchapter and appoint and pay the members 
    of such groups, except that officers and employees of the United 
    States shall not receive additional compensation for service as 
    members of such groups;
        (7) may secure for the National Institutes of Health 
    consultation services and advice of persons from the United States 
    or abroad;
        (8) 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;
        (9) may, for purposes of study, admit and treat at facilities of 
    the National Institutes of Health individuals not otherwise eligible 
    for such treatment;
        (10) may accept voluntary and uncompensated services;
        (11) may perform such other administrative functions as the 
    Secretary determines are needed to effectively carry out this 
    subchapter;
        (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 
    section 287d(b) of this title;
        (13) may conduct and support research training--
            (A) for which fellowship support is not provided under 
        section 288 of this title; and
            (B) which does not consist of residency training of 
        physicians or other health professionals; and

        (14) may appoint physicians, dentists, and other health care 
    professionals, subject to the provisions of title 5 relating to 
    appointments and classifications in the competitive service, and may 
    compensate such professionals subject to the provisions of chapter 
    74 of title 38.

The Federal Advisory Committee Act shall not apply to the duration of a 
peer review group appointed under paragraph (6). 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 section 3109 
of title 5, but without regard to the limitation in such section on the 
period of service) the services of not more than 220 experts or 
consultants, with scientific or other professional qualifications, for 
the National Institutes of Health.
    (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 (Public Law 102-73).

(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) Enhancing competitiveness of certain entities in obtaining research 
        funds

    (1)(A) In the case of entities described in subparagraph (B), the 
Director of NIH, acting through the Director of the National Center for 
Research Resources, shall establish a program to enhance the 
competitiveness of such entities in obtaining funds from the national 
research institutes for conducting biomedical and behavioral research.
    (B) The entities referred to in subparagraph (A) are entities that 
conduct biomedical and behavioral research and are located in a State in 
which the aggregate success rate for applications to the national 
research institutes for assistance for such research by the entities in 
the State has historically constituted a low success rate of obtaining 
such funds, relative to such aggregate rate for such entities in other 
States.
    (C) With respect to enhancing competitiveness for purposes of 
subparagraph (A), the Director of NIH, in carrying out the program 
established under such subparagraph, may--
        (i) provide technical assistance to the entities involved, 
    including technical assistance in the preparation of applications 
    for obtaining funds from the national research institutes;
        (ii) assist the entities in developing a plan for biomedical or 
    behavioral research proposals; and
        (iii) assist the entities in implementing such plan.

    (2) The Director of NIH shall establish a program of supporting 
projects of biomedical or behavioral research whose principal 
researchers are individuals who have not previously served as the 
principal researchers of such projects supported by the Director.

(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) Discretionary fund; uses; report to Congressional committees; 
        authorization of appropriations

    (1) There is established a fund, consisting of amounts appropriated 
under paragraph (3) and made available for the fund, for use by the 
Director of NIH to carry out the activities authorized in this chapter 
for the National Institutes of Health. The purposes for which such fund 
may be expended include--
        (A) providing for research on matters that have not received 
    significant funding relative to other matters, responding to new 
    issues and scientific emergencies, and acting on research 
    opportunities of high priority;
        (B) supporting research that is not exclusively within the 
    authority of any single agency of such Institutes; and
        (C) purchasing or renting equipment and quarters for activities 
    of such Institutes.

    (2) Not later than February 10 of each fiscal year, the Secretary 
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, a report describing the activities undertaken and 
expenditures made under this section during the preceding fiscal year. 
The report may contain such comments of the Secretary regarding this 
section as the Secretary determines to be appropriate.
    (3) For the purpose of carrying out this subsection, there are 
authorized to be appropriated $25,000,000 for fiscal year 1994, and such 
sums as may be necessary for each of the fiscal years 1995 and 1996.

(j) 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 section 355(i) of title 21, which provides a description 
    of the purpose of each experimental drug, either with the consent of 
    the protocol sponsor, or when a trial to test effectiveness begins. 
    Information provided shall consist of eligibility criteria for 
    participation in the clinical trials, a description of the location 
    of trial sites, and a point of contact for those wanting to enroll 
    in the trial, and shall be in a form that can be readily understood 
    by members of the public. Such information shall be forwarded to the 
    data bank by the sponsor of the trial not later than 21 days after 
    the approval of the protocol.
        (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 section 360bbb(c) 
        of title 21; or
            (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) For the purpose of carrying out this subsection, there are 
authorized to be appropriated such sums as may be necessary. Fees 
collected under section 379h of title 21 shall not be used in carrying 
out this subsection.

(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) Interagency research on trauma

    The Director of NIH shall carry out the program established in part 
F of subchapter X of this chapter (relating to interagency research on 
trauma).

(July 1, 1944, ch. 373, title IV, Sec. 402, as added Pub. L. 99-158, 
Sec. 2, Nov. 20, 1985, 99 Stat. 823; amended Pub. L. 100-607, title I, 
Sec. 111, Nov. 4, 1988, 102 Stat. 3052; Pub. L. 102-321, title I, 
Sec. 163(b)(3), July 10, 1992, 106 Stat. 376; Pub. L. 103-43, title I, 
Sec. 141(b), title II, Secs. 201, 202, 206, 208, 210(b), (c), title III, 
Sec. 303(b), June 10, 1993, 107 Stat. 139, 144, 148-150, 153; Pub. L. 
105-115, title I, Sec. 113(a), Nov. 21, 1997, 111 Stat. 2310; Pub. L. 
105-362, title VI, Sec. 601(a)(1)(A), Nov. 10, 1998, 112 Stat. 3285; 
Pub. L. 105-392, title IV, Sec. 409, Nov. 13, 1998, 112 Stat. 3589.)

                       References in Text

    The provisions of title 5 governing appointments in the competitive 
service, referred to in subsec. (b)(6), (14), are classified generally 
to section 3301 et seq. of Title 5, Government Organization and 
Employees.
    The General Schedule, referred to in subsec. (b)(6), is set out 
under section 5332 of Title 5, Government Organization and Employees.
    The provisions of title 5 relating to classifications, referred to 
in subsec. (b)(14), are classified generally to chapter 51 (Sec. 5101 et 
seq.) and to subchapter III (Sec. 5331 et seq.) of chapter 53 of Title 
5, Government Organization and Employees.
    The Federal Advisory Committee Act, referred to in subsec. (b), is 
Pub. L. 92-463, Oct. 6, 1972, 86 Stat. 770, as amended, which is set out 
in the Appendix to Title 5, Government Organization and Employees.
    The provisions of title 5 relating to reimbursement for travel 
expenses, referred to in subsec. (d)(2)(A), are classified generally to 
section 5701 et seq. of Title 5, Government Organization and Employees.
    The National Literacy Act of 1991, referred to in subsec. (e)(5), is 
Pub. L. 102-73, July 25, 1991, 105 Stat. 333, as amended, which was 
repealed by Pub. L. 105-220, title II, Sec. 251(a)(2), Aug. 7, 1998, 112 
Stat. 1079. For complete classification of this Act to the Code, see 
Tables.


                               Amendments

    1998--Subsec. (b)(13), (14). Pub. L. 105-392 added pars. (13) and 
(14).
    Subsec. (f). Pub. L. 105-362 inserted ``and'' at end of par. (1), 
substituted a period for ``; and'' at end of par. (2), and struck out 
par. (3) which read as follows: ``annually prepare and submit to the 
Director of NIH a report concerning the prevention and dissemination 
activities undertaken by the Associate Director, including--
        ``(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). Pub. L. 105-115 added subsec. (j) and 
redesignated former subsecs. (j) and (k) as (k) and (l), respectively.
    1993--Subsec. (b)(12). Pub. L. 103-43, Sec. 141(b), added par. (12).
    Subsec. (e)(5). Pub. L. 103-43, Sec. 210(b), added par. (5).
    Subsec. (f). Pub. L. 103-43, Sec. 201, substituted ``other public 
and private entities, including elementary, secondary, and post-
secondary schools. The Associate Director shall--'' and pars. (1) to (3) 
for ``other public and private entities. The Associate Director shall 
annually report to the Director of NIH on the prevention activities 
undertaken by the Associate Director. The report shall include a 
detailed statement of the expenditures made for the activities reported 
on and the personnel used in connection with such activities''.
    Subsec. (g). Pub. L. 103-43, Sec. 202, added subsec. (g).
    Subsec. (h). Pub. L. 103-43, Sec. 206, added subsec. (h).
    Subsec. (i). Pub. L. 103-43, Sec. 208, added subsec. (i).
    Subsec. (j). Pub. L. 103-43, Sec. 210(c), added subsec. (j).
    Subsec. (k). Pub. L. 103-43, Sec. 303(b), added subsec. (k).
    1992--Subsec. (d)(1). Pub. L. 102-321 substituted ``220'' for ``two 
hundred''.
    1988--Subsec. (b)(6). Pub. L. 100-607 inserted ``and scientific 
program advisory committees'' after ``peer review groups''.

                         Change of Name

    Committee on Energy and Commerce of House of Representatives treated 
as referring to Committee on Commerce of House of Representatives by 
section 1(a) of Pub. L. 104-14, set out as a note preceding section 21 
of Title 2, The Congress.


                    Effective Date of 1997 Amendment

    Amendment by Pub. L. 105-115 effective 90 days after Nov. 21, 1997, 
except as otherwise provided, see section 501 of Pub. L. 105-115, set 
out as a note under section 321 of Title 21, Food and Drugs.


                    Effective Date of 1992 Amendment

    Amendment by Pub. L. 102-321 effective Oct. 1, 1992, with provision 
for programs providing financial assistance, see section 801(c), (d) of 
Pub. L. 102-321, set out as a note under section 236 of this title.


                        Collaboration and Report

    Section 113(b) of Pub. L. 105-115 provided that:
    ``(1) In general.--The Secretary of Health and Human Services, the 
Director of the National Institutes of Health, and the Commissioner of 
Food and Drugs shall collaborate to determine the feasibility of 
including device investigations within the scope of the data bank under 
section 402(j) of the Public Health Service Act [subsec. (j) of this 
section].
    ``(2) Report.--Not later than two years after the date of enactment 
of this section [Nov. 21, 1997], the Secretary of Health and Human 
Services shall prepare and submit to the Committee on Labor and Human 
Resources of the Senate and the Committee on Commerce of the House of 
Representatives a report--
        ``(A) of the public health need, if any, for inclusion of device 
    investigations within the scope of the data bank under section 
    402(j) of the Public Health Service Act;
        ``(B) on the adverse impact, if any, on device innovation and 
    research in the United States if information relating to such device 
    investigations is required to be publicly disclosed; and
        ``(C) on such other issues relating to such section 402(j) as 
    the Secretary determines to be appropriate.''


   Chronic Fatigue Syndrome; Experts and Research Representatives on 
                     Advisory Committees and Boards

    Section 902(c) of Pub. L. 103-43 provided that: ``The Secretary of 
Health and Human Services, acting through the Director of the National 
Institutes of Health, shall ensure that appropriate individuals with 
expertise in chronic fatigue syndrome or neuromuscular diseases and 
representative of a variety of disciplines and fields within the 
research community are appointed to appropriate National Institutes of 
Health advisory committees and boards.''


Third-Party Payments Regarding Certain Clinical Trials and Certain Life-
                          Threatening Illnesses

    Section 1901(a) of Pub. L. 103-43 provided that: ``The Secretary of 
Health and Human Services, acting through the Director of the National 
Institutes of Health, shall conduct a study for the purpose of--
        ``(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

    Section 1905 of Pub. L. 103-43 directed Secretary of Health and 
Human Services, acting through Director of National Institutes of 
Health, to conduct a study to review the retention, recruitment, vacancy 
and turnover rates of support staff, including firefighters, law 
enforcement, procurement officers, technicians, nurses and clerical 
employees, to ensure that National Institutes of Health is adequately 
supporting conduct of efficient, effective and high quality research for 
the American public, and to submit a report to Congress on results of 
such study not later than 1 year after June 10, 1993.


                         Chronic Pain Conditions

    Section 1907 of Pub. L. 103-43 directed Director of the National 
Institutes of Health to submit to Congress, not later than 2 years after 
June 10, 1993, a report and study on the incidence in the United States 
of cases of chronic pain, including chronic pain resulting from back 
injuries, reflex sympathetic dystrophy syndrome, temporomandibular joint 
disorder, post-herpetic neuropathy, painful diabetic neuropathy, phantom 
pain, and post-stroke pain, and the effect of such cases on the costs of 
health care in the United States.


                   Support for Bioengineering Research

    Section 1912 of Pub. L. 103-43 directed Secretary of Health and 
Human Services, acting through Director of the National Institutes of 
Health, to conduct a study for the purpose of determining the sources 
and amounts of public and private funding devoted to basic research in 
bioengineering, including biomaterials sciences, cellular bioprocessing, 
tissue and rehabilitation engineering, evaluating whether that 
commitment is sufficient to maintain the innovative edge that the United 
States has in these technologies, evaluating the role of the National 
Institutes of Health or any other Federal agency to achieve a greater 
commitment to innovation in bioengineering, and evaluating the need for 
better coordination and collaboration among Federal agencies and between 
the public and private sectors, and, not later than 1 year after June 
10, 1993, to prepare and submit to Committee on Labor and Human 
Resources of Senate, and Committee on Energy and Commerce of House of 
Representatives, a report containing the findings of the study together 
with recommendations concerning the enactment of legislation to 
implement the results of such study.


          Master Plan for Physical Infrastructure for Research

    Section 2002 of Pub. L. 103-43 directed Secretary of Health and 
Human Services, acting through Director of the National Institutes of 
Health, not later than June 1, 1994, to present to Congress a master 
plan to provide for replacement or refurbishment of less than adequate 
buildings, utility equipment and distribution systems (including the 
resources that provide electrical and other utilities, chilled water, 
air handling, and other services that the Secretary, acting through the 
Director, deemed necessary), roads, walkways, parking areas, and grounds 
that underpin the laboratory and clinical facilities of the National 
Institutes of Health, and provided that the plan could make 
recommendations for the undertaking of new projects that are consistent 
with the objectives of this section, such as encircling the National 
Institutes of Health Federal enclave with an adequate chilled water 
conduit.

                  Section Referred to in Other Sections

    This section is referred to in sections 283, 284, 285g-4, 289a of 
this title; title 21 section 360bbb.
