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tigation’ 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 med-
ical informatics.
‘‘(E) Ethical and regulatory issues.
‘‘(F) Biomedical writing.
‘‘(5) AUTHORIZATION OF APPROPRIATIONS.—For
the purpose of carrying out this subsection, there are
authorized to be appropriated such sums as may be
necessary for each fiscal year.
‘‘(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 in-
stitutions for the development and support of pro-
grams of core curricula for training clinical inves-
tigators, including medical students. Such core cur-
ricula may include training in areas such as the fol-
lowing:
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‘‘(A) Analytical methods, biostatistics, and
study design.
‘‘(B) Principles of clinical pharmacology
and pharmacokinetics.
‘‘(C) Clinical epidemiology.
‘‘(D) Computer data management and med-
ical informatics.
‘‘(E) Ethical and regulatory issues.
‘‘(F) Biomedical writing.
‘‘(2) APPLICATIONS.—An application for a grant
under this subsection shall be submitted by an indi-
vidual institution or a consortium of institutions at
such time as the Director may require. An institution
may submit only 1 such application.
‘‘(3) LIMITATIONS.—Grants under this sub-
section shall be for terms of up to 5 years and may
be renewable.
‘‘(4) AUTHORIZATION OF APPROPRIATIONS.—For
the purpose of carrying out this subsection, there are
authorized to be appropriated such sums as may be
necessary for each fiscal year.’’.
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SEC. 205. LOAN REPAYMENT PROGRAM REGARDING CLIN-
ICAL RESEARCHERS.
Part G of title IV of the Public Health Service Act
is amended by inserting after section 487E (42 U.S.C. 288–
5) the following:
‘‘SEC. 487F. LOAN REPAYMENT PROGRAM REGARDING CLIN-
ICAL RESEARCHERS.
‘‘(a) IN GENERAL.—The Secretary, acting through the
Director of the National Institutes of Health, shall establish
a program to enter into contracts with qualified health pro-
fessionals under which such health professionals agree to
conduct clinical research, in consideration of the Federal
Government agreeing to repay, for each year of service con-
ducting such research, not more than $35,000 of the prin-
cipal and interest of the educational loans of such health
professionals.
‘‘(b) APPLICATION OF PROVISIONS.—The provisions of
sections 338B, 338C, and 338E shall, except as inconsistent
with subsection (a) of this section, apply to the program
established under subsection (a) to the same extent and in
the same manner as such provisions apply to the National
Health Service Corps Loan Repayment Program established
in subpart III of part D of title III.
‘‘(c) FUNDING.—
‘‘(1) AUTHORIZATION OF APPROPRIATIONS.—For
the purpose of carrying out this section, there are au-
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thorized to be appropriated such sums as may be nec-
essary for each fiscal year.
‘‘(2) AVAILABILITY.—Amounts appropriated for
carrying out this section shall remain available until
the expiration of the second fiscal year beginning
after the fiscal year for which the amounts were made
available.’’.
SEC. 206. DEFINITION.
Section 409 of the Public Health Service Act (42
U.S.C. 284d) is amended—
(1) by striking ‘‘For purposes’’ and inserting
‘‘(a) HEALTH SERVICE RESEARCH.—For purposes’’;
and
(2) by adding at the end the following:
‘‘(b) CLINICAL RESEARCH.—As used in this title, the
term ‘clinical research’ means patient oriented clinical re-
search conducted with human subjects, or research on the
causes and consequences of disease in human populations
involving material of human origin (such as tissue speci-
mens 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 epidemio-
logic or behavioral studies, outcomes research or health serv-
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ices research, or developing new technologies, therapeutic
interventions, or clinical trials.’’.
SEC. 207. OVERSIGHT BY GENERAL ACCOUNTING OFFICE.
Not later than 18 months after the date of enactment
of this Act, the Comptroller General of the United States
shall submit to the Congress a reporting describing the ex-
tent to which the National Institutes of Health has complied
with the amendments made by this title.
TITLE III—RESEARCH
LABORATORY INFRASTRUCTURE
SEC. 301. SHORT TITLE.
This title may be cited as the ‘‘Twenty-First Century
Research Laboratories Act’’.
SEC. 302. FINDINGS.
Congress finds that—
(1) the National Institutes of Health is the prin-
cipal 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 Con-
gress for the purpose of expanding the national in-
vestment of the United States in behavioral and bio-
medical research;
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(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 cut-
ting-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 equip-
ment used in research;
(5) many of the research facilities and labora-
tories in the United States are outdated and inad-
equate;
(6) the National Science Foundation found, in a
1998 report on the status of biomedical research fa-
cilities, 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 extra-
mural research facilities in the United States and the
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purchase of state-of-the-art laboratory instrumenta-
tion.
SEC. 303. BIOMEDICAL AND BEHAVIORAL RESEARCH FA-
CILITIES.
Section 481A of the Public Health Service Act (42
U.S.C. 287a–2 et seq.) is amended to read as follows:
‘‘SEC. 481A. BIOMEDICAL AND BEHAVIORAL RESEARCH FA-
CILITIES.
‘‘(a) MODERNIZATION AND CONSTRUCTION OF FACILI-
TIES.—
‘‘(1) IN GENERAL.—The Director of NIH, acting
through the Director of the Center, may make grants
or contracts to public and nonprofit private entities
to expand, remodel, renovate, or alter existing re-
search facilities or construct new research facilities,
subject to the provisions of this section.
‘‘(2) CONSTRUCTION AND COST OF CONSTRUC-
TION.—For purposes of this section, the terms ‘con-
struction’ and ‘cost of construction’ include the con-
struction of new buildings and the expansion, renova-
tion, 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.—
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‘‘(1) IN GENERAL: APPROVAL AS PRECONDITION
TO GRANTS.—
‘‘(A) ESTABLISHMENT.—There is estab-
lished within the Center a Scientific and Tech-
nical Review Board on Biomedical and Behav-
ioral Research Facilities (referred to in this sec-
tion as the ‘Board’).
‘‘(B) REQUIREMENT.—The Director of the
Center 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 ad-
vice to the Director of the Center and the advi-
sory council established under section 480 (in
this section referred to as the ‘Advisory Council’)
in carrying out this section.
‘‘(B) DETERMINATION OF MERIT.—In car-
rying out subparagraph (A), the Board shall
make a determination of the merit of each appli-
cation submitted for a grant under subsection
(a), after consideration of the requirements estab-
lished in subsection (c), and shall report the re-
sults of the determination to the Director of the
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Center and the Advisory Council. Such deter-
minations shall be conducted in a manner con-
sistent with procedures established under section
492.
‘‘(C) AMOUNT.—In carrying out subpara-
graph (A), the Board shall, in the case of appli-
cations recommended for approval, make rec-
ommendations to the Director and the Advisory
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 the Center and
the Advisory 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 expendi-
tures made under this section;
‘‘(ii) provide a summary of the types,
numbers, and amounts of applications that
were recommended for grants under sub-
section (a) but that were not approved by
the Director of the Center; and
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‘‘(iii) contain the recommendations of
the Board for any changes in the adminis-
tration of this section.
‘‘(3) MEMBERSHIP.—
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), the Board shall be composed of 15
members to be appointed by the Director of the
Center, and such ad-hoc or temporary members
as the Director of the Center determines to be ap-
propriate. All members of the Board, including
temporary and ad-hoc members, shall be voting
members.
‘‘(B) LIMITATION.—Not more than 3 indi-
viduals who are officers or employees of the Fed-
eral Government may serve as members of the
Board.
‘‘(4) CERTAIN REQUIREMENTS REGARDING MEM-
BERSHIP.—In selecting individuals for membership
on the Board, the Director of the Center 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 in-
dividuals for such membership, the Director of the
Center shall ensure that the members of the Board
collectively—
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‘‘(A) are experienced in the planning, con-
struction, financing, and administration of enti-
ties that conduct biomedical or behavioral re-
search sciences;
‘‘(B) are knowledgeable in making deter-
minations 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 re-
search 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 con-
vene workshops and conferences, and collect data
as the Board considers appropriate.
‘‘(B) SUBCOMMITTEES.—In carrying out
paragraph (2), the Board may establish sub-
committees within the Board. Such subcommit-
tees may hold meetings as determined necessary
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to enable the subcommittee to carry out its du-
ties.
‘‘(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 ap-
pointed for the remainder of the term of the
predecessor.
‘‘(B) STAGGERED
TERMS.—Members ap-
pointed to the Board shall serve staggered terms
as specified by the Director of the Center 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 com-
pensation at the same rate received by members of
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other national advisory councils established under
this title.
‘‘(c) REQUIREMENTS FOR GRANTS.—
‘‘(1) IN GENERAL.—The Director of the Center
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 sat-
isfactory 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 ef-
fective use of the facility for the research for
which it is being constructed; and
‘‘(iv) the proposed construction will ex-
pand the applicant’s capacity for research,
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or is necessary to improve or maintain the
quality of the applicant’s research.
‘‘(C) The applicant meets reasonable quali-
fications 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 ex-
panding the capacity for biomedical or be-
havioral 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 ac-
tivities to be carried out within the facility
with the research and investigator man-
power 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 re-
search productivity of the applicant.
‘‘(2) 
INSTITUTIONS
OF
EMERGING
EXCEL-
LENCE.—From the amount appropriated under sub-
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section (i) for a fiscal year up to $50,000,000, the Di-
rector of the Center shall make available 25 percent
of such amount, and from the amount appropriated
under such subsection for a fiscal year that is over
$50,000,000, the Director of the Center 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 bio-
medical or behavioral research, as follows:
‘‘(A) The applicant has a plan for research
or training advancement and possesses the abil-
ity 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 739;
‘‘(ii) is located in a geographic area
whose population includes a significant
number of individuals with health status
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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 pro-
tecting the health status of such population.
‘‘(d) REQUIREMENT OF APPLICATION.—The Director
of the Center 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 man-
ner, and contains such agreements, assurances, and infor-
mation 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 the Center, except that such amount
shall not exceed—
‘‘(A) 50 percent of the necessary cost of the
construction of a proposed facility as determined
by the Director; or
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‘‘(B) in the case of a multipurpose facility,
40 percent of that part of the necessary cost of
construction that the Director determines to be
proportionate to the contemplated use of the fa-
cility.
‘‘(2) RESERVATION OF AMOUNTS.—On the ap-
proval of any application for a grant under sub-
section (a), the Director of the Center 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 in-
stallments consistent with the construction progress,
as the Director may determine appropriate. The res-
ervation 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 deter-
mining 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
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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 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) the applicant or other owner of the facility
shall cease to be a public or non profit private entity;
or
‘‘(2) the facility shall cease to be used for the re-
search purposes for which it was constructed (unless
the Director determines, in accordance with regula-
tions, that there is good cause for releasing the appli-
cant or other owner from obligation to do so);
the United States shall be entitled to recover from the appli-
cant or other owner of the facility the amount bearing the
same ratio to the current value (as determined by an agree-
ment between the parties or by action brought in the United
States District Court for the district in which such facility