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‘‘SEC. 319. PUBLIC HEALTH EMERGENCIES.
‘‘(a) EMERGENCIES.—If the Secretary determines,
after consultation with such public health officials as may
be necessary, that—
‘‘(1) a disease or disorder presents a public
health emergency; or
‘‘(2) a public health emergency, including sig-
nificant outbreaks of infectious diseases or bioterrorist
attacks, otherwise exists,
the Secretary may take such action as may be appropriate
to respond to the public health emergency, including mak-
ing grants and entering into contracts and conducting and
supporting investigations into the cause, treatment, or pre-
vention of a disease or disorder as described in paragraphs
(1) and (2).
‘‘(b) PUBLIC HEALTH EMERGENCY FUND.—
‘‘(1) IN GENERAL.—There is established in the
Treasury a fund to be designated as the ‘Public
Health Emergency Fund’ to be made available to the
Secretary without fiscal year limitation to carry out
subsection (a) only if a public health emergency has
been declared by the Secretary under such subsection.
There is authorized to be appropriated to the Fund
such sums as may be necessary.
‘‘(2) REPORT.—Not later than 90 days after the
end of each fiscal year, the Secretary shall prepare
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and submit to the Committee on Health, Education,
Labor, and Pensions and the Committee on Appro-
priations of the Senate and the Committee on Com-
merce and the Committee on Appropriations of the
House of Representatives a report describing—
‘‘(A) the expenditures made from the Public
Health Emergency Fund in such fiscal year; and
‘‘(B) each public health emergency for which
the expenditures were made and the activities
undertaken with respect to each emergency which
was conducted or supported by expenditures from
the Fund.
‘‘(c) SUPPLEMENT NOT SUPPLANT.—Funds appro-
priated under this section shall be used to supplement and
not supplant other Federal, State, and local public funds
provided for activities under this section.
‘‘SEC. 319A. NATIONAL NEEDS TO COMBAT THREATS TO
PUBLIC HEALTH.
‘‘(a) CAPACITIES.—
‘‘(1) IN GENERAL.—Not later than 1 year after
the date of enactment of this section, the Secretary,
and such Administrators, Directors, or Commis-
sioners, as may be appropriate, and in collaboration
with State and local health officials, shall establish
reasonable capacities that are appropriate for na-
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tional, State, and local public health systems and the
personnel or work forces of such systems. Such capac-
ities shall be revised every 10 years, or more fre-
quently as the Secretary determines to be necessary.
‘‘(2) BASIS.—The capacities established under
paragraph (1) shall improve, enhance or expand the
capacity of national, state and local public health
agencies to detect and respond effectively to signifi-
cant public health threats, including major outbreaks
of infectious disease, pathogens resistant to anti-
microbial agents and acts of bioterrorism. Such ca-
pacities may include the capacity to—
‘‘(A) recognize the clinical signs and epide-
miological characteristic of significant outbreaks
of infectious disease;
‘‘(B) identify disease-causing pathogens
rapidly and accurately;
‘‘(C) develop and implement plans to pro-
vide medical care for persons infected with dis-
ease-causing agents and to provide preventive
care as needed for individuals likely to be ex-
posed to disease-causing agents;
‘‘(D) communicate information relevant to
significant public health threats rapidly to local,
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State and national health agencies, and health
care providers; or
‘‘(E) develop or implement policies to pre-
vent the spread of infectious disease or anti-
microbial resistance.
‘‘(b) SUPPLEMENT NOT SUPPLANT.—Funds appro-
priated under this section shall be used to supplement and
not supplant other Federal, State, and local public funds
provided for activities under this section.
‘‘(c) TECHNICAL ASSISTANCE.—The Secretary shall
provide technical assistance to the States to assist such
States in fulfilling the requirements of this section.
‘‘(d) AUTHORIZATION
OF APPROPRIATIONS.—There
are authorized to be appropriated to carry out this section
$4,000,000 for fiscal year 2001, and such sums as may be
necessary for each subsequent fiscal year through 2006.
‘‘SEC. 319B. ASSESSMENT OF PUBLIC HEALTH NEEDS.
‘‘(a) PROGRAM AUTHORIZED.—Not later than 1 year
after the date of enactment of this section and every 10
years thereafter, the Secretary shall award grants to States,
or consortia of 2 or more States or political subdivisions
of States, to perform, in collaboration with local public
health agencies, an evaluation to determine the extent to
which the States or local public health agencies can achieve
the capacities applicable to State and local public health
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agencies described in subsection (a) of section 319A. The
Secretary shall provide technical assistance to States, or
consortia of 2 or more States or political subdivisions of
States, in addition to awarding such grants.
‘‘(b) PROCEDURE.—
‘‘(1) IN GENERAL.—A State, or a consortium of
2 or more States or political subdivisions of States,
may contract with an outside entity to perform the
evaluation described in subsection (a).
‘‘(2) METHODS.—To the extent practicable, the
evaluation described in subsection (a) shall be com-
pleted by using methods, to be developed by the Sec-
retary in collaboration with State and local health of-
ficials, that facilitate the comparison of evaluations
conducted by a State to those conducted by other
States receiving funds under this section.
‘‘(c) REPORT.—Not later than 1 year after the date
on which a State, or a consortium of 2 or more States or
political subdivisions of States, receives a grant under this
subsection, such State, or a consortium of 2 or more States
or political subdivisions of States, shall prepare and submit
to the Secretary a report describing the results of the evalua-
tion described in subsection (a) with respect to such State,
or consortia of 2 or more States or political subdivisions
of States.
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‘‘(d) SUPPLEMENT NOT SUPPLANT.—Funds appro-
priated under this section shall be used to supplement and
not supplant other Federal, State, and local public funds
provided for activities under this section.
‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—There are
authorized to be appropriated to carry out this section
$45,000,000 for fiscal year 2001, and such sums as may
be necessary for each subsequent fiscal year through 2003.
‘‘SEC. 319C. GRANTS TO IMPROVE STATE AND LOCAL PUB-
LIC HEALTH AGENCIES.
‘‘(a) PROGRAM AUTHORIZED.—The Secretary shall
award competitive grants to eligible entities to address core
public health capacity needs using the capacities developed
under section 319A, with a particular focus on building ca-
pacity to identify, detect, monitor, and respond to threats
to the public health.
‘‘(b) ELIGIBLE ENTITIES.—A State or political sub-
division of a State, or a consortium of 2 or more States
or political subdivisions of States, that has completed an
evaluation under section 319B(a), or an evaluation that is
substantially equivalent as determined by the Secretary
under section 319B(a), shall be eligible for grants under
subsection (a).
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appropriated $180,000,000 for fiscal year 2001, and such
sums as may be necessary for each subsequent fiscal year
through 2010.
‘‘SEC. 319E. COMBATING ANTIMICROBIAL RESISTANCE.
‘‘(a) TASK FORCE.—
‘‘(1) IN GENERAL.—The Secretary shall establish
an Antimicrobial Resistance Task Force to provide
advice and recommendations to the Secretary and co-
ordinate Federal programs relating to antimicrobial
resistance. The Secretary may appoint or select a
committee, or other organization in existence as of the
date of enactment of this section, to serve as such a
task force, if such committee, or other organization
meets the requirements of this section.
‘‘(2) MEMBERS OF TASK FORCE.—The task force
described in paragraph (1) shall be composed of rep-
resentatives from such Federal agencies, and shall seek
input from public health constituencies, manufactur-
ers, veterinary and medical professional societies and
others, as determined to be necessary by the Secretary,
to develop and implement a comprehensive plan to
address the public health threat of antimicrobial re-
sistance.
‘‘(3) AGENDA.—
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‘‘(A) IN GENERAL.—The task force described
in paragraph (1) shall consider factors the Sec-
retary considers appropriate, including—
‘‘(i) public health factors contributing
to increasing antimicrobial resistance;
‘‘(ii) public health needs to detect and
monitor antimicrobial resistance;
‘‘(iii) detection, prevention, and con-
trol strategies for resistant pathogens;
‘‘(iv) the need for improved informa-
tion and data collection;
‘‘(v) the assessment of the risk imposed
by pathogens presenting a threat to the pub-
lic health; and
‘‘(vi) any other issues which the Sec-
retary determines are relevant to anti-
microbial resistance.
‘‘(B) DETECTION AND CONTROL.—The Sec-
retary, in consultation with the task force de-
scribed in paragraph (1) and State and local
public health officials, shall—
‘‘(i) develop, improve, coordinate or en-
hance participation in a surveillance plan
to detect and monitor emerging anti-
microbial resistance; and
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‘‘(ii) develop, improve, coordinate or
enhance participation in an integrated in-
formation system to assimilate, analyze,
and exchange antimicrobial resistance data
between public health departments.
‘‘(4) MEETINGS.—The task force described under
paragraph (1) shall convene not less than twice a
year, or more frequently as the Secretary determines
to be appropriate.
‘‘(b) RESEARCH AND DEVELOPMENT OF NEW ANTI-
MICROBIAL DRUGS AND DIAGNOSTICS.—The Secretary and
the Director of Agricultural Research Services, consistent
with the recommendations of the task force established
under subsection (a), shall conduct and support research,
investigations, experiments, demonstrations, and studies in
the health sciences that are related to—
‘‘(1) the development of new therapeutics, includ-
ing vaccines and antimicrobials, against resistant
pathogens;
‘‘(2) the development or testing of medical
diagnostics 
to 
detect 
pathogens 
resistant 
to
antimicrobials;
‘‘(3) the epidemiology, mechanisms, and patho-
genesis of antimicrobial resistance;
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‘‘(4) the sequencing of the genomes of priority
pathogens as determined by the Director of the Na-
tional Institutes of Health in consultation with the
task force established under subsection (a); and
‘‘(5) other relevant research areas.
‘‘(c) EDUCATION OF MEDICAL AND PUBLIC HEALTH
PERSONNEL.—The Secretary, after consultation with the
Assistant Secretary for Health, the Surgeon General, the
Director of the Centers for Disease Control and Prevention,
the Administrator of the Health Resources and Services Ad-
ministration, the Director of the Agency for Healthcare Re-
search and Quality, members of the task force described in
subsection (a), professional organizations and societies, and
such other public health officials as may be necessary,
shall—
‘‘(1) develop and implement educational pro-
grams to increase the awareness of the general public
with respect to the public health threat of anti-
microbial resistance and the appropriate use of anti-
biotics;
‘‘(2) develop and implement educational pro-
grams to instruct health care professionals in the pru-
dent use of antibiotics; and
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‘‘(3) develop and implement programs to train
laboratory personnel in the recognition or identifica-
tion of resistance in pathogens.
‘‘(d) GRANTS.—
‘‘(1) IN GENERAL.—The Secretary shall award
competitive grants to eligible entities to enable such
entities to increase the capacity to detect, monitor,
and combat antimicrobial resistance.
‘‘(2) ELIGIBLE ENTITIES.—Eligible entities for
grants under paragraph (1) shall be State or local
public health agencies, Indian tribes or tribal organi-
zations, or other public or private nonprofit entities.
‘‘(3) USE OF FUNDS.—An eligible entity receiv-
ing a grant under paragraph (1) shall use funds from
such grant for activities that are consistent with the
factors identified by the task force under subsection
(a)(3), which may include activities that—
‘‘(A) provide training to enable such entity
to identify patterns of resistance rapidly and ac-
curately;
‘‘(B) develop, improve, coordinate or en-
hance participation in information systems by
which data on resistant infections can be shared
rapidly among relevant national, State, and
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local health agencies and health care providers;
and
‘‘(C) develop and implement policies to con-
trol the spread of antimicrobial resistance.
‘‘(e) GRANTS FOR DEMONSTRATION PROGRAMS.—
‘‘(1) IN GENERAL.—The Secretary shall award
competitive grants to eligible entities to establish dem-
onstration programs to promote judicious use of anti-
microbial drugs or control the spread of anti-
microbial-resistant pathogens.
‘‘(2) ELIGIBLE ENTITIES.—Eligible entities for
grants under paragraph (1) may include hospitals,
clinics, institutions of long-term care, professional
medical societies, or other public or private nonprofit
entities.
‘‘(3) TECHNICAL
ASSISTANCE.—The Secretary
shall provide appropriate technical assistance to eligi-
ble entities that receive grants under paragraph (1).
‘‘(f) SUPPLEMENT NOT SUPPLANT.—Funds appro-
priated under this section shall be used to supplement and
not supplant other Federal, State, and local public funds
provided for activities under this section.
‘‘(g) AUTHORIZATION
OF APPROPRIATIONS.—There
are authorized to be appropriated to carry out this section,
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$40,000,000 for fiscal year 2001, and such sums as may
be necessary for each subsequent fiscal year through 2006.
‘‘SEC. 319F. PUBLIC HEALTH COUNTERMEASURES TO A BIO-
TERRORIST ATTACK.
‘‘(a) WORKING GROUP ON PREPAREDNESS FOR ACTS
OF BIOTERRORISM.—The Secretary, in coordination with
the Secretary of Defense, shall establish a joint interdepart-
mental working group on preparedness and readiness for
the medical and public health effects of a bioterrorist attack
on the civilian population. Such joint working group
shall—
‘‘(1) coordinate research on pathogens likely to be
used in a bioterrorist attack on the civilian popu-
lation as well as therapies to treat such pathogens;
‘‘(2) coordinate research and development into
equipment to detect pathogens likely to be used in a
bioterrorist attack on the civilian population and
protect against infection from such pathogens;
‘‘(3) develop shared standards for equipment to
detect and to protect against infection from pathogens
likely to be used in a bioterrorist attack on the civil-
ian population; and
‘‘(4) coordinate the development, maintenance,
and procedures for the release of, strategic reserves of
vaccines, drugs, and medical supplies which may be
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needed rapidly after a bioterrorist attack upon the ci-
vilian population.
‘‘(b) WORKING GROUP ON THE PUBLIC HEALTH AND
MEDICAL CONSEQUENCES OF BIOTERRORISM.—
‘‘(1) IN GENERAL.—The Secretary, in collabora-
tion with the Director of the Federal Emergency Man-
agement Agency, the Attorney General, and the Sec-
retary of Agriculture, shall establish a joint inter-
departmental working group to address the public
health and medical consequences of a bioterrorist at-
tack on the civilian population.
‘‘(2) FUNCTIONS.—Such working group shall—
‘‘(A) assess the priorities for and enhance
the preparedness of public health institutions,
providers of medical care, and other emergency
service personnel to detect, diagnose, and respond
to a bioterrorist attack; and
‘‘(B) in the recognition that medical and
public health professionals are likely to provide
much of the first response to such an attack, de-
velop, coordinate, enhance, and assure the qual-
ity of joint planning and training programs that
address the public health and medical con-
sequences of a bioterrorist attack on the civilian
population between—
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‘‘(i) local firefighters, ambulance per-
sonnel, police and public security officers,
or other emergency response personnel; and
‘‘(ii) hospitals, primary care facilities,
and public health agencies.
‘‘(3) WORKING GROUP MEMBERSHIP.—In estab-
lishing such working group, the Secretary shall act
through the Assistant Secretary for Health and the
Director of the Centers for Disease Control and Pre-
vention.
‘‘(4) COORDINATION.—The Secretary shall ensure
coordination and communication between the working
groups established in this subsection and subsection
(a).
‘‘(c) GRANTS.—
‘‘(1) IN GENERAL.—The Secretary, in coordina-
tion with the working group established under sub-
section (b), shall, on a competitive basis and following
scientific or technical review, award grants to or
enter into cooperative agreements with eligible entities
to enable such entities to increase their capacity to
detect, diagnose, and respond to acts of bioterrorism
upon the civilian population.
‘‘(2) ELIGIBILITY.—To be an eligible entity
under this subsection, such entity must be a State, po-
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litical subdivision of a State, a consortium of 2 or
more States or political subdivisions of States, or a
hospital, clinic, or primary care facility.
‘‘(3) USE OF FUNDS.—An entity that receives a
grant under this subsection shall use such funds for
activities that are consistent with the priorities iden-
tified by the working group under subsection (b),
including—
‘‘(A) training health care professionals and
public health personnel to enhance the ability of
such personnel to recognize the symptoms and
epidemiological characteristics of exposure to a
potential bioweapon;
‘‘(B) addressing rapid and accurate identi-
fication of potential bioweapons;
‘‘(C) coordinating medical care for individ-
uals exposed to bioweapons; and
‘‘(D) facilitating and coordinating rapid
communication of data generated from a bioter-
rorist attack between national, State, and local
health agencies, and health care providers.
‘‘(4) COORDINATION.—The Secretary, in award-
ing grants under this subsection, shall—
‘‘(A) notify the Director of the Office of Jus-
tice Programs, and the Director of the National
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Domestic Preparedness Office annually as to the
amount and status of grants awarded under this
subsection; and
‘‘(B) coordinate grants awarded under this
subsection with grants awarded by the Office of
Emergency Preparedness and the Centers for
Disease Control and Prevention for the purpose
of improving the capacity of health care pro-
viders and public health agencies to respond to
bioterrorist attacks on the civilian population.
‘‘(5) ACTIVITIES.—An entity that receives a
grant under this subsection shall, to the greatest ex-
tent practicable, coordinate activities carried out with
such funds with the activities of a local Metropolitan
Medical Response System.
‘‘(d) FEDERAL ASSISTANCE.—The Secretary shall en-
sure that the Department of Health and Human Services
is able to provide such assistance as may be needed to State
and local health agencies to enable such agencies to respond
effectively to bioterrorist attacks.
‘‘(e) EDUCATION.—The Secretary, in collaboration
with members of the working group described in subsection
(b), and professional organizations and societies, shall—
‘‘(1) develop and implement educational pro-
grams to instruct public health officials, medical pro-
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fessionals, and other personnel working in health care
facilities in the recognition and care of victims of a
bioterrorist attack; and
‘‘(2) develop and implement programs to train
laboratory personnel in the recognition and identi-
fication of a potential bioweapon.
‘‘(f) FUTURE RESOURCE DEVELOPMENT.—The Sec-
retary shall consult with the working group described in
subsection (a), to develop priorities for and conduct re-
search, investigations, experiments, demonstrations, and
studies in the health sciences related to—
‘‘(1) the epidemiology and pathogenesis of poten-
tial bioweapons;
‘‘(2) the development of new vaccines or other
therapeutics against pathogens likely to be used in a
bioterrorist attack;
‘‘(3) the development of medical diagnostics to
detect potential bioweapons; and
‘‘(4) other relevant research areas.
‘‘(g) GENERAL ACCOUNTING OFFICE REPORT.—Not
later than 180 days after the date of enactment of this sec-
tion, the Comptroller General shall submit to the Committee
on Health, Education, Labor, and Pensions and the Com-
mittee on Appropriations of the Senate and the Committee
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on Commerce and the Committee on Appropriations of the
House of Representatives a report that describes—
‘‘(1) Federal activities primarily related to re-
search on, preparedness for, and the management of
the public health and medical consequences of a bio-
terrorist attack against the civilian population;
‘‘(2) the coordination of the activities described
in paragraph (1);
‘‘(3) the amount of Federal funds authorized or
appropriated for the activities described in paragraph
(1); and
‘‘(4) the effectiveness of such efforts in preparing
national, State, and local authorities to address the
public health and medical consequences of a potential
bioterrorist attack against the civilian population.
‘‘(h) SUPPLEMENT NOT SUPPLANT.—Funds appro-
priated under this section shall be used to supplement and
not supplant other Federal, State, and local public funds
provided for activities under this section.
‘‘(i) AUTHORIZATION OF APPROPRIATIONS.—There are
authorized to be appropriated to carry out this section
$215,000,000 for fiscal year 2001, and such sums as may
be necessary for each subsequent fiscal year through 2006.
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‘‘SEC. 319G. DEMONSTRATION PROGRAM TO ENHANCE BIO-
TERRORISM TRAINING, COORDINATION, AND
READINESS.
‘‘(a) IN GENERAL.—The Secretary shall make grants
to not more than three eligible entities to carry out dem-
onstration programs to improve the detection of pathogens
likely to be used in a bioterrorist attack, the development
of plans and measures to respond to bioterrorist attacks,
and the training of personnel involved with the various re-
sponsibilities and capabilities needed to respond to acts of
bioterrorism upon the civilian population. Such awards
shall be made on a competitive basis and pursuant to sci-
entific and technical review.
‘‘(b) ELIGIBLE ENTITIES.—Eligible entities for grants
under subsection (a) are States, political subdivisions of
States, and public or private non-profit organizations.
‘‘(c) SPECIFIC CRITERIA.—In making grants under
subsection (a), the Secretary shall take into account the fol-
lowing factors:
‘‘(1) Whether the eligible entity involved is proxi-
mate to, and collaborates with, a major research uni-
versity with expertise in scientific training, identi-
fication of biological agents, medicine, and life
sciences.
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‘‘(2) Whether the entity is proximate to, and col-
laborates with, a laboratory that has expertise in the
identification of biological agents.
‘‘(3) Whether the entity demonstrates, in the ap-
plication for the program, support and participation
of State and local governments and research institu-
tions in the conduct of the program.
‘‘(4) Whether the entity is proximate to, and col-
laborates with, or is, an academic medical center that
has the capacity to serve an uninsured or underserved
population, and is equipped to educate medical per-
sonnel.
‘‘(5) Such other factors as the Secretary deter-
mines to be appropriate.
‘‘(d) DURATION OF AWARD.—The period during which
payments are made under a grant under subsection (a)
may not exceed five years. The provision of such payments
shall be subject to annual approval by the Secretary of the
payments and subject to the availability of appropriations
for the fiscal year involved to make the payments.
‘‘ (e) SUPPLEMENT NOT SUPPLANT.—Grants under
subsection (a) shall be used to supplement, and not sup-
plant, other Federal, State, or local public funds provided
for the activities described in such subsection.
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‘‘(f) GENERAL ACCOUNTING OFFICE REPORT.—Not
later than 180 days after the conclusion of the demonstra-
tion programs carried out under subsection (a), the Comp-
troller General of the United States shall submit to the Com-
mittee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate, and the Com-
mittee on Commerce and the Committee on Appropriations
of the House of Representatives, a report that describes the
ability of grantees under such subsection to detect pathogens
likely to be used in a bioterrorist attack, develop plans and
measures for dealing with such threats, and train personnel
involved with the various responsibilities and capabilities
needed to deal with bioterrorist threats.
‘‘(g) AUTHORIZATION OF APPROPRIATIONS.—There is
authorized to be appropriated to carry out this section
$6,000,000 for fiscal year 2001, and such sums as may be
necessary through fiscal year 2006.’’.
TITLE II—CLINICAL RESEARCH
ENHANCEMENT
SEC. 201. SHORT TITLE.
This title may be cited as the ‘‘Clinical Research En-
hancement Act of 1999’’.
SEC. 202. FINDINGS AND PURPOSE.
(a) FINDINGS.—Congress makes the following findings:
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(1) Clinical research is critical to the advance-
ment 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 re-
search which is an integral part of the research proc-
ess leading to general human applications. It is the
bridge between the laboratory and new methods of di-
agnosis, treatment, and prevention and is thus essen-
tial 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 In-
stitutes of Health was $15,600,000,000 only 1 percent
of that total.
(5) Studies at the Institute of Medicine, the Na-
tional 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 rec-
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ommended expanded support for existing National In-
stitutes of Health clinical research programs and the
creation of new initiatives to recruit and retain clin-
ical 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, en-
thusiasm, 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 ap-
plying 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 ex-
pected to raise funds to support their new re-
search programs and a substantial proportion of
their own salaries.
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(9) The following have been cited as reasons for
the decline in the number of active clinical research-
ers, and those choosing this career path:
(A) A medical school graduate incurs an
average debt of $85,619, as reported in the Med-
ical School Graduation Questionnaire by the As-
sociation of American Medical Colleges (AAMC).
(B) The prolonged period of clinical train-
ing required increases the accumulated debt bur-
den.
(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 experi-
encing difficulties in maintaining a proper envi-
ronment for research in a highly competitive
health care marketplace, which are compounded
by the decreased willingness of third party pay-
ers to cover health care costs for patients engaged
in research studies and research procedures.
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(10) In 1960, general clinical research centers
were established under the Office of the Director of the
National Institutes of Health with an initial appro-
priation 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 approxi-
mately 3 percent to 1 percent of the National Insti-
tutes of Health budget.
(13) In fiscal year 1999, there were 77 general
clinical research centers in operation, supplying pa-
tients in the areas in which such centers operate with
access to the most modern clinical research and clin-
ical research facilities and technologies.
(b) PURPOSE.—It is the purpose of this title to provide
additional support for and to expand clinical research pro-
grams.
SEC. 203. INCREASING THE INVOLVEMENT OF THE NA-
TIONAL INSTITUTES OF HEALTH IN CLINICAL
RESEARCH.
Part B of title IV of the Public Health Service Act
(42 U.S.C. 284 et seq.) is amended by adding at the end
the following:
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‘‘SEC. 409C. CLINICAL RESEARCH.
‘‘(a) IN GENERAL.—The Director of National Insti-
tutes 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 Divi-
sion of Research Grants Clinical Research Study
Group and other recommendations for enhancing
clinical research; and
‘‘(2) establish intramural and extramural clin-
ical research fellowship programs directed specifically
at medical and dental students and a continuing edu-
cation clinical research training program at the Na-
tional 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 inpa-
tient, outpatient, and critical care clinical research.
‘‘(d) PEER REVIEW.—The Director of National Insti-
tutes of Health shall establish peer review mechanisms to
evaluate applications for the awards and fellowships pro-
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vided for in subsection (b)(2) and section 409D. Such re-
view mechanisms shall include individuals who are excep-
tionally qualified to appraise the merits of potential clin-
ical research training and research grant proposals.’’.
SEC. 204. GENERAL CLINICAL RESEARCH CENTERS.
(a) GRANTS.—Subpart 1 of part E of title IV of the
Public Health Service Act (42 U.S.C. 287 et seq.) is amend-
ed by adding at the end the following:
‘‘SEC. 481C. GENERAL CLINICAL RESEARCH CENTERS.
‘‘(a) GRANTS.—The Director of the National Center for
Research Resources shall award grants for the establishment
of general clinical research centers to provide the infrastruc-
ture for clinical research including clinical research train-
ing and career enhancement. Such centers shall support
clinical studies and career development in all settings of
the hospital or academic medical center involved.
‘‘(b) ACTIVITIES.—In carrying out subsection (a), the
Director of National Institutes of Health shall expand the
activities of the general clinical research centers through the
increased use of telecommunications and telemedicine ini-
tiatives.
‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—For the
purpose of carrying out this section, there are authorized
to be appropriated such sums as may be necessary for each
fiscal year.’’.
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(b) ENHANCEMENT AWARDS.—Part B of title IV of the
Public Health Service Act (42 U.S.C. 284 et seq.), as
amended by section 203, is further amended by adding at
the end the following:
‘‘SEC. 409D. ENHANCEMENT AWARDS.
‘‘(a) MENTORED PATIENT-ORIENTED RESEARCH CA-
REER DEVELOPMENT AWARDS.—
‘‘(1) GRANTS.—
‘‘(A) IN GENERAL.—The Director of the Na-
tional Institutes of Health shall make grants (to
be referred to as ‘Mentored Patient-Oriented Re-
search 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-ori-
ented 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 indi-
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vidual scientist at such time as the Director may re-
quire.
‘‘(3) 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.
‘‘(b) MID-CAREER INVESTIGATOR AWARDS
IN PA-
TIENT-ORIENTED RESEARCH.—
‘‘(1) GRANTS.—
‘‘(A) IN GENERAL.—The Director of the Na-
tional Institutes of Health shall make grants (to
be referred to as ‘Mid-Career Investigator
Awards in Patient-Oriented Research’) to sup-
port individual clinical research projects at gen-
eral clinical research centers or at other institu-
tions that have the infrastructure and resources
deemed appropriate for conducting patient-ori-
ented clinical research.
‘‘(B) USE.—Grants under subparagraph
(A) shall be used to provide support for mid-ca-
reer level clinicians to allow such clinicians to
devote time to clinical research and to act as
mentors for beginning clinical investigators.
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‘‘(2) APPLICATIONS.—An application for a grant
under this subsection shall be submitted by an indi-
vidual scientist at such time as the Director requires.
‘‘(3) 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.
‘‘(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 indi-
vidual scientist at such time as the Director may re-
quire.
‘‘(3) LIMITATIONS.—Grants under this sub-
section shall be for terms of 2 years or more and shall
provide stipend, tuition, and institutional support for
individual advanced degree programs in clinical in-
vestigation.
‘‘(4) DEFINITION.—As used in this subsection,
the term ‘advanced degree programs in clinical inves-