[Congressional Record Volume 146, Number 136 (Thursday, October 26, 2000)]
[House]
[Pages H11303-H11317]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
CARDIAC ARREST SURVIVAL ACT OF 2000
Mr. BILIRAKIS. Mr. Speaker, I move to suspend the rules, concur in
the Senate amendment to the bill (H.R. 2498) to amend the Public Health
Service Act to provide for recommendations of the Secretary of Health
and Human Services regarding the placement of automatic external
defibrillators in Federal buildings in order to improve survival rates
of individuals who experience cardiac arrest in such buildings, and to
establish protections from civil liability arising from the emergency
use of the devices.
The Clerk read as follows:
Senate amendment:
Strike out all after the enacting clause and insert:
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Public
Health Improvement Act''.
(b) Table of Contents.--The table of contents of this Act
is as follows:
Sec. 1. Short title; table of contents.
[[Page H11304]]
TITLE I--EMERGING THREATS TO PUBLIC HEALTH
Sec. 101. Short title.
Sec. 102. Amendments to the Public Health Service Act.
TITLE II--CLINICAL RESEARCH ENHANCEMENT
Sec. 201. Short title.
Sec. 202. Findings and purpose.
Sec. 203. Increasing the involvement of the National Institutes of
Health in clinical research.
Sec. 204. General clinical research centers.
Sec. 205. Loan repayment program regarding clinical researchers.
Sec. 206. Definition.
Sec. 207. Oversight by General Accounting Office.
TITLE III--RESEARCH LABORATORY INFRASTRUCTURE
Sec. 301. Short title.
Sec. 302. Findings.
Sec. 303. Biomedical and behavioral research facilities.
Sec. 304. Construction program for National Primate Research Centers.
Sec. 305. Shared instrumentation grant program.
TITLE IV--CARDIAC ARREST SURVIVAL
Subtitle A--Recommendations for Federal Buildings
Sec. 401. Short title.
Sec. 402. Findings.
Sec. 403. Recommendations and guidelines of Secretary of Health and
Human Services regarding automated external
defibrillators for Federal buildings.
Sec. 404. Good samaritan protections regarding emergency use of
automated external defibrillators.
Subtitle B--Rural Access to Emergency Devices
Sec. 411. Short title.
Sec. 412. Findings.
Sec. 413. Grants.
TITLE V--LUPUS RESEARCH AND CARE
Sec. 501. Short title.
Sec. 502. Findings.
Subtitle A--Research on Lupus
Sec. 511. Expansion and intensification of activities.
Subtitle B--Delivery of Services Regarding Lupus
Sec. 521. Establishment of program of grants.
Sec. 522. Certain requirements.
Sec. 523. Technical assistance.
Sec. 524. Definitions.
Sec. 525. Authorization of appropriations.
TITLE VI--PROSTATE CANCER RESEARCH AND PREVENTION
Sec. 601. Short title.
Sec. 602. Amendments to the Public Health Service Act.
TITLE VII--ORGAN PROCUREMENT AND DONATION
Sec. 701. Organ procurement organization certification.
Sec. 702. Designation of Give Thanks, Give Life Day.
TITLE VIII--ALZHEIMER'S CLINICAL RESEARCH AND TRAINING
Sec. 801. Alzheimer's clinical research and training awards.
TITLE IX--SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH AND TRAINING
Sec. 901. Sexually transmitted disease clinical research and training
awards.
TITLE X--MISCELLANEOUS PROVISION
Sec. 1001. Technical correction to the Children's Health Act of 2000.
TITLE I--EMERGING THREATS TO PUBLIC HEALTH
SEC. 101. SHORT TITLE.
This title may be cited as the ``Public Health Threats and
Emergencies Act''.
SEC. 102. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.
Part B of title III of the Public Health Service Act (42
U.S.C. 243 et seq.) is amended by striking section 319 and
inserting the following:
``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 significant
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 making
grants and entering into contracts and conducting and
supporting investigations into the cause, treatment, or
prevention 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 and submit to the
Committee on Health, Education, Labor, and Pensions and the
Committee on Appropriations of the Senate and the Committee
on Commerce 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 appropriated 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 Commissioners, as may be
appropriate, and in collaboration with State and local health
officials, shall establish reasonable capacities that are
appropriate for national, State, and local public health
systems and the personnel or work forces of such systems.
Such capacities shall be revised every 10 years, or more
frequently 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 significant public health threats,
including major outbreaks of infectious disease, pathogens
resistant to antimicrobial agents and acts of bioterrorism.
Such capacities may include the capacity to--
``(A) recognize the clinical signs and epidemiological
characteristic of significant outbreaks of infectious
disease;
``(B) identify disease-causing pathogens rapidly and
accurately;
``(C) develop and implement plans to provide medical care
for persons infected with disease-causing agents and to
provide preventive care as needed for individuals likely to
be exposed to disease-causing agents;
``(D) communicate information relevant to significant
public health threats rapidly to local, State and national
health agencies, and health care providers; or
``(E) develop or implement policies to prevent the spread
of infectious disease or antimicrobial resistance.
``(b) Supplement Not Supplant.--Funds appropriated 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
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 completed by using
methods, to be developed by the Secretary in collaboration
with State and local health officials, 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
evaluation described in subsection (a) with respect to such
State, or consortia of 2 or more States or political
subdivisions of States.
``(d) Supplement Not Supplant.--Funds appropriated 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 PUBLIC 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
capacity to identify, detect, monitor, and respond to threats
to the public health.
``(b) Eligible Entities.--A State or political subdivision
of a State, or a consortium of 2 or more States or political
subdivisions of States, that has completed an evaluation
under section
[[Page H11305]]
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).
``(c) Use of Funds.--An eligible entity that receives a
grant under subsection (a), may use funds received under such
grant to--
``(1) train public health personnel;
``(2) develop, enhance, coordinate, or improve
participation in an electronic network by which disease
detection and public health related information can be
rapidly shared among national, regional, State, and local
public health agencies and health care providers;
``(3) develop a plan for responding to public health
emergencies, including significant outbreaks of infectious
diseases or bioterrorism attacks, which is coordinated with
the capacities of applicable national, State, and local
health agencies and health care providers; and
``(4) enhance laboratory capacity and facilities.
``(d) Report.--No later than January 1, 2005, the Secretary
shall prepare and submit to the Committee on Health,
Education, Labor, and Pensions and the Committee on
Appropriations of the Senate and the Committee on Commerce
and the Committee on Appropriations of the House of
Representatives a report that describes the activities
carried out under sections 319A, 319B, and 319C.
``(e) Supplement Not Supplant.--Funds appropriated under
this section shall be used to supplement and not supplant
other Federal, State, and local public funds provided for
activities under this section.
``(f) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section
$50,000,000 for fiscal year 2001, and such sums as may be
necessary for each subsequent fiscal year through 2006.
``SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE CONTROL AND
PREVENTION.
``(a) Findings.--Congress finds that the Centers for
Disease Control and Prevention have an essential role in
defending against and combatting public health threats of the
twenty-first century and requires secure and modern
facilities that are sufficient to enable such Centers to
conduct this important mission.
``(b) Authorization of Appropriations.--For the purposes of
achieving the mission of the Centers for Disease Control and
Prevention described in subsection (a), for constructing new
facilities and renovating existing facilities of such
Centers, including laboratories, laboratory support
buildings, health communication facilities, office buildings
and other facilities and infrastructure, for better
conducting the capacities described in section 319A, and for
supporting related public health activities, there are
authorized to be 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 coordinate 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 representatives from such
Federal agencies, and shall seek input from public health
constituencies, manufacturers, 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 resistance.
``(3) Agenda.--
``(A) In general.--The task force described in paragraph
(1) shall consider factors the Secretary 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 control strategies for
resistant pathogens;
``(iv) the need for improved information and data
collection;
``(v) the assessment of the risk imposed by pathogens
presenting a threat to the public health; and
``(vi) any other issues which the Secretary determines are
relevant to antimicrobial resistance.
``(B) Detection and control.--The Secretary, in
consultation with the task force described in paragraph (1)
and State and local public health officials, shall--
``(i) develop, improve, coordinate or enhance participation
in a surveillance plan to detect and monitor emerging
antimicrobial resistance; and
``(ii) develop, improve, coordinate or enhance
participation in an integrated information 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 Antimicrobial 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, including
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 pathogenesis of
antimicrobial resistance;
``(4) the sequencing of the genomes of priority pathogens
as determined by the Director of the National 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
Administration, the Director of the Agency for Healthcare
Research 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 programs to
increase the awareness of the general public with respect to
the public health threat of antimicrobial resistance and the
appropriate use of antibiotics;
``(2) develop and implement educational programs to
instruct health care professionals in the prudent use of
antibiotics; and
``(3) develop and implement programs to train laboratory
personnel in the recognition or identification 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 organizations, or other
public or private nonprofit entities.
``(3) Use of funds.--An eligible entity receiving 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 accurately;
``(B) develop, improve, coordinate or enhance participation
in information systems by which data on resistant infections
can be shared rapidly among relevant national, State, and
local health agencies and health care providers; and
``(C) develop and implement policies to control the spread
of antimicrobial resistance.
``(e) Grants for Demonstration Programs.--
``(1) In general.--The Secretary shall award competitive
grants to eligible entities to establish demonstration
programs to promote judicious use of antimicrobial drugs or
control the spread of antimicrobial-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 eligible entities that
receive grants under paragraph (1).
``(f) Supplement Not Supplant.--Funds appropriated 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,
$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 BIOTERRORIST
ATTACK.
``(a) Working Group on Preparedness for Acts of
Bioterrorism.--The Secretary, in coordination with the
Secretary of Defense, shall establish a joint
interdepartmental 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 population 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 civilian population; and
``(4) coordinate the development, maintenance, and
procedures for the release of, strategic reserves of
vaccines, drugs, and medical supplies which may be needed
rapidly after a bioterrorist attack upon the civilian
population.
``(b) Working Group on the Public Health and Medical
Consequences of Bioterrorism.--
``(1) In general.--The Secretary, in collaboration with the
Director of the Federal Emergency Management Agency, the
Attorney General, and the Secretary of Agriculture, shall
establish a joint interdepartmental working group to address
the public health and medical consequences of a bioterrorist
attack 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
[[Page H11306]]
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, develop, coordinate, enhance, and
assure the quality of joint planning and training programs
that address the public health and medical consequences of a
bioterrorist attack on the civilian population between--
``(i) local firefighters, ambulance personnel, 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 establishing such
working group, the Secretary shall act through the Assistant
Secretary for Health and the Director of the Centers for
Disease Control and Prevention.
``(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 coordination with the
working group established under subsection (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, political
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 identified 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 identification of
potential bioweapons;
``(C) coordinating medical care for individuals exposed to
bioweapons; and
``(D) facilitating and coordinating rapid communication of
data generated from a bioterrorist attack between national,
State, and local health agencies, and health care providers.
``(4) Coordination.--The Secretary, in awarding grants
under this subsection, shall--
``(A) notify the Director of the Office of Justice
Programs, and the Director of the National 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 providers
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 extent practicable,
coordinate activities carried out with such funds with the
activities of a local Metropolitan Medical Response System.
``(d) Federal Assistance.--The Secretary shall ensure 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 programs to
instruct public health officials, medical professionals, 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 identification of a
potential bioweapon.
``(f) Future Resource Development.--The Secretary shall
consult with the working group described in subsection (a),
to develop priorities for and conduct research,
investigations, experiments, demonstrations, and studies in
the health sciences related to--
``(1) the epidemiology and pathogenesis of potential
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 section, the
Comptroller General shall submit to the Committee on Health,
Education, Labor, and Pensions and the Committee on
Appropriations of the Senate and the Committee on Commerce
and the Committee on Appropriations of the House of
Representatives a report that describes--
``(1) Federal activities primarily related to research on,
preparedness for, and the management of the public health and
medical consequences of a bioterrorist 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 appropriated 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.
``SEC. 319G. DEMONSTRATION PROGRAM TO ENHANCE BIOTERRORISM
TRAINING, COORDINATION, AND READINESS.
``(a) In General.--The Secretary shall make grants to not
more than three eligible entities to carry out demonstration
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 responsibilities 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 scientific 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 following
factors:
``(1) Whether the eligible entity involved is proximate to,
and collaborates with, a major research university with
expertise in scientific training, identification of
biological agents, medicine, and life sciences.
``(2) Whether the entity is proximate to, and collaborates
with, a laboratory that has expertise in the identification
of biological agents.
``(3) Whether the entity demonstrates, in the application
for the program, support and participation of State and local
governments and research institutions in the conduct of the
program.
``(4) Whether the entity is proximate to, and collaborates
with, or is, an academic medical center that has the capacity
to serve an uninsured or underserved population, and is
equipped to educate medical personnel.
``(5) Such other factors as the Secretary determines 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 supplant, other Federal,
State, or local public funds provided for the activities
described in such subsection.
``(f) General Accounting Office Report.--Not later than 180
days after the conclusion of the demonstration programs
carried out under subsection (a), the Comptroller General of
the United States shall submit to the Committee on Health,
Education, Labor, and Pensions and the Committee on
Appropriations of the Senate, and the Committee 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
Enhancement Act of 1999''.
SEC. 202. FINDINGS AND PURPOSE.
(a) Findings.--Congress makes the following findings:
(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:
[[Page H11307]]
(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) Purpose.--It is the purpose of this title to provide
additional support for and to expand clinical research
programs.
SEC. 203. INCREASING THE INVOLVEMENT OF THE NATIONAL
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:
``SEC. 409C. 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 section 409D. Such review mechanisms
shall include individuals who are exceptionally qualified to
appraise the merits of potential clinical 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 amended 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
infrastructure for clinical research including clinical
research training 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
initiatives.
``(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.''.
(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 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.
``(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 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.
``(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 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.
``(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 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 1 such application.
``(3) Limitations.--Grants under this subsection 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.''.
SEC. 205. LOAN REPAYMENT PROGRAM REGARDING CLINICAL
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 CLINICAL
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 professionals under which such health professionals
agree to conduct clinical research, in consideration of the
Federal Government agreeing to
[[Page H11308]]
repay, for each year of service conducting such research, not
more than $35,000 of the principal 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 authorized to be
appropriated such sums as may be necessary 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 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.''.
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 extent 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 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.
SEC. 303. BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES.
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 FACILITIES.
``(a) Modernization and Construction of Facilities.--
``(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 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 within the
Center 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 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 advice to the
Director of the Center and the advisory council established
under section 480 (in this section referred to as the
`Advisory Council') in carrying out this section.
``(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 the Center and the Advisory
Council. Such determinations shall be conducted in a manner
consistent with procedures established under section 492.
``(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 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 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
the Center; 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 the Center, and such ad-hoc or temporary members
as the Director of the Center determines to be appropriate.
All members of the Board, including temporary and ad-hoc
members, shall be voting members.
``(B) Limitation.--Not more than 3 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 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 individuals for such membership, the Director
of the Center 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
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 compensation at the same rate received
by members of 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 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;
[[Page H11309]]
``(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 under subsection (i) for a fiscal year up to
$50,000,000, the Director 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 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 739;
``(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 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 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 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
``(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 facility.
``(2) Reservation of amounts.--On the approval of any
application for a grant under subsection (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
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
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 research
purposes for which it was constructed (unless the Director
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 the date
of the enactment of this section, the Director of the Center,
after consultation with the Advisory Council, shall issue
guidelines with respect to grants under subsection (a).
``(h) Report to Congress.--The Director of the Center shall
prepare and submit to the appropriate committees of Congress
a biennial report concerning the status of the biomedical and
behavioral research facilities and the availability and
condition of technologically sophisticated laboratory
equipment in the United States. Such reports shall be
developed in concert with the report prepared by the National
Science Foundation on the needs of research facilities of
universities as required under section 108 of the National
Science Foundation Authorization Act for Fiscal Year 1986 (42
U.S.C. 1886).
``(i) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $250,000,000 for fiscal year 2001, and such sums
as may be necessary for each of the fiscal years 2002 and
2003.''.
SEC. 304. CONSTRUCTION PROGRAM FOR NATIONAL PRIMATE RESEARCH
CENTERS.
Section 481B(a) of the Public Health Service Act (42 U.S.C.
287a-3(a)) is amended by striking ``1994'' and all that
follows through ``$5,000,000'' and inserting ``2000 through
2002, reserve from the amounts appropriated under section
481A(i) such sums as necessary''.
SEC. 305. SHARED INSTRUMENTATION GRANT PROGRAM.
(a) Authorization of Appropriations.--There is authorized
to be appropriated $100,000,000 for fiscal year 2000, and
such sums as may be necessary for each subsequent fiscal
year, to enable the Secretary of Health and Human Services,
acting through the Director of the National Center for
Research Resources, to provide for the continued operation of
the Shared Instrumentation Grant Program (initiated in fiscal
year 1992 under the authority of section 479 of the Public
Health Service Act (42 U.S.C. 287 et seq.)).
(b) Requirements for Grants.--In determining whether to
award a grant to an applicant under the program described in
subsection (a), the Director of the National Center for
Research Resources 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.
(c) Peer Review.--In awarding grants under the program
described in subsection (a) Director of the National Center
for Research Resources shall comply with the peer review
requirements in section 492 of the Public Health Service Act
(42 U.S.C. 289a).
TITLE IV--CARDIAC ARREST SURVIVAL
Subtitle A--Recommendations for Federal Buildings
SEC. 401. SHORT TITLE.
This subtitle may be cited as the ``Cardiac Arrest Survival
Act of 2000''.
SEC. 402. FINDINGS.
Congress makes the following findings:
(1) Over 700 lives are lost every day to sudden cardiac
arrest in the United States alone.
(2) Two out of every three sudden cardiac deaths occur
before a victim can reach a hospital.
(3) More than 95 percent of these cardiac arrest victims
will die, many because of lack of readily available life
saving medical equipment.
(4) With current medical technology, up to 30 percent of
cardiac arrest victims could be saved if victims had access
to immediate medical response, including defibrillation and
cardiopulmonary resuscitation.
(5) Once a victim has suffered a cardiac arrest, every
minute that passes before returning the heart to a normal
rhythm decreases the chance of survival by 10 percent.
(6) Most cardiac arrests are caused by abnormal heart
rhythms called ventricular fibrillation. Ventricular
fibrillation occurs when the heart's electrical system
malfunctions, causing a chaotic rhythm that prevents the
heart from pumping oxygen to the victim's brain and body.
(7) Communities that have implemented programs ensuring
widespread public access to defibrillators, combined with
appropriate training, maintenance, and coordination with
local emergency medical systems, have dramatically improved
the survival rates from cardiac arrest.
(8) Automated external defibrillator devices have been
demonstrated to be safe and effective, even when used by lay
people, since the devices are designed not to allow a user to
administer a shock until after the device has analyzed a
victim's heart rhythm and determined that an electric shock
is required.
[[Page H11310]]
(9) Increasing public awareness regarding automated
external defibrillator devices and encouraging their use in
Federal buildings will greatly facilitate their adoption.
(10) Limiting the liability of Good Samaritans and
acquirers of automated external defibrillator devices in
emergency situations may encourage the use of automated
external defibrillator devices, and result in saved lives.
SEC. 403. RECOMMENDATIONS AND GUIDELINES OF SECRETARY OF
HEALTH AND HUMAN SERVICES REGARDING AUTOMATED
EXTERNAL DEFIBRILLATORS FOR FEDERAL BUILDINGS.
Part B of title II of the Public Health Service Act (42
U.S.C. 238 et seq.) is amended by adding at the end the
following:
``recommendations and guidelines regarding automated external
defibrillators for federal buildings
``Sec. 247. (a) Guidelines on Placement.--The Secretary
shall establish guidelines with respect to placing automated
external defibrillator devices in Federal buildings. Such
guidelines shall take into account the extent to which such
devices may be used by lay persons, the typical number of
employees and visitors in the buildings, the extent of the
need for security measures regarding the buildings, buildings
or portions of buildings in which there are special
circumstances such as high electrical voltage or extreme heat
or cold, and such other factors as the Secretary determines
to be appropriate.
``(b) Related Recommendations.--The Secretary shall publish
in the Federal Register the recommendations of the Secretary
on the appropriate implementation of the placement of
automated external defibrillator devices under subsection
(a), including procedures for the following:
``(1) Implementing appropriate training courses in the use
of such devices, including the role of cardiopulmonary
resuscitation.
``(2) Proper maintenance and testing of the devices.
``(3) Ensuring coordination with appropriate licensed
professionals in the oversight of training of the devices.
``(4) Ensuring coordination with local emergency medical
systems regarding the placement and incidents of use of the
devices.
``(c) Consultations; Consideration of Certain
Recommendations.--In carrying out this section, the Secretary
shall--
``(1) consult with appropriate public and private entities;
``(2) consider the recommendations of national and local
public-health organizations for improving the survival rates
of individuals who experience cardiac arrest in nonhospital
settings by minimizing the time elapsing between the onset of
cardiac arrest and the initial medical response, including
defibrillation as necessary; and
``(3) consult with and counsel other Federal agencies where
such devices are to be used.
``(d) Date Certain for Establishing Guidelines and
Recommendations.--The Secretary shall comply with this
section not later than 180 days after the date of the
enactment of the Cardiac Arrest Survival Act of 2000.
``(e) Definitions.--For purposes of this section:
``(1) The term `automated external defibrillator device'
has the meaning given such term in section 248.
``(2) The term `Federal building' includes a building or
portion of a building leased or rented by a Federal agency,
and includes buildings on military installations of the
United States.''.
SEC. 404. GOOD SAMARITAN PROTECTIONS REGARDING EMERGENCY USE
OF AUTOMATED EXTERNAL DEFIBRILLATORS.
Part B of title II of the Public Health Service Act, as
amended by section 403, is amended by adding at the end the
following:
``liability regarding emergency use of automated external
defibrillators
``Sec. 248. (a) Good Samaritan Protections Regarding
AEDs.--Except as provided in subsection (b), any person who
uses or attempts to use an automated external defibrillator
device on a victim of a perceived medical emergency is immune
from civil liability for any harm resulting from the use or
attempted use of such device; and in addition, any person who
acquired the device is immune from such liability, if the
harm was not due to the failure of such acquirer of the
device--
``(1) to notify local emergency response personnel or other
appropriate entities of the most recent placement of the
device within a reasonable period of time after the device
was placed;
``(2) to properly maintain and test the device; or
``(3) to provide appropriate training in the use of the
device to an employee or agent of the acquirer when the
employee or agent was the person who used the device on the
victim, except that such requirement of training does not
apply if--
``(A) the employee or agent was not an employee or agent
who would have been reasonably expected to use the device; or
``(B) the period of time elapsing between the engagement of
the person as an employee or agent and the occurrence of the
harm (or between the acquisition of the device and the
occurrence of the harm, in any case in which the device was
acquired after such engagement of the person) was not a
reasonably sufficient period in which to provide the
training.
``(b) Inapplicability of Immunity.--Immunity under
subsection (a) does not apply to a person if--
``(1) the harm involved was caused by willful or criminal
misconduct, gross negligence, reckless misconduct, or a
conscious, flagrant indifference to the rights or safety of
the victim who was harmed; or
``(2) the person is a licensed or certified health
professional who used the automated external defibrillator
device while acting within the scope of the license or
certification of the professional and within the scope of the
employment or agency of the professional; or
``(3) the person is a hospital, clinic, or other entity
whose purpose is providing health care directly to patients,
and the harm was caused by an employee or agent of the entity
who used the device while acting within the scope of the
employment or agency of the employee or agent; or
``(4) the person is an acquirer of the device who leased
the device to a health care entity (or who otherwise provided
the device to such entity for compensation without selling
the device to the entity), and the harm was caused by an
employee or agent of the entity who used the device while
acting within the scope of the employment or agency of the
employee or agent.
``(c) Rules of Construction.--
``(1) In general.--The following applies with respect to
this section:
``(A) This section does not establish any cause of action,
or require that an automated external defibrillator device be
placed at any building or other location.
``(B) With respect to a class of persons for which this
section provides immunity from civil liability, this section
supersedes the law of a State only to the extent that the
State has no statute or regulations that provide persons in
such class with immunity for civil liability arising from the
use by such persons of automated external defibrillator
devices in emergency situations (within the meaning of the
State law or regulation involved).
``(C) This section does not waive any protection from
liability for Federal officers or employees under--
``(i) section 224; or
``(ii) sections 1346(b), 2672, and 2679 of title 28, United
States Code, or under alternative benefits provided by the
United States where the availability of such benefits
precludes a remedy under section 1346(b) of title 28.
``(2) Civil actions under federal law.--
``(A) In general.--The applicability of subsections (a) and
(b) includes applicability to any action for civil liability
described in subsection (a) that arises under Federal law.
``(B) Federal areas adopting state law.--If a geographic
area is under Federal jurisdiction and is located within a
State but out of the jurisdiction of the State, and if,
pursuant to Federal law, the law of the State applies in such
area regarding matters for which there is no applicable
Federal law, then an action for civil liability described in
subsection (a) that in such area arises under the law of the
State is subject to subsections (a) through (c) in lieu of
any related State law that would apply in such area in the
absence of this subparagraph.
``(d) Federal Jurisdiction.--In any civil action arising
under State law, the courts of the State involved have
jurisdiction to apply the provisions of this section
exclusive of the jurisdiction of the courts of the United
States.
``(e) Definitions.--
``(1) Perceived medical emergency.--For purposes of this
section, the term `perceived medical emergency' means
circumstances in which the behavior of an individual leads a
reasonable person to believe that the individual is
experiencing a life-threatening medical condition that
requires an immediate medical response regarding the heart or
other cardiopulmonary functioning of the individual.
``(2) Other definitions.--For purposes of this section:
``(A) The term `automated external defibrillator device'
means a defibrillator device that--
``(i) is commercially distributed in accordance with the
Federal Food, Drug, and Cosmetic Act;
``(ii) is capable of recognizing the presence or absence of
ventricular fibrillation, and is capable of determining
without intervention by the user of the device whether
defibrillation should be performed;
``(iii) upon determining that defibrillation should be
performed, is able to deliver an electrical shock to an
individual; and
``(iv) in the case of a defibrillator device that may be
operated in either an automated or a manual mode, is set to
operate in the automated mode.
``(B)(i) The term `harm' includes physical, nonphysical,
economic, and noneconomic losses.
``(ii) The term `economic loss' means any pecuniary loss
resulting from harm (including the loss of earnings or other
benefits related to employment, medical expense loss,
replacement services loss, loss due to death, burial costs,
and loss of business or employment opportunities) to the
extent recovery for such loss is allowed under applicable
State law.
``(iii) The term `noneconomic losses' means losses for
physical and emotional pain, suffering, inconvenience,
physical impairment, mental anguish, disfigurement, loss of
enjoyment of life, loss of society and companionship, loss of
consortium (other than loss of domestic service), hedonic
damages, injury to reputation and all other nonpecuniary
losses of any kind or nature.''.
Subtitle B--Rural Access to Emergency Devices
SEC. 411. SHORT TITLE.
This subtitle may be cited as the ``Rural Access to
Emergency Devices Act'' or the ``Rural AED Act''.
SEC. 412. FINDINGS.
Congress makes the following findings:
(1) Heart disease is the leading cause of death in the
United States.
(2) The American Heart Association estimates that 250,000
Americans die from sudden cardiac arrest each year.
[[Page H11311]]
(3) A cardiac arrest victim's chance of survival drops 10
percent for every minute that passes before his or her heart
is returned to normal rhythm.
(4) Because most cardiac arrest victims are initially in
ventricular fibrillation, and the only treatment for
ventricular fibrillation is defibrillation, prompt access to
defibrillation to return the heart to normal rhythm is
essential.
(5) Lifesaving technology, the automated external
defibrillator, has been developed to allow trained lay
rescuers to respond to cardiac arrest by using this simple
device to shock the heart into normal rhythm.
(6) Those people who are likely to be first on the scene of
a cardiac arrest situation in many communities, particularly
smaller and rural communities, lack sufficient numbers of
automated external defibrillators to respond to cardiac
arrest in a timely manner.
(7) The American Heart Association estimates that more than
50,000 deaths could be prevented each year if defibrillators
were more widely available to designated responders.
(8) Legislation should be enacted to encourage greater
public access to automated external defibrillators in
communities across the United States.
SEC. 413. GRANTS.
(a) In General.--The Secretary of Health and Human
Services, acting through the Rural Health Outreach Office of
the Health Resources and Services Administration, shall award
grants to community partnerships that meet the requirements
of subsection (b) to enable such partnerships to purchase
equipment and provide training as provided for in subsection
(c).
(b) Community Partnerships.--A community partnership meets
the requirements of this subsection if such partnership--
(1) is composed of local emergency response entities such
as community training facilities, local emergency responders,
fire and rescue departments, police, community hospitals, and
local non-profit entities and for-profit entities concerned
about cardiac arrest survival rates;
(2) evaluates the local community emergency response times
to assess whether they meet the standards established by
national public health organizations such as the American
Heart Association and the American Red Cross; and
(3) submits to the Secretary of Health and Human Services
an application at such time, in such manner, and containing
such information as the Secretary may require.
(c) Use of Funds.--Amounts provided under a grant under
this section shall be used--
(1) to purchase automated external defibrillators that have
been approved, or cleared for marketing, by the Food and Drug
Administration; and
(2) to provide defibrillator and basic life support
training in automated external defibrillator usage through
the American Heart Association, the American Red Cross, or
other nationally recognized training courses.
(d) Report.--Not later than 4 years after the date of
enactment of this Act, the Secretary of Health and Human
Services shall prepare and submit to the appropriate
committees of Congress a report containing data relating to
whether the increased availability of defibrillators has
affected survival rates in the communities in which grantees
under this section operated. The procedures under which the
Secretary obtains data and prepares the report under this
subsection shall not impose an undue burden on program
participants under this section.
(e) Authorization of Appropriations.--There is authorized
to be appropriated $25,000,000 for fiscal years 2001 through
2003 to carry out this section.
TITLE V--LUPUS RESEARCH AND CARE
SEC. 501. SHORT TITLE.
This title may be cited as the ``Lupus Research and Care
Amendments of 2000''.
SEC. 502. FINDINGS.
The Congress finds that--
(1) lupus is a serious, complex, inflammatory, autoimmune
disease of particular concern to women;
(2) lupus affects women nine times more often than men;
(3) there are three main types of lupus: systemic lupus, a
serious form of the disease that affects many parts of the
body; discoid lupus, a form of the disease that affects
mainly the skin; and drug-induced lupus caused by certain
medications;
(4) lupus can be fatal if not detected and treated early;
(5) the disease can simultaneously affect various areas of
the body, such as the skin, joints, kidneys, and brain, and
can be difficult to diagnose because the symptoms of lupus
are similar to those of many other diseases;
(6) lupus disproportionately affects African-American
women, as the prevalence of the disease among such women is
three times the prevalence among white women, and an
estimated 1 in 250 African-American women between the ages of
15 and 65 develops the disease;
(7) it has been estimated that between 1,400,000 and
2,000,000 Americans have been diagnosed with the disease, and
that many more have undiagnosed cases;
(8) current treatments for the disease can be effective,
but may lead to damaging side effects;
(9) many victims of the disease suffer debilitating pain
and fatigue, making it difficult to maintain employment and
lead normal lives; and
(10) in fiscal year 1996, the amount allocated by the
National Institutes of Health for research on lupus was
$33,000,000, which is less than one-half of 1 percent of the
budget for such Institutes.
Subtitle A--Research on Lupus
SEC. 511. EXPANSION AND INTENSIFICATION OF ACTIVITIES.
Subpart 4 of part C of title IV of the Public Health
Service Act (42 U.S.C. 285d et seq.) is amended by inserting
after section 441 the following:
``lupus
``Sec. 441A. (a) In General.--The Director of the Institute
shall expand and intensify research and related activities of
the Institute with respect to lupus.
``(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 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 lupus.
``(c) Programs for Lupus.--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
find a cure for, lupus. Activities under such subsection
shall include conducting and supporting the following:
``(1) Research to determine the reasons underlying the
elevated prevalence of lupus in women, including African-
American women.
``(2) Basic research concerning the etiology and causes of
the disease.
``(3) Epidemiological studies to address the frequency and
natural history of the disease and the differences among the
sexes and among racial and ethnic groups with respect to the
disease.
``(4) The development of improved diagnostic techniques.
``(5) Clinical research for the development and evaluation
of new treatments, including new biological agents.
``(6) Information and education programs for health care
professionals and the public.
``(d) 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 of the
fiscal years 2001 through 2003.''.
Subtitle B--Delivery of Services Regarding Lupus
SEC. 521. ESTABLISHMENT OF PROGRAM OF GRANTS.
(a) In General.--The Secretary of Health and Human Services
shall in accordance with this subtitle make grants to provide
for projects for the establishment, operation, and
coordination of effective and cost-efficient systems for the
delivery of essential services to individuals with lupus and
their families.
(b) Recipients of Grants.--A grant under subsection (a) may
be made to an entity only if the entity is a public or
nonprofit private entity, which may include a State or local
government; a public or nonprofit private hospital,
community-based organization, hospice, ambulatory care
facility, community health center, migrant health center, or
homeless health center; or other appropriate public or
nonprofit private entity.
(c) Certain Activities.--To the extent practicable and
appropriate, the Secretary shall ensure that projects under
subsection (a) provide services for the diagnosis and disease
management of lupus. Activities that the Secretary may
authorize for such projects may also include the following:
(1) Delivering or enhancing outpatient, ambulatory, and
home-based health and support services, including case
management and comprehensive treatment services, for
individuals with lupus; and delivering or enhancing support
services for their families.
(2) Delivering or enhancing inpatient care management
services that prevent unnecessary hospitalization or that
expedite discharge, as medically appropriate, from inpatient
facilities of individuals with lupus.
(3) Improving the quality, availability, and organization
of health care and support services (including transportation
services, attendant care, homemaker services, day or respite
care, and providing counseling on financial assistance and
insurance) for individuals with lupus and support services
for their families.
(d) Integration With Other Programs.--To the extent
practicable and appropriate, the Secretary shall integrate
the program under this subtitle with other grant programs
carried out by the Secretary, including the program under
section 330 of the Public Health Service Act.
SEC. 522. CERTAIN REQUIREMENTS.
A grant may be made under section 521 only if the applicant
involved makes the following agreements:
(1) Not more than 5 percent of the grant will be used for
administration, accounting, reporting, and program oversight
functions.
(2) The grant will be used to supplement and not supplant
funds from other sources related to the treatment of lupus.
(3) The applicant will abide by any limitations deemed
appropriate by the Secretary on any charges to individuals
receiving services pursuant to the grant. As deemed
appropriate by the Secretary, such limitations on charges may
vary based on the financial circumstances of the individual
receiving services.
(4) The grant will not be expended to make payment for
services authorized under section 521(a) to the extent that
payment has been made, or can reasonably be expected to be
made, with respect to such services--
(A) under any State compensation program, under an
insurance policy, or under any Federal or State health
benefits program; or
(B) by an entity that provides health services on a prepaid
basis.
(5) The applicant will, at each site at which the applicant
provides services under section 521(a), post a conspicuous
notice informing individuals who receive the services of any
Federal policies that apply to the applicant with respect to
the imposition of charges on such individuals.
[[Page H11312]]
SEC. 523. TECHNICAL ASSISTANCE.
The Secretary may provide technical assistance to assist
entities in complying with the requirements of this subtitle
in order to make such entities eligible to receive grants
under section 521.
SEC. 524. DEFINITIONS.
For purposes of this subtitle:
(1) Official poverty line.--The term ``official poverty
line'' means the poverty line established by the Director of
the Office of Management and Budget and revised by the
Secretary in accordance with section 673(2) of the Omnibus
Budget Reconciliation Act of 1981.
(2) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
SEC. 525. AUTHORIZATION OF APPROPRIATIONS.
For the purpose of carrying out this subtitle, there are
authorized to be appropriated such sums as may be necessary
for each of the fiscal years 2001 through 2003.
TITLE VI--PROSTATE CANCER RESEARCH AND PREVENTION
SEC. 601. SHORT TITLE.
This title may be cited as the ``Prostate Cancer Research
and Prevention Act''.
SEC. 602. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.
(a) Preventive Health Measures.--Section 317D of the Public
Health Service Act (42 U.S.C. 247b-5) is amended--
(1) by striking subsection (a) and inserting the following:
``(a) In General.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention,
may make grants to States and local health departments for
the purpose of enabling such States and departments to carry
out programs that may include the following:
``(1) To identify factors that influence the attitudes or
levels of awareness of men and health care practitioners
regarding screening for prostate cancer.
``(2) To evaluate, in consultation with the Agency for
Health Care Policy and Research and the National Institutes
of Health, the effectiveness of screening strategies for
prostate cancer.
``(3) To identify, in consultation with the Agency for
Health Care Policy and Research, issues related to the
quality of life for men after prostrate cancer screening and
followup.
``(4) To develop and disseminate public information and
education programs for prostate cancer, including appropriate
messages about the risks and benefits of prostate cancer
screening for the general public, health care providers,
policy makers and other appropriate individuals.
``(5) To improve surveillance for prostate cancer.
``(6) To address the needs of underserved and minority
populations regarding prostate cancer.
``(7) Upon a determination by the Secretary, who shall take
into consideration recommendations by the United States
Preventive Services Task Force and shall seek input, where
appropriate, from professional societies and other private
and public entities, that there is sufficient consensus on
the effectiveness of prostate cancer screening--
``(A) to screen men for prostate cancer as a preventive
health measure;
``(B) to provide appropriate referrals for the medical
treatment of men who have been screened under subparagraph
(A) and to ensure, to the extent practicable, the provision
of appropriate followup services and support services such as
case management;
``(C) to establish mechanisms through which State and local
health departments can monitor the quality of screening
procedures for prostate cancer, including the interpretation
of such procedures; and
``(D) to improve, in consultation with the Health Resources
and Services Administration, the education, training, and
skills of health practitioners (including appropriate allied
health professionals) in the detection and control of
prostate cancer.
``(8) To evaluate activities conducted under paragraphs (1)
through (7) through appropriate surveillance or program
monitoring activities.''; and
(2) in subsection (l)(1), by striking ``1998'' and
inserting ``2004''.
(b) National Institutes of Health.--Section 417B(c) of the
Public Health Service Act (42 U.S.C. 286a-8(c)) is amended by
striking ``and 1996'' and inserting ``through 2004''.
TITLE VII--ORGAN PROCUREMENT AND DONATION
SEC. 701. ORGAN PROCUREMENT ORGANIZATION CERTIFICATION.
(a) Short Title.--This section may be cited as the ``Organ
Procurement Organization Certification Act of 2000''.
(b) Findings.--Congress makes the following findings:
(1) Organ procurement organizations play an important role
in the effort to increase organ donation in the United
States.
(2) The current process for the certification and
recertification of organ procurement organizations conducted
by the Department of Health and Human Services has created a
level of uncertainty that is interfering with the
effectiveness of organ procurement organizations in raising
the level of organ donation.
(3) The General Accounting Office, the Institute of
Medicine, and the Harvard School of Public Health have
identified substantial limitations in the organ procurement
organization certification and recertification process and
have recommended changes in that process.
(4) The limitations in the recertification process include:
(A) An exclusive reliance on population-based measures of
performance that do not account for the potential in the
population for organ donation and do not permit consideration
of other outcome and process standards that would more
accurately reflect the relative capability and performance of
each organ procurement organization.
(B) A lack of due process to appeal to the Secretary of
Health and Human Services for recertification on either
substantive or procedural grounds.
(5) The Secretary of Health and Human Services has the
authority under section 1138(b)(1)(A)(i) of the Social
Security Act (42 U.S.C. 1320b-8(b)(1)(A)(i)) to extend the
period for recertification of an organ procurement
organization from 2 to 4 years on the basis of its past
practices in order to avoid the inappropriate disruption of
the nation's organ system.
(6) The Secretary of Health and Human Services can use the
extended period described in paragraph (5) for
recertification of all organ procurement organizations to--
(A) develop improved performance measures that would
reflect organ donor potential and interim outcomes, and to
test these measures to ensure that they accurately measure
performance differences among the organ procurement
organizations; and
(B) improve the overall certification process by
incorporating process as well as outcome performance
measures, and developing equitable processes for appeals.
(c) Certification and Recertification of Organ Procurement
Organizations.--Section 371(b)(1) of the Public Health
Service Act (42 U.S.C. 273(b)(1)) is amended--
(1) by redesignating subparagraphs (D) through (G) as
subparagraphs (E) through (H), respectively;
(2) by realigning the margin of subparagraph (F) (as so
redesignated) so as to align with subparagraph (E) (as so
redesignated); and
(3) by inserting after subparagraph (C) the following:
``(D) notwithstanding any other provision of law, has met
the other requirements of this section and has been certified
or recertified by the Secretary within the previous 4-year
period as meeting the performance standards to be a qualified
organ procurement organization through a process that
either--
``(i) granted certification or recertification within such
4-year period with such certification or recertification in
effect as of January 1, 2000, and remaining in effect through
the earlier of--
``(I) January 1, 2002; or
``(II) the completion of recertification under the
requirements of clause (ii); or
``(ii) is defined through regulations that are promulgated
by the Secretary by not later than January 1, 2002, that--
``(I) require recertifications of qualified organ
procurement organizations not more frequently than once every
4 years;
``(II) rely on outcome and process performance measures
that are based on empirical evidence, obtained through
reasonable efforts, of organ donor potential and other
related factors in each service area of qualified organ
procurement organizations;
``(III) use multiple outcome measures as part of the
certification process; and
``(IV) provide for a qualified organ procurement
organization to appeal a decertification to the Secretary on
substantive and procedural grounds;''.
SEC. 702. DESIGNATION OF GIVE THANKS, GIVE LIFE DAY.
(a) Findings.--Congress finds that--
(1) traditionally, Thanksgiving is a time for families to
take time out of their busy lives to come together and to
give thanks for the many blessings in their lives;
(2) approximately 21,000 men, women, and children in the
United States are given the gift of life each year through
transplantation surgery, made possible by the generosity of
organ and tissue donations;
(3) more than 66,000 Americans are awaiting their chance to
prolong their lives by finding a matching donor;
(4) nearly 5,000 of these patients each year (or 13
patients each day) die while waiting for a donated heart,
liver, kidney, or other organ;
(5) nationwide there are up to 15,000 potential donors
annually, but families' consent to donation is received for
less than 6,000;
(6) the need for organ donations greatly exceeds the supply
available;
(7) designation as an organ donor on a driver's license or
voter's registration is a valuable step, but does not ensure
donation when an occasion arises;
(8) the demand for transplantation will likely increase in
the coming years due to the growing safety of transplantation
surgery due to improvements in technology and drug
developments, prolonged life expectancy, and increased
prevalence of diseases that may lead to organ damage and
failure, including hypertension, alcoholism, and hepatitis C
infection;
(9) the need for a more diverse donor pool, including a
variety of racial and ethnic minorities, will continue to
grow in the coming years;
(10) the final decision on whether a potential donor can
share the gift of life usually is made by surviving family
members regardless of the patient's initial intent;
(11) many Americans have indicated a willingness to donate
their organs and tissues but have not discussed this critical
matter with the family members who are most likely to make
the decision, if the occasion arises, as to whether that
person will be an organ and tissue donor;
(12) some family members may be reluctant to give consent
to donate their deceased loved one's organs and tissues at a
very difficult and emotional time if that person has not
clearly expressed a desire or willingness to do so;
(13) the vast majority of Americans are likely to spend
part of Thanksgiving Day with some of
[[Page H11313]]
those family members who would be approached to make such a
decision; and
(14) it is fitting for families to spend a portion of that
day discussing how they might give life to others on a day
devoted to giving thanks for their own blessings.
(b) Designation.--November 23, 2000, Thanksgiving Day, is
hereby designated as a day to ``Give Thanks, Give Life'' and
to discuss organ and tissue donation with other family
members so that informed decisions can be made if the
occasion to donate arises.
TITLE VIII--ALZHEIMER'S CLINICAL RESEARCH AND TRAINING
SEC. 801. ALZHEIMER'S CLINICAL RESEARCH AND TRAINING AWARDS.
Subpart 5 of part C of title IV of the Public Health
Service Act (42 U.S.C. 285e et seq.) is amended--
(1) by redesignating section 445I as section 445J; and
(2) by inserting after section 445H the following:
``SEC. 445I. ALZHEIMER'S CLINICAL RESEARCH AND TRAINING
AWARDS.
``(a) In General.--The Director of the Institute is
authorized to establish and maintain a program to enhance and
promote the translation of new scientific knowledge into
clinical practice related to the diagnosis, care and
treatment of individuals with Alzheimer's disease.
``(b) Support of Promising Clinicians.--In order to foster
the application of the most current developments in the
etiology, pathogenesis, diagnosis, prevention and treatment
of Alzheimer's disease, amounts made available under this
section shall be directed to the support of promising
clinicians through awards for research, study, and practice
at centers of excellence in Alzheimer's disease research and
treatment.
``(c) Excellence in Certain Fields.--Research shall be
carried out under awards made under subsection (b) in
environments of demonstrated excellence in neuroscience,
neurobiology, geriatric medicine, and psychiatry and shall
foster innovation and integration of such disciplines or
other environments determined suitable by the Director of the
Institute.
``(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $2,250,000 for fiscal year 2001, and such sums
as may be necessary for each of fiscal years 2002 through
2005.''.
TITLE IX--SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH AND TRAINING
SEC. 901. SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH AND
TRAINING AWARDS.
Subpart 6 of part C of title IV of the Public Health
Service Act (42 U.S.C. 285f et seq.) is amended by adding at
the end the following:
``SEC. 447B. SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH
AND TRAINING AWARDS.
``(a) In General.--The Director of the Institute is
authorized to establish and maintain a program to enhance and
promote the translation of new scientific knowledge into
clinical practice related to the diagnosis, care and
treatment of individuals with sexually transmitted diseases.
``(b) Support of Promising Clinicians.--In order to foster
the application of the most current developments in the
etiology, pathogenesis, diagnosis, prevention and treatment
of sexually transmitted diseases, amounts made available
under this section shall be directed to the support of
promising clinicians through awards for research, study, and
practice at centers of excellence in sexually transmitted
disease research and treatment.
``(c) Excellence in Certain Fields.--Research shall be
carried out under awards made under subsection (b) in
environments of demonstrated excellence in the etiology and
pathogenesis of sexually transmitted diseases and shall
foster innovation and integration of such disciplines or
other environments determined suitable by the Director of the
Institute.
``(d) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated $2,250,000 for fiscal year 2001, and such sums
as may be necessary for each of fiscal years 2002 through
2005.''.
TITLE X--MISCELLANEOUS PROVISION
SEC. 1001. TECHNICAL CORRECTION TO THE CHILDREN'S HEALTH ACT
OF 2000.
(a) In General.--Section 2701 of the Children's Health Act
of 2000 is amended by striking ``part 45 of title 46'' and
inserting ``part 46 of title 45''.
(b) Effective Date.--The amendment made by subsection (a)
takes effect on the date of enactment of the Children's
Health Act of 2000.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Florida (Mr. Bilirakis) and the gentleman from Ohio (Mr. Brown) each
will control 20 minutes.
The Chair recognizes the gentleman from Florida (Mr. Bilirakis).
General Leave
Mr. BILIRAKIS. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days within which to revise and extend their
remarks and to insert extraneous material on H.R. 2498.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Florida?
There was no objection.
Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I rise today in strong support of H.R. 2498, and I urge
my colleagues to join me in voting to approve this very critical
legislation.
The bill before us today is comprised of a number of bipartisan,
noncontroversial public health measures. It includes key provisions to
respond to emerging health threats, save victims of cardiac arrest,
promote clinical research, improve our research infrastructure, and
fight prostate cancer and lupus.
I would like to highlight a few of these provisions. First, H.R. 2498
includes the provisions of the 21st Century Research Laboratories Act,
legislation which I introduced earlier this year. There is no doubt
that America is the worldwide leader in medical research, both at the
National Institutes of Health and at our research facilities throughout
the Nation. However, while Congress has worked successfully to increase
funding for medical research, monies for building construction and
renovation have lagged.
Mr. Speaker, my legislation responds to this problem by authorizing
the director of the National Center for Research Resources at the NIH
to make grants or enter into contracts to expand or renovate existing
research facilities and construct new research facilities. It also
authorizes grants for the purchase of state-of-the-art laboratory
instrumentation.
In addition, H.R. 2498 includes the provisions of the Lupus Research
Act, which was originally introduced by the gentlewoman from Florida
(Mrs. Meek). She has been a tireless advocate for this proposal, and it
was overwhelmingly approved by the House earlier this month.
Today, over 1.4 million Americans have lupus, a devastating disease
that causes the immune system to attack the body's own cells and
organs. Ninety percent of the victims of lupus are women, and the
disease is more common among women of color. By the time some lupus
patients are diagnosed, especially in poor or rural communities,
irreversible damage to vital organs has already occurred.
The bill before us expands Federal lupus research activities through
the NIH, and it authorizes the Secretary of Health and Human Services
to make project grants for the delivery of essential services. These
projects will help identify innovative ways to respond to this terrible
disease.
H.R. 2498, Mr. Speaker, also includes the provisions of the Cardiac
Arrest Survival Act, which was authored by the gentleman from Florida
(Mr. Stearns). I want to truly commend him for his leadership in
advancing this initiative, which passed the House in May with strong
support.
Each year, a quarter million Americans die due to cardiac arrest.
Many of these victims could be saved if portable medical devices called
automated external defibrillators, or AEDs, were used. AEDs can analyze
heart rhythms for abnormalities, and if warranted, deliver a life-
saving shock to the heart. An estimated 20,000 to 100,000 lives could
be saved annually by greater access to AEDs.
H.R. 2498 directs the Secretary of Health and Human Services to issue
regulations to provide for the placement of AEDs in Federal buildings.
The bill also establishes protections from civil liability arising from
the emergency use of these devices.
Mr. Speaker, the proposals incorporated in this legislative package
will literally save lives, and I am grateful to the many Members of
both sides of the aisle who worked so hard to advance this cause.
In that regard, I want to thank the gentleman from Virginia (Mr.
Bliley), chairman of the Committee on Commerce, the gentleman from
Michigan (Mr. Dingell), ranking member, and in particular the gentleman
from Ohio (Mr. Brown), a ranking member of the Subcommittee on Health
and Environment.
I also want to recognize and thank the gentleman from Pennsylvania
(Mr. Greenwood) and the gentleman from North Carolina (Mr. Burr) for
their contributions to this legislation.
The bill before us is a critical public health measure worthy of
bipartisan support. I urge every Member to support H.R. 2498.
Mr. Speaker, I reserve the balance of my time.
Mr. BROWN of Ohio. Mr. Speaker I yield myself such time as I may
consume.
[[Page H11314]]
Mr. Speaker, in 1906, Upton Sinclair wrote a book called ``The
Jungle,'' documenting problems in the unsafe working conditions and
unsafe food production in the Chicago slaughterhouses.
In the year 1906, when Upton Sinclair's book was published, which
resulted later in the creation soon after of the Food and Drug
Administration, which has guaranteed food safety in this country for 9
decades, in that year in 1906, a boy born that year had a life
expectancy of 46 years. A girl born in 1906 had a life expectancy of 48
years.
Nine-plus decades later, life expectancy in this country has been
lengthened 30 years. Boys and girls born in this country have 30 years
more life expectancy than they did just a century ago.
That is not mostly from high-tech medicine. It is mostly from public
health, everything from pure food to safe drinking water, from
immunizations to antibiotics, from seat belts to a knowledge that
alcohol and tobacco cause health problems, to issue after issue after
issue of pure food laws and environmental laws and public health laws
and worker safety laws and all the things that we in this body and in
State legislatures across the country and in public health agencies
across the country have done to together to enhance public health.
That is why it is a pleasure, from my perspective, a pleasure to
support this bill, to be a cosponsor of this bill, and support the
gentleman from Florida (Mr. Bilirakis) in his efforts to promote public
health, which does make such a difference in the lives of every
American.
This legislation includes the 21st Century Research Laboratories Act,
a bill that I joined the gentleman from Florida (Mr. Bilirakis) in
sponsoring. I also want to commend Senator Harkin for his leadership on
this bill.
The U.S. invests generously in medical research through the National
Institutes of Health, reflecting the public's strong interest in
reducing the burden of disease here and abroad. But to secure the most
benefit of that investment, it makes sense to couple dollars for
research grants with funding to bolster the Nation's research
infrastructure. The two go hand in hand.
Our bill would put that principle into practice by enabling NIH to
devote additional resources to state-of-the-art research laboratories
and instrumentations.
Like laboratory research, clinical research is invaluable. It is a
bridge between the laboratory and new methods of diagnosis, treatment,
and prevention. Despite the benefits of clinical research, the current
level of training and support for health professionals in clinical
research is too often inadequate to the task.
I am pleased to be an original cosponsor of the bill that is now
incorporated into this bill from the gentleman from Pennsylvania (Mr.
Greenwood) that supports and expands NIH involvement in clinical
research and increases resources available for the clinical research
community.
This package of bills also contains legislation put forward by
Senators Frist and Kennedy and my colleagues on the Committee on
Commerce and the Subcommittee on Health and Environment, the gentleman
from North Carolina (Mr. Burr) and the gentleman from Michigan (Mr.
Stupak), on public health threats and emergencies.
Our Nation faces grave new threats in the 21st century that imperil
the extraordinary progress we have made on public health in the 20th
century.
New or resurgent infectious diseases, West Nile virus, lyme disease
and others are on the upswing. Microbes that cause infectious diseases
are evolving to become resistant, resisting antibiotics so that
formerly treatable infections, such as TB, as I mentioned in an earlier
talk tonight, may become incurable.
We are also vulnerable to terrorist attacks using biological weapons
that could spread deadly diseases, such as small pox or anthrax.
This title authorizes steps that are widely agreed to be essential to
prepare for emerging threats to public health.
I am particularly pleased the bill authorizes perhaps its most
important feature, funding to revitalize Centers for Disease Control
facilities. The gentleman from Florida (Mr. Bilirakis) and I saw the
absolute amazingly poor conditions under which employees of the CDC,
some of the greatest scientists and public health experts in the
country, the conditions under which they labor in Atlanta. We can do so
much better than that.
The provisions on combatting antimicrobial resistance are a good step
towards addressing one of the most serious threats to public health
that we face. They lay the groundwork for addressing the misuse and
overuse of antibiotics, both in human medicine and in the agriculture
sector.
I would add that this Congress went on record a couple of months ago
in support of an amendment I had to direct the FDA's veterinary
medicine office to get more serious about antibiotic resistance in farm
animals. Fifty percent of the antibiotics used in this country are used
for nonmedicinal purposes in farm animals, something that we probably
cannot afford to do as a Nation much longer.
{time} 2015
I am also pleased this package includes important public health
initiatives that would help the Nation combat diseases that take a
tremendous toll on patients and their families, including lupus,
prostate cancer, and Alzheimer's, as well as measures promoting access
to defibrillators, an issue the gentleman from Wisconsin (Mr. Kind) has
worked hard on, in Federal buildings and rural communities to aid
victims of sudden heart attacks.
Prostate cancer is the most commonly diagnosed form of cancer, other
than skin cancer, and second only to lung cancer as a cause of cancer-
related death among men. This bill recognizes the immense toll that
prostate cancer has taken on our country. I commend my colleague, the
gentlewoman from Florida (Mrs. Meek), for her endless dedication to
raising awareness about lupus. Her tireless work has made a difference
in this bill's efforts to treat lupus.
The American Heart Association estimates that more than 50,000
American deaths a year could be prevented if defibrillators were
available to designated responders. Nothing can be more frightening
than watching someone suffer a heart attack. With proper use of a
defibrillator and proper training, communities can respond quickly and
effectively to a victim and improve that victim's chances of survival
immensely.
Like so many of these illnesses we have discussed today, Alzheimer's
is a complicated disease afflicted by more questions than answers.
Alzheimer's is characteristically more difficult for the family to
bear; a person's slow deterioration in health begins with common
forgetfulness and progresses slowly until the family is faced with no
choice but to move their loved one to another facility. I commend my
colleagues, the gentleman from New Jersey (Mr. Smith) and the gentleman
from Massachusetts (Mr. Markey), for their leadership on this measure.
Overall, Mr. Speaker, I again thank the gentleman from Florida (Mr.
Bilirakis) because this bipartisan legislation covers a lot of
important ground. It bolsters public health, something this body has
not done nearly enough of in the past, an infrastructure that has been
neglected for too many years, the public health infrastructure; it
invests in the fight against lupus, Alzheimer's and other traumatic
health care conditions; it brings attention to the life-saving
potential of portable defibrillators and the invaluable gift of organ
donation.
This bill reflects the breadth and complexity of health and health
care in the U.S., and it sets in motion practical steps to improve
both. In my mind, this may be the most important health issue this
Congress has passed. It does so much for so many in this country.
I wish this body would get as serious about dealing with the
prescription drug issue and dealing with the Patients' Bill of Rights
as it has this issue, but I particularly extend my thanks to the
gentleman from Florida (Mr. Bilirakis), to the gentleman from Virginia
(Mr. Bliley), to the gentleman from Michigan (Mr. Dingell), and all who
have played a major role in this bill.
Mr. Speaker, I reserve the balance of my time.
Mr. BILIRAKIS. Mr. Speaker, I yield 6 minutes to the gentleman from
Florida (Mr. Stearns), a gentleman about
[[Page H11315]]
whom people many not now know this, but people in the future will be
indebted to him for his persistence and his perseverance in offering
and sticking with this defibrillator legislation.
Mr. STEARNS. Mr. Speaker, I thank the chairman of the Subcommittee on
Health and Environment of the Committee on Commerce for yielding me
this time.
I think this is a very, very rewarding evening, to have had the
Senate pass the original 2498, which was the Cardiac Arrest Survival
Act of 2000, which now has been amended to include different sections
of what we have tonight and is now called the Public Health Improvement
Act of 2000.
My portion of the bill, which is section 4, is something I am very
proud of because, Mr. Speaker, between 200,000 to 300,000 Americans are
lost every year to sudden cardiac arrest in the United States. Many of
these victims could be simply saved if they had access to immediate
medical response, including defibrillation. Just today, Mr. Speaker,
the New England Journal of Medicine released the results of two recent
studies in which nearly half of the victims of cardiac arrest were
saved with the help of an automatic external defibrillator. That
represents 10 times the usual survival rate of 5 percent for people who
suffer cardiac arrest in a nonhospital setting.
For the last several years, I have been working closely with the
American Heart Association, the American Red Cross, and local emergency
medical systems to develop bipartisan support to encourage the
widespread use of automatic external defibrillator devices to help save
lives. These devices, AEDs, are small portable medical devices. They
are regulated by the Food and Drug Administration and can measure a
victim's heart rate, determine whether the victim is suffering from
ventricular fibrillation and, if electric shock is necessary, can
instruct the lay user how to use it and when to use it to shock the
victim, and even tell them when to use CPR. So these devices are safe,
effective and do not allow a shock to be administered until after the
device has measured the victim's heart and determined whether a shock
is really required.
Do my colleagues know that for every minute of delay in returning the
heart to its normal pattern of beating it decreases the chance of that
person's survival by 10 percent? And let me tell my colleagues tonight,
because we all feel, probably, that we are in good health, that Robert
Adams felt he was in good health. He was 42 years old and was an
attorney working in Manhattan. On the weekends he was an NCAA referee.
Obviously, he was in great condition. He had recently passed several
extensive physical exams with flying colors; yet he suffered sudden
cardiac arrest on July 3rd, a weekend, in Grand Central Station in New
York City.
Fortunately, by the grace of God, the station had just received
delivery of an AED the day before. A couple of nearby construction
workers saw Mr. Adams fall to the ground. They grabbed the AED, which
was still in its package. They prayed and hoped that the batteries were
installed and charged. And, sure enough, they were. They shocked Mr.
Adams back to life.
Now, Mr. Speaker, unfortunately, AEDs are not being widely employed
because of the perception among would-be purchasers and users of these
devices that if they do use them they are going to be sued. Our
legislation removes this barrier to adopting AED programs with a Good
Samaritan clause. If a Good Samaritan or building owner or renter acts
in good faith to purchase or use an AED to help save someone's life,
this bill will protect them from unfair lawsuits. We may not want to
force people to provide medical care to someone having a heart attack;
but if they are willing to do so, if they are volunteers, we should not
put them at risk of being sued for unlimited damages if something went
wrong.
So this legislation also directs the Secretary of Health and Human
Services to develop guidelines for the placement of defibrillators in
Federal buildings. It is a moment in our history when we have to have
these accessible throughout all the Federal and State and local
buildings. It is inexcusable that we do not have these life-saving
devices widely available today. We need to be a role model for the
private sector by demonstrating our commitment to protecting the lives
of our Federal employees.
H.R. 2498 does not impose any new regulations or obligations on the
private sector, and it does not preempt State law where the State has
provided immunity for the person being sued. My colleagues, let us help
save 250,000 American lives who are lost annually to sudden cardiac
arrest. It could be any one of us on any day in the 365 days. The
Senate passed this bill, as I mentioned, earlier today; and I urge my
colleagues to support and pass this bill.
Lastly, Mr. Speaker, it has been a long journey for all of us to get
this bill passed through Congress. I want to thank the chairman, the
gentleman from Florida (Mr. Bilirakis), for his support and
encouragement all during this process and for the work he and his staff
do; and also the gentleman from Virginia (Mr. Bliley) for his help in
moving this legislation to where we are tonight.
I also want to thank those who have worked so hard on the bill,
including my staff, Veronica Crowe; as well as the folks on the
Committee on Commerce, Marc Wheat, Robert Gordon, and Brent Delmonte;
and Pete Goodloe, who was legislative counsel; and, of course, Mr.
Speaker, the American Heart Association and the American Red Cross.
This is a red letter day, and I think all Americans will benefit. I
urge the passage of this valuable legislation.
Mr. BROWN of Ohio. Mr. Speaker, I yield such time as he may consume
to the gentleman from Wisconsin (Mr. Kind), who has helped to lead the
charge in support of the defibrillator part of this legislation.
Mr. KIND. Mr. Speaker, I thank my friend from Ohio for yielding me
this time, and I too want to rise in support of H.R. 2498, and I want
to commend the chairman, the gentleman from Virginia (Mr. Bliley), the
ranking member, the gentleman from Michigan (Mr. Dingell), the chairman
and ranking member on the subcommittee, and the bipartisan support that
this legislation received and the work product that went into it from
the Committee on Commerce.
Obviously, this was a work in progress with a lot of input from a lot
of areas, and it is nice to be on the floor here tonight with a true
bipartisan form of health care legislation. I think many Americans will
reap dividends throughout our country in future years.
I am happy to support the bill not only because placing automatic
external defibrillators, AEDs for short, in Federal buildings will help
save lives for those who live in urban areas, as the gentleman from
Florida (Mr. Stearns) has just pointed out, and I also commend him for
the work and the leadership he has provided in recognizing the
importance to have access to AEDs for more Americans, but also because
this bill includes the language of H.R. 4953, the Rural Access to
Emergency Devices Act, which I along with the gentleman from Georgia
(Mr. Deal) introduced earlier this year.
In my home State of Wisconsin, nearly 200,000 people are afflicted
with heart disease. It is the number one killer throughout the State,
the number one killer in every county throughout the State, taking the
lives of nearly 20,000 Wisconsonites every year. New technology, such
as AEDs, can improve survival rates, but only if the devices are
accessible and available.
Unfortunately, in rural areas, the availability of AEDs is limited.
Hospitals are often located far from the scene of an emergency, and
fewer than half of all ambulances in the United States actually carry
AEDs. By giving grants to emergency responders and community
partnerships to purchase AEDs and to train people on how to administer
CPR, citizens in rural areas especially will benefit and will have a
better chance of surviving cardiac arrest.
In western Wisconsin, we have seen the benefits of AED access
already. Thanks to Scott Wuerch, an American Heart Association
volunteer, all Eau Claire County sheriffs are now trained to use and
are equipped with AEDs, and it is my hope that with passage of this
bill that citizens in rural America will have a better chance of
surviving cardiac arrest.
The gentleman from Florida (Mr. Stearns) already indicated the
article
[[Page H11316]]
that appeared in the New England Journal of Medicine, the two studies
showing the benefits in the use of AEDs. Most of the major newspaper
publications this week have been printing stories in regard to the
effectiveness of AEDs and the need to increase access for it. In fact,
this week I hope a lot of my colleagues were able to capture the
article in USA Today on Wednesday titled ``The Prescription to Save
Lives.'' It provides a condensed, but very good, account of the
important role that AEDs are now performing throughout America and
increased access to it, but also the work that needs to be done.
The gentleman from Florida already indicated that during cardiac
arrest every minute of failed treatment results in a 10 percent less
chance of survival. Ten minutes usually results in fatality. But what
this article also pointed out was how simple the training of AEDs can
be. In fact, after a few short minutes, even children can be trained to
use it. Most of these devices now have computerized voices that
actually walk the people through on how to effectively use AEDs. In
fact, recent studies show that 50 percent of even untrained people can
successfully use AEDs in emergency situations.
So I think the evidence, the studies that have come out now, also the
support that we are seeing here tonight on the floor, is indication
enough of just how important this legislation is and being able to
provide access to automatic external defibrillators for more people in
the country, but especially in rural areas, Mr. Speaker.
So again I commend the leadership on the committee. I commend the
gentleman from Georgia (Mr. Deal) for introducing the rural access bill
earlier this year, and I would encourage all my colleagues to support
this good bipartisan piece of health care legislation before us.
Mr. BROWN of Ohio. Mr. Speaker, I have no further requests for time,
and I yield back the balance of my time.
Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I wish to add my gratitude to the many staff members on
the Committee on Commerce, particularly for their hard work on this
legislation; as well as people on our personal staffs, Anne Esposito of
my personal staff and others who have helped out.
Mr. DINGELL. Mr. Speaker, I rise in support of H.R. 2498, the Public
Health Improvement Act. This is an excellent package of public health
measures, and I am pleased to see this Congress act on this legislation
before it adjourns. H.R. 2498 contains several broadly supported, non-
controversial provisions that amend the Public Health Service Act.
Title I, ``Emerging Threats to Public Health,'' is of particular
interest to my colleague from Michigan, Mr. Stupak. This provision
strengthens America's capacity to detect and respond to serious public
health threats and emergencies through several initiatives. On a local
level, public health departments and agencies will be provided the
resources to update their laboratory and electronic communication
equipment, readying them to combat an infectious disease outbreak. They
will also be able to engage in planning rapid response strategies and
train personnel. On a national level, the often antiquated facilities
at the Centers for Disease Control and Prevention--our nation's first
line of defense against biological threats--will be revitalized to meet
the demands of the 21st century. This legislation also authorizes
activities to combat antimicrobial resistance and protect the nation
from bioterrorist attacks, both of which are issues of long-standing
interest to my colleague Mr. Brown of Ohio. The World Health
Organization, and more recently the CIA's National Intelligence Council
have named resistant infections and bioterrorism as major threats to
global security. This provision will put the public health
infrastructure of the United States in the best defensive position,
should such an outbreak occur.
Title II, ``Clinical Research Enhancement,'' directs NIH to expand
the nation's clinical research capacity in response to a documented
need for such activities. Clinical research translates basic science
discoveries into medical interventions that can be used for patient
care. This provision strengthens America's clinical research
infrastructure by expanding facilities and faculty of the NIH-supported
General Clinical Research Centers. It also sets forth three career
investigator grant award programs, and provides a loan repayment option
for young investigators wishing to dedicate their careers to clinical
research. This provision endorses no specific clinical research agendas
or priorities; rather, it facilitates a breadth of activities that can
be carried out by a variety of scientists and health professionals,
including qualified social science researchers and nurses. A separate
provision in H.R. 2498 authorizes specific clinical research and
training award programs in Alzheimer's disease. We are grateful to our
colleague, Mr. Markey, for his work on this matter.
While a number of provisions in this bill respond to the research and
treatment needs of our nation, advances in these areas are often
hampered by the facilities in which the activities occur. Title III,
known as the ``Twenty-First Century Research Laboratories Act,''
authorizes funds for construction and modernization of our nation's
biomedical and behavioral research laboratories and facilities,
including the purchase of new laboratory equipment.
Title IV of this bill, the ``Cardiac Arrest Survival Act'' passed the
House on May 23rd. This provision directs the Secretary to develop
guidelines for the placement of automated external defibrillators in
Federal buildings. It also promotes public and health professional
education in cardiopulmonary resuscitation and the use of
defibrillators in order to save the lives. I commend my colleague from
California, Ms. Capps, for managing this bill when the House passed it
earlier this year. I also commend my colleague from Wisconsin, Mr.
Kind, for shepherding through a related provision providing access to
defibrillators and emergency devises to residents of rural areas.
Title V is based on the H.R. 762, the ``Lupus Research and Care
Amendments,'' introduced by my colleague from Florida, Mrs. Meek. Lupus
is a debilitating and sometimes fatal autoimmune disease that
disproportionately afflicts women, particularly women of color. This
title addresses research on this disease and it authorizes
appropriations to expand and intensify activities that focus on earlier
diagnosis, better treatment, and an eventual cure. Significantly, a
companion section of the provision addresses on-going primary care and
treatment needs of poor and uninsured individuals with this expensive-
to-treat and debilitating disease. It authorizes the Secretary to award
care grants to local governments, community hospitals, health centers,
and other non-profit health facilities for the provision of out-patient
care and a breadth of support services to affected individuals and the
family members who are involved in their care. This bill previously
passed the House by a vote of 385-2.
Title VI, addresses the growing problem of prostate cancer in
Americans males by revising and extending the CDC's prostrate cancer
screening preventing health program, and reauthorizing the National
Institutes of Health prostate cancer research programs. I am pleased to
see this provision also addresses the needs of underserved and minority
populations with prostate cancer.
H.R. 2498 concludes with an organ donation provision that includes
asking all Americans to recognize this Thanksgiving day as ``Give
Thanks, Give Life Day.'' As families sit down together this
Thanksgiving day, they are encouraged to spend a moment thinking about
the thousands of Americans in need of organ transplants, and discuss
openly their own decisions to donate organs or tissue in a forum where
relatives can be made aware of their wishes.
There are many more things I had hoped to do for the health of the
American people during the 106th Congress. These include: enactment of
a real Patients' Bill of Rights; restoration of federal jurisdiction to
control tobacco use by America's children; access to prescription drugs
for senior citizens; long-term care for the elderly; access for
America's children with rare and/or serious health problems to
pediatric specialists, medications and clinical trials; adequate
protection for human research subjects; protection of predictive
genetic information from discrimination by health insurers and
employers; and enhanced protection of confidential medical records. For
those of my colleagues who will be returning next year, I look forward
to working with you on these issues.
Mr. MARKEY. Mr. Speaker, I rise in support of H.R. 2498, The Cardiac
Arrest Survivors Act which includes language based on a bill I
introduced in March together with my colleague from New Jersey and Co-
Chairman of the Bipartisan Task Force on Alzheimer's Disease, Chris
Smith. Our bill, ``The Alzheimer's Clinical Research and Training
Awards Act of 2000'' creates a new clinical research program at NIH to
improve the diagnosis and treatment of Alzheimer's Disease.
Mr. Speaker, I want to say a special word of thanks to Commerce
Committee Chairman Tom Bliley for accepting the Alzheimer's provision
as part of this legislation. This important public health bill is a
feather in his health care cap as he prepares to retire from this body,
and I thank him. I would also like to thank the Ranking Member of the
Commerce Committee John Dingell, and Senators Kennedy and Frist in the
other body, for constructing a strong bipartisan public health bill.
[[Page H11317]]
Alzheimer's Disease is on track to become the epidemic of the 21st
Century. Today 4 million Americans are afflicted and by 2050 it is
estimated that this number will increase to 14 million.
That's right Mr. Speaker, 14 million Americans will face the
devastation of losing their independence, their personality, and their
memory--the very threads of life that gives one his or her identity.
Funding for basic research to find a cure for Alzheimer's Disease is
important and I'm pleased that this year's funding levels will increase
to over $550 million. But there's no way to know when a cure will
present itself--it could be in two years or ten years or twenty years.
In the meantime people are suffering.
A recent study conducted at the Oregon Health Sciences University
indicated that 65% of patients with probable dementia are going
undiagnosed. This study highlights the crucial need to improve
recognition and assessment of dementia patients.
The language included in H.R. 2498 addresses this need. The
Alzhiemer's Clinical Research and Training Awards program is designed
to compliment the 30 Alzheimer's Research Centers across our nation
which currently focus on basic research and are administered through
the National Institutes on Aging at NIH. During my own personal
experience with my mother's Alzheimer's disease, top Alzheimer's
researchers and clinicians underscored the crucial need for providing a
bridge between Alzheimer's laboratory research and new methods of
diagnosis, treatment and prevention. This program provides awards to
junior and mid-level physicians to focus their careers on Alzheimer's
and to train as physician scientist specialists to improve and apply
cutting edge research to Alzheimer's patients.
Researching a cure for tomorrow is critical, but we also need to do
better in treating those suffering with Alzheimer's Disease today.
The Alzheimer's Clinical Research and Training Awards program takes a
first step in doing the very best we can in providing cutting edge
diagnosis, treatment and prevention for those who are and will be
effected by the epidemic of the 21st century.
{time} 2030
Mr. BILIRAKIS. Mr. Speaker, I yield back the balance of my time.
The SPEAKER pro tempore (Mr. Thune). The question is on the motion
offered by the gentleman from Florida (Mr. Bilirakis) that the House
suspend the rules and concur in the Senate amendment to the bill, H.R.
2498.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds of
those present have voted in the affirmative.
Mr. BROWN of Ohio. Mr. Speaker, I object to the vote on the ground
that a quorum is not present and make the point of order that a quorum
is not present.
The SPEAKER pro tempore. Pursuant to clause 8, rule XX and the
Chair's prior announcement, further proceedings on this motion will be
postponed.
The point of no quorum is considered withdrawn.
____________________