[106th Congress Public Law 505]
[From the U.S. Government Printing Office]
<DOC>
[DOCID: f:publ505.106]
[[Page 114 STAT. 2314]]
Public Law 106-505
106th Congress
An Act
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. <<NOTE: Nov. 13,
2000 - [H.R. 2498]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress <<NOTE: Public Health Improvement
Act.>> assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. <<NOTE: 42 USC 201 note.>>
(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.
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.
[[Page 114 STAT. 2315]]
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 <<NOTE: Public Health Threats and Emergencies Act.>> I--EMERGING
THREATS TO PUBLIC HEALTH
SEC. <<NOTE: 42 USC 201 note.>> 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. <<NOTE: 42 USC 247d.>> 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'
[[Page 114 STAT. 2316]]
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) <<NOTE: Deadline.>> 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. <<NOTE: 42 USC 247d-1.>> 319A. NATIONAL NEEDS TO COMBAT THREATS
TO PUBLIC HEALTH.
``(a) Capacities.--
``(1) In <<NOTE: Deadline.>> general.--Not later than 1 year
after the date of the 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
[[Page 114 STAT. 2317]]
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. <<NOTE: 42 USC 247d-2.>> 319B. ASSESSMENT OF PUBLIC HEALTH NEEDS.
``(a) Program <<NOTE: Deadline.>> Authorized.--Not later than 1 year
after the date of the enactment of this section and every 10 years
thereafter, the Secretary shall award grants to States, or consortia of
two 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 two 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 two 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) <<NOTE: Deadline.>> Report.--Not later than 1 year after the
date on which a State, or a consortium of two or more States or
political subdivisions of States, receives a grant under this
subsection, such State, or a consortium of two 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 two 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. <<NOTE: 42 USC 247d-3.>> 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.
[[Page 114 STAT. 2318]]
``(b) Eligible Entities.--A State or political subdivision of a
State, or a consortium of two or more States or political subdivisions
of States, that has completed an evaluation under section 319B(a), or an
evaluation that is substantially equivalent as determined by the
Secretary under section 319B(a), shall be eligible for grants under
subsection (a).
``(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 <<NOTE: Deadline.>> 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. <<NOTE: 42 USC 247d-4.>> 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 21st 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. <<NOTE: 42 USC 247d-5.>> COMBATING ANTIMICROBIAL
RESISTANCE.
``(a) Task Force.--
[[Page 114 STAT. 2319]]
``(1) In <<NOTE: Establishment.>> 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 the 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;
[[Page 114 STAT. 2320]]
``(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.
[[Page 114 STAT. 2321]]
``(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. <<NOTE: 42 USC 247d-6.>> 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 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
[[Page 114 STAT. 2322]]
``(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 two 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.
[[Page 114 STAT. 2323]]
``(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 <<NOTE: Deadline.>> Accounting Office Report.--Not
later than 180 days after the date of the 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. <<NOTE: 42 USC 247d-7.>> 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
[[Page 114 STAT. 2324]]
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 5 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 <<NOTE: Deadline.>> 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.''.
[[Page 114 STAT. 2325]]
TITLE <<NOTE: Clinical Research Enhancement Act of 2000.>> II--CLINICAL
RESEARCH ENHANCEMENT
SEC. <<NOTE: 42 USC 201 note.>> 201. SHORT TITLE.
This title may be cited as the ``Clinical Research Enhancement Act
of 2000''.
SEC. <<NOTE: 42 USC 284k note.>> 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:
(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).
[[Page 114 STAT. 2326]]
(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. <<NOTE: 42 USC 284k.>> 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
[[Page 114 STAT. 2327]]
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. <<NOTE: 42 USC 287a-4.>> 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. <<NOTE: 42 USC 284l.>> 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
[[Page 114 STAT. 2328]]
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.
[[Page 114 STAT. 2329]]
``(D) Computer data management and medical
informatics.
``(E) Ethical and regulatory issues.
``(F) Biomedical writing.
``(2) Applications.--An application for a grant under this
subsection shall be submitted by an individual institution or a
consortium of institutions at such time as the Director may
require. An institution may submit only one such application.
``(3) Limitations.--Grants under this subsection shall be
for terms of up to 5 years and may be renewable.
``(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. <<NOTE: 42 USC 288-5a.>> 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 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
[[Page 114 STAT. 2330]]
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. <<NOTE: Deadline. 42 USC 284k note.>> 207. OVERSIGHT BY GENERAL
ACCOUNTING OFFICE.
Not later than 18 months after the date of the 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 <<NOTE: Twenty-First Century Research Laboratories Act.>> III--
RESEARCH LABORATORY INFRASTRUCTURE
SEC. <<NOTE: 42 USC 201 note.>> 301. SHORT TITLE.
This title may be cited as the ``Twenty-First Century Research
Laboratories Act''.
SEC. 302. <<NOTE: 42 USC 287a-2 note.>> 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.--
[[Page 114 STAT. 2331]]
``(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.--
[[Page 114 STAT. 2332]]
``(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 three individuals
who are officers or employees of the Federal Government
may serve as members of the Board.
``(4) Certain requirements regarding membership.--In
selecting individuals for membership on the Board, the Director
of 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
[[Page 114 STAT. 2333]]
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;
``(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.
[[Page 114 STAT. 2334]]
``(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.
[[Page 114 STAT. 2335]]
``(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 <<NOTE: Deadline.>> 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. <<NOTE: 42 USC 287 note.>> 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.)).
[[Page 114 STAT. 2336]]
(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 <<NOTE: Cardiac Arrest Survival Act of 2000.>> IV--CARDIAC ARREST
SURVIVAL
Subtitle A--Recommendations for Federal Buildings
SEC. 401. <<NOTE: 42 USC 201 note.>> SHORT TITLE.
This subtitle may be cited as the ``Cardiac Arrest Survival Act of
2000''.
SEC. <<NOTE: 42 USC 238p note.>> 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
[[Page 114 STAT. 2337]]
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.
(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. <<NOTE: 42 USC 238p.>> 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 <<NOTE: Federal Register,
publication.>> 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;
[[Page 114 STAT. 2338]]
``(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 <<NOTE: Deadline.>> 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. <<NOTE: 42 USC 238q.>> (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--
[[Page 114 STAT. 2339]]
``(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;
``(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;
``(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.
[[Page 114 STAT. 2340]]
``(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 <<NOTE: Rural Access to Emergency Devices Act.>> B--Rural
Access to Emergency Devices
SEC. 411. <<NOTE: 42 USC 254c note.>> SHORT TITLE.
This subtitle may be cited as the ``Rural Access to Emergency
Devices Act'' or the ``Rural AED Act''.
SEC. 412. <<NOTE: 42 USC 254c note.>> FINDINGS.
Congress makes the following findings:
(1) Heart disease is the leading cause of death in the
United States.
[[Page 114 STAT. 2341]]
(2) The American Heart Association estimates that 250,000
Americans die from sudden cardiac arrest each year.
(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. <<NOTE: 42 USC 254c note.>> 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 <<NOTE: Deadline.>> later than 4 years after the
date of the enactment of this Act, the Secretary of Health and Human
Services
[[Page 114 STAT. 2342]]
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 <<NOTE: Lupus Research and Care Amendments of
2000.>> RESEARCH AND CARE
SEC. 501. SHORT <<NOTE: 42 USC 201 note.>> TITLE.
This title may be cited as the ``Lupus Research and Care Amendments
of 2000''.
SEC. 502. <<NOTE: 42 USC 285d-6a note.>> 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:
[[Page 114 STAT. 2343]]
``lupus
``Sec. <<NOTE: 42 USC 285d-6a.>> 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. <<NOTE: 42 USC 254c-9.>> 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:
[[Page 114 STAT. 2344]]
(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. <<NOTE: 42 USC 254c-10.>> 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.
SEC. <<NOTE: 42 USC 254c-11.>> 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. <<NOTE: 42 USC 254c-12.>> DEFINITIONS.
For purposes of this subtitle:
[[Page 114 STAT. 2345]]
(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. <<NOTE: 42 USC 254c-13.>> 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 <<NOTE: Prostate Cancer Research and Prevention
Act.>> CANCER RESEARCH AND PREVENTION
SEC. 601. <<NOTE: 42 USC 201 note.>> 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) <<NOTE: Public information.>> 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;
[[Page 114 STAT. 2346]]
``(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 <<NOTE: Organ Procurement Organization Certification
Act of 2000.>> PROCUREMENT AND DONATION
SEC. 701. ORGAN PROCUREMENT ORGANIZATION CERTIFICATION.
(a) Short <<NOTE: 42 USC 201 note.>> Title.--This section may be
cited as the ``Organ Procurement Organization Certification Act of
2000''.
(b) Findings.--Congress <<NOTE: 42 USC 273 note.>> 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
[[Page 114 STAT. 2347]]
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) <<NOTE: Deadline.>> 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--
[[Page 114 STAT. 2348]]
(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 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.
[[Page 114 STAT. 2349]]
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) <<NOTE: 42 USC 285e-11.>> by redesignating section 445I
as section 445J; and
(2) by inserting after section 445H the following:
``SEC. 445I. <<NOTE: 42 USC 285e-10a.>> 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. <<NOTE: 42 USC 285f-3.>> 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,
[[Page 114 STAT. 2350]]
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 <<NOTE: 42 USC 289 note.>> 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 <<NOTE: 42 USC 289 note.>> Date.--The amendment made
by subsection (a) takes effect on the date of the enactment of the
Children's Health Act of 2000.
Approved November 13, 2000.
LEGISLATIVE HISTORY--H.R. 2498:
---------------------------------------------------------------------------
HOUSE REPORTS: No. 106-634 (Comm. on Commerce).
CONGRESSIONAL RECORD, Vol. 146 (2000):
May 23, considered and passed House.
Oct. 26, considered and passed Senate, amended.
Oct. 27, House concurred in Senate amendment.
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