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<PRE>[DOCID: f:h2498enr.txt]
        H.R.2498

                       One Hundred Sixth Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

           Begun and held at the City of Washington on Monday,
             the twenty-fourth day of January, two thousand


                                 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Public Health 
Improvement Act''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:
Sec. 1. Short title; table of contents.

               TITLE I--EMERGING THREATS TO PUBLIC HEALTH

Sec. 101. Short title.
Sec. 102. Amendments to the Public Health Service Act.

                 TITLE II--CLINICAL RESEARCH ENHANCEMENT

Sec. 201. Short title.
Sec. 202. Findings and purpose.
Sec. 203. Increasing the involvement of the National Institutes of 
          Health in clinical research.
Sec. 204. General clinical research centers.
Sec. 205. Loan repayment program regarding clinical researchers.
Sec. 206. Definition.
Sec. 207. Oversight by General Accounting Office.

              TITLE III--RESEARCH LABORATORY INFRASTRUCTURE

Sec. 301. Short title.
Sec. 302. Findings.
Sec. 303. Biomedical and behavioral research facilities.
Sec. 304. Construction program for National Primate Research Centers.
Sec. 305. Shared instrumentation grant program.

                    TITLE IV--CARDIAC ARREST SURVIVAL

            Subtitle A--Recommendations for Federal Buildings

Sec. 401. Short title.
Sec. 402. Findings.
Sec. 403. Recommendations and guidelines of Secretary of Health and 
          Human Services regarding automated external defibrillators for 
          Federal buildings.
Sec. 404. Good samaritan protections regarding emergency use of 
          automated external defibrillators.

              Subtitle B--Rural Access to Emergency Devices

Sec. 411. Short title.
Sec. 412. Findings.
Sec. 413. Grants.

                    TITLE V--LUPUS RESEARCH AND CARE

Sec. 501. Short title.
Sec. 502. Findings.

                      Subtitle A--Research on Lupus

Sec. 511. Expansion and intensification of activities.

            Subtitle B--Delivery of Services Regarding Lupus

Sec. 521. Establishment of program of grants.
Sec. 522. Certain requirements.
Sec. 523. Technical assistance.
Sec. 524. Definitions.
Sec. 525. Authorization of appropriations.

            TITLE VI--PROSTATE CANCER RESEARCH AND PREVENTION

Sec. 601. Short title.
Sec. 602. Amendments to the Public Health Service Act.

                TITLE VII--ORGAN PROCUREMENT AND DONATION

Sec. 701. Organ procurement organization certification.
Sec. 702. Designation of Give Thanks, Give Life Day.

         TITLE VIII--ALZHEIMER'S CLINICAL RESEARCH AND TRAINING

Sec. 801. Alzheimer's clinical research and training awards.

  TITLE IX--SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH AND TRAINING

Sec. 901. Sexually transmitted disease clinical research and training 
          awards.

                    TITLE X--MISCELLANEOUS PROVISION

Sec. 1001. Technical correction to the Children's Health Act of 2000.

               TITLE I--EMERGING THREATS TO PUBLIC HEALTH

SEC. 101. SHORT TITLE.

    This title may be cited as the ``Public Health Threats and 
Emergencies Act''.

SEC. 102. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.

    Part B of title III of the Public Health Service Act (42 U.S.C. 243 
et seq.) is amended by striking section 319 and inserting the 
following:

``SEC. 319. PUBLIC HEALTH EMERGENCIES.

    ``(a) Emergencies.--If the Secretary determines, after consultation 
with such public health officials as may be necessary, that--
        ``(1) a disease or disorder presents a public health emergency; 
    or
        ``(2) a public health emergency, including significant 
    outbreaks of infectious diseases or bioterrorist attacks, otherwise 
    exists,
the Secretary may take such action as may be appropriate to respond to 
the public health emergency, including making grants and entering into 
contracts and conducting and supporting investigations into the cause, 
treatment, or prevention of a disease or disorder as described in 
paragraphs (1) and (2).
    ``(b) Public Health Emergency Fund.--
        ``(1) In general.--There is established in the Treasury a fund 
    to be designated as the `Public Health Emergency Fund' to be made 
    available to the Secretary without fiscal year limitation to carry 
    out subsection (a) only if a public health emergency has been 
    declared by the Secretary under such subsection. There is 
    authorized to be appropriated to the Fund such sums as may be 
    necessary.
        ``(2) Report.--Not later than 90 days after the end of each 
    fiscal year, the Secretary shall prepare and submit to the 
    Committee on Health, Education, Labor, and Pensions and the 
    Committee on Appropriations of the Senate and the Committee on 
    Commerce and the Committee on Appropriations of the House of 
    Representatives a report describing--
            ``(A) the expenditures made from the Public Health 
        Emergency Fund in such fiscal year; and
            ``(B) each public health emergency for which the 
        expenditures were made and the activities undertaken with 
        respect to each emergency which was conducted or supported by 
        expenditures from the Fund.
    ``(c) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other Federal, 
State, and local public funds provided for activities under this 
section.

``SEC. 319A. NATIONAL NEEDS TO COMBAT THREATS TO PUBLIC HEALTH.

    ``(a) Capacities.--
        ``(1) In general.--Not later than 1 year after the date of 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 
sect
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ion shall be used to supplement and not supplant other Federal, 
State, and local public funds provided for activities under this 
section.
    ``(c) Technical Assistance.--The Secretary shall provide technical 
assistance to the States to assist such States in fulfilling the 
requirements of this section.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $4,000,000 for fiscal year 2001, 
and such sums as may be necessary for each subsequent fiscal year 
through 2006.

``SEC. 319B. ASSESSMENT OF PUBLIC HEALTH NEEDS.

    ``(a) Program Authorized.--Not later than 1 year after the date of 
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) 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. 319C. GRANTS TO IMPROVE STATE AND LOCAL PUBLIC HEALTH AGENCIES.

    ``(a) Program Authorized.--The Secretary shall award competitive 
grants to eligible entities to address core public health capacity 
needs using the capacities developed under section 319A, with a 
particular focus on building capacity to identify, detect, monitor, and 
respond to threats to the public health.
    ``(b) Eligible Entities.--A State or political subdivision of a 
State, or a consortium of 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 later than January 1, 2005, the Secretary shall 
prepare and submit to the Committee on Health, Education, Labor, and 
Pensions and the Committee on Appropriations of the Senate and the 
Committee on Commerce and the Committee on Appropriations of the House 
of Representatives a report that describes the activities carried out 
under sections 319A, 319B, and 319C.
    ``(e) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other Federal, 
State, and local public funds provided for activities under this 
section.
    ``(f) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $50,000,000 for fiscal year 
2001, and such sums as may be necessary for each subsequent fiscal year 
through 2006.

``SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE CONTROL AND 
              PREVENTION.

    ``(a) Findings.--Congress finds that the Centers for Disease 
Control and Prevention have an essential role in defending against and 
combatting public health threats of the 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. COMBATING ANTIMICROBIAL RESISTANCE.

    ``(a) Task Force.--
        ``(1) In general.--The Secretary shall establish an 
    Antimicrobial Resistance Task Force to provide advice and 
    recommendations to the Secretary and coordinate Federal programs 
    relating to antimicrobial resistance. The Secretary may appoint or 
    select a committee, or other organization in existence as of the 
    date of 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 
       
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     are relevant to antimicrobial resistance.
            ``(B) Detection and control.--The Secretary, in 
        consultation with the task force described in paragraph (1) and 
        State and local public health officials, shall--
                ``(i) develop, improve, coordinate or enhance 
            participation in a surveillance plan to detect and monitor 
            emerging antimicrobial resistance; and
                ``(ii) develop, improve, coordinate or enhance 
            participation in an integrated information system to 
            assimilate, analyze, and exchange antimicrobial resistance 
            data between public health departments.
        ``(4) Meetings.--The task force described under paragraph (1) 
    shall convene not less than twice a year, or more frequently as the 
    Secretary determines to be appropriate.
    ``(b) Research and Development of New Antimicrobial Drugs and 
Diagnostics.--The Secretary and the Director of Agricultural Research 
Services, consistent with the recommendations of the task force 
established under subsection (a), shall conduct and support research, 
investigations, experiments, demonstrations, and studies in the health 
sciences that are related to--
        ``(1) the development of new therapeutics, including vaccines 
    and antimicrobials, against resistant pathogens;
        ``(2) the development or testing of medical diagnostics to 
    detect pathogens resistant to antimicrobials;
        ``(3) the epidemiology, mechanisms, and pathogenesis of 
    antimicrobial resistance;
        ``(4) the sequencing of the genomes of priority pathogens as 
    determined by the Director of the National Institutes of Health in 
    consultation with the task force established under subsection (a); 
    and
        ``(5) other relevant research areas.
    ``(c) Education of Medical and Public Health Personnel.--The 
Secretary, after consultation with the Assistant Secretary for Health, 
the Surgeon General, the Director of the Centers for Disease Control 
and Prevention, the Administrator of the Health Resources and Services 
Administration, the Director of the Agency for Healthcare Research and 
Quality, members of the task force described in subsection (a), 
professional organizations and societies, and such other public health 
officials as may be necessary, shall--
        ``(1) develop and implement educational programs to increase 
    the awareness of the general public with respect to the public 
    health threat of antimicrobial resistance and the appropriate use 
    of antibiotics;
        ``(2) develop and implement educational programs to instruct 
    health care professionals in the prudent use of antibiotics; and
        ``(3) develop and implement programs to train laboratory 
    personnel in the recognition or identification of resistance in 
    pathogens.
    ``(d) Grants.--
        ``(1) In general.--The Secretary shall award competitive grants 
    to eligible entities to enable such entities to increase the 
    capacity to detect, monitor, and combat antimicrobial resistance.
        ``(2) Eligible entities.--Eligible entities for grants under 
    paragraph (1) shall be State or local public health agencies, 
    Indian tribes or tribal organizations, or other public or private 
    nonprofit entities.
        ``(3) Use of funds.--An eligible entity receiving a grant under 
    paragraph (1) shall use funds from such grant for activities that 
    are consistent with the factors identified by the task force under 
    subsection (a)(3), which may include activities that--
            ``(A) provide training to enable such entity to identify 
        patterns of resistance rapidly and accurately;
            ``(B) develop, improve, coordinate or enhance participation 
        in information systems by which data on resistant infections 
        can be shared rapidly among relevant national, State, and local 
        health agencies and health care providers; and
            ``(C) develop and implement policies to control the spread 
        of antimicrobial resistance.
    ``(e) Grants for Demonstration Programs.--
        ``(1) In general.--The Secretary shall award competitive grants 
    to eligible entities to establish demonstration programs to promote 
    judicious use of antimicrobial drugs or control the spread of 
    antimicrobial-resistant pathogens.
        ``(2) Eligible entities.--Eligible entities for grants under 
    paragraph (1) may include hospitals, clinics, institutions of long-
    term care, professional medical societies, or other public or 
    private nonprofit entities.
        ``(3) Technical assistance.--The Secretary shall provide 
    appropriate technical assistance to eligible entities that receive 
    grants under paragraph (1).
    ``(f) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other Federal, 
State, and local public funds provided for activities under this 
section.
    ``(g) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, $40,000,000 for fiscal year 
2001, and such sums as may be necessary for each subsequent fiscal year 
through 2006.

``SEC. 319F. PUBLIC HEALTH COUNTERMEASURES TO A BIOTERRORIST ATTACK.

    ``(a) Working Group on Preparedness for Acts of Bioterrorism.--The 
Secretary, in coordination with the Secretary of Defense, shall 
establish a joint interdepartmental working group on preparedness and 
readiness for the medical and public health effects of a bioterrorist 
attack on the civilian population. Such joint working group shall--
        ``(1) coordinate research on pathogens likely to be used in a 
    bioterrorist attack on the civilian population as well as therapies 
    to treat such pathogens;
        ``(2) coordinate research and development into equipment to 
    detect pathogens likely to be used in a bioterrorist attack on the 
    civilian population and protect against infection from such 
    pathogens;
        ``(3) develop shared standards for equipment to detect and to 
    protect against infection from pathogens likely to be used in a 
    bioterrorist attack on the civilian population; and
        ``(4) coordinate the development, maintenance, and procedures 
    for the release of, strategic reserves of vaccines, drugs, and 
    medical supplies which may be needed rapidly after a bioterrorist 
    attack upon the civilian population.
    ``(b) Working Group on the Public Health and Medical Consequences 
of Bioterrorism.--
        ``(1) In general.--The Secretary, in collaboration with the 
    Director of the Federal Emergency Management Agency, the Attorney 
    General, and the Secretary of Agriculture, shall establish a joint 
    interdepartmental working group to address the public health and 
    medical consequences of a bioterrorist attack on the civilian 
    population.
        ``(2) Functions.--Such working group shall--
            ``(A) assess the priorities for and enhance the 
        preparedness of public health institutions, providers of 
        medical care, and other emergency service personnel to detect, 
        diagnose, and respond to a bioterrorist attack; and
            ``(B) in the recognition that medical and public health 
        professionals are likely to provide much of the first response 
        to such an attack, develop, coordinate, enhance, and assure the 
        quality of joint planning and training programs that address 
        the public health and medical consequences of a bioterrorist 
        attack on the civilian population between--
                ``(i) local firefighters, ambulance personnel, police 
            and public security officers, or other emergency response 
            personnel; and
                ``(ii) hospitals, primary care facilities, and public 
            health agencies.
        ``(3) Working group membership.--In establishing such working 
    group, the Secretary shall act through the Assistant Secretary for 
    Health and the Director of the Centers for Disease Control an
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d 
    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.
    ``(e) Education.--The Secretary, in collaboration with members of 
the working group described in subsection (b), and professional 
organizations and societies, shall--
        ``(1) develop and implement educational programs to instruct 
    public health officials, medical professionals, and other personnel 
    working in health care facilities in the recognition and care of 
    victims of a bioterrorist attack; and
        ``(2) develop and implement programs to train laboratory 
    personnel in the recognition and identification of a potential 
    bioweapon.
    ``(f) Future Resource Development.--The Secretary shall consult 
with the working group described in subsection (a), to develop 
priorities for and conduct research, investigations, experiments, 
demonstrations, and studies in the health sciences related to--
        ``(1) the epidemiology and pathogenesis of potential 
    bioweapons;
        ``(2) the development of new vaccines or other therapeutics 
    against pathogens likely to be used in a bioterrorist attack;
        ``(3) the development of medical diagnostics to detect 
    potential bioweapons; and
        ``(4) other relevant research areas.
    ``(g) General Accounting Office Report.--Not later than 180 days 
after the date of 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. DEMONSTRATION PROGRAM TO ENHANCE BIOTERRORISM TRAINING, 
              COORDINATION, AND READINESS.

    ``(a) In General.--The Secretary shall make grants to not more than 
three eligible entities to carry out demonstration programs to improve 
the detection of pathogens likely to be used in a bioterrorist attack, 
the development of plans and measures to respond to bioterrorist 
attacks, and the training of personnel involved with the various 
responsibilities and capabilities needed to respond to acts of 
bioterrorism upon the civilian population. Such awards shall be made on 
a competitive basis and pursuant to scientific and technical review.
    ``(b) Eligible Entities.--Eligible entities for grants under 
subsection (a) are States, political subdivisions of States, and public 
or private non-profit organizations.
    ``(c) Specific Criteria.--In making grants under subsection (a), 
the Secretary shall take into account the following factors:
        ``(1) Whether the eligible entity involved is proximate to, and 
    collaborates with, a major research university with expertise in 
    scientific training, identification of biological agents, medicine, 
    and life sciences.
        ``(2) Whether the entity is proximate to, and collaborates 
    with, a laboratory that has expertise in the identification of 
    biological agents.
        ``(3) Whether the entity demonstrates, in the application for 
    the program, support and participation of State and local 
    governments and research institutions in the conduct of the 
    program.
        ``(4) Whether the entity is proximate to, and collaborates 
    with, or is, an academic medical center that has the capacity to 
    serve an uninsured or underserved population, and is equipped to 
    educate medical personnel.
        ``(5) Such other factors as the Secretary determines to be 
    appropriate.
    ``(d) Duration of Award.--The period during which payments are made 
under a grant under subsection (a) may not exceed 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 des
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cribed in such subsection.
    ``(f) General Accounting Office Report.--Not later than 180 days 
after the conclusion of the demonstration programs carried out under 
subsection (a), the Comptroller General of the United States shall 
submit to the Committee on Health, Education, Labor, and Pensions and 
the Committee on Appropriations of the Senate, and the Committee on 
Commerce and the Committee on Appropriations of the House of 
Representatives, a report that describes the ability of grantees under 
such subsection to detect pathogens likely to be used in a bioterrorist 
attack, develop plans and measures for dealing with such threats, and 
train personnel involved with the various responsibilities and 
capabilities needed to deal with bioterrorist threats.
    ``(g) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $6,000,000 for fiscal year 2001, 
and such sums as may be necessary through fiscal year 2006.''.

                TITLE II--CLINICAL RESEARCH ENHANCEMENT

SEC. 201. SHORT TITLE.

    This title may be cited as the ``Clinical Research Enhancement Act 
of 2000''.

SEC. 202. FINDINGS AND PURPOSE.

    (a) Findings.--Congress makes the following findings:
        (1) Clinical research is critical to the advancement of 
    scientific knowledge and to the development of cures and improved 
    treatment for disease.
        (2) Tremendous advances in biology are opening doors to new 
    insights into human physiology, pathophysiology and disease, 
    creating extraordinary opportunities for clinical research.
        (3) Clinical research includes translational research which is 
    an integral part of the research process leading to general human 
    applications. It is the bridge between the laboratory and new 
    methods of diagnosis, treatment, and prevention and is thus 
    essential to progress against cancer and other diseases.
        (4) The United States will spend more than $1,200,000,000,000 
    on health care in 1999, but the Federal budget for health research 
    at the National Institutes of Health was $15,600,000,000 only 1 
    percent of that total.
        (5) Studies at the Institute of Medicine, the National Research 
    Council, and the National Academy of Sciences have all addressed 
    the current problems in clinical research.
        (6) The Director of the National Institutes of Health has 
    recognized the current problems in clinical research and appointed 
    a special panel, which recommended expanded support for existing 
    National Institutes of Health clinical research programs and the 
    creation of new initiatives to recruit and retain clinical 
    investigators.
        (7) The current level of training and support for health 
    professionals in clinical research is fragmented, undervalued, and 
    underfunded.
        (8) Young investigators are not only apprentices for future 
    positions but a crucial source of energy, enthusiasm, and ideas in 
    the day-to-day research that constitutes the scientific enterprise. 
    Serious questions about the future of life-science research are 
    raised by the following:
            (A) The number of young investigators applying for grants 
        dropped by 54 percent between 1985 and 1993.
            (B) The number of physicians applying for first-time 
        National Institutes of Health research project grants fell from 
        1226 in 1994 to 963 in 1998, a 21 percent reduction.
            (C) Newly independent life-scientists are expected to raise 
        funds to support their new research programs and a substantial 
        proportion of their own salaries.
        (9) The following have been cited as reasons for the decline in 
    the number of active clinical researchers, and those choosing this 
    career path:
            (A) A medical school graduate incurs an average debt of 
        $85,619, as reported in the Medical School Graduation 
        Questionnaire by the Association of American Medical Colleges 
        (AAMC).
            (B) The prolonged period of clinical training required 
        increases the accumulated debt burden.
            (C) The decreasing number of mentors and role models.
            (D) The perceived instability of funding from the National 
        Institutes of Health and other Federal agencies.
            (E) The almost complete absence of clinical research 
        training in the curriculum of training grant awardees.
            (F) Academic Medical Centers are experiencing difficulties 
        in maintaining a proper environment for research in a highly 
        competitive health care marketplace, which are compounded by 
        the decreased willingness of third party payers to cover health 
        care costs for patients engaged in research studies and 
        research procedures.
        (10) In 1960, general clinical research centers were 
    established under the Office of the Director of the National 
    Institutes of Health with an initial appropriation of $3,000,000.
        (11) Appropriations for general clinical research centers in 
    fiscal year 1999 equaled $200,500,000.
        (12) Since the late 1960s, spending for general clinical 
    research centers has declined from approximately 3 percent to 1 
    percent of the National Institutes of Health budget.
        (13) In fiscal year 1999, there were 77 general clinical 
    research centers in operation, supplying patients in the areas in 
    which such centers operate with access to the most modern clinical 
    research and clinical research facilities and technologies.
    (b) Purpose.--It is the purpose of this title to provide additional 
support for and to expand clinical research programs.

SEC. 203. INCREASING THE INVOLVEMENT OF THE NATIONAL INSTITUTES OF 
              HEALTH IN CLINICAL RESEARCH.

    Part B of title IV of the Public Health Service Act (42 U.S.C. 284 
et seq.) is amended by adding at the end the following:

``SEC. 409C. CLINICAL RESEARCH.

    ``(a) In General.--The Director of National Institutes of Health 
shall undertake activities to support and expand the involvement of the 
National Institutes of Health in clinical research.
    ``(b) Requirements.--In carrying out subsection (a), the Director 
of National Institutes of Health shall--
        ``(1) consider the recommendations of the Division of Research 
    Grants Clinical Research Study Group and other recommendations for 
    enhancing clinical research; and
        ``(2) establish intramural and extramural clinical research 
    fellowship programs directed specifically at medical and dental 
    students and a continuing education clinical research training 
    program at the National Institutes of Health.
    ``(c) Support for the Diverse Needs of Clinical Research.--The 
Director of National Institutes of Health, in cooperation with the 
Directors of the Institutes, Centers, and Divisions of the National 
Institutes of Health, shall support and expand the resources available 
for the diverse needs of the clinical research community, including 
inpatient, outpatient, and critical care clinical research.
    ``(d) Peer Review.--The Director of National Institutes of Health 
shall establish peer review mechanisms to evaluate applications for the 
awards and fellowships provided for in subsection (b)(2) and section 
409D. Such review mechanisms shall include individuals who are 
exceptionally qualified to appraise the merits of potential clinical 
research training and research grant proposals.''.

SEC. 204. GENERAL CLINICAL RESEARCH CENTERS.

    (a) Grants.--Subpart 1 of part E of title IV of the Public Health 
Service Act (42 U.S.C. 287 et seq.) is amended by adding at the end the 
following:

``SEC. 481C. GENERAL CLINICAL RESEARCH CENTERS.

    ``(a) Grants.--The Director of the National Center for Research 
Resources shall award grants for the establishment of general clinical 
research centers to provide the infrastructure for clinical research 
including clinical research training and career enhancement. Such 
centers shall support clinical st
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udies and career development in all 
settings of the hospital or academic medical center involved.
    ``(b) Activities.--In carrying out subsection (a), the Director of 
National Institutes of Health shall expand the activities of the 
general clinical research centers through the increased use of 
telecommunications and telemedicine initiatives.
    ``(c) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each fiscal year.''.
    (b) Enhancement Awards.--Part B of title IV of the Public Health 
Service Act (42 U.S.C. 284 et seq.), as amended by section 203, is 
further amended by adding at the end the following:

``SEC. 409D. ENHANCEMENT AWARDS.

    ``(a) Mentored Patient-Oriented Research Career Development 
Awards.--
        ``(1) Grants.--
            ``(A) In general.--The Director of the National Institutes 
        of Health shall make grants (to be referred to as `Mentored 
        Patient-Oriented Research Career Development Awards') to 
        support individual careers in clinical research at general 
        clinical research centers or at other institutions that have 
        the infrastructure and resources deemed appropriate for 
        conducting patient-oriented clinical research.
            ``(B) Use.--Grants under subparagraph (A) shall be used to 
        support clinical investigators in the early phases of their 
        independent careers by providing salary and such other support 
        for a period of supervised study.
        ``(2) Applications.--An application for a grant under this 
    subsection shall be submitted by an individual scientist at such 
    time as the Director may require.
        ``(3) Authorization of appropriations.--For the purpose of 
    carrying out this subsection, there are authorized to be 
    appropriated such sums as may be necessary for each fiscal year.
    ``(b) Mid-Career Investigator Awards in Patient-Oriented 
Research.--
        ``(1) Grants.--
            ``(A) In general.--The Director of the National Institutes 
        of Health shall make grants (to be referred to as `Mid-Career 
        Investigator Awards in Patient-Oriented Research') to support 
        individual clinical research projects at general clinical 
        research centers or at other institutions that have the 
        infrastructure and resources deemed appropriate for conducting 
        patient-oriented clinical research.
            ``(B) Use.--Grants under subparagraph (A) shall be used to 
        provide support for mid-career level clinicians to allow such 
        clinicians to devote time to clinical research and to act as 
        mentors for beginning clinical investigators.
        ``(2) Applications.--An application for a grant under this 
    subsection shall be submitted by an individual scientist at such 
    time as the Director requires.
        ``(3) Authorization of appropriations.--For the purpose of 
    carrying out this subsection, there are authorized to be 
    appropriated such sums as may be necessary for each fiscal year.
    ``(c) Graduate Training in Clinical Investigation Award.--
        ``(1) In general.--The Director of the National Institutes of 
    Health shall make grants (to be referred to as `Graduate Training 
    in Clinical Investigation Awards') to support individuals pursuing 
    master's or doctoral degrees in clinical investigation.
        ``(2) Applications.--An application for a grant under this 
    subsection shall be submitted by an individual scientist at such 
    time as the Director may require.
        ``(3) Limitations.--Grants under this subsection shall be for 
    terms of 2 years or more and shall provide stipend, tuition, and 
    institutional support for individual advanced degree programs in 
    clinical investigation.
        ``(4) Definition.--As used in this subsection, the term 
    `advanced degree programs in clinical investigation' means programs 
    that award a master's or Ph.D. degree in clinical investigation 
    after 2 or more years of training in areas such as the following:
            ``(A) Analytical methods, biostatistics, and study design.
            ``(B) Principles of clinical pharmacology and 
        pharmacokinetics.
            ``(C) Clinical epidemiology.
            ``(D) Computer data management and medical informatics.
            ``(E) Ethical and regulatory issues.
            ``(F) Biomedical writing.
        ``(5) Authorization of appropriations.--For the purpose of 
    carrying out this subsection, there are authorized to be 
    appropriated such sums as may be necessary for each fiscal year.
    ``(d) Clinical Research Curriculum Awards.--
        ``(1) In general.--The Director of the National Institutes of 
    Health shall make grants (to be referred to as `Clinical Research 
    Curriculum Awards') to institutions for the development and support 
    of programs of core curricula for training clinical investigators, 
    including medical students. Such core curricula may include 
    training in areas such as the following:
            ``(A) Analytical methods, biostatistics, and study design.
            ``(B) Principles of clinical pharmacology and 
        pharmacokinetics.
            ``(C) Clinical epidemiology.
            ``(D) Computer data management and medical informatics.
            ``(E) Ethical and regulatory issues.
            ``(F) Biomedical writing.
        ``(2) Applications.--An application for a grant under this 
    subsection shall be submitted by an individual institution or a 
    consortium of institutions at such time as the Director may 
    require. An institution may submit only 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. 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 conseque
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nces of disease in 
human populations involving material of human origin (such as tissue 
specimens and cognitive phenomena) for which an investigator or 
colleague directly interacts with human subjects in an outpatient or 
inpatient setting to clarify a problem in human physiology, 
pathophysiology or disease, or epidemiologic or behavioral studies, 
outcomes research or health services research, or developing new 
technologies, therapeutic interventions, or clinical trials.''.

SEC. 207. OVERSIGHT BY GENERAL ACCOUNTING OFFICE.

    Not later than 18 months after the date of 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 III--RESEARCH LABORATORY INFRASTRUCTURE

SEC. 301. SHORT TITLE.

    This title may be cited as the ``Twenty-First Century Research 
Laboratories Act''.

SEC. 302. FINDINGS.

    Congress finds that--
        (1) the National Institutes of Health is the principal source 
    of Federal funding for medical research at universities and other 
    research institutions in the United States;
        (2) the National Institutes of Health has received a 
    substantial increase in research funding from Congress for the 
    purpose of expanding the national investment of the United States 
    in behavioral and biomedical research;
        (3) the infrastructure of our research institutions is central 
    to the continued leadership of the United States in medical 
    research;
        (4) as Congress increases the investment in cutting-edge basic 
    and clinical research, it is critical that Congress also examine 
    the current quality of the laboratories and buildings where 
    research is being conducted, as well as the quality of laboratory 
    equipment used in research;
        (5) many of the research facilities and laboratories in the 
    United States are outdated and inadequate;
        (6) the National Science Foundation found, in a 1998 report on 
    the status of biomedical research facilities, that over 60 percent 
    of research-performing institutions indicated that they had an 
    inadequate amount of medical research space;
        (7) the National Science Foundation reports that academic 
    institutions have deferred nearly $11,000,000,000 in renovation and 
    construction projects because of a lack of funds; and
        (8) future increases in Federal funding for the National 
    Institutes of Health must include increased support for the 
    renovation and construction of extramural research facilities in 
    the United States and the purchase of state-of-the-art laboratory 
    instrumentation.

SEC. 303. BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES.

    Section 481A of the Public Health Service Act (42 U.S.C. 287a-2 et 
seq.) is amended to read as follows:

``SEC. 481A. BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES.

    ``(a) Modernization and Construction of Facilities.--
        ``(1) In general.--The Director of NIH, acting through the 
    Director of the Center, may make grants or contracts to public and 
    nonprofit private entities to expand, remodel, renovate, or alter 
    existing research facilities or construct new research facilities, 
    subject to the provisions of this section.
        ``(2) Construction and cost of construction.--For purposes of 
    this section, the terms `construction' and `cost of construction' 
    include the construction of new buildings and the expansion, 
    renovation, remodeling, and alteration of existing buildings, 
    including architects' fees, but do not include the cost of 
    acquisition of land or off-site improvements.
    ``(b) Scientific and Technical Review Boards for Merit-Based Review 
of Proposals.--
        ``(1) In general: approval as precondition to grants.--
            ``(A) Establishment.--There is established within the 
        Center a Scientific and Technical Review Board on Biomedical 
        and Behavioral Research Facilities (referred to in this section 
        as the `Board').
            ``(B) Requirement.--The Director of the Center may approve 
        an application for a grant under subsection (a) only if the 
        Board has under paragraph (2) recommended the application for 
        approval.
        ``(2) Duties.--
            ``(A) Advice.--The Board shall provide advice to the 
        Director of the Center and the advisory council established 
        under section 480 (in this section referred to as the `Advisory 
        Council') in carrying out this section.
            ``(B) Determination of merit.--In carrying out subparagraph 
        (A), the Board shall make a determination of the merit of each 
        application submitted for a grant under subsection (a), after 
        consideration of the requirements established in subsection 
        (c), and shall report the results of the determination to the 
        Director of the Center and the Advisory Council. Such 
        determinations shall be conducted in a manner consistent with 
        procedures established under section 492.
            ``(C) Amount.--In carrying out subparagraph (A), the Board 
        shall, in the case of applications recommended for approval, 
        make recommendations to the Director and the Advisory Council 
        on the amount that should be provided under the grant.
            ``(D) Annual report.--In carrying out subparagraph (A), the 
        Board shall prepare an annual report for the Director of the 
        Center and the Advisory Council describing the activities of 
        the Board in the fiscal year for which the report is made. Each 
        such report shall be available to the public, and shall--
                ``(i) summarize and analyze expenditures made under 
            this section;
                ``(ii) provide a summary of the types, numbers, and 
            amounts of applications that were recommended for grants 
            under subsection (a) but that were not approved by the 
            Director of the Center; and
                ``(iii) contain the recommendations of the Board for 
            any changes in the administration of this section.
        ``(3) Membership.--
            ``(A) In general.--Subject to subparagraph (B), the Board 
        shall be composed of 15 members to be appointed by the Director 
        of the Center, and such ad-hoc or temporary members as the 
        Director of the Center determines to be appropriate. All 
        members of the Board, including temporary and ad-hoc members, 
        shall be voting members.
            ``(B) Limitation.--Not more than 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.--
      
2000
      ``(A) Workshops and conferences.--In carrying out paragraph 
        (2), the Board may convene workshops and conferences, and 
        collect data as the Board considers appropriate.
            ``(B) Subcommittees.--In carrying out paragraph (2), the 
        Board may establish subcommittees within the Board. Such 
        subcommittees may hold meetings as determined necessary to 
        enable the subcommittee to carry out its duties.
        ``(6) Terms.--
            ``(A) In general.--Except as provided in subparagraph (B), 
        each appointed member of the Board shall hold office for a term 
        of 4 years. Any member appointed to fill a vacancy occurring 
        prior to the expiration of the term for which such member's 
        predecessor was appointed shall be appointed for the remainder 
        of the term of the predecessor.
            ``(B) Staggered terms.--Members appointed to the Board 
        shall serve staggered terms as specified by the Director of the 
        Center when making the appointments.
            ``(C) Reappointment.--No member of the Board shall be 
        eligible for reappointment to the Board until 1 year has 
        elapsed after the end of the most recent term of the member.
        ``(7) Compensation.--Members of the Board who are not officers 
    or employees of the United States shall receive for each day the 
    members are engaged in the performance of the functions of the 
    Board compensation at the same rate received by members of other 
    national advisory councils established under this title.
    ``(c) Requirements for Grants.--
        ``(1) In general.--The Director of the Center may make a grant 
    under subsection (a) only if the applicant for the grant meets the 
    following conditions:
            ``(A) The applicant is determined by such Director to be 
        competent to engage in the type of research for which the 
        proposed facility is to be constructed.
            ``(B) The applicant provides assurances satisfactory to the 
        Director that--
                ``(i) for not less than 20 years after completion of 
            the construction involved, the facility will be used for 
            the purposes of the research for which it is to be 
            constructed;
                ``(ii) sufficient funds will be available to meet the 
            non-Federal share of the cost of constructing the facility;
                ``(iii) sufficient funds will be available, when 
            construction is completed, for the effective use of the 
            facility for the research for which it is being 
            constructed; and
                ``(iv) the proposed construction will expand the 
            applicant's capacity for research, or is necessary to 
            improve or maintain the quality of the applicant's 
            research.
            ``(C) The applicant meets reasonable qualifications 
        established by the Director with respect to--
                ``(i) the relative scientific and technical merit of 
            the applications, and the relative effectiveness of the 
            proposed facilities, in expanding the capacity for 
            biomedical or behavioral research and in improving the 
            quality of such research;
                ``(ii) the quality of the research or training, or 
            both, to be carried out in the facilities involved;
                ``(iii) the congruence of the research activities to be 
            carried out within the facility with the research and 
            investigator manpower needs of the United States; and
                ``(iv) the age and condition of existing research 
            facilities.
            ``(D) The applicant has demonstrated a commitment to 
        enhancing and expanding the research productivity of the 
        applicant.
        ``(2) Institutions of emerging excellence.--From the amount 
    appropriated under subsection (i) for a fiscal year up to 
    $50,000,000, the Director of the Center shall make available 25 
    percent of such amount, and from the amount appropriated under such 
    subsection for a fiscal year that is over $50,000,000, the Director 
    of the Center shall make available up to 25 percent of such amount, 
    for grants under subsection (a) to applicants that in addition to 
    meeting the requirements established in paragraph (1), have 
    demonstrated emerging excellence in biomedical or behavioral 
    research, as follows:
            ``(A) The applicant has a plan for research or training 
        advancement and possesses the ability to carry out the plan.
            ``(B) The applicant carries out research and research 
        training programs that have a special relevance to a problem, 
        concern, or unmet health need of the United States.
            ``(C) The applicant has been productive in research or 
        research development and training.
            ``(D) The applicant--
                ``(i) has been designated as a center of excellence 
            under section 739;
                ``(ii) is located in a geographic area whose population 
            includes a significant number of individuals with health 
            status deficit, and the applicant provides health services 
            to such individuals; or
                ``(iii) is located in a geographic area in which a 
            deficit in health care technology, services, or research 
            resources may adversely affect the health status of the 
            population of the area in the future, and the applicant is 
            carrying out activities with respect to protecting the 
            health status of such population.
    ``(d) Requirement of Application.--The Director of the Center may 
make a grant under subsection (a) only if an application for the grant 
is submitted to the Director and the application is in such form, is 
made in such manner, and contains such agreements, assurances, and 
information as the Director determines to be necessary to carry out 
this section.
    ``(e) Amount of Grant; Payments.--
        ``(1) Amount.--The amount of any grant awarded under subsection 
    (a) shall be determined by the Director of the Center, except that 
    such amount shall not exceed--
            ``(A) 50 percent of the necessary cost of the construction 
        of a proposed facility as determined by the Director; or
            ``(B) in the case of a multipurpose facility, 40 percent of 
        that part of the necessary cost of construction that the 
        Director determines to be proportionate to the contemplated use 
        of the facility.
        ``(2) Reservation of amounts.--On the approval of any 
    application for a grant under subsection (a), the Director of the 
    Center shall reserve, from any appropriation available for such 
    grants, the amount of such grant, and shall pay such amount, in 
    advance or by way of reimbursement, and in such installments 
    consistent with the construction progress, as the Director may 
    determine appropriate. The reservation of any amount by the 
    Director under this paragraph may be amended by the Director, 
    either on the approval of an amendment of the application or on the 
    revision of the estimated cost of construction of the facility.
        ``(3) Exclusion of certain costs.--In determining the amount of 
    any grant under subsection (a), there shall be excluded from the 
    cost of construction an amount equal to the sum of--
            ``(A) the amount of any other Federal grant that the 
        applicant has obtained, or is assured of obtaining, with 
        respect to construction that is to be financed in part by a 
        grant authorized under this section; and
            ``(B) the amount of any non-Federal funds required to be 
        expended as a condition of such other Federal grant.
        ``(4) Waiver of limitations.--The limitations imposed under 
    paragraph (1) may be waived at the discretion of the Director for 
    applicants meeting the conditions described i
2000
n subsection (c).
    ``(f) Recapture of Payments.--If, not later than 20 years after the 
completion of construction for which a grant has been awarded under 
subsection (a)--
        ``(1) the applicant or other owner of the facility shall cease 
    to be a public or non profit private entity; or
        ``(2) the facility shall cease to be used for the research 
    purposes for which it was constructed (unless the Director 
    determines, in accordance with regulations, that there is good 
    cause for releasing the applicant or other owner from obligation to 
    do so),
the United States shall be entitled to recover from the applicant or 
other owner of the facility the amount bearing the same ratio to the 
current value (as determined by an agreement between the parties or by 
action brought in the United States District Court for the district in 
which such facility is situated) of the facility as the amount of the 
Federal participation bore to the cost of the construction of such 
facility.
    ``(g) Guidelines.--Not later than 6 months after the date of the 
enactment of this section, the Director of the Center, after 
consultation with the Advisory Council, shall issue guidelines with 
respect to grants under subsection (a).
    ``(h) Report to Congress.--The Director of the Center shall prepare 
and submit to the appropriate committees of Congress a biennial report 
concerning the status of the biomedical and behavioral research 
facilities and the availability and condition of technologically 
sophisticated laboratory equipment in the United States. Such reports 
shall be developed in concert with the report prepared by the National 
Science Foundation on the needs of research facilities of universities 
as required under section 108 of the National Science Foundation 
Authorization Act for Fiscal Year 1986 (42 U.S.C. 1886).
    ``(i) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $250,000,000 
for fiscal year 2001, and such sums as may be necessary for each of the 
fiscal years 2002 and 2003.''.

SEC. 304. CONSTRUCTION PROGRAM FOR NATIONAL PRIMATE RESEARCH CENTERS.

    Section 481B(a) of the Public Health Service Act (42 U.S.C. 287a-
3(a)) is amended by striking ``1994'' and all that follows through 
``$5,000,000'' and inserting ``2000 through 2002, reserve from the 
amounts appropriated under section 481A(i) such sums as necessary''.

SEC. 305. SHARED INSTRUMENTATION GRANT PROGRAM.

    (a) Authorization of Appropriations.--There is authorized to be 
appropriated $100,000,000 for fiscal year 2000, and such sums as may be 
necessary for each subsequent fiscal year, to enable the Secretary of 
Health and Human Services, acting through the Director of the National 
Center for Research Resources, to provide for the continued operation 
of the Shared Instrumentation Grant Program (initiated in fiscal year 
1992 under the authority of section 479 of the Public Health Service 
Act (42 U.S.C. 287 et seq.)).
    (b) Requirements for Grants.--In determining whether to award a 
grant to an applicant under the program described in subsection (a), 
the Director of the National Center for Research Resources shall 
consider--
        (1) the extent to which an award for the specific instrument 
    involved would meet the scientific needs and enhance the planned 
    research endeavors of the major users by providing an instrument 
    that is unavailable or to which availability is highly limited;
        (2) with respect to the instrument involved, the availability 
    and commitment of the appropriate technical expertise within the 
    major user group or the applicant institution for use of the 
    instrumentation;
        (3) the adequacy of the organizational plan for the use of the 
    instrument involved and the internal advisory committee for 
    oversight of the applicant, including sharing arrangements if any;
        (4) the applicant's commitment for continued support of the 
    utilization and maintenance of the instrument; and
        (5) the extent to which the specified instrument will be shared 
    and the benefit of the proposed instrument to the overall research 
    community to be served.
    (c) Peer Review.--In awarding grants under the program described in 
subsection (a) Director of the National Center for Research Resources 
shall comply with the peer review requirements in section 492 of the 
Public Health Service Act (42 U.S.C. 289a).

                   TITLE IV--CARDIAC ARREST SURVIVAL
           Subtitle A--Recommendations for Federal Buildings

SEC. 401. SHORT TITLE.

    This subtitle may be cited as the ``Cardiac Arrest Survival Act of 
2000''.

SEC. 402. FINDINGS.

    Congress makes the following findings:
        (1) Over 700 lives are lost every day to sudden cardiac arrest 
    in the United States alone.
        (2) Two out of every three sudden cardiac deaths occur before a 
    victim can reach a hospital.
        (3) More than 95 percent of these cardiac arrest victims will 
    die, many because of lack of readily available life saving medical 
    equipment.
        (4) With current medical technology, up to 30 percent of 
    cardiac arrest victims could be saved if victims had access to 
    immediate medical response, including defibrillation and 
    cardiopulmonary resuscitation.
        (5) Once a victim has suffered a cardiac arrest, every minute 
    that passes before returning the heart to a normal rhythm decreases 
    the chance of survival by 10 percent.
        (6) Most cardiac arrests are caused by abnormal heart rhythms 
    called ventricular fibrillation. Ventricular fibrillation occurs 
    when the heart's electrical system malfunctions, causing a chaotic 
    rhythm that prevents the heart from pumping oxygen to the victim's 
    brain and body.
        (7) Communities that have implemented programs ensuring 
    widespread public access to defibrillators, combined with 
    appropriate training, maintenance, and coordination with local 
    emergency medical systems, have dramatically improved the survival 
    rates from cardiac arrest.
        (8) Automated external defibrillator devices have been 
    demonstrated to be safe and effective, even when used by lay 
    people, since the devices are designed not to allow a user to 
    administer a shock until after the device has analyzed a victim's 
    heart rhythm and determined that an electric shock is required.
        (9) Increasing public awareness regarding automated external 
    defibrillator devices and encouraging their use in Federal 
    buildings will greatly facilitate their adoption.
        (10) Limiting the liability of Good Samaritans and acquirers of 
    automated external defibrillator devices in emergency situations 
    may encourage the use of automated external defibrillator devices, 
    and result in saved lives.

SEC. 403. RECOMMENDATIONS AND GUIDELINES OF SECRETARY OF HEALTH AND 
              HUMAN SERVICES REGARDING AUTOMATED EXTERNAL 
              DEFIBRILLATORS FOR FEDERAL BUILDINGS.

    Part B of title II of the Public Health Service Act (42 U.S.C. 238 
et seq.) is amended by adding at the end the following:


      ``recommendations and guidelines regarding automated external 
                  defibrillators for federal buildings

    ``Sec. 247. (a) Guidelines on Placement.--The Secretary shall 
establish guidelines with respect to placing automated external 
defibrillator devices in Federal buildings. Such guidelines shall take 
into account the extent to which such devices may be used by lay 
persons, the typical number of employees and visitors in the buildings, 
the extent of the need for security measures regarding the buildings, 
buildings or portions of buildings in which there are special 
circumstances such as high electrical voltage or extreme heat or cold, 
and such other factors as the Secretary determines to be appropriate.
    ``(b) Related Recommendations.--The Secretary shall publish in the 
Federal Register the recommendations of the Secretary on the 
appropriate implementation
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 of the placement of automated external 
defibrillator devices under subsection (a), including procedures for 
the following:
        ``(1) Implementing appropriate training courses in the use of 
    such devices, including the role of cardiopulmonary resuscitation.
        ``(2) Proper maintenance and testing of the devices.
        ``(3) Ensuring coordination with appropriate licensed 
    professionals in the oversight of training of the devices.
        ``(4) Ensuring coordination with local emergency medical 
    systems regarding the placement and incidents of use of the 
    devices.
    ``(c) Consultations; Consideration of Certain Recommendations.--In 
carrying out this section, the Secretary shall--
        ``(1) consult with appropriate public and private entities;
        ``(2) consider the recommendations of national and local 
    public-health organizations for improving the survival rates of 
    individuals who experience cardiac arrest in nonhospital settings 
    by minimizing the time elapsing between the onset of cardiac arrest 
    and the initial medical response, including defibrillation as 
    necessary; and
        ``(3) consult with and counsel other Federal agencies where 
    such devices are to be used.
    ``(d) Date Certain for Establishing Guidelines and 
Recommendations.--The Secretary shall comply with this section not 
later than 180 days after the date of the enactment of the Cardiac 
Arrest Survival Act of 2000.
    ``(e) Definitions.--For purposes of this section:
        ``(1) The term `automated external defibrillator device' has 
    the meaning given such term in section 248.
        ``(2) The term `Federal building' includes a building or 
    portion of a building leased or rented by a Federal agency, and 
    includes buildings on military installations of the United 
    States.''.

SEC. 404. GOOD SAMARITAN PROTECTIONS REGARDING EMERGENCY USE OF 
              AUTOMATED EXTERNAL DEFIBRILLATORS.

    Part B of title II of the Public Health Service Act, as amended by 
section 403, is amended by adding at the end the following:


        ``liability regarding emergency use of automated external 
                             defibrillators

    ``Sec. 248. (a) Good Samaritan Protections Regarding AEDs.--Except 
as provided in subsection (b), any person who uses or attempts to use 
an automated external defibrillator device on a victim of a perceived 
medical emergency is immune from civil liability for any harm resulting 
from the use or attempted use of such device; and in addition, any 
person who acquired the device is immune from such liability, if the 
harm was not due to the failure of such acquirer of the device--
        ``(1) to notify local emergency response personnel or other 
    appropriate entities of the most recent placement of the device 
    within a reasonable period of time after the device was placed;
        ``(2) to properly maintain and test the device; or
        ``(3) to provide appropriate training in the use of the device 
    to an employee or agent of the acquirer when the employee or agent 
    was the person who used the device on the victim, except that such 
    requirement of training does not apply if--
            ``(A) the employee or agent was not an employee or agent 
        who would have been reasonably expected to use the device; or
            ``(B) the period of time elapsing between the engagement of 
        the person as an employee or agent and the occurrence of the 
        harm (or between the acquisition of the device and the 
        occurrence of the harm, in any case in which the device was 
        acquired after such engagement of the person) was not a 
        reasonably sufficient period in which to provide the training.
    ``(b) Inapplicability of Immunity.--Immunity under subsection (a) 
does not apply to a person if--
        ``(1) the harm involved was caused by willful or criminal 
    misconduct, gross negligence, reckless misconduct, or a conscious, 
    flagrant indifference to the rights or safety of the victim who was 
    harmed;
        ``(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.
    ``(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 defi
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brillator device that--
                ``(i) is commercially distributed in accordance with 
            the Federal Food, Drug, and Cosmetic Act;
                ``(ii) is capable of recognizing the presence or 
            absence of ventricular fibrillation, and is capable of 
            determining without intervention by the user of the device 
            whether defibrillation should be performed;
                ``(iii) upon determining that defibrillation should be 
            performed, is able to deliver an electrical shock to an 
            individual; and
                ``(iv) in the case of a defibrillator device that may 
            be operated in either an automated or a manual mode, is set 
            to operate in the automated mode.
            ``(B)(i) The term `harm' includes physical, nonphysical, 
        economic, and noneconomic losses.
            ``(ii) The term `economic loss' means any pecuniary loss 
        resulting from harm (including the loss of earnings or other 
        benefits related to employment, medical expense loss, 
        replacement services loss, loss due to death, burial costs, and 
        loss of business or employment opportunities) to the extent 
        recovery for such loss is allowed under applicable State law.
            ``(iii) The term `noneconomic losses' means losses for 
        physical and emotional pain, suffering, inconvenience, physical 
        impairment, mental anguish, disfigurement, loss of enjoyment of 
        life, loss of society and companionship, loss of consortium 
        (other than loss of domestic service), hedonic damages, injury 
        to reputation and all other nonpecuniary losses of any kind or 
        nature.''.

             Subtitle B--Rural Access to Emergency Devices

SEC. 411. SHORT TITLE.

    This subtitle may be cited as the ``Rural Access to Emergency 
Devices Act'' or the ``Rural AED Act''.

SEC. 412. FINDINGS.

    Congress makes the following findings:
        (1) Heart disease is the leading cause of death in the United 
    States.
        (2) The American Heart Association estimates that 250,000 
    Americans die from sudden cardiac arrest each year.
        (3) A cardiac arrest victim's chance of survival drops 10 
    percent for every minute that passes before his or her heart is 
    returned to normal rhythm.
        (4) Because most cardiac arrest victims are initially in 
    ventricular fibrillation, and the only treatment for ventricular 
    fibrillation is defibrillation, prompt access to defibrillation to 
    return the heart to normal rhythm is essential.
        (5) Lifesaving technology, the automated external 
    defibrillator, has been developed to allow trained lay rescuers to 
    respond to cardiac arrest by using this simple device to shock the 
    heart into normal rhythm.
        (6) Those people who are likely to be first on the scene of a 
    cardiac arrest situation in many communities, particularly smaller 
    and rural communities, lack sufficient numbers of automated 
    external defibrillators to respond to cardiac arrest in a timely 
    manner.
        (7) The American Heart Association estimates that more than 
    50,000 deaths could be prevented each year if defibrillators were 
    more widely available to designated responders.
        (8) Legislation should be enacted to encourage greater public 
    access to automated external defibrillators in communities across 
    the United States.

SEC. 413. GRANTS.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Rural Health Outreach Office of the Health Resources and 
Services Administration, shall award grants to community partnerships 
that meet the requirements of subsection (b) to enable such 
partnerships to purchase equipment and provide training as provided for 
in subsection (c).
    (b) Community Partnerships.--A community partnership meets the 
requirements of this subsection if such partnership--
        (1) is composed of local emergency response entities such as 
    community training facilities, local emergency responders, fire and 
    rescue departments, police, community hospitals, and local non-
    profit entities and for-profit entities concerned about cardiac 
    arrest survival rates;
        (2) evaluates the local community emergency response times to 
    assess whether they meet the standards established by national 
    public health organizations such as the American Heart Association 
    and the American Red Cross; and
        (3) submits to the Secretary of Health and Human Services an 
    application at such time, in such manner, and containing such 
    information as the Secretary may require.
    (c) Use of Funds.--Amounts provided under a grant under this 
section shall be used--
        (1) to purchase automated external defibrillators that have 
    been approved, or cleared for marketing, by the Food and Drug 
    Administration; and
        (2) to provide defibrillator and basic life support training in 
    automated external defibrillator usage through the American Heart 
    Association, the American Red Cross, or other nationally recognized 
    training courses.
    (d) Report.--Not later than 4 years after the date of the enactment 
of this Act, the Secretary of Health and Human Services shall prepare 
and submit to the appropriate committees of Congress a report 
containing data relating to whether the increased availability of 
defibrillators has affected survival rates in the communities in which 
grantees under this section operated. The procedures under which the 
Secretary obtains data and prepares the report under this subsection 
shall not impose an undue burden on program participants under this 
section.
    (e) Authorization of Appropriations.--There is authorized to be 
appropriated $25,000,000 for fiscal years 2001 through 2003 to carry 
out this section.

                    TITLE V--LUPUS RESEARCH AND CARE

SEC. 501. SHORT TITLE.

    This title may be cited as the ``Lupus Research and Care Amendments 
of 2000''.

SEC. 502. FINDINGS.

    The Congress finds that--
        (1) lupus is a serious, complex, inflammatory, autoimmune 
    disease of particular concern to women;
        (2) lupus affects women nine times more often than men;
        (3) there are three main types of lupus: systemic lupus, a 
    serious form of the disease that affects many parts of the body; 
    discoid lupus, a form of the disease that affects mainly the skin; 
    and drug-induced lupus caused by certain medications;
        (4) lupus can be fatal if not detected and treated early;
        (5) the disease can simultaneously affect various areas of the 
    body, such as the skin, joints, kidneys, and brain, and can be 
    difficult to diagnose because the symptoms of lupus are similar to 
    those of many other diseases;
        (6) lupus disproportionately affects African-American women, as 
    the prevalence of the disease among such women is three times the 
    prevalence among white women, and an estimated 1 in 250 African-
    American women between the ages of 15 and 65 develops the disease;
        (7) it has been estimated that between 1,400,000 and 2,000,000 
    Americans have been diagnosed with the disease, and that many more 
    have undiagnosed cases;
        (8) current treatments for the disease can be effective, but 
    may lead to damaging side effects;
        (9) many victims of the disease suffer debilitating pain and 
    fatigue, making it difficult to maintain employment and lead normal 
    lives; and
        (10) in fiscal year 1996, the amount allocated by the National 
    Institutes of Health for research on lupus was $33,000,000, which 
    is less than one-half of 1 percent of the budget for such 
    Institutes.

                     Subtitle A--Research on Lupus

SEC. 511. EXPANSION AND INTENSIFICATION OF ACTIVITIES.

    Subpart 4 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 285d et seq.) is amended by inserting after section 441 the 
following:


                                 ``lupus

   
2000
 ``Sec. 441A. (a) In General.--The Director of the Institute shall 
expand and intensify research and related activities of the Institute 
with respect to lupus.
    ``(b) Coordination With Other Institutes.--The Director of the 
Institute shall coordinate the activities of the Director under 
subsection (a) with similar activities conducted by the other national 
research institutes and agencies of the National Institutes of Health 
to the extent that such Institutes and agencies have responsibilities 
that are related to lupus.
    ``(c) Programs for Lupus.--In carrying out subsection (a), the 
Director of the Institute shall conduct or support research to expand 
the understanding of the causes of, and to find a cure for, lupus. 
Activities under such subsection shall include conducting and 
supporting the following:
        ``(1) Research to determine the reasons underlying the elevated 
    prevalence of lupus in women, including African-American women.
        ``(2) Basic research concerning the etiology and causes of the 
    disease.
        ``(3) Epidemiological studies to address the frequency and 
    natural history of the disease and the differences among the sexes 
    and among racial and ethnic groups with respect to the disease.
        ``(4) The development of improved diagnostic techniques.
        ``(5) Clinical research for the development and evaluation of 
    new treatments, including new biological agents.
        ``(6) Information and education programs for health care 
    professionals and the public.
    ``(d) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each of the fiscal years 2001 through 2003.''.

            Subtitle B--Delivery of Services Regarding Lupus

SEC. 521. ESTABLISHMENT OF PROGRAM OF GRANTS.

    (a) In General.--The Secretary of Health and Human Services shall 
in accordance with this subtitle make grants to provide for projects 
for the establishment, operation, and coordination of effective and 
cost-efficient systems for the delivery of essential services to 
individuals with lupus and their families.
    (b) Recipients of Grants.--A grant under subsection (a) may be made 
to an entity only if the entity is a public or nonprofit private 
entity, which may include a State or local government; a public or 
nonprofit private hospital, community-based organization, hospice, 
ambulatory care facility, community health center, migrant health 
center, or homeless health center; or other appropriate public or 
nonprofit private entity.
    (c) Certain Activities.--To the extent practicable and appropriate, 
the Secretary shall ensure that projects under subsection (a) provide 
services for the diagnosis and disease management of lupus. Activities 
that the Secretary may authorize for such projects may also include the 
following:
        (1) Delivering or enhancing outpatient, ambulatory, and home-
    based health and support services, including case management and 
    comprehensive treatment services, for individuals with lupus; and 
    delivering or enhancing support services for their families.
        (2) Delivering or enhancing inpatient care management services 
    that prevent unnecessary hospitalization or that expedite 
    discharge, as medically appropriate, from inpatient facilities of 
    individuals with lupus.
        (3) Improving the quality, availability, and organization of 
    health care and support services (including transportation 
    services, attendant care, homemaker services, day or respite care, 
    and providing counseling on financial assistance and insurance) for 
    individuals with lupus and support services for their families.
    (d) Integration With Other Programs.--To the extent practicable and 
appropriate, the Secretary shall integrate the program under this 
subtitle with other grant programs carried out by the Secretary, 
including the program under section 330 of the Public Health Service 
Act.

SEC. 522. CERTAIN REQUIREMENTS.

    A grant may be made under section 521 only if the applicant 
involved makes the following agreements:
        (1) Not more than 5 percent of the grant will be used for 
    administration, accounting, reporting, and program oversight 
    functions.
        (2) The grant will be used to supplement and not supplant funds 
    from other sources related to the treatment of lupus.
        (3) The applicant will abide by any limitations deemed 
    appropriate by the Secretary on any charges to individuals 
    receiving services pursuant to the grant. As deemed appropriate by 
    the Secretary, such limitations on charges may vary based on the 
    financial circumstances of the individual receiving services.
        (4) The grant will not be expended to make payment for services 
    authorized under section 521(a) to the extent that payment has been 
    made, or can reasonably be expected to be made, with respect to 
    such services--
            (A) under any State compensation program, under an 
        insurance policy, or under any Federal or State health benefits 
        program; or
            (B) by an entity that provides health services on a prepaid 
        basis.
        (5) The applicant will, at each site at which the applicant 
    provides services under section 521(a), post a conspicuous notice 
    informing individuals who receive the services of any Federal 
    policies that apply to the applicant with respect to the imposition 
    of charges on such individuals.

SEC. 523. TECHNICAL ASSISTANCE.

    The Secretary may provide technical assistance to assist entities 
in complying with the requirements of this subtitle in order to make 
such entities eligible to receive grants under section 521.

SEC. 524. DEFINITIONS.

    For purposes of this subtitle:
        (1) Official poverty line.--The term ``official poverty line'' 
    means the poverty line established by the Director of the Office of 
    Management and Budget and revised by the Secretary in accordance 
    with section 673(2) of the Omnibus Budget Reconciliation Act of 
    1981.
        (2) Secretary.--The term ``Secretary'' means the Secretary of 
    Health and Human Services.

SEC. 525. AUTHORIZATION OF APPROPRIATIONS.

    For the purpose of carrying out this subtitle, there are authorized 
to be appropriated such sums as may be necessary for each of the fiscal 
years 2001 through 2003.

           TITLE VI--PROSTATE CANCER RESEARCH AND PREVENTION

SEC. 601. SHORT TITLE.

    This title may be cited as the ``Prostate Cancer Research and 
Prevention Act''.

SEC. 602. AMENDMENTS TO THE PUBLIC HEALTH SERVICE ACT.

    (a) Preventive Health Measures.--Section 317D of the Public Health 
Service Act (42 U.S.C. 247b-5) is amended--
        (1) by striking subsection (a) and inserting the following:
    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, may make grants to 
States and local health departments for the purpose of enabling such 
States and departments to carry out programs that may include the 
following:
        ``(1) To identify factors that influence the attitudes or 
    levels of awareness of men and health care practitioners regarding 
    screening for prostate cancer.
        ``(2) To evaluate, in consultation with the Agency for Health 
    Care Policy and Research and the National Institutes of Health, the 
    effectiveness of screening strategies for prostate cancer.
        ``(3) To identify, in consultation with the Agency for Health 
    Care Policy and Research, issues related to the quality of life for 
    men after prostrate cancer screening and followup.
        ``(4) To develop and disseminate public information and 
    education programs for prostate cancer, including appropriate 
    messages about the risks and benefits of prostate cancer screening 
    for the general public, health care providers, policy makers and 
    other appropriate individuals.
        ``(5) To improve surveillance for prostate cancer.
        ``(6) To 
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address the needs of underserved and minority 
    populations regarding prostate cancer.
        ``(7) Upon a determination by the Secretary, who shall take 
    into consideration recommendations by the United States Preventive 
    Services Task Force and shall seek input, where appropriate, from 
    professional societies and other private and public entities, that 
    there is sufficient consensus on the effectiveness of prostate 
    cancer screening--
            ``(A) to screen men for prostate cancer as a preventive 
        health measure;
            ``(B) to provide appropriate referrals for the medical 
        treatment of men who have been screened under subparagraph (A) 
        and to ensure, to the extent practicable, the provision of 
        appropriate followup services and support services such as case 
        management;
            ``(C) to establish mechanisms through which State and local 
        health departments can monitor the quality of screening 
        procedures for prostate cancer, including the interpretation of 
        such procedures; and
            ``(D) to improve, in consultation with the Health Resources 
        and Services Administration, the education, training, and 
        skills of health practitioners (including appropriate allied 
        health professionals) in the detection and control of prostate 
        cancer.
        ``(8) To evaluate activities conducted under paragraphs (1) 
    through (7) through appropriate surveillance or program monitoring 
    activities.''; and
        (2) in subsection (l)(1), by striking ``1998'' and inserting 
    ``2004''.
    (b) National Institutes of Health.--Section 417B(c) of the Public 
Health Service Act (42 U.S.C. 286a-8(c)) is amended by striking ``and 
1996'' and inserting ``through 2004''.

               TITLE VII--ORGAN PROCUREMENT AND DONATION

SEC. 701. ORGAN PROCUREMENT ORGANIZATION CERTIFICATION.

    (a) Short Title.--This section may be cited as the ``Organ 
Procurement Organization Certification Act of 2000''.
    (b) Findings.--Congress makes the following findings:
        (1) Organ procurement organizations play an important role in 
    the effort to increase organ donation in the United States.
        (2) The current process for the certification and 
    recertification of organ procurement organizations conducted by the 
    Department of Health and Human Services has created a level of 
    uncertainty that is interfering with the effectiveness of organ 
    procurement organizations in raising the level of organ donation.
        (3) The General Accounting Office, the Institute of Medicine, 
    and the Harvard School of Public Health have identified substantial 
    limitations in the organ procurement organization certification and 
    recertification process and have recommended changes in that 
    process.
        (4) The limitations in the recertification process include:
            (A) An exclusive reliance on population-based measures of 
        performance that do not account for the potential in the 
        population for organ donation and do not permit consideration 
        of other outcome and process standards that would more 
        accurately reflect the relative capability and performance of 
        each organ procurement organization.
            (B) A lack of due process to appeal to the Secretary of 
        Health and Human Services for recertification on either 
        substantive or procedural grounds.
        (5) The Secretary of Health and Human Services has the 
    authority under section 1138(b)(1)(A)(i) of the Social Security Act 
    (42 U.S.C. 1320b-8(b)(1)(A)(i)) to extend the period for 
    recertification of an organ procurement organization from 2 to 4 
    years on the basis of its past practices in order to avoid the 
    inappropriate disruption of the nation's organ system.
        (6) The Secretary of Health and Human Services can use the 
    extended period described in paragraph (5) for recertification of 
    all organ procurement organizations to--
            (A) develop improved performance measures that would 
        reflect organ donor potential and interim outcomes, and to test 
        these measures to ensure that they accurately measure 
        performance differences among the organ procurement 
        organizations; and
            (B) improve the overall certification process by 
        incorporating process as well as outcome performance measures, 
        and developing equitable processes for appeals.
    (c) Certification and Recertification of Organ Procurement 
Organizations.--Section 371(b)(1) of the Public Health Service Act (42 
U.S.C. 273(b)(1)) is amended--
        (1) by redesignating subparagraphs (D) through (G) as 
    subparagraphs (E) through (H), respectively;
        (2) by realigning the margin of subparagraph (F) (as so 
    redesignated) so as to align with subparagraph (E) (as so 
    redesignated); and
        (3) by inserting after subparagraph (C) the following:
        ``(D) notwithstanding any other provision of law, has met the 
    other requirements of this section and has been certified or 
    recertified by the Secretary within the previous 4-year period as 
    meeting the performance standards to be a qualified organ 
    procurement organization through a process that either--
            ``(i) granted certification or recertification within such 
        4-year period with such certification or recertification in 
        effect as of January 1, 2000, and remaining in effect through 
        the earlier of--
                ``(I) January 1, 2002; or
                ``(II) the completion of recertification under the 
            requirements of clause (ii); or
            ``(ii) is defined through regulations that are promulgated 
        by the Secretary by not later than January 1, 2002, that--
                ``(I) require recertifications of qualified organ 
            procurement organizations not more frequently than once 
            every 4 years;
                ``(II) rely on outcome and process performance measures 
            that are based on empirical evidence, obtained through 
            reasonable efforts, of organ donor potential and other 
            related factors in each service area of qualified organ 
            procurement organizations;
                ``(III) use multiple outcome measures as part of the 
            certification process; and
                ``(IV) provide for a qualified organ procurement 
            organization to appeal a decertification to the Secretary 
            on substantive and procedural grounds;''.

SEC. 702. DESIGNATION OF GIVE THANKS, GIVE LIFE DAY.

    (a) Findings.--Congress finds that--
        (1) traditionally, Thanksgiving is a time for families to take 
    time out of their busy lives to come together and to give thanks 
    for the many blessings in their lives;
        (2) approximately 21,000 men, women, and children in the United 
    States are given the gift of life each year through transplantation 
    surgery, made possible by the generosity of organ and tissue 
    donations;
        (3) more than 66,000 Americans are awaiting their chance to 
    prolong their lives by finding a matching donor;
        (4) nearly 5,000 of these patients each year (or 13 patients 
    each day) die while waiting for a donated heart, liver, kidney, or 
    other organ;
        (5) nationwide there are up to 15,000 potential donors 
    annually, but families' consent to donation is received for less 
    than 6,000;
        (6) the need for organ donations greatly exceeds the supply 
    available;
        (7) designation as an organ donor on a driver's license or 
    voter's registration is a valuable step, but does not ensure 
    donation when an occasion arises;
        (8) the demand for transplantation will likely increase in the 
    coming years due to the growing safety of transplantation surgery 
    due to improvements in technology and drug developments, prolonged 
    life expectancy, and increased prevalence of diseases that may
16a4
 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.

         TITLE VIII--ALZHEIMER'S CLINICAL RESEARCH AND TRAINING

SEC. 801. ALZHEIMER'S CLINICAL RESEARCH AND TRAINING AWARDS.

    Subpart 5 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 285e et seq.) is amended--
        (1) by redesignating section 445I as section 445J; and
        (2) by inserting after section 445H the following:

``SEC. 445I. ALZHEIMER'S CLINICAL RESEARCH AND TRAINING AWARDS.

    ``(a) In General.--The Director of the Institute is authorized to 
establish and maintain a program to enhance and promote the translation 
of new scientific knowledge into clinical practice related to the 
diagnosis, care and treatment of individuals with Alzheimer's disease.
    ``(b) Support of Promising Clinicians.--In order to foster the 
application of the most current developments in the etiology, 
pathogenesis, diagnosis, prevention and treatment of Alzheimer's 
disease, amounts made available under this section shall be directed to 
the support of promising clinicians through awards for research, study, 
and practice at centers of excellence in Alzheimer's disease research 
and treatment.
    ``(c) Excellence in Certain Fields.--Research shall be carried out 
under awards made under subsection (b) in environments of demonstrated 
excellence in neuroscience, neurobiology, geriatric medicine, and 
psychiatry and shall foster innovation and integration of such 
disciplines or other environments determined suitable by the Director 
of the Institute.
    ``(d) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $2,250,000 
for fiscal year 2001, and such sums as may be necessary for each of 
fiscal years 2002 through 2005.''.

 TITLE IX--SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH AND TRAINING

SEC. 901. SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH AND TRAINING 
              AWARDS.

    Subpart 6 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 285f et seq.) is amended by adding at the end the following:

``SEC. 447B. SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH AND 
              TRAINING AWARDS.

    ``(a) In General.--The Director of the Institute is authorized to 
establish and maintain a program to enhance and promote the translation 
of new scientific knowledge into clinical practice related to the 
diagnosis, care and treatment of individuals with sexually transmitted 
diseases.
    ``(b) Support of Promising Clinicians.--In order to foster the 
application of the most current developments in the etiology, 
pathogenesis, diagnosis, prevention and treatment of sexually 
transmitted diseases, amounts made available under this section shall 
be directed to the support of promising clinicians through awards for 
research, study, and practice at centers of excellence in sexually 
transmitted disease research and treatment.
    ``(c) Excellence in Certain Fields.--Research shall be carried out 
under awards made under subsection (b) in environments of demonstrated 
excellence in the etiology and pathogenesis of sexually transmitted 
diseases and shall foster innovation and integration of such 
disciplines or other environments determined suitable by the Director 
of the Institute.
    ``(d) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $2,250,000 
for fiscal year 2001, and such sums as may be necessary for each of 
fiscal years 2002 through 2005.''.

                    TITLE X--MISCELLANEOUS PROVISION

SEC. 1001. TECHNICAL CORRECTION TO THE CHILDREN'S HEALTH ACT OF 2000.

    (a) In General.--Section 2701 of the Children's Health Act of 2000 
is amended by striking ``part 45 of title 46'' and inserting ``part 46 
of title 45''.
    (b) Effective Date.--The amendment made by subsection (a) takes 
effect on the date of the enactment of the Children's Health Act of 
2000.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.

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