```

[106th Congress Public Law 505]
[From the U.S. Government Printing Office]

<DOC>
[DOCID: f:publ505.106]

[[Page 114 STAT. 2314]]

Public Law 106-505
106th Congress

                                 An Act

 
To amend the Public Health Service Act to provide for recommendations of 
 the Secretary of Health and Human Services regarding the placement of 
   automatic external defibrillators in Federal buildings in order to 
 improve survival rates of individuals who experience cardiac arrest in 
   such buildings, and to establish protections from civil liability 
    arising from the emergency use of the devices. <<NOTE: Nov. 13, 
                         2000 -  [H.R. 2498]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress <<NOTE: Public Health Improvement 
Act.>> assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS. <<NOTE: 42 USC 201 note.>> 

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

Sec. 1. Short title; table of contents.

               TITLE I--EMERGING THREATS TO PUBLIC HEALTH

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

                 TITLE II--CLINICAL RESEARCH ENHANCEMENT

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

              TITLE III--RESEARCH LABORATORY INFRASTRUCTURE

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

                    TITLE IV--CARDIAC ARREST SURVIVAL

            Subtitle A--Recommendations for Federal Buildings

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

              Subtitle B--Rural Access to Emergency Devices

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

[[Page 114 STAT. 2315]]

                    TITLE V--LUPUS RESEARCH AND CARE

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

                      Subtitle A--Research on Lupus

Sec. 511. Expansion and intensification of activities.

            Subtitle B--Delivery of Services Regarding Lupus

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

            TITLE VI--PROSTATE CANCER RESEARCH AND PREVENTION

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

                TITLE VII--ORGAN PROCUREMENT AND DONATION

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

         TITLE VIII--ALZHEIMER'S CLINICAL RESEARCH AND TRAINING

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

  TITLE IX--SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH AND TRAINING

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

                    TITLE X--MISCELLANEOUS PROVISION

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

 TITLE <<NOTE: Public Health Threats and Emergencies Act.>> I--EMERGING 
THREATS TO PUBLIC HEALTH

SEC. <<NOTE: 42 USC 201 note.>> 101. SHORT TITLE.

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

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

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

``SEC. <<NOTE: 42 USC 247d.>> 319. PUBLIC HEALTH EMERGENCIES.

    ``(a) Emergencies.--If the Secretary determines, after consultation 
with such public health officials as may be necessary, that--
            ``(1) a disease or disorder presents a public health 
        emergency; or
            ``(2) a public health emergency, including significant 
        outbreaks of infectious diseases or bioterrorist attacks, 
        otherwise exists,

the Secretary may take such action as may be appropriate to respond to 
the public health emergency, including making grants and entering into 
contracts and conducting and supporting investigations into the cause, 
treatment, or prevention of a disease or disorder as described in 
paragraphs (1) and (2).
    ``(b) Public Health Emergency Fund.--
            ``(1) In general.--There is established in the Treasury a 
        fund to be designated as the `Public Health Emergency Fund'

[[Page 114 STAT. 2316]]

        to be made available to the Secretary without fiscal year 
        limitation to carry out subsection (a) only if a public health 
        emergency has been declared by the Secretary under such 
        subsection. There is authorized to be appropriated to the Fund 
        such sums as may be necessary.
            ``(2) <<NOTE: Deadline.>> Report.--Not later than 90 days 
        after the end of each fiscal year, the Secretary shall prepare 
        and submit to the Committee on Health, Education, Labor, and 
        Pensions and the Committee on Appropriations of the Senate and 
        the Committee on Commerce and the Committee on Appropriations of 
        the House of Representatives a report describing--
                    ``(A) the expenditures made from the Public Health 
                Emergency Fund in such fiscal year; and
                    ``(B) each public health emergency for which the 
                expenditures were made and the activities undertaken 
                with respect to each emergency which was conducted or 
                supported by expenditures from the Fund.

    ``(c) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other Federal, 
State, and local public funds provided for activities under this 
section.

``SEC. <<NOTE: 42 USC 247d-1.>> 319A. NATIONAL NEEDS TO COMBAT THREATS 
            TO PUBLIC HEALTH.

    ``(a) Capacities.--
            ``(1) In <<NOTE: Deadline.>> general.--Not later than 1 year 
        after the date of the enactment of this section, the Secretary, 
        and such Administrators, Directors, or Commissioners, as may be 
        appropriate, and in collaboration with State and local health 
        officials, shall establish reasonable capacities that are 
        appropriate for national, State, and local public health systems 
        and the personnel or work forces of such systems. Such 
        capacities shall be revised every 10 years, or more frequently 
        as the Secretary determines to be necessary.
            ``(2) Basis.--The capacities established under paragraph (1) 
        shall improve, enhance or expand the capacity of national, State 
        and local public health agencies to detect and respond 
        effectively to significant public health threats, including 
        major outbreaks of infectious disease, pathogens resistant to 
        antimicrobial agents and acts of bioterrorism. Such capacities 
        may include the capacity to--
                    ``(A) recognize the clinical signs and 
                epidemiological characteristic of significant outbreaks 
                of infectious disease;
                    ``(B) identify disease-causing pathogens rapidly and 
                accurately;
                    ``(C) develop and implement plans to provide medical 
                care for persons infected with disease-causing agents 
                and to provide preventive care as needed for individuals 
                likely to be exposed to disease-causing agents;
                    ``(D) communicate information relevant to 
                significant public health threats rapidly to local, 
                State and national health agencies, and health care 
                providers; or
                    ``(E) develop or implement policies to prevent the 
                spread of infectious disease or antimicrobial 
                resistance.

    ``(b) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other

[[Page 114 STAT. 2317]]

Federal, State, and local public funds provided for activities under 
this section.
    ``(c) Technical Assistance.--The Secretary shall provide technical 
assistance to the States to assist such States in fulfilling the 
requirements of this section.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $4,000,000 for fiscal year 2001, 
and such sums as may be necessary for each subsequent fiscal year 
through 2006.

``SEC. <<NOTE: 42 USC 247d-2.>> 319B. ASSESSMENT OF PUBLIC HEALTH NEEDS.

    ``(a) Program <<NOTE: Deadline.>> Authorized.--Not later than 1 year 
after the date of the enactment of this section and every 10 years 
thereafter, the Secretary shall award grants to States, or consortia of 
two or more States or political subdivisions of States, to perform, in 
collaboration with local public health agencies, an evaluation to 
determine the extent to which the States or local public health agencies 
can achieve the capacities applicable to State and local public health 
agencies described in subsection (a) of section 319A. The Secretary 
shall provide technical assistance to States, or consortia of two or 
more States or political subdivisions of States, in addition to awarding 
such grants.

    ``(b) Procedure.--
            ``(1) In general.--A State, or a consortium of two or more 
        States or political subdivisions of States, may contract with an 
        outside entity to perform the evaluation described in subsection 
        (a).
            ``(2) Methods.--To the extent practicable, the evaluation 
        described in subsection (a) shall be completed by using methods, 
        to be developed by the Secretary in collaboration with State and 
        local health officials, that facilitate the comparison of 
        evaluations conducted by a State to those conducted by other 
        States receiving funds under this section.

    ``(c) <<NOTE: Deadline.>> Report.--Not later than 1 year after the 
date on which a State, or a consortium of two or more States or 
political subdivisions of States, receives a grant under this 
subsection, such State, or a consortium of two or more States or 
political subdivisions of States, shall prepare and submit to the 
Secretary a report describing the results of the evaluation described in 
subsection (a) with respect to such State, or consortia of two or more 
States or political subdivisions of States.

    ``(d) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other Federal, 
State, and local public funds provided for activities under this 
section.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $45,000,000 for fiscal year 2001, 
and such sums as may be necessary for each subsequent fiscal year 
through 2003.

``SEC. <<NOTE: 42 USC 247d-3.>> 319C. GRANTS TO IMPROVE STATE AND LOCAL 
            PUBLIC HEALTH AGENCIES.

    ``(a) Program Authorized.--The Secretary shall award competitive 
grants to eligible entities to address core public health capacity needs 
using the capacities developed under section 319A, with a particular 
focus on building capacity to identify, detect, monitor, and respond to 
threats to the public health.

[[Page 114 STAT. 2318]]

    ``(b) Eligible Entities.--A State or political subdivision of a 
State, or a consortium of two or more States or political subdivisions 
of States, that has completed an evaluation under section 319B(a), or an 
evaluation that is substantially equivalent as determined by the 
Secretary under section 319B(a), shall be eligible for grants under 
subsection (a).
    ``(c) Use of Funds.--An eligible entity that receives a grant under 
subsection (a), may use funds received under such grant to--
            ``(1) train public health personnel;
            ``(2) develop, enhance, coordinate, or improve participation 
        in an electronic network by which disease detection and public 
        health related information can be rapidly shared among national, 
        regional, State, and local public health agencies and health 
        care providers;
            ``(3) develop a plan for responding to public health 
        emergencies, including significant outbreaks of infectious 
        diseases or bioterrorism attacks, which is coordinated with the 
        capacities of applicable national, State, and local health 
        agencies and health care providers; and
            ``(4) enhance laboratory capacity and facilities.

    ``(d) Report.--No <<NOTE: Deadline.>> later than January 1, 2005, 
the Secretary shall prepare and submit to the Committee on Health, 
Education, Labor, and Pensions and the Committee on Appropriations of 
the Senate and the Committee on Commerce and the Committee on 
Appropriations of the House of Representatives a report that describes 
the activities carried out under sections 319A, 319B, and 319C.

    ``(e) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other Federal, 
State, and local public funds provided for activities under this 
section.
    ``(f ) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $50,000,000 for fiscal year 2001, 
and such sums as may be necessary for each subsequent fiscal year 
through 2006.

``SEC. 319D. <<NOTE: 42 USC 247d-4.>> REVITALIZING THE CENTERS FOR 
            DISEASE CONTROL AND PREVENTION.

    ``(a) Findings.--Congress finds that the Centers for Disease Control 
and Prevention have an essential role in defending against and 
combatting public health threats of the 21st century and requires secure 
and modern facilities that are sufficient to enable such Centers to 
conduct this important mission.
    ``(b) Authorization of Appropriations.--For the purposes of 
achieving the mission of the Centers for Disease Control and Prevention 
described in subsection (a), for constructing new facilities and 
renovating existing facilities of such Centers, including laboratories, 
laboratory support buildings, health communication facilities, office 
buildings and other facilities and infrastructure, for better conducting 
the capacities described in section 319A, and for supporting related 
public health activities, there are authorized to be appropriated 
$180,000,000 for fiscal year 2001, and such sums as may be necessary for 
each subsequent fiscal year through 2010.

``SEC. 319E. <<NOTE: 42 USC 247d-5.>> COMBATING ANTIMICROBIAL 
            RESISTANCE.

    ``(a) Task Force.--

[[Page 114 STAT. 2319]]

            ``(1) In <<NOTE: Establishment.>> general.--The Secretary 
        shall establish an Antimicrobial Resistance Task Force to 
        provide advice and recommendations to the Secretary and 
        coordinate Federal programs relating to antimicrobial 
        resistance. The Secretary may appoint or select a committee, or 
        other organization in existence as of the date of the enactment 
        of this section, to serve as such a task force, if such 
        committee, or other organization meets the requirements of this 
        section.
            ``(2) Members of task force.--The task force described in 
        paragraph (1) shall be composed of representatives from such 
        Federal agencies, and shall seek input from public health 
        constituencies, manufacturers, veterinary and medical 
        professional societies and others, as determined to be necessary 
        by the Secretary, to develop and implement a comprehensive plan 
        to address the public health threat of antimicrobial resistance.
            ``(3) Agenda.--
                    ``(A) In general.--The task force described in 
                paragraph (1) shall consider factors the Secretary 
                considers appropriate, including--
                          ``(i) public health factors contributing to 
                      increasing antimicrobial resistance;
                          ``(ii) public health needs to detect and 
                      monitor antimicrobial resistance;
                          ``(iii) detection, prevention, and control 
                      strategies for resistant pathogens;
                          ``(iv) the need for improved information and 
                      data collection;
                          ``(v) the assessment of the risk imposed by 
                      pathogens presenting a threat to the public 
                      health; and
                          ``(vi) any other issues which the Secretary 
                      determines are relevant to antimicrobial 
                      resistance.
                    ``(B) Detection and control.--The Secretary, in 
                consultation with the task force described in paragraph 
                (1) and State and local public health officials, shall--
                          ``(i) develop, improve, coordinate or enhance 
                      participation in a surveillance plan to detect and 
                      monitor emerging antimicrobial resistance; and
                          ``(ii) develop, improve, coordinate or enhance 
                      participation in an integrated information system 
                      to assimilate, analyze, and exchange antimicrobial 
                      resistance data between public health departments.
            ``(4) Meetings.--The task force described under paragraph 
        (1) shall convene not less than twice a year, or more frequently 
        as the Secretary determines to be appropriate.

    ``(b) Research and Development of New Antimicrobial Drugs and 
Diagnostics.--The Secretary and the Director of Agricultural Research 
Services, consistent with the recommendations of the task force 
established under subsection (a), shall conduct and support research, 
investigations, experiments, demonstrations, and studies in the health 
sciences that are related to--
            ``(1) the development of new therapeutics, including 
        vaccines and antimicrobials, against resistant pathogens;
            ``(2) the development or testing of medical diagnostics to 
        detect pathogens resistant to antimicrobials;
            ``(3) the epidemiology, mechanisms, and pathogenesis of 
        antimicrobial resistance;

[[Page 114 STAT. 2320]]

            ``(4) the sequencing of the genomes of priority pathogens as 
        determined by the Director of the National Institutes of Health 
        in consultation with the task force established under subsection 
        (a); and
            ``(5) other relevant research areas.

    ``(c) Education of Medical and Public Health Personnel.--The 
Secretary, after consultation with the Assistant Secretary for Health, 
the Surgeon General, the Director of the Centers for Disease Control and 
Prevention, the Administrator of the Health Resources and Services 
Administration, the Director of the Agency for Healthcare Research and 
Quality, members of the task force described in subsection (a), 
professional organizations and societies, and such other public health 
officials as may be necessary, shall--
            ``(1) develop and implement educational programs to increase 
        the awareness of the general public with respect to the public 
        health threat of antimicrobial resistance and the appropriate 
        use of antibiotics;
            ``(2) develop and implement educational programs to instruct 
        health care professionals in the prudent use of antibiotics; and
            ``(3) develop and implement programs to train laboratory 
        personnel in the recognition or identification of resistance in 
        pathogens.

    ``(d) Grants.--
            ``(1) In general.--The Secretary shall award competitive 
        grants to eligible entities to enable such entities to increase 
        the capacity to detect, monitor, and combat antimicrobial 
        resistance.
            ``(2) Eligible entities.--Eligible entities for grants under 
        paragraph (1) shall be State or local public health agencies, 
        Indian tribes or tribal organizations, or other public or 
        private nonprofit entities.
            ``(3) Use of funds.--An eligible entity receiving a grant 
        under paragraph (1) shall use funds from such grant for 
        activities that are consistent with the factors identified by 
        the task force under subsection (a)(3), which may include 
        activities that--
                    ``(A) provide training to enable such entity to 
                identify patterns of resistance rapidly and accurately;
                    ``(B) develop, improve, coordinate or enhance 
                participation in information systems by which data on 
                resistant infections can be shared rapidly among 
                relevant national, State, and local health agencies and 
                health care providers; and
                    ``(C) develop and implement policies to control the 
                spread of antimicrobial resistance.

    ``(e) Grants for Demonstration Programs.--
            ``(1) In general.--The Secretary shall award competitive 
        grants to eligible entities to establish demonstration programs 
        to promote judicious use of antimicrobial drugs or control the 
        spread of antimicrobial-resistant pathogens.
            ``(2) Eligible entities.--Eligible entities for grants under 
        paragraph (1) may include hospitals, clinics, institutions of 
        long-term care, professional medical societies, or other public 
        or private nonprofit entities.

[[Page 114 STAT. 2321]]

            ``(3) Technical assistance.--The Secretary shall provide 
        appropriate technical assistance to eligible entities that 
        receive grants under paragraph (1).

    ``(f ) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other Federal, 
State, and local public funds provided for activities under this 
section.
    ``(g) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section, $40,000,000 for fiscal year 
2001, and such sums as may be necessary for each subsequent fiscal year 
through 2006.

``SEC. 319F. <<NOTE: 42 USC 247d-6.>> PUBLIC HEALTH COUNTERMEASURES TO A 
            BIOTERRORIST ATTACK.

    ``(a) Working Group on Preparedness for Acts of Bioterrorism.--The 
Secretary, in coordination with the Secretary of Defense, shall 
establish a joint interdepartmental working group on preparedness and 
readiness for the medical and public health effects of a bioterrorist 
attack on the civilian population. Such joint working group shall--
            ``(1) coordinate research on pathogens likely to be used in 
        a bioterrorist attack on the civilian population as well as 
        therapies to treat such pathogens;
            ``(2) coordinate research and development into equipment to 
        detect pathogens likely to be used in a bioterrorist attack on 
        the civilian population and protect against infection from such 
        pathogens;
            ``(3) develop shared standards for equipment to detect and 
        to protect against infection from pathogens likely to be used in 
        a bioterrorist attack on the civilian population; and
            ``(4) coordinate the development, maintenance, and 
        procedures for the release of, strategic reserves of vaccines, 
        drugs, and medical supplies which may be needed rapidly after a 
        bioterrorist attack upon the civilian population.

    ``(b) Working Group on the Public Health and Medical Consequences of 
Bioterrorism.--
            ``(1) In general.--The Secretary, in collaboration with the 
        Director of the Federal Emergency Management Agency, the 
        Attorney General, and the Secretary of Agriculture, shall 
        establish a joint interdepartmental working group to address the 
        public health and medical consequences of a bioterrorist attack 
        on the civilian population.
            ``(2) Functions.--Such working group shall--
                    ``(A) assess the priorities for and enhance the 
                preparedness of public health institutions, providers of 
                medical care, and other emergency service personnel to 
                detect, diagnose, and respond to a bioterrorist attack; 
                and
                    ``(B) in the recognition that medical and public 
                health professionals are likely to provide much of the 
                first response to such an attack, develop, coordinate, 
                enhance, and assure the quality of joint planning and 
                training programs that address the public health and 
                medical consequences of a bioterrorist attack on the 
                civilian population between--
                          ``(i) local firefighters, ambulance personnel, 
                      police and public security officers, or other 
                      emergency response personnel; and

[[Page 114 STAT. 2322]]

                          ``(ii) hospitals, primary care facilities, and 
                      public health agencies.
            ``(3) Working group membership.--In establishing such 
        working group, the Secretary shall act through the Assistant 
        Secretary for Health and the Director of the Centers for Disease 
        Control and Prevention.
            ``(4) Coordination.--The Secretary shall ensure coordination 
        and communication between the working groups established in this 
        subsection and subsection (a).

    ``(c) Grants.--
            ``(1) In general.--The Secretary, in coordination with the 
        working group established under subsection (b), shall, on a 
        competitive basis and following scientific or technical review, 
        award grants to or enter into cooperative agreements with 
        eligible entities to enable such entities to increase their 
        capacity to detect, diagnose, and respond to acts of 
        bioterrorism upon the civilian population.
            ``(2) Eligibility.--To be an eligible entity under this 
        subsection, such entity must be a State, political subdivision 
        of a State, a consortium of two or more States or political 
        subdivisions of States, or a hospital, clinic, or primary care 
        facility.
            ``(3) Use of funds.--An entity that receives a grant under 
        this subsection shall use such funds for activities that are 
        consistent with the priorities identified by the working group 
        under subsection (b), including--
                    ``(A) training health care professionals and public 
                health personnel to enhance the ability of such 
                personnel to recognize the symptoms and epidemiological 
                characteristics of exposure to a potential bioweapon;
                    ``(B) addressing rapid and accurate identification 
                of potential bioweapons;
                    ``(C) coordinating medical care for individuals 
                exposed to bioweapons; and
                    ``(D) facilitating and coordinating rapid 
                communication of data generated from a bioterrorist 
                attack between national, State, and local health 
                agencies, and health care providers.
            ``(4) Coordination.--The Secretary, in awarding grants under 
        this subsection, shall--
                    ``(A) notify the Director of the Office of Justice 
                Programs, and the Director of the National Domestic 
                Preparedness Office annually as to the amount and status 
                of grants awarded under this subsection; and
                    ``(B) coordinate grants awarded under this 
                subsection with grants awarded by the Office of 
                Emergency Preparedness and the Centers for Disease 
                Control and Prevention for the purpose of improving the 
                capacity of health care providers and public health 
                agencies to respond to bioterrorist attacks on the 
                civilian population.
            ``(5) Activities.--An entity that receives a grant under 
        this subsection shall, to the greatest extent practicable, 
        coordinate activities carried out with such funds with the 
        activities of a local Metropolitan Medical Response System.

    ``(d) Federal Assistance.--The Secretary shall ensure that the 
Department of Health and Human Services is able to provide such 
assistance as may be needed to State and local health agencies to enable 
such agencies to respond effectively to bioterrorist attacks.

[[Page 114 STAT. 2323]]

    ``(e) Education.--The Secretary, in collaboration with members of 
the working group described in subsection (b), and professional 
organizations and societies, shall--
            ``(1) develop and implement educational programs to instruct 
        public health officials, medical professionals, and other 
        personnel working in health care facilities in the recognition 
        and care of victims of a bioterrorist attack; and
            ``(2) develop and implement programs to train laboratory 
        personnel in the recognition and identification of a potential 
        bioweapon.

    ``(f ) Future Resource Development.--The Secretary shall consult 
with the working group described in subsection (a), to develop 
priorities for and conduct research, investigations, experiments, 
demonstrations, and studies in the health sciences related to--
            ``(1) the epidemiology and pathogenesis of potential 
        bioweapons;
            ``(2) the development of new vaccines or other therapeutics 
        against pathogens likely to be used in a bioterrorist attack;
            ``(3) the development of medical diagnostics to detect 
        potential bioweapons; and
            ``(4) other relevant research areas.

    ``(g) General <<NOTE: Deadline.>> Accounting Office Report.--Not 
later than 180 days after the date of the enactment of this section, the 
Comptroller General shall submit to the Committee on Health, Education, 
Labor, and Pensions and the Committee on Appropriations of the Senate 
and the Committee on Commerce and the Committee on Appropriations of the 
House of Representatives a report that describes--
            ``(1) Federal activities primarily related to research on, 
        preparedness for, and the management of the public health and 
        medical consequences of a bioterrorist attack against the 
        civilian population;
            ``(2) the coordination of the activities described in 
        paragraph (1);
            ``(3) the amount of Federal funds authorized or appropriated 
        for the activities described in paragraph (1); and
            ``(4) the effectiveness of such efforts in preparing 
        national, State, and local authorities to address the public 
        health and medical consequences of a potential bioterrorist 
        attack against the civilian population.

    ``(h) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other Federal, 
State, and local public funds provided for activities under this 
section.
    ``(i) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $215,000,000 for fiscal year 
2001, and such sums as may be necessary for each subsequent fiscal year 
through 2006.

``SEC. 319G. <<NOTE: 42 USC 247d-7.>> DEMONSTRATION PROGRAM TO ENHANCE 
            BIOTERRORISM TRAINING, COORDINATION, AND READINESS.

    ``(a) In General.--The Secretary shall make grants to not more than 
three eligible entities to carry out demonstration programs to improve 
the detection of pathogens likely to be used in a bioterrorist attack, 
the development of plans and measures to respond to bioterrorist 
attacks, and the training of personnel

[[Page 114 STAT. 2324]]

involved with the various responsibilities and capabilities needed to 
respond to acts of bioterrorism upon the civilian population. Such 
awards shall be made on a competitive basis and pursuant to scientific 
and technical review.
    ``(b) Eligible Entities.--Eligible entities for grants under 
subsection (a) are States, political subdivisions of States, and public 
or private non-profit organizations.
    ``(c) Specific Criteria.--In making grants under subsection (a), the 
Secretary shall take into account the following factors:
            ``(1) Whether the eligible entity involved is proximate to, 
        and collaborates with, a major research university with 
        expertise in scientific training, identification of biological 
        agents, medicine, and life sciences.
            ``(2) Whether the entity is proximate to, and collaborates 
        with, a laboratory that has expertise in the identification of 
        biological agents.
            ``(3) Whether the entity demonstrates, in the application 
        for the program, support and participation of State and local 
        governments and research institutions in the conduct of the 
        program.
            ``(4) Whether the entity is proximate to, and collaborates 
        with, or is, an academic medical center that has the capacity to 
        serve an uninsured or underserved population, and is equipped to 
        educate medical personnel.
            ``(5) Such other factors as the Secretary determines to be 
        appropriate.

    ``(d) Duration of Award.--The period during which payments are made 
under a grant under subsection (a) may not exceed 5 years. The provision 
of such payments shall be subject to annual approval by the Secretary of 
the payments and subject to the availability of appropriations for the 
fiscal year involved to make the payments.
    ``(e) Supplement Not Supplant.--Grants under subsection (a) shall be 
used to supplement, and not supplant, other Federal, State, or local 
public funds provided for the activities described in such subsection.
    ``(f ) General <<NOTE: Deadline.>> Accounting Office Report.--Not 
later than 180 days after the conclusion of the demonstration programs 
carried out under subsection (a), the Comptroller General of the United 
States shall submit to the Committee on Health, Education, Labor, and 
Pensions and the Committee on Appropriations of the Senate, and the 
Committee on Commerce and the Committee on Appropriations of the House 
of Representatives, a report that describes the ability of grantees 
under such subsection to detect pathogens likely to be used in a 
bioterrorist attack, develop plans and measures for dealing with such 
threats, and train personnel involved with the various responsibilities 
and capabilities needed to deal with bioterrorist threats.

    ``(g) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section $6,000,000 for fiscal year 2001, 
and such sums as may be necessary through fiscal year 2006.''.

[[Page 114 STAT. 2325]]

TITLE <<NOTE: Clinical Research Enhancement Act of 2000.>> II--CLINICAL 
RESEARCH ENHANCEMENT

SEC. <<NOTE: 42 USC 201 note.>> 201. SHORT TITLE.

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

SEC. <<NOTE: 42 USC 284k note.>> 202. FINDINGS AND PURPOSE.

    (a) Findings.--Congress makes the following findings:
            (1) Clinical research is critical to the advancement of 
        scientific knowledge and to the development of cures and 
        improved treatment for disease.
            (2) Tremendous advances in biology are opening doors to new 
        insights into human physiology, pathophysiology and disease, 
        creating extraordinary opportunities for clinical research.
            (3) Clinical research includes translational research which 
        is an integral part of the research process leading to general 
        human applications. It is the bridge between the laboratory and 
        new methods of diagnosis, treatment, and prevention and is thus 
        essential to progress against cancer and other diseases.
            (4) The United States will spend more than 
        $1,200,000,000,000 on health care in 1999, but the Federal 
        budget for health research at the National Institutes of Health 
        was $15,600,000,000 only 1 percent of that total.
            (5) Studies at the Institute of Medicine, the National 
        Research Council, and the National Academy of Sciences have all 
        addressed the current problems in clinical research.
            (6) The Director of the National Institutes of Health has 
        recognized the current problems in clinical research and 
        appointed a special panel, which recommended expanded support 
        for existing National Institutes of Health clinical research 
        programs and the creation of new initiatives to recruit and 
        retain clinical investigators.
            (7) The current level of training and support for health 
        professionals in clinical research is fragmented, undervalued, 
        and underfunded.
            (8) Young investigators are not only apprentices for future 
        positions but a crucial source of energy, enthusiasm, and ideas 
        in the day-to-day research that constitutes the scientific 
        enterprise. Serious questions about the future of life-science 
        research are raised by the following:
                    (A) The number of young investigators applying for 
                grants dropped by 54 percent between 1985 and 1993.
                    (B) The number of physicians applying for first-time 
                National Institutes of Health research project grants 
                fell from 1226 in 1994 to 963 in 1998, a 21 percent 
                reduction.
                    (C) Newly independent life-scientists are expected 
                to raise funds to support their new research programs 
                and a substantial proportion of their own salaries.
            (9) The following have been cited as reasons for the decline 
        in the number of active clinical researchers, and those choosing 
        this career path:
                    (A) A medical school graduate incurs an average debt 
                of $85,619, as reported in the Medical School Graduation 
                Questionnaire by the Association of American Medical 
                Colleges (AAMC).

[[Page 114 STAT. 2326]]

                    (B) The prolonged period of clinical training 
                required increases the accumulated debt burden.
                    (C) The decreasing number of mentors and role 
                models.
                    (D) The perceived instability of funding from the 
                National Institutes of Health and other Federal 
                agencies.
                    (E) The almost complete absence of clinical research 
                training in the curriculum of training grant awardees.
                    (F) Academic Medical Centers are experiencing 
                difficulties in maintaining a proper environment for 
                research in a highly competitive health care 
                marketplace, which are compounded by the decreased 
                willingness of third party payers to cover health care 
                costs for patients engaged in research studies and 
                research procedures.
            (10) In 1960, general clinical research centers were 
        established under the Office of the Director of the National 
        Institutes of Health with an initial appropriation of 
        $3,000,000.
            (11) Appropriations for general clinical research centers in 
        fiscal year 1999 equaled $200,500,000.
            (12) Since the late 1960s, spending for general clinical 
        research centers has declined from approximately 3 percent to 1 
        percent of the National Institutes of Health budget.
            (13) In fiscal year 1999, there were 77 general clinical 
        research centers in operation, supplying patients in the areas 
        in which such centers operate with access to the most modern 
        clinical research and clinical research facilities and 
        technologies.

    (b) Purpose.--It is the purpose of this title to provide additional 
support for and to expand clinical research programs.

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

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

``SEC. <<NOTE: 42 USC 284k.>> 409C. CLINICAL RESEARCH.

    ``(a) In General.--The Director of National Institutes of Health 
shall undertake activities to support and expand the involvement of the 
National Institutes of Health in clinical research.
    ``(b) Requirements.--In carrying out subsection (a), the Director of 
National Institutes of Health shall--
            ``(1) consider the recommendations of the Division of 
        Research Grants Clinical Research Study Group and other 
        recommendations for enhancing clinical research; and
            ``(2) establish intramural and extramural clinical research 
        fellowship programs directed specifically at medical and dental 
        students and a continuing education clinical research training 
        program at the National Institutes of Health.

    ``(c) Support for the Diverse Needs of Clinical Research.--The 
Director of National Institutes of Health, in cooperation with the 
Directors of the Institutes, Centers, and Divisions of the National 
Institutes of Health, shall support and expand the resources available 
for the diverse needs of the clinical research community, including 
inpatient, outpatient, and critical care clinical research.
    ``(d) Peer Review.--The Director of National Institutes of Health 
shall establish peer review mechanisms to evaluate applications for the 
awards and fellowships provided for in subsection (b)(2) and section 
409D. Such review mechanisms shall include

[[Page 114 STAT. 2327]]

individuals who are exceptionally qualified to appraise the merits of 
potential clinical research training and research grant proposals.''.

SEC. 204. GENERAL CLINICAL RESEARCH CENTERS.

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

``SEC. 481C. <<NOTE: 42 USC 287a-4.>> GENERAL CLINICAL RESEARCH CENTERS.

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

``SEC. <<NOTE: 42 USC 284l.>> 409D. ENHANCEMENT AWARDS.

    ``(a) Mentored Patient-Oriented Research Career Development 
Awards.--
            ``(1) Grants.--
                    ``(A) In general.--The Director of the National 
                Institutes of Health shall make grants (to be referred 
                to as `Mentored Patient-Oriented Research Career 
                Development Awards') to support individual careers in 
                clinical research at general clinical research centers 
                or at other institutions that have the infrastructure 
                and resources deemed appropriate for conducting patient-
                oriented clinical research.
                    ``(B) Use.--Grants under subparagraph (A) shall be 
                used to support clinical investigators in the early 
                phases of their independent careers by providing salary 
                and such other support for a period of supervised study.
            ``(2) Applications.--An application for a grant under this 
        subsection shall be submitted by an individual scientist at such 
        time as the Director may require.
            ``(3) Authorization of appropriations.--For the purpose of 
        carrying out this subsection, there are authorized to be 
        appropriated such sums as may be necessary for each fiscal year.

    ``(b) Mid-Career Investigator Awards in Patient-Oriented Research.--
            ``(1) Grants.--
                    ``(A) In general.--The Director of the National 
                Institutes of Health shall make grants (to be referred 
                to as `Mid-Career Investigator Awards in Patient-
                Oriented Research') to support individual clinical 
                research projects

[[Page 114 STAT. 2328]]

                at general clinical research centers or at other 
                institutions that have the infrastructure and resources 
                deemed appropriate for conducting patient-oriented 
                clinical research.
                    ``(B) Use.--Grants under subparagraph (A) shall be 
                used to provide support for mid-career level clinicians 
                to allow such clinicians to devote time to clinical 
                research and to act as mentors for beginning clinical 
                investigators.
            ``(2) Applications.--An application for a grant under this 
        subsection shall be submitted by an individual scientist at such 
        time as the Director requires.
            ``(3) Authorization of appropriations.--For the purpose of 
        carrying out this subsection, there are authorized to be 
        appropriated such sums as may be necessary for each fiscal year.

    ``(c) Graduate Training in Clinical Investigation Award.--
            ``(1) In general.--The Director of the National Institutes 
        of Health shall make grants (to be referred to as `Graduate 
        Training in Clinical Investigation Awards') to support 
        individuals pursuing master's or doctoral degrees in clinical 
        investigation.
            ``(2) Applications.--An application for a grant under this 
        subsection shall be submitted by an individual scientist at such 
        time as the Director may require.
            ``(3) Limitations.--Grants under this subsection shall be 
        for terms of 2 years or more and shall provide stipend, tuition, 
        and institutional support for individual advanced degree 
        programs in clinical investigation.
            ``(4) Definition.--As used in this subsection, the term 
        `advanced degree programs in clinical investigation' means 
        programs that award a master's or Ph.D. degree in clinical 
        investigation after 2 or more years of training in areas such as 
        the following:
                    ``(A) Analytical methods, biostatistics, and study 
                design.
                    ``(B) Principles of clinical pharmacology and 
                pharmacokinetics.
                    ``(C) Clinical epidemiology.
                    ``(D) Computer data management and medical 
                informatics.
                    ``(E) Ethical and regulatory issues.
                    ``(F) Biomedical writing.
            ``(5) Authorization of appropriations.--For the purpose of 
        carrying out this subsection, there are authorized to be 
        appropriated such sums as may be necessary for each fiscal year.

    ``(d) Clinical Research Curriculum Awards.--
            ``(1) In general.--The Director of the National Institutes 
        of Health shall make grants (to be referred to as `Clinical 
        Research Curriculum Awards') to institutions for the development 
        and support of programs of core curricula for training clinical 
        investigators, including medical students. Such core curricula 
        may include training in areas such as the following:
                    ``(A) Analytical methods, biostatistics, and study 
                design.
                    ``(B) Principles of clinical pharmacology and 
                pharmacokinetics.
                    ``(C) Clinical epidemiology.

[[Page 114 STAT. 2329]]

                    ``(D) Computer data management and medical 
                informatics.
                    ``(E) Ethical and regulatory issues.
                    ``(F) Biomedical writing.
            ``(2) Applications.--An application for a grant under this 
        subsection shall be submitted by an individual institution or a 
        consortium of institutions at such time as the Director may 
        require. An institution may submit only one such application.
            ``(3) Limitations.--Grants under this subsection shall be 
        for terms of up to 5 years and may be renewable.
            ``(4) Authorization of appropriations.--For the purpose of 
        carrying out this subsection, there are authorized to be 
        appropriated such sums as may be necessary for each fiscal 
        year.''.

SEC. 205. LOAN REPAYMENT PROGRAM REGARDING CLINICAL RESEARCHERS.

    Part G of title IV of the Public Health Service Act is amended by 
inserting after section 487E (42 U.S.C. 288-5) the following:

``SEC. 487F. <<NOTE: 42 USC 288-5a.>> LOAN REPAYMENT PROGRAM REGARDING 
            CLINICAL RESEARCHERS.

    ``(a) In General.--The Secretary, acting through the Director of the 
National Institutes of Health, shall establish a program to enter into 
contracts with qualified health professionals under which such health 
professionals agree to conduct clinical research, in consideration of 
the Federal Government agreeing to repay, for each year of service 
conducting such research, not more than $35,000 of the principal and 
interest of the educational loans of such health professionals.
    ``(b) Application of Provisions.--The provisions of sections 338B, 
338C, and 338E shall, except as inconsistent with subsection (a) of this 
section, apply to the program established under subsection (a) to the 
same extent and in the same manner as such provisions apply to the 
National Health Service Corps Loan Repayment Program established in 
subpart III of part D of title III.
    ``(c) Funding.--
            ``(1) Authorization of appropriations.--For the purpose of 
        carrying out this section, there are authorized to be 
        appropriated such sums as may be necessary for each fiscal year.
            ``(2) Availability.--Amounts appropriated for carrying out 
        this section shall remain available until the expiration of the 
        second fiscal year beginning after the fiscal year for which the 
        amounts were made available.''.

SEC. 206. DEFINITION.

    Section 409 of the Public Health Service Act (42 U.S.C. 284d) is 
amended--
            (1) by striking ``For purposes'' and inserting ``(a) Health 
        Service Research.--For purposes''; and
            (2) by adding at the end the following:

    ``(b) Clinical Research.--As used in this title, the term `clinical 
research' means patient oriented clinical research conducted with human 
subjects, or research on the causes and consequences of disease in human 
populations involving material of human origin (such as tissue specimens 
and cognitive phenomena) for which an investigator or colleague directly 
interacts with human subjects in an outpatient or inpatient setting to 
clarify a problem in human

[[Page 114 STAT. 2330]]

physiology, pathophysiology or disease, or epidemiologic or behavioral 
studies, outcomes research or health services research, or developing 
new technologies, therapeutic interventions, or clinical trials.''.

SEC. <<NOTE: Deadline. 42 USC 284k note.>> 207. OVERSIGHT BY GENERAL 
            ACCOUNTING OFFICE.

    Not later than 18 months after the date of the enactment of this 
Act, the Comptroller General of the United States shall submit to the 
Congress a reporting describing the extent to which the National 
Institutes of Health has complied with the amendments made by this 
title.

  TITLE <<NOTE: Twenty-First Century Research Laboratories Act.>> III--
RESEARCH LABORATORY INFRASTRUCTURE

SEC. <<NOTE: 42 USC 201 note.>> 301. SHORT TITLE.

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

SEC. 302. <<NOTE: 42 USC 287a-2 note.>> FINDINGS.

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

SEC. 303. BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES.

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

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

    ``(a) Modernization and Construction of Facilities.--

[[Page 114 STAT. 2331]]

            ``(1) In general.--The Director of NIH, acting through the 
        Director of the Center, may make grants or contracts to public 
        and nonprofit private entities to expand, remodel, renovate, or 
        alter existing research facilities or construct new research 
        facilities, subject to the provisions of this section.
            ``(2) Construction and cost of construction.--For purposes 
        of this section, the terms `construction' and `cost of 
        construction' include the construction of new buildings and the 
        expansion, renovation, remodeling, and alteration of existing 
        buildings, including architects' fees, but do not include the 
        cost of acquisition of land or off-site improvements.

    ``(b) Scientific and Technical Review Boards for Merit-Based Review 
of Proposals.--
            ``(1) In general: approval as precondition to grants.--
                    ``(A) Establishment.--There is established within 
                the Center a Scientific and Technical Review Board on 
                Biomedical and Behavioral Research Facilities (referred 
                to in this section as the `Board').
                    ``(B) Requirement.--The Director of the Center may 
                approve an application for a grant under subsection (a) 
                only if the Board has under paragraph (2) recommended 
                the application for approval.
            ``(2) Duties.--
                    ``(A) Advice.--The Board shall provide advice to the 
                Director of the Center and the advisory council 
                established under section 480 (in this section referred 
                to as the `Advisory Council') in carrying out this 
                section.
                    ``(B) Determination of merit.--In carrying out 
                subparagraph (A), the Board shall make a determination 
                of the merit of each application submitted for a grant 
                under subsection (a), after consideration of the 
                requirements established in subsection (c), and shall 
                report the results of the determination to the Director 
                of the Center and the Advisory Council. Such 
                determinations shall be conducted in a manner consistent 
                with procedures established under section 492.
                    ``(C) Amount.--In carrying out subparagraph (A), the 
                Board shall, in the case of applications recommended for 
                approval, make recommendations to the Director and the 
                Advisory Council on the amount that should be provided 
                under the grant.
                    ``(D) Annual report.--In carrying out subparagraph 
                (A), the Board shall prepare an annual report for the 
                Director of the Center and the Advisory Council 
                describing the activities of the Board in the fiscal 
                year for which the report is made. Each such report 
                shall be available to the public, and shall--
                          ``(i) summarize and analyze expenditures made 
                      under this section;
                          ``(ii) provide a summary of the types, 
                      numbers, and amounts of applications that were 
                      recommended for grants under subsection (a) but 
                      that were not approved by the Director of the 
                      Center; and
                          ``(iii) contain the recommendations of the 
                      Board for any changes in the administration of 
                      this section.
            ``(3) Membership.--

[[Page 114 STAT. 2332]]

                    ``(A) In general.--Subject to subparagraph (B), the 
                Board shall be composed of 15 members to be appointed by 
                the Director of the Center, and such ad-hoc or temporary 
                members as the Director of the Center determines to be 
                appropriate. All members of the Board, including 
                temporary and ad-hoc members, shall be voting members.
                    ``(B) Limitation.--Not more than three individuals 
                who are officers or employees of the Federal Government 
                may serve as members of the Board.
            ``(4) Certain requirements regarding membership.--In 
        selecting individuals for membership on the Board, the Director 
        of the Center shall ensure that the members are individuals who, 
        by virtue of their training or experience, are eminently 
        qualified to perform peer review functions. In selecting such 
        individuals for such membership, the Director of the Center 
        shall ensure that the members of the Board collectively--
                    ``(A) are experienced in the planning, construction, 
                financing, and administration of entities that conduct 
                biomedical or behavioral research sciences;
                    ``(B) are knowledgeable in making determinations of 
                the need of entities for biomedical or behavioral 
                research facilities, including such facilities for the 
                dentistry, nursing, pharmacy, and allied health 
                professions;
                    ``(C) are knowledgeable in evaluating the relative 
                priorities for applications for grants under subsection 
                (a) in view of the overall research needs of the United 
                States; and
                    ``(D) are experienced with emerging centers of 
                excellence, as described in subsection (c)(2).
            ``(5) Certain authorities.--
                    ``(A) Workshops and conferences.--In carrying out 
                paragraph (2), the Board may convene workshops and 
                conferences, and collect data as the Board considers 
                appropriate.
                    ``(B) Subcommittees.--In carrying out paragraph (2), 
                the Board may establish subcommittees within the Board. 
                Such subcommittees may hold meetings as determined 
                necessary to enable the subcommittee to carry out its 
                duties.
            ``(6) Terms.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), each appointed member of the Board 
                shall hold office for a term of 4 years. Any member 
                appointed to fill a vacancy occurring prior to the 
                expiration of the term for which such member's 
                predecessor was appointed shall be appointed for the 
                remainder of the term of the predecessor.
                    ``(B) Staggered terms.--Members appointed to the 
                Board shall serve staggered terms as specified by the 
                Director of the Center when making the appointments.
                    ``(C) Reappointment.--No member of the Board shall 
                be eligible for reappointment to the Board until 1 year 
                has elapsed after the end of the most recent term of the 
                member.
            ``(7) Compensation.--Members of the Board who are not 
        officers or employees of the United States shall receive for 
        each day the members are engaged in the performance of the 
        functions of the Board compensation at the same rate

[[Page 114 STAT. 2333]]

        received by members of other national advisory councils 
        established under this title.

    ``(c) Requirements for Grants.--
            ``(1) In general.--The Director of the Center may make a 
        grant under subsection (a) only if the applicant for the grant 
        meets the following conditions:
                    ``(A) The applicant is determined by such Director 
                to be competent to engage in the type of research for 
                which the proposed facility is to be constructed.
                    ``(B) The applicant provides assurances satisfactory 
                to the Director that--
                          ``(i) for not less than 20 years after 
                      completion of the construction involved, the 
                      facility will be used for the purposes of the 
                      research for which it is to be constructed;
                          ``(ii) sufficient funds will be available to 
                      meet the non-Federal share of the cost of 
                      constructing the facility;
                          ``(iii) sufficient funds will be available, 
                      when construction is completed, for the effective 
                      use of the facility for the research for which it 
                      is being constructed; and
                          ``(iv) the proposed construction will expand 
                      the applicant's capacity for research, or is 
                      necessary to improve or maintain the quality of 
                      the applicant's research.
                    ``(C) The applicant meets reasonable qualifications 
                established by the Director with respect to--
                          ``(i) the relative scientific and technical 
                      merit of the applications, and the relative 
                      effectiveness of the proposed facilities, in 
                      expanding the capacity for biomedical or 
                      behavioral research and in improving the quality 
                      of such research;
                          ``(ii) the quality of the research or 
                      training, or both, to be carried out in the 
                      facilities involved;
                          ``(iii) the congruence of the research 
                      activities to be carried out within the facility 
                      with the research and investigator manpower needs 
                      of the United States; and
                          ``(iv) the age and condition of existing 
                      research facilities.
                    ``(D) The applicant has demonstrated a commitment to 
                enhancing and expanding the research productivity of the 
                applicant.
            ``(2) Institutions of emerging excellence.--From the amount 
        appropriated under subsection (i) for a fiscal year up to 
        $50,000,000, the Director of the Center shall make available 25 
        percent of such amount, and from the amount appropriated under 
        such subsection for a fiscal year that is over $50,000,000, the 
        Director of the Center shall make available up to 25 percent of 
        such amount, for grants under subsection (a) to applicants that 
        in addition to meeting the requirements established in paragraph 
        (1), have demonstrated emerging excellence in biomedical or 
        behavioral research, as follows:
                    ``(A) The applicant has a plan for research or 
                training advancement and possesses the ability to carry 
                out the plan.

[[Page 114 STAT. 2334]]

                    ``(B) The applicant carries out research and 
                research training programs that have a special relevance 
                to a problem, concern, or unmet health need of the 
                United States.
                    ``(C) The applicant has been productive in research 
                or research development and training.
                    ``(D) The applicant--
                          ``(i) has been designated as a center of 
                      excellence under section 739;
                          ``(ii) is located in a geographic area whose 
                      population includes a significant number of 
                      individuals with health status deficit, and the 
                      applicant provides health services to such 
                      individuals; or
                          ``(iii) is located in a geographic area in 
                      which a deficit in health care technology, 
                      services, or research resources may adversely 
                      affect the health status of the population of the 
                      area in the future, and the applicant is carrying 
                      out activities with respect to protecting the 
                      health status of such population.

    ``(d) Requirement of Application.--The Director of the Center may 
make a grant under subsection (a) only if an application for the grant 
is submitted to the Director and the application is in such form, is 
made in such manner, and contains such agreements, assurances, and 
information as the Director determines to be necessary to carry out this 
section.
    ``(e) Amount of Grant; Payments.--
            ``(1) Amount.--The amount of any grant awarded under 
        subsection (a) shall be determined by the Director of the 
        Center, except that such amount shall not exceed--
                    ``(A) 50 percent of the necessary cost of the 
                construction of a proposed facility as determined by the 
                Director; or
                    ``(B) in the case of a multipurpose facility, 40 
                percent of that part of the necessary cost of 
                construction that the Director determines to be 
                proportionate to the contemplated use of the facility.
            ``(2) Reservation of amounts.--On the approval of any 
        application for a grant under subsection (a), the Director of 
        the Center shall reserve, from any appropriation available for 
        such grants, the amount of such grant, and shall pay such 
        amount, in advance or by way of reimbursement, and in such 
        installments consistent with the construction progress, as the 
        Director may determine appropriate. The reservation of any 
        amount by the Director under this paragraph may be amended by 
        the Director, either on the approval of an amendment of the 
        application or on the revision of the estimated cost of 
        construction of the facility.
            ``(3) Exclusion of certain costs.--In determining the amount 
        of any grant under subsection (a), there shall be excluded from 
        the cost of construction an amount equal to the sum of--
                    ``(A) the amount of any other Federal grant that the 
                applicant has obtained, or is assured of obtaining, with 
                respect to construction that is to be financed in part 
                by a grant authorized under this section; and
                    ``(B) the amount of any non-Federal funds required 
                to be expended as a condition of such other Federal 
                grant.

[[Page 114 STAT. 2335]]

            ``(4) Waiver of limitations.--The limitations imposed under 
        paragraph (1) may be waived at the discretion of the Director 
        for applicants meeting the conditions described in subsection 
        (c).

    ``(f ) Recapture of Payments.--If, not later than 20 years after the 
completion of construction for which a grant has been awarded under 
subsection (a)--
            ``(1) the applicant or other owner of the facility shall 
        cease to be a public or non profit private entity; or
            ``(2) the facility shall cease to be used for the research 
        purposes for which it was constructed (unless the Director 
        determines, in accordance with regulations, that there is good 
        cause for releasing the applicant or other owner from obligation 
        to do so),

the United States shall be entitled to recover from the applicant or 
other owner of the facility the amount bearing the same ratio to the 
current value (as determined by an agreement between the parties or by 
action brought in the United States District Court for the district in 
which such facility is situated) of the facility as the amount of the 
Federal participation bore to the cost of the construction of such 
facility.
    ``(g) Guidelines.--Not <<NOTE: Deadline.>> later than 6 months after 
the date of the enactment of this section, the Director of the Center, 
after consultation with the Advisory Council, shall issue guidelines 
with respect to grants under subsection (a).

    ``(h) Report to Congress.--The Director of the Center shall prepare 
and submit to the appropriate committees of Congress a biennial report 
concerning the status of the biomedical and behavioral research 
facilities and the availability and condition of technologically 
sophisticated laboratory equipment in the United States. Such reports 
shall be developed in concert with the report prepared by the National 
Science Foundation on the needs of research facilities of universities 
as required under section 108 of the National Science Foundation 
Authorization Act for Fiscal Year 1986 (42 U.S.C. 1886).
    ``(i) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $250,000,000 
for fiscal year 2001, and such sums as may be necessary for each of the 
fiscal years 2002 and 2003.''.

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

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

SEC. 305. <<NOTE: 42 USC 287 note.>> SHARED INSTRUMENTATION GRANT 
            PROGRAM.

    (a) Authorization of Appropriations.--There is authorized to be 
appropriated $100,000,000 for fiscal year 2000, and such sums as may be 
necessary for each subsequent fiscal year, to enable the Secretary of 
Health and Human Services, acting through the Director of the National 
Center for Research Resources, to provide for the continued operation of 
the Shared Instrumentation Grant Program (initiated in fiscal year 1992 
under the authority of section 479 of the Public Health Service Act (42 
U.S.C. 287 et seq.)).

[[Page 114 STAT. 2336]]

    (b) Requirements for Grants.--In determining whether to award a 
grant to an applicant under the program described in subsection (a), the 
Director of the National Center for Research Resources shall consider--
            (1) the extent to which an award for the specific instrument 
        involved would meet the scientific needs and enhance the planned 
        research endeavors of the major users by providing an instrument 
        that is unavailable or to which availability is highly limited;
            (2) with respect to the instrument involved, the 
        availability and commitment of the appropriate technical 
        expertise within the major user group or the applicant 
        institution for use of the instrumentation;
            (3) the adequacy of the organizational plan for the use of 
        the instrument involved and the internal advisory committee for 
        oversight of the applicant, including sharing arrangements if 
        any;
            (4) the applicant's commitment for continued support of the 
        utilization and maintenance of the instrument; and
            (5) the extent to which the specified instrument will be 
        shared and the benefit of the proposed instrument to the overall 
        research community to be served.

    (c) Peer Review.--In awarding grants under the program described in 
subsection (a) Director of the National Center for Research Resources 
shall comply with the peer review requirements in section 492 of the 
Public Health Service Act (42 U.S.C. 289a).

TITLE <<NOTE: Cardiac Arrest Survival Act of 2000.>> IV--CARDIAC ARREST 
SURVIVAL

            Subtitle A--Recommendations for Federal Buildings

SEC. 401. <<NOTE: 42 USC 201 note.>> SHORT TITLE.

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

SEC. <<NOTE: 42 USC 238p note.>> 402. FINDINGS.

    Congress makes the following findings:
            (1) Over 700 lives are lost every day to sudden cardiac 
        arrest in the United States alone.
            (2) Two out of every three sudden cardiac deaths occur 
        before a victim can reach a hospital.
            (3) More than 95 percent of these cardiac arrest victims 
        will die, many because of lack of readily available life saving 
        medical equipment.
            (4) With current medical technology, up to 30 percent of 
        cardiac arrest victims could be saved if victims had access to 
        immediate medical response, including defibrillation and 
        cardiopulmonary resuscitation.
            (5) Once a victim has suffered a cardiac arrest, every 
        minute that passes before returning the heart to a normal rhythm 
        decreases the chance of survival by 10 percent.
            (6) Most cardiac arrests are caused by abnormal heart 
        rhythms called ventricular fibrillation. Ventricular 
        fibrillation occurs when the heart's electrical system 
        malfunctions, causing

[[Page 114 STAT. 2337]]

        a chaotic rhythm that prevents the heart from pumping oxygen to 
        the victim's brain and body.
            (7) Communities that have implemented programs ensuring 
        widespread public access to defibrillators, combined with 
        appropriate training, maintenance, and coordination with local 
        emergency medical systems, have dramatically improved the 
        survival rates from cardiac arrest.
            (8) Automated external defibrillator devices have been 
        demonstrated to be safe and effective, even when used by lay 
        people, since the devices are designed not to allow a user to 
        administer a shock until after the device has analyzed a 
        victim's heart rhythm and determined that an electric shock is 
        required.
            (9) Increasing public awareness regarding automated external 
        defibrillator devices and encouraging their use in Federal 
        buildings will greatly facilitate their adoption.
            (10) Limiting the liability of Good Samaritans and acquirers 
        of automated external defibrillator devices in emergency 
        situations may encourage the use of automated external 
        defibrillator devices, and result in saved lives.

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

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

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

    ``Sec. <<NOTE: 42 USC 238p.>> 247. (a) Guidelines on Placement.--The 
Secretary shall establish guidelines with respect to placing automated 
external defibrillator devices in Federal buildings. Such guidelines 
shall take into account the extent to which such devices may be used by 
lay persons, the typical number of employees and visitors in the 
buildings, the extent of the need for security measures regarding the 
buildings, buildings or portions of buildings in which there are special 
circumstances such as high electrical voltage or extreme heat or cold, 
and such other factors as the Secretary determines to be appropriate.

    ``(b) Related <<NOTE: Federal Register, 
publication.>> Recommendations.--The Secretary shall publish in the 
Federal Register the recommendations of the Secretary on the appropriate 
implementation of the placement of automated external defibrillator 
devices under subsection (a), including procedures for the following:
            ``(1) Implementing appropriate training courses in the use 
        of such devices, including the role of cardiopulmonary 
        resuscitation.
            ``(2) Proper maintenance and testing of the devices.
            ``(3) Ensuring coordination with appropriate licensed 
        professionals in the oversight of training of the devices.
            ``(4) Ensuring coordination with local emergency medical 
        systems regarding the placement and incidents of use of the 
        devices.

    ``(c) Consultations; Consideration of Certain Recommendations.--In 
carrying out this section, the Secretary shall--
            ``(1) consult with appropriate public and private entities;

[[Page 114 STAT. 2338]]

            ``(2) consider the recommendations of national and local 
        public-health organizations for improving the survival rates of 
        individuals who experience cardiac arrest in nonhospital 
        settings by minimizing the time elapsing between the onset of 
        cardiac arrest and the initial medical response, including 
        defibrillation as necessary; and
            ``(3) consult with and counsel other Federal agencies where 
        such devices are to be used.

    ``(d) Date <<NOTE: Deadline.>> Certain for Establishing Guidelines 
and Recommendations.--The Secretary shall comply with this section not 
later than 180 days after the date of the enactment of the Cardiac 
Arrest Survival Act of 2000.

    ``(e) Definitions.--For purposes of this section:
            ``(1) The term `automated external defibrillator device' has 
        the meaning given such term in section 248.
            ``(2) The term `Federal building' includes a building or 
        portion of a building leased or rented by a Federal agency, and 
        includes buildings on military installations of the United 
        States.''.

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

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

``liability regarding emergency use of automated external defibrillators

    ``Sec. 248. <<NOTE: 42 USC 238q.>> (a) Good Samaritan Protections 
Regarding AEDs.--Except as provided in subsection (b), any person who 
uses or attempts to use an automated external defibrillator device on a 
victim of a perceived medical emergency is immune from civil liability 
for any harm resulting from the use or attempted use of such device; and 
in addition, any person who acquired the device is immune from such 
liability, if the harm was not due to the failure of such acquirer of 
the device--
            ``(1) to notify local emergency response personnel or other 
        appropriate entities of the most recent placement of the device 
        within a reasonable period of time after the device was placed;
            ``(2) to properly maintain and test the device; or
            ``(3) to provide appropriate training in the use of the 
        device to an employee or agent of the acquirer when the employee 
        or agent was the person who used the device on the victim, 
        except that such requirement of training does not apply if--
                    ``(A) the employee or agent was not an employee or 
                agent who would have been reasonably expected to use the 
                device; or
                    ``(B) the period of time elapsing between the 
                engagement of the person as an employee or agent and the 
                occurrence of the harm (or between the acquisition of 
                the device and the occurrence of the harm, in any case 
                in which the device was acquired after such engagement 
                of the person) was not a reasonably sufficient period in 
                which to provide the training.

    ``(b) Inapplicability of Immunity.--Immunity under subsection (a) 
does not apply to a person if--

[[Page 114 STAT. 2339]]

            ``(1) the harm involved was caused by willful or criminal 
        misconduct, gross negligence, reckless misconduct, or a 
        conscious, flagrant indifference to the rights or safety of the 
        victim who was harmed;
            ``(2) the person is a licensed or certified health 
        professional who used the automated external defibrillator 
        device while acting within the scope of the license or 
        certification of the professional and within the scope of the 
        employment or agency of the professional;
            ``(3) the person is a hospital, clinic, or other entity 
        whose purpose is providing health care directly to patients, and 
        the harm was caused by an employee or agent of the entity who 
        used the device while acting within the scope of the employment 
        or agency of the employee or agent; or
            ``(4) the person is an acquirer of the device who leased the 
        device to a health care entity (or who otherwise provided the 
        device to such entity for compensation without selling the 
        device to the entity), and the harm was caused by an employee or 
        agent of the entity who used the device while acting within the 
        scope of the employment or agency of the employee or agent.

    ``(c) Rules of Construction.--
            ``(1) In general.--The following applies with respect to 
        this section:
                    ``(A) This section does not establish any cause of 
                action, or require that an automated external 
                defibrillator device be placed at any building or other 
                location.
                    ``(B) With respect to a class of persons for which 
                this section provides immunity from civil liability, 
                this section supersedes the law of a State only to the 
                extent that the State has no statute or regulations that 
                provide persons in such class with immunity for civil 
                liability arising from the use by such persons of 
                automated external defibrillator devices in emergency 
                situations (within the meaning of the State law or 
                regulation involved).
                    ``(C) This section does not waive any protection 
                from liability for Federal officers or employees under--
                          ``(i) section 224; or
                          ``(ii) sections 1346(b), 2672, and 2679 of 
                      title 28, United States Code, or under alternative 
                      benefits provided by the United States where the 
                      availability of such benefits precludes a remedy 
                      under section 1346(b) of title 28.
            ``(2) Civil actions under federal law.--
                    ``(A) In general.--The applicability of subsections 
                (a) and (b) includes applicability to any action for 
                civil liability described in subsection (a) that arises 
                under Federal law.
                    ``(B) Federal areas adopting state law.--If a 
                geographic area is under Federal jurisdiction and is 
                located within a State but out of the jurisdiction of 
                the State, and if, pursuant to Federal law, the law of 
                the State applies in such area regarding matters for 
                which there is no applicable Federal law, then an action 
                for civil liability described in subsection (a) that in 
                such area arises under the law of the State is subject 
                to subsections (a) through (c) in lieu of any related 
                State law that would apply in such area in the absence 
                of this subparagraph.

[[Page 114 STAT. 2340]]

    ``(d) Federal Jurisdiction.--In any civil action arising under State 
law, the courts of the State involved have jurisdiction to apply the 
provisions of this section exclusive of the jurisdiction of the courts 
of the United States.
    ``(e) Definitions.--
            ``(1) Perceived medical emergency.--For purposes of this 
        section, the term `perceived medical emergency' means 
        circumstances in which the behavior of an individual leads a 
        reasonable person to believe that the individual is experiencing 
        a life-threatening medical condition that requires an immediate 
        medical response regarding the heart or other cardiopulmonary 
        functioning of the individual.
            ``(2) Other definitions.--For purposes of this section:
                    ``(A) The term `automated external defibrillator 
                device' means a defibrillator device that--
                          ``(i) is commercially distributed in 
                      accordance with the Federal Food, Drug, and 
                      Cosmetic Act;
                          ``(ii) is capable of recognizing the presence 
                      or absence of ventricular fibrillation, and is 
                      capable of determining without intervention by the 
                      user of the device whether defibrillation should 
                      be performed;
                          ``(iii) upon determining that defibrillation 
                      should be performed, is able to deliver an 
                      electrical shock to an individual; and
                          ``(iv) in the case of a defibrillator device 
                      that may be operated in either an automated or a 
                      manual mode, is set to operate in the automated 
                      mode.
                    ``(B)(i) The term `harm' includes physical, 
                nonphysical, economic, and noneconomic losses.
                    ``(ii) The term `economic loss' means any pecuniary 
                loss resulting from harm (including the loss of earnings 
                or other benefits related to employment, medical expense 
                loss, replacement services loss, loss due to death, 
                burial costs, and loss of business or employment 
                opportunities) to the extent recovery for such loss is 
                allowed under applicable State law.
                    ``(iii) The term `noneconomic losses' means losses 
                for physical and emotional pain, suffering, 
                inconvenience, physical impairment, mental anguish, 
                disfigurement, loss of enjoyment of life, loss of 
                society and companionship, loss of consortium (other 
                than loss of domestic service), hedonic damages, injury 
                to reputation and all other nonpecuniary losses of any 
                kind or nature.''.

   Subtitle <<NOTE: Rural Access to Emergency Devices Act.>> B--Rural 
Access to Emergency Devices

SEC. 411. <<NOTE: 42 USC 254c note.>> SHORT TITLE.

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

SEC. 412. <<NOTE: 42 USC 254c note.>> FINDINGS.

    Congress makes the following findings:
            (1) Heart disease is the leading cause of death in the 
        United States.

[[Page 114 STAT. 2341]]

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

SEC. 413. <<NOTE: 42 USC 254c note.>> GRANTS.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Rural Health Outreach Office of the Health Resources and 
Services Administration, shall award grants to community partnerships 
that meet the requirements of subsection (b) to enable such partnerships 
to purchase equipment and provide training as provided for in subsection 
(c).
    (b) Community Partnerships.--A community partnership meets the 
requirements of this subsection if such partnership--
            (1) is composed of local emergency response entities such as 
        community training facilities, local emergency responders, fire 
        and rescue departments, police, community hospitals, and local 
        non-profit entities and for-profit entities concerned about 
        cardiac arrest survival rates;
            (2) evaluates the local community emergency response times 
        to assess whether they meet the standards established by 
        national public health organizations such as the American Heart 
        Association and the American Red Cross; and
            (3) submits to the Secretary of Health and Human Services an 
        application at such time, in such manner, and containing such 
        information as the Secretary may require.

    (c) Use of Funds.--Amounts provided under a grant under this section 
shall be used--
            (1) to purchase automated external defibrillators that have 
        been approved, or cleared for marketing, by the Food and Drug 
        Administration; and
            (2) to provide defibrillator and basic life support training 
        in automated external defibrillator usage through the American 
        Heart Association, the American Red Cross, or other nationally 
        recognized training courses.

    (d) Report.--Not <<NOTE: Deadline.>> later than 4 years after the 
date of the enactment of this Act, the Secretary of Health and Human 
Services

[[Page 114 STAT. 2342]]

shall prepare and submit to the appropriate committees of Congress a 
report containing data relating to whether the increased availability of 
defibrillators has affected survival rates in the communities in which 
grantees under this section operated. The procedures under which the 
Secretary obtains data and prepares the report under this subsection 
shall not impose an undue burden on program participants under this 
section.

    (e) Authorization of Appropriations.--There is authorized to be 
appropriated $25,000,000 for fiscal years 2001 through 2003 to carry out 
this section.

      TITLE V--LUPUS <<NOTE: Lupus Research and Care Amendments of 
2000.>> RESEARCH AND CARE

SEC. 501. SHORT <<NOTE: 42 USC 201 note.>> TITLE.

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

SEC. 502. <<NOTE: 42 USC 285d-6a note.>> FINDINGS.

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

                      Subtitle A--Research on Lupus

SEC. 511. EXPANSION AND INTENSIFICATION OF ACTIVITIES.

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

[[Page 114 STAT. 2343]]

                                 ``lupus

    ``Sec. <<NOTE: 42 USC 285d-6a.>> 441A. (a) In General.--The Director 
of the Institute shall expand and intensify research and related 
activities of the Institute with respect to lupus.

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

    ``(d) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated such sums as 
may be necessary for each of the fiscal years 2001 through 2003.''.

            Subtitle B--Delivery of Services Regarding Lupus

SEC. 521. <<NOTE: 42 USC 254c-9.>> ESTABLISHMENT OF PROGRAM OF GRANTS.

    (a) In General.--The Secretary of Health and Human Services shall in 
accordance with this subtitle make grants to provide for projects for 
the establishment, operation, and coordination of effective and cost-
efficient systems for the delivery of essential services to individuals 
with lupus and their families.
    (b) Recipients of Grants.--A grant under subsection (a) may be made 
to an entity only if the entity is a public or nonprofit private entity, 
which may include a State or local government; a public or nonprofit 
private hospital, community-based organization, hospice, ambulatory care 
facility, community health center, migrant health center, or homeless 
health center; or other appropriate public or nonprofit private entity.
    (c) Certain Activities.--To the extent practicable and appropriate, 
the Secretary shall ensure that projects under subsection (a) provide 
services for the diagnosis and disease management of lupus. Activities 
that the Secretary may authorize for such projects may also include the 
following:

[[Page 114 STAT. 2344]]

            (1) Delivering or enhancing outpatient, ambulatory, and 
        home-based health and support services, including case 
        management and comprehensive treatment services, for individuals 
        with lupus; and delivering or enhancing support services for 
        their families.
            (2) Delivering or enhancing inpatient care management 
        services that prevent unnecessary hospitalization or that 
        expedite discharge, as medically appropriate, from inpatient 
        facilities of individuals with lupus.
            (3) Improving the quality, availability, and organization of 
        health care and support services (including transportation 
        services, attendant care, homemaker services, day or respite 
        care, and providing counseling on financial assistance and 
        insurance) for individuals with lupus and support services for 
        their families.

    (d) Integration With Other Programs.--To the extent practicable and 
appropriate, the Secretary shall integrate the program under this 
subtitle with other grant programs carried out by the Secretary, 
including the program under section 330 of the Public Health Service 
Act.

SEC. 522. <<NOTE: 42 USC 254c-10.>> CERTAIN REQUIREMENTS.

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

SEC. <<NOTE: 42 USC 254c-11.>> 523. TECHNICAL ASSISTANCE.

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

SEC. 524. <<NOTE: 42 USC 254c-12.>> DEFINITIONS.

    For purposes of this subtitle:

[[Page 114 STAT. 2345]]

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

SEC. 525. <<NOTE: 42 USC 254c-13.>> AUTHORIZATION OF APPROPRIATIONS.

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

   TITLE VI--PROSTATE <<NOTE: Prostate Cancer Research and Prevention 
Act.>> CANCER RESEARCH AND PREVENTION

SEC. 601. <<NOTE: 42 USC 201 note.>> SHORT TITLE.

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

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

    (a) Preventive Health Measures.--Section 317D of the Public Health 
Service Act (42 U.S.C. 247b-5) is amended--
            (1) by striking subsection (a) and inserting the following:

    ``(a) In General.--The Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, may make grants to States 
and local health departments for the purpose of enabling such States and 
departments to carry out programs that may include the following:
            ``(1) To identify factors that influence the attitudes or 
        levels of awareness of men and health care practitioners 
        regarding screening for prostate cancer.
            ``(2) To evaluate, in consultation with the Agency for 
        Health Care Policy and Research and the National Institutes of 
        Health, the effectiveness of screening strategies for prostate 
        cancer.
            ``(3) To identify, in consultation with the Agency for 
        Health Care Policy and Research, issues related to the quality 
        of life for men after prostrate cancer screening and followup.
            ``(4) <<NOTE: Public information.>> To develop and 
        disseminate public information and education programs for 
        prostate cancer, including appropriate messages about the risks 
        and benefits of prostate cancer screening for the general 
        public, health care providers, policy makers and other 
        appropriate individuals.
            ``(5) To improve surveillance for prostate cancer.
            ``(6) To address the needs of underserved and minority 
        populations regarding prostate cancer.
            ``(7) Upon a determination by the Secretary, who shall take 
        into consideration recommendations by the United States 
        Preventive Services Task Force and shall seek input, where 
        appropriate, from professional societies and other private and 
        public entities, that there is sufficient consensus on the 
        effectiveness of prostate cancer screening--
                    ``(A) to screen men for prostate cancer as a 
                preventive health measure;

[[Page 114 STAT. 2346]]

                    ``(B) to provide appropriate referrals for the 
                medical treatment of men who have been screened under 
                subparagraph (A) and to ensure, to the extent 
                practicable, the provision of appropriate followup 
                services and support services such as case management;
                    ``(C) to establish mechanisms through which State 
                and local health departments can monitor the quality of 
                screening procedures for prostate cancer, including the 
                interpretation of such procedures; and
                    ``(D) to improve, in consultation with the Health 
                Resources and Services Administration, the education, 
                training, and skills of health practitioners (including 
                appropriate allied health professionals) in the 
                detection and control of prostate cancer.
            ``(8) To evaluate activities conducted under paragraphs (1) 
        through (7) through appropriate surveillance or program 
        monitoring activities.''; and
            (2) in subsection (l)(1), by striking ``1998'' and inserting 
        ``2004''.

    (b) National Institutes of Health.--Section 417B(c) of the Public 
Health Service Act (42 U.S.C. 286a-8(c)) is amended by striking ``and 
1996'' and inserting ``through 2004''.

 TITLE VII--ORGAN <<NOTE: Organ Procurement Organization Certification 
Act of 2000.>> PROCUREMENT AND DONATION

SEC. 701. ORGAN PROCUREMENT ORGANIZATION CERTIFICATION.

    (a) Short <<NOTE: 42 USC 201 note.>> Title.--This section may be 
cited as the ``Organ Procurement Organization Certification Act of 
2000''.

    (b) Findings.--Congress <<NOTE: 42 USC 273 note.>> makes the 
following findings:
            (1) Organ procurement organizations play an important role 
        in the effort to increase organ donation in the United States.
            (2) The current process for the certification and 
        recertification of organ procurement organizations conducted by 
        the Department of Health and Human Services has created a level 
        of uncertainty that is interfering with the effectiveness of 
        organ procurement organizations in raising the level of organ 
        donation.
            (3) The General Accounting Office, the Institute of 
        Medicine, and the Harvard School of Public Health have 
        identified substantial limitations in the organ procurement 
        organization certification and recertification process and have 
        recommended changes in that process.
            (4) The limitations in the recertification process include:
                    (A) An exclusive reliance on population-based 
                measures of performance that do not account for the 
                potential in the population for organ donation and do 
                not permit consideration of other outcome and process 
                standards that would more accurately reflect the 
                relative capability and performance of each organ 
                procurement organization.
                    (B) A lack of due process to appeal to the Secretary 
                of Health and Human Services for recertification on 
                either substantive or procedural grounds.
            (5) The Secretary of Health and Human Services has the 
        authority under section 1138(b)(1)(A)(i) of the Social Security

[[Page 114 STAT. 2347]]

        Act (42 U.S.C. 1320b-8(b)(1)(A)(i)) to extend the period for 
        recertification of an organ procurement organization from 2 to 4 
        years on the basis of its past practices in order to avoid the 
        inappropriate disruption of the nation's organ system.
            (6) The Secretary of Health and Human Services can use the 
        extended period described in paragraph (5) for recertification 
        of all organ procurement organizations to--
                    (A) develop improved performance measures that would 
                reflect organ donor potential and interim outcomes, and 
                to test these measures to ensure that they accurately 
                measure performance differences among the organ 
                procurement organizations; and
                    (B) improve the overall certification process by 
                incorporating process as well as outcome performance 
                measures, and developing equitable processes for 
                appeals.

    (c) Certification and Recertification of Organ Procurement 
Organizations.--Section 371(b)(1) of the Public Health Service Act (42 
U.S.C. 273(b)(1)) is amended--
            (1) by redesignating subparagraphs (D) through (G) as 
        subparagraphs (E) through (H), respectively;
            (2) by realigning the margin of subparagraph (F) (as so 
        redesignated) so as to align with subparagraph (E) (as so 
        redesignated); and
            (3) by inserting after subparagraph (C) the following:
            ``(D) notwithstanding any other provision of law, has met 
        the other requirements of this section and has been certified or 
        recertified by the Secretary within the previous 4-year period 
        as meeting the performance standards to be a qualified organ 
        procurement organization through a process that either--
                    ``(i) granted certification or recertification 
                within such 4-year period with such certification or 
                recertification in effect as of January 1, 2000, and 
                remaining in effect through the earlier of--
                          ``(I) January 1, 2002; or
                          ``(II) the completion of recertification under 
                      the requirements of clause (ii); or
                    ``(ii) <<NOTE: Deadline.>> is defined through 
                regulations that are promulgated by the Secretary by not 
                later than January 1, 2002, that--
                          ``(I) require recertifications of qualified 
                      organ procurement organizations not more 
                      frequently than once every 4 years;
                          ``(II) rely on outcome and process performance 
                      measures that are based on empirical evidence, 
                      obtained through reasonable efforts, of organ 
                      donor potential and other related factors in each 
                      service area of qualified organ procurement 
                      organizations;
                          ``(III) use multiple outcome measures as part 
                      of the certification process; and
                          ``(IV) provide for a qualified organ 
                      procurement organization to appeal a 
                      decertification to the Secretary on substantive 
                      and procedural grounds;''.

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

    (a) Findings.--Congress finds that--

[[Page 114 STAT. 2348]]

            (1) traditionally, Thanksgiving is a time for families to 
        take time out of their busy lives to come together and to give 
        thanks for the many blessings in their lives;
            (2) approximately 21,000 men, women, and children in the 
        United States are given the gift of life each year through 
        transplantation surgery, made possible by the generosity of 
        organ and tissue donations;
            (3) more than 66,000 Americans are awaiting their chance to 
        prolong their lives by finding a matching donor;
            (4) nearly 5,000 of these patients each year (or 13 patients 
        each day) die while waiting for a donated heart, liver, kidney, 
        or other organ;
            (5) nationwide there are up to 15,000 potential donors 
        annually, but families' consent to donation is received for less 
        than 6,000;
            (6) the need for organ donations greatly exceeds the supply 
        available;
            (7) designation as an organ donor on a driver's license or 
        voter's registration is a valuable step, but does not ensure 
        donation when an occasion arises;
            (8) the demand for transplantation will likely increase in 
        the coming years due to the growing safety of transplantation 
        surgery due to improvements in technology and drug developments, 
        prolonged life expectancy, and increased prevalence of diseases 
        that may lead to organ damage and failure, including 
        hypertension, alcoholism, and hepatitis C infection;
            (9) the need for a more diverse donor pool, including a 
        variety of racial and ethnic minorities, will continue to grow 
        in the coming years;
            (10) the final decision on whether a potential donor can 
        share the gift of life usually is made by surviving family 
        members regardless of the patient's initial intent;
            (11) many Americans have indicated a willingness to donate 
        their organs and tissues but have not discussed this critical 
        matter with the family members who are most likely to make the 
        decision, if the occasion arises, as to whether that person will 
        be an organ and tissue donor;
            (12) some family members may be reluctant to give consent to 
        donate their deceased loved one's organs and tissues at a very 
        difficult and emotional time if that person has not clearly 
        expressed a desire or willingness to do so;
            (13) the vast majority of Americans are likely to spend part 
        of Thanksgiving Day with some of those family members who would 
        be approached to make such a decision; and
            (14) it is fitting for families to spend a portion of that 
        day discussing how they might give life to others on a day 
        devoted to giving thanks for their own blessings.

    (b) Designation.--November 23, 2000, Thanksgiving Day, is hereby 
designated as a day to ``Give Thanks, Give Life'' and to discuss organ 
and tissue donation with other family members so that informed decisions 
can be made if the occasion to donate arises.

[[Page 114 STAT. 2349]]

         TITLE VIII--ALZHEIMER'S CLINICAL RESEARCH AND TRAINING

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

    Subpart 5 of part C of title IV of the Public Health Service Act (42 
U.S.C. 285e et seq.) is amended--
            (1) <<NOTE: 42 USC 285e-11.>> by redesignating section 445I 
        as section 445J; and
            (2) by inserting after section 445H the following:

``SEC. 445I. <<NOTE: 42 USC 285e-10a.>> ALZHEIMER'S CLINICAL RESEARCH 
            AND TRAINING AWARDS.

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

  TITLE IX--SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH AND TRAINING

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

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

``SEC. 447B. <<NOTE: 42 USC 285f-3.>> SEXUALLY TRANSMITTED DISEASE 
            CLINICAL RESEARCH AND TRAINING AWARDS.

    ``(a) In General.--The Director of the Institute is authorized to 
establish and maintain a program to enhance and promote the translation 
of new scientific knowledge into clinical practice related to the 
diagnosis, care and treatment of individuals with sexually transmitted 
diseases.
    ``(b) Support of Promising Clinicians.--In order to foster the 
application of the most current developments in the etiology,

[[Page 114 STAT. 2350]]

pathogenesis, diagnosis, prevention and treatment of sexually 
transmitted diseases, amounts made available under this section shall be 
directed to the support of promising clinicians through awards for 
research, study, and practice at centers of excellence in sexually 
transmitted disease research and treatment.
    ``(c) Excellence in Certain Fields.--Research shall be carried out 
under awards made under subsection (b) in environments of demonstrated 
excellence in the etiology and pathogenesis of sexually transmitted 
diseases and shall foster innovation and integration of such disciplines 
or other environments determined suitable by the Director of the 
Institute.
    ``(d) Authorization of Appropriations.--For the purpose of carrying 
out this section, there are authorized to be appropriated $2,250,000 for 
fiscal year 2001, and such sums as may be necessary for each of fiscal 
years 2002 through 2005.''.

                    TITLE X--MISCELLANEOUS PROVISION

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

    (a) In <<NOTE: 42 USC 289 note.>> General.--Section 2701 of the 
Children's Health Act of 2000 is amended by striking ``part 45 of title 
46'' and inserting ``part 46 of title 45''.

    (b) Effective <<NOTE: 42 USC 289 note.>> Date.--The amendment made 
by subsection (a) takes effect on the date of the enactment of the 
Children's Health Act of 2000.

    Approved November 13, 2000.

LEGISLATIVE HISTORY--H.R. 2498:
---------------------------------------------------------------------------

HOUSE REPORTS: No. 106-634 (Comm. on Commerce).
CONGRESSIONAL RECORD, Vol. 146 (2000):
            May 23, considered and passed House.
            Oct. 26, considered and passed Senate, amended.
            Oct. 27, House concurred in Senate amendment.

                                  <all>
```