[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2498 Engrossed Amendment Senate (EAS)]

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  

                  In the Senate of the United States,

                      October 26 (legislative day, September 22), 2000.
    Resolved, That the bill from the House of Representatives (H.R. 
2498) entitled ``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.'', do pass with the following

                               AMENDMENT:

            Strike out all after the enacting clause and insert:

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

Sec. 1. Short title; table of contents.

               TITLE I--EMERGING THREATS TO PUBLIC HEALTH

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

                TITLE II--CLINICAL RESEARCH ENHANCEMENT

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

             TITLE III--RESEARCH LABORATORY INFRASTRUCTURE

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

                   TITLE IV--CARDIAC ARREST SURVIVAL

           Subtitle A--Recommendations for Federal Buildings

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

             Subtitle B--Rural Access to Emergency Devices

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

                    TITLE V--LUPUS RESEARCH AND CARE

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

                     Subtitle A--Research on Lupus

Sec. 511. Expansion and intensification of activities.

            Subtitle B--Delivery of Services Regarding Lupus

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

           TITLE VI--PROSTATE CANCER RESEARCH AND PREVENTION

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

               TITLE VII--ORGAN PROCUREMENT AND DONATION

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

         TITLE VIII--ALZHEIMER'S CLINICAL RESEARCH AND TRAINING

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

 TITLE IX--SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH AND TRAINING

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

                    TITLE X--MISCELLANEOUS PROVISION

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

               TITLE I--EMERGING THREATS TO PUBLIC HEALTH

SEC. 101. SHORT TITLE.

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

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

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

``SEC. 319. PUBLIC HEALTH EMERGENCIES.

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

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

    ``(a) Capacities.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this section, the Secretary, and such 
        Administrators, Directors, or Commissioners, as may be 
        appropriate, and in collaboration with State and local health 
        officials, shall establish reasonable capacities that are 
        appropriate for national, State, and local public health 
        systems and the personnel or work forces of such systems. Such 
        capacities shall be revised every 10 years, or more frequently 
        as the Secretary determines to be necessary.
            ``(2) Basis.--The capacities established under paragraph 
        (1) shall improve, enhance or expand the capacity of national, 
        state and local public health agencies to detect and respond 
        effectively to significant public health threats, including 
        major outbreaks of infectious disease, pathogens resistant to 
        antimicrobial agents and acts of bioterrorism. Such capacities 
        may include the capacity to--
                    ``(A) recognize the clinical signs and 
                epidemiological characteristic of significant outbreaks 
                of infectious disease;
                    ``(B) identify disease-causing pathogens rapidly 
                and accurately;
                    ``(C) develop and implement plans to provide 
                medical care for persons infected with disease-causing 
                agents and to provide preventive care as needed for 
                individuals likely to be exposed to disease-causing 
                agents;
                    ``(D) communicate information relevant to 
                significant public health threats rapidly to local, 
                State and national health agencies, and health care 
                providers; or
                    ``(E) develop or implement policies to prevent the 
                spread of infectious disease or antimicrobial 
                resistance.
    ``(b) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other Federal, 
State, and local public funds provided for activities under this 
section.
    ``(c) Technical Assistance.--The Secretary shall provide technical 
assistance to the States to assist such States in fulfilling the 
requirements of this section.
    ``(d) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $4,000,000 for fiscal year 2001, 
and such sums as may be necessary for each subsequent fiscal year 
through 2006.

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

    ``(a) Program Authorized.--Not later than 1 year after the date of 
enactment of this section and every 10 years thereafter, the Secretary 
shall award grants to States, or consortia of 2 or more States or 
political subdivisions of States, to perform, in collaboration with 
local public health agencies, an evaluation to determine the extent to 
which the States or local public health agencies can achieve the 
capacities applicable to State and local public health agencies 
described in subsection (a) of section 319A. The Secretary shall 
provide technical assistance to States, or consortia of 2 or more 
States or political subdivisions of States, in addition to awarding 
such grants.
    ``(b) Procedure.--
            ``(1) In general.--A State, or a consortium of 2 or more 
        States or political subdivisions of States, may contract with 
        an outside entity to perform the evaluation described in 
        subsection (a).
            ``(2) Methods.--To the extent practicable, the evaluation 
        described in subsection (a) shall be completed by using 
        methods, to be developed by the Secretary in collaboration with 
        State and local health officials, that facilitate the 
        comparison of evaluations conducted by a State to those 
        conducted by other States receiving funds under this section.
    ``(c) Report.--Not later than 1 year after the date on which a 
State, or a consortium of 2 or more States or political subdivisions of 
States, receives a grant under this subsection, such State, or a 
consortium of 2 or more States or political subdivisions of States, 
shall prepare and submit to the Secretary a report describing the 
results of the evaluation described in subsection (a) with respect to 
such State, or consortia of 2 or more States or political subdivisions 
of States.
    ``(d) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other Federal, 
State, and local public funds provided for activities under this 
section.
    ``(e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $45,000,000 for fiscal year 
2001, and such sums as may be necessary for each subsequent fiscal year 
through 2003.

``SEC. 319C. GRANTS TO IMPROVE STATE AND LOCAL PUBLIC HEALTH AGENCIES.

    ``(a) Program Authorized.--The Secretary shall award competitive 
grants to eligible entities to address core public health capacity 
needs using the capacities developed under section 319A, with a 
particular focus on building capacity to identify, detect, monitor, and 
respond to threats to the public health.
    ``(b) Eligible Entities.--A State or political subdivision of a 
State, or a consortium of 2 or more States or political subdivisions of 
States, that has completed an evaluation under section 319B(a), or an 
evaluation that is substantially equivalent as determined by the 
Secretary under section 319B(a), shall be eligible for grants under 
subsection (a).
    ``(c) Use of Funds.--An eligible entity that receives a grant under 
subsection (a), may use funds received under such grant to--
            ``(1) train public health personnel;
            ``(2) develop, enhance, coordinate, or improve 
        participation in an electronic network by which disease 
        detection and public health related information can be rapidly 
        shared among national, regional, State, and local public health 
        agencies and health care providers;
            ``(3) develop a plan for responding to public health 
        emergencies, including significant outbreaks of infectious 
        diseases or bioterrorism attacks, which is coordinated with the 
        capacities of applicable national, State, and local health 
        agencies and health care providers; and
            ``(4) enhance laboratory capacity and facilities.
    ``(d) Report.--No later than January 1, 2005, the Secretary shall 
prepare and submit to the Committee on Health, Education, Labor, and 
Pensions and the Committee on Appropriations of the Senate and the 
Committee on Commerce and the Committee on Appropriations of the House 
of Representatives a report that describes the activities carried out 
under sections 319A, 319B, and 319C.
    ``(e) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other Federal, 
State, and local public funds provided for activities under this 
section.
    ``(f) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $50,000,000 for fiscal year 
2001, and such sums as may be necessary for each subsequent fiscal year 
through 2006.

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

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

``SEC. 319E. COMBATING ANTIMICROBIAL RESISTANCE.

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

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

    ``(a) Working Group on Preparedness for Acts of Bioterrorism.--The 
Secretary, in coordination with the Secretary of Defense, shall 
establish a joint interdepartmental working group on preparedness and 
readiness for the medical and public health effects of a bioterrorist 
attack on the civilian population. Such joint working group shall--
            ``(1) coordinate research on pathogens likely to be used in 
        a bioterrorist attack on the civilian population as well as 
        therapies to treat such pathogens;
            ``(2) coordinate research and development into equipment to 
        detect pathogens likely to be used in a bioterrorist attack on 
        the civilian population and protect against infection from such 
        pathogens;
            ``(3) develop shared standards for equipment to detect and 
        to protect against infection from pathogens likely to be used 
        in a bioterrorist attack on the civilian population; and
            ``(4) coordinate the development, maintenance, and 
        procedures for the release of, strategic reserves of vaccines, 
        drugs, and medical supplies which may be needed rapidly after a 
        bioterrorist attack upon the civilian population.
    ``(b) Working Group on the Public Health and Medical Consequences 
of Bioterrorism.--
            ``(1) In general.--The Secretary, in collaboration with the 
        Director of the Federal Emergency Management Agency, the 
        Attorney General, and the Secretary of Agriculture, shall 
        establish a joint interdepartmental working group to address 
        the public health and medical consequences of a bioterrorist 
        attack on the civilian population.
            ``(2) Functions.--Such working group shall--
                    ``(A) assess the priorities for and enhance the 
                preparedness of public health institutions, providers 
                of medical care, and other emergency service personnel 
                to detect, diagnose, and respond to a bioterrorist 
                attack; and
                    ``(B) in the recognition that medical and public 
                health professionals are likely to provide much of the 
                first response to such an attack, develop, coordinate, 
                enhance, and assure the quality of joint planning and 
                training programs that address the public health and 
                medical consequences of a bioterrorist attack on the 
                civilian population between--
                            ``(i) local firefighters, ambulance 
                        personnel, police and public security officers, 
                        or other emergency response personnel; and
                            ``(ii) hospitals, primary care facilities, 
                        and public health agencies.
            ``(3) Working group membership.--In establishing such 
        working group, the Secretary shall act through the Assistant 
        Secretary for Health and the Director of the Centers for 
        Disease Control and Prevention.
            ``(4) Coordination.--The Secretary shall ensure 
        coordination and communication between the working groups 
        established in this subsection and subsection (a).
    ``(c) Grants.--
            ``(1) In general.--The Secretary, in coordination with the 
        working group established under subsection (b), shall, on a 
        competitive basis and following scientific or technical review, 
        award grants to or enter into cooperative agreements with 
        eligible entities to enable such entities to increase their 
        capacity to detect, diagnose, and respond to acts of 
        bioterrorism upon the civilian population.
            ``(2) Eligibility.--To be an eligible entity under this 
        subsection, such entity must be a State, political subdivision 
        of a State, a consortium of 2 or more States or political 
        subdivisions of States, or a hospital, clinic, or primary care 
        facility.
            ``(3) Use of funds.--An entity that receives a grant under 
        this subsection shall use such funds for activities that are 
        consistent with the priorities identified by the working group 
        under subsection (b), including--
                    ``(A) training health care professionals and public 
                health personnel to enhance the ability of such 
                personnel to recognize the symptoms and epidemiological 
                characteristics of exposure to a potential bioweapon;
                    ``(B) addressing rapid and accurate identification 
                of potential bioweapons;
                    ``(C) coordinating medical care for individuals 
                exposed to bioweapons; and
                    ``(D) facilitating and coordinating rapid 
                communication of data generated from a bioterrorist 
                attack between national, State, and local health 
                agencies, and health care providers.
            ``(4) Coordination.--The Secretary, in awarding grants 
        under this subsection, shall--
                    ``(A) notify the Director of the Office of Justice 
                Programs, and the Director of the National Domestic 
                Preparedness Office annually as to the amount and 
                status of grants awarded under this subsection; and
                    ``(B) coordinate grants awarded under this 
                subsection with grants awarded by the Office of 
                Emergency Preparedness and the Centers for Disease 
                Control and Prevention for the purpose of improving the 
                capacity of health care providers and public health 
                agencies to respond to bioterrorist attacks on the 
                civilian population.
            ``(5) Activities.--An entity that receives a grant under 
        this subsection shall, to the greatest extent practicable, 
        coordinate activities carried out with such funds with the 
        activities of a local Metropolitan Medical Response System.
    ``(d) Federal Assistance.--The Secretary shall ensure that the 
Department of Health and Human Services is able to provide such 
assistance as may be needed to State and local health agencies to 
enable such agencies to respond effectively to bioterrorist attacks.
    ``(e) Education.--The Secretary, in collaboration with members of 
the working group described in subsection (b), and professional 
organizations and societies, shall--
            ``(1) develop and implement educational programs to 
        instruct public health officials, medical professionals, and 
        other personnel working in health care facilities in the 
        recognition and care of victims of a bioterrorist attack; and
            ``(2) develop and implement programs to train laboratory 
        personnel in the recognition and identification of a potential 
        bioweapon.
    ``(f) Future Resource Development.--The Secretary shall consult 
with the working group described in subsection (a), to develop 
priorities for and conduct research, investigations, experiments, 
demonstrations, and studies in the health sciences related to--
            ``(1) the epidemiology and pathogenesis of potential 
        bioweapons;
            ``(2) the development of new vaccines or other therapeutics 
        against pathogens likely to be used in a bioterrorist attack;
            ``(3) the development of medical diagnostics to detect 
        potential bioweapons; and
            ``(4) other relevant research areas.
    ``(g) General Accounting Office Report.--Not later than 180 days 
after the date of enactment of this section, the Comptroller General 
shall submit to the Committee on Health, Education, Labor, and Pensions 
and the Committee on Appropriations of the Senate and the Committee on 
Commerce and the Committee on Appropriations of the House of 
Representatives a report that describes--
            ``(1) Federal activities primarily related to research on, 
        preparedness for, and the management of the public health and 
        medical consequences of a bioterrorist attack against the 
        civilian population;
            ``(2) the coordination of the activities described in 
        paragraph (1);
            ``(3) the amount of Federal funds authorized or 
        appropriated for the activities described in paragraph (1); and
            ``(4) the effectiveness of such efforts in preparing 
        national, State, and local authorities to address the public 
        health and medical consequences of a potential bioterrorist 
        attack against the civilian population.
    ``(h) Supplement Not Supplant.--Funds appropriated under this 
section shall be used to supplement and not supplant other Federal, 
State, and local public funds provided for activities under this 
section.
    ``(i) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $215,000,000 for fiscal year 
2001, and such sums as may be necessary for each subsequent fiscal year 
through 2006.

``SEC. 319G. DEMONSTRATION PROGRAM TO ENHANCE BIOTERRORISM TRAINING, 
              COORDINATION, AND READINESS.

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

                TITLE II--CLINICAL RESEARCH ENHANCEMENT

SEC. 201. SHORT TITLE.

    This title may be cited as the ``Clinical Research Enhancement Act 
of 1999''.

SEC. 202. FINDINGS AND PURPOSE.

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

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

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

``SEC. 409C. CLINICAL RESEARCH.

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

SEC. 204. GENERAL CLINICAL RESEARCH CENTERS.

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

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

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

``SEC. 409D. ENHANCEMENT AWARDS.

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

SEC. 205. LOAN REPAYMENT PROGRAM REGARDING CLINICAL RESEARCHERS.

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

``SEC. 487F. LOAN REPAYMENT PROGRAM REGARDING CLINICAL RESEARCHERS.

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

SEC. 206. DEFINITION.

    Section 409 of the Public Health Service Act (42 U.S.C. 284d) is 
amended--
            (1) by striking ``For purposes'' and inserting ``(a) Health 
        Service Research.--For purposes''; and
            (2) by adding at the end the following:
    ``(b) Clinical Research.--As used in this title, the term `clinical 
research' means patient oriented clinical research conducted with human 
subjects, or research on the causes and consequences of disease in 
human populations involving material of human origin (such as tissue 
specimens and cognitive phenomena) for which an investigator or 
colleague directly interacts with human subjects in an outpatient or 
inpatient setting to clarify a problem in human physiology, 
pathophysiology or disease, or epidemiologic or behavioral studies, 
outcomes research or health services research, or developing new 
technologies, therapeutic interventions, or clinical trials.''.

SEC. 207. OVERSIGHT BY GENERAL ACCOUNTING OFFICE.

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

             TITLE III--RESEARCH LABORATORY INFRASTRUCTURE

SEC. 301. SHORT TITLE.

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

SEC. 302. FINDINGS.

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

SEC. 303. BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES.

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

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

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

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

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

SEC. 305. SHARED INSTRUMENTATION GRANT PROGRAM.

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

                   TITLE IV--CARDIAC ARREST SURVIVAL

           Subtitle A--Recommendations for Federal Buildings

SEC. 401. SHORT TITLE.

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

SEC. 402. FINDINGS.

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

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

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

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

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

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

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

       ``liability regarding emergency use of automated external 
                             defibrillators

    ``Sec. 248. (a) Good Samaritan Protections Regarding AEDs.--Except 
as provided in subsection (b), any person who uses or attempts to use 
an automated external defibrillator device on a victim of a perceived 
medical emergency is immune from civil liability for any harm resulting 
from the use or attempted use of such device; and in addition, any 
person who acquired the device is immune from such liability, if the 
harm was not due to the failure of such acquirer of the device--
            ``(1) to notify local emergency response personnel or other 
        appropriate entities of the most recent placement of the device 
        within a reasonable period of time after the device was placed;
            ``(2) to properly maintain and test the device; or
            ``(3) to provide appropriate training in the use of the 
        device to an employee or agent of the acquirer when the 
        employee or agent was the person who used the device on the 
        victim, except that such requirement of training does not apply 
        if--
                    ``(A) the employee or agent was not an employee or 
                agent who would have been reasonably expected to use 
                the device; or
                    ``(B) the period of time elapsing between the 
                engagement of the person as an employee or agent and 
                the occurrence of the harm (or between the acquisition 
                of the device and the occurrence of the harm, in any 
                case in which the device was acquired after such 
                engagement of the person) was not a reasonably 
                sufficient period in which to provide the training.
    ``(b) Inapplicability of Immunity.--Immunity under subsection (a) 
does not apply to a person if--
            ``(1) the harm involved was caused by willful or criminal 
        misconduct, gross negligence, reckless misconduct, or a 
        conscious, flagrant indifference to the rights or safety of the 
        victim who was harmed; or
            ``(2) the person is a licensed or certified health 
        professional who used the automated external defibrillator 
        device while acting within the scope of the license or 
        certification of the professional and within the scope of the 
        employment or agency of the professional; or
            ``(3) the person is a hospital, clinic, or other entity 
        whose purpose is providing health care directly to patients, 
        and the harm was caused by an employee or agent of the entity 
        who used the device while acting within the scope of the 
        employment or agency of the employee or agent; or
            ``(4) the person is an acquirer of the device who leased 
        the device to a health care entity (or who otherwise provided 
        the device to such entity for compensation without selling the 
        device to the entity), and the harm was caused by an employee 
        or agent of the entity who used the device while acting within 
        the scope of the employment or agency of the employee or agent.
    ``(c) Rules of Construction.--
            ``(1) In general.--The following applies with respect to 
        this section:
                    ``(A) This section does not establish any cause of 
                action, or require that an automated external 
                defibrillator device be placed at any building or other 
                location.
                    ``(B) With respect to a class of persons for which 
                this section provides immunity from civil liability, 
                this section supersedes the law of a State only to the 
                extent that the State has no statute or regulations 
                that provide persons in such class with immunity for 
                civil liability arising from the use by such persons of 
                automated external defibrillator devices in emergency 
                situations (within the meaning of the State law or 
                regulation involved).
                    ``(C) This section does not waive any protection 
                from liability for Federal officers or employees 
                under--
                            ``(i) section 224; or
                            ``(ii) sections 1346(b), 2672, and 2679 of 
                        title 28, United States Code, or under 
                        alternative benefits provided by the United 
                        States where the availability of such benefits 
                        precludes a remedy under section 1346(b) of 
                        title 28.
            ``(2) Civil actions under federal law.--
                    ``(A) In general.--The applicability of subsections 
                (a) and (b) includes applicability to any action for 
                civil liability described in subsection (a) that arises 
                under Federal law.
                    ``(B) Federal areas adopting state law.--If a 
                geographic area is under Federal jurisdiction and is 
                located within a State but out of the jurisdiction of 
                the State, and if, pursuant to Federal law, the law of 
                the State applies in such area regarding matters for 
                which there is no applicable Federal law, then an 
                action for civil liability described in subsection (a) 
                that in such area arises under the law of the State is 
                subject to subsections (a) through (c) in lieu of any 
                related State law that would apply in such area in the 
                absence of this subparagraph.
    ``(d) Federal Jurisdiction.--In any civil action arising under 
State law, the courts of the State involved have jurisdiction to apply 
the provisions of this section exclusive of the jurisdiction of the 
courts of the United States.
    ``(e) Definitions.--
            ``(1) Perceived medical emergency.--For purposes of this 
        section, the term `perceived medical emergency' means 
        circumstances in which the behavior of an individual leads a 
        reasonable person to believe that the individual is 
        experiencing a life-threatening medical condition that requires 
        an immediate medical response regarding the heart or other 
        cardiopulmonary functioning of the individual.
            ``(2) Other definitions.--For purposes of this section:
                    ``(A) The term `automated external defibrillator 
                device' means a defibrillator device that--
                            ``(i) is commercially distributed in 
                        accordance with the Federal Food, Drug, and 
                        Cosmetic Act;
                            ``(ii) is capable of recognizing the 
                        presence or absence of ventricular 
                        fibrillation, and is capable of determining 
                        without intervention by the user of the device 
                        whether defibrillation should be performed;
                            ``(iii) upon determining that 
                        defibrillation should be performed, is able to 
                        deliver an electrical shock to an individual; 
                        and
                            ``(iv) in the case of a defibrillator 
                        device that may be operated in either an 
                        automated or a manual mode, is set to operate 
                        in the automated mode.
                    ``(B)(i) The term `harm' includes physical, 
                nonphysical, economic, and noneconomic losses.
                    ``(ii) The term `economic loss' means any pecuniary 
                loss resulting from harm (including the loss of 
                earnings or other benefits related to employment, 
                medical expense loss, replacement services loss, loss 
                due to death, burial costs, and loss of business or 
                employment opportunities) to the extent recovery for 
                such loss is allowed under applicable State law.
                    ``(iii) The term `noneconomic losses' means losses 
                for physical and emotional pain, suffering, 
                inconvenience, physical impairment, mental anguish, 
                disfigurement, loss of enjoyment of life, loss of 
                society and companionship, loss of consortium (other 
                than loss of domestic service), hedonic damages, injury 
                to reputation and all other nonpecuniary losses of any 
                kind or nature.''.

             Subtitle B--Rural Access to Emergency Devices

SEC. 411. SHORT TITLE.

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

SEC. 412. FINDINGS.

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

SEC. 413. GRANTS.

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

                    TITLE V--LUPUS RESEARCH AND CARE

SEC. 501. SHORT TITLE.

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

SEC. 502. FINDINGS.

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

                     Subtitle A--Research on Lupus

SEC. 511. EXPANSION AND INTENSIFICATION OF ACTIVITIES.

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

                                ``lupus

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

            Subtitle B--Delivery of Services Regarding Lupus

SEC. 521. ESTABLISHMENT OF PROGRAM OF GRANTS.

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

SEC. 522. CERTAIN REQUIREMENTS.

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

SEC. 523. TECHNICAL ASSISTANCE.

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

SEC. 524. DEFINITIONS.

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

SEC. 525. AUTHORIZATION OF APPROPRIATIONS.

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

           TITLE VI--PROSTATE CANCER RESEARCH AND PREVENTION

SEC. 601. SHORT TITLE.

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

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

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

               TITLE VII--ORGAN PROCUREMENT AND DONATION

SEC. 701. ORGAN PROCUREMENT ORGANIZATION CERTIFICATION.

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

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

    (a) Findings.--Congress finds that--
            (1) traditionally, Thanksgiving is a time for families to 
        take time out of their busy lives to come together and to give 
        thanks for the many blessings in their lives;
            (2) approximately 21,000 men, women, and children in the 
        United States are given the gift of life each year through 
        transplantation surgery, made possible by the generosity of 
        organ and tissue donations;
            (3) more than 66,000 Americans are awaiting their chance to 
        prolong their lives by finding a matching donor;
            (4) nearly 5,000 of these patients each year (or 13 
        patients each day) die while waiting for a donated heart, 
        liver, kidney, or other organ;
            (5) nationwide there are up to 15,000 potential donors 
        annually, but families' consent to donation is received for 
        less than 6,000;
            (6) the need for organ donations greatly exceeds the supply 
        available;
            (7) designation as an organ donor on a driver's license or 
        voter's registration is a valuable step, but does not ensure 
        donation when an occasion arises;
            (8) the demand for transplantation will likely increase in 
        the coming years due to the growing safety of transplantation 
        surgery due to improvements in technology and drug 
        developments, prolonged life expectancy, and increased 
        prevalence of diseases that may lead to organ damage and 
        failure, including hypertension, alcoholism, and hepatitis C 
        infection;
            (9) the need for a more diverse donor pool, including a 
        variety of racial and ethnic minorities, will continue to grow 
        in the coming years;
            (10) the final decision on whether a potential donor can 
        share the gift of life usually is made by surviving family 
        members regardless of the patient's initial intent;
            (11) many Americans have indicated a willingness to donate 
        their organs and tissues but have not discussed this critical 
        matter with the family members who are most likely to make the 
        decision, if the occasion arises, as to whether that person 
        will be an organ and tissue donor;
            (12) some family members may be reluctant to give consent 
        to donate their deceased loved one's organs and tissues at a 
        very difficult and emotional time if that person has not 
        clearly expressed a desire or willingness to do so;
            (13) the vast majority of Americans are likely to spend 
        part of Thanksgiving Day with some of those family members who 
        would be approached to make such a decision; and
            (14) it is fitting for families to spend a portion of that 
        day discussing how they might give life to others on a day 
        devoted to giving thanks for their own blessings.
    (b) Designation.--November 23, 2000, Thanksgiving Day, is hereby 
designated as a day to ``Give Thanks, Give Life'' and to discuss organ 
and tissue donation with other family members so that informed 
decisions can be made if the occasion to donate arises.

         TITLE VIII--ALZHEIMER'S CLINICAL RESEARCH AND TRAINING

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

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

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

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

 TITLE IX--SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH AND TRAINING

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

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

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

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

                    TITLE X--MISCELLANEOUS PROVISION

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

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

            Attest:

                                                             Secretary.
106th CONGRESS

  2d Session

                               H. R. 2498

_______________________________________________________________________

                               AMENDMENT

HR 2498 EAS----2
HR 2498 EAS----3
HR 2498 EAS----4
HR 2498 EAS----5
HR 2498 EAS----6
HR 2498 EAS----7
HR 2498 EAS----8
HR 2498 EAS----9
HR 2498 EAS----10