[Congressional Record (Bound Edition), Volume 146 (2000), Part 17]
[House]
[Pages 25012-25026]
[From the U.S. Government Publishing Office, www.gpo.gov]



                  CARDIAC ARREST SURVIVAL ACT OF 2000

  Mr. BILIRAKIS. Mr. Speaker, I move to suspend the rules, concur in 
the Senate amendment to the bill (H.R. 2498) to amend the Public Health 
Service Act to provide for recommendations of the Secretary of Health 
and Human Services regarding the placement of automatic external 
defibrillators in Federal buildings in order to improve survival rates 
of individuals who experience cardiac arrest in such buildings, and to 
establish protections from civil liability arising from the emergency 
use of the devices.
  The Clerk read as follows:

       Senate amendment:
       Strike out all after the enacting clause and insert:

     SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

Sec. 1. Short title; table of contents.

               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.

[[Page 25013]]

 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.--

[[Page 25014]]

       ``(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.

[[Page 25015]]

       ``(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.

[[Page 25016]]

       (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

[[Page 25017]]

     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.

[[Page 25018]]

       ``(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.

[[Page 25019]]



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

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


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

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

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

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


       ``liability regarding emergency use of automated external 
                             defibrillators

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

             Subtitle B--Rural Access to Emergency Devices

     SEC. 411. SHORT TITLE.

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

     SEC. 412. FINDINGS.

       Congress makes the following findings:
       (1) Heart disease is the leading cause of death in the 
     United States.
       (2) The American Heart Association estimates that 250,000 
     Americans die from sudden cardiac arrest each year.

[[Page 25020]]

       (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--

[[Page 25021]]

       (A) under any State compensation program, under an 
     insurance policy, or under any Federal or State health 
     benefits program; or
       (B) by an entity that provides health services on a prepaid 
     basis.
       (5) The applicant will, at each site at which the applicant 
     provides services under section 521(a), post a conspicuous 
     notice informing individuals who receive the services of any 
     Federal policies that apply to the applicant with respect to 
     the imposition of charges on such individuals.

     SEC. 523. TECHNICAL ASSISTANCE.

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

     SEC. 524. DEFINITIONS.

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

     SEC. 525. AUTHORIZATION OF APPROPRIATIONS.

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

           TITLE VI--PROSTATE CANCER RESEARCH AND PREVENTION

     SEC. 601. SHORT TITLE.

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

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

       (a) Preventive Health Measures.--Section 317D of the Public 
     Health Service Act (42 U.S.C. 247b-5) is amended--
       (1) by striking subsection (a) and inserting the following:
       ``(a) In General.--The Secretary, acting through the 
     Director of the Centers for Disease Control and Prevention, 
     may make grants to States and local health departments for 
     the purpose of enabling such States and departments to carry 
     out programs that may include the following:
       ``(1) To identify factors that influence the attitudes or 
     levels of awareness of men and health care practitioners 
     regarding screening for prostate cancer.
       ``(2) To evaluate, in consultation with the Agency for 
     Health Care Policy and Research and the National Institutes 
     of Health, the effectiveness of screening strategies for 
     prostate cancer.
       ``(3) To identify, in consultation with the Agency for 
     Health Care Policy and Research, issues related to the 
     quality of life for men after prostrate cancer screening and 
     followup.
       ``(4) To develop and disseminate public information and 
     education programs for prostate cancer, including appropriate 
     messages about the risks and benefits of prostate cancer 
     screening for the general public, health care providers, 
     policy makers and other appropriate individuals.
       ``(5) To improve surveillance for prostate cancer.
       ``(6) To 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

[[Page 25022]]

     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.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Florida (Mr. Bilirakis) and the gentleman from Ohio (Mr. Brown) each 
will control 20 minutes.
  The Chair recognizes the gentleman from Florida (Mr. Bilirakis).


                             General Leave

  Mr. BILIRAKIS. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days within which to revise and extend their 
remarks and to insert extraneous material on H.R. 2498.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Florida?
  There was no objection.
  Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, I rise today in strong support of H.R. 2498, and I urge 
my colleagues to join me in voting to approve this very critical 
legislation.
  The bill before us today is comprised of a number of bipartisan, 
noncontroversial public health measures. It includes key provisions to 
respond to emerging health threats, save victims of cardiac arrest, 
promote clinical research, improve our research infrastructure, and 
fight prostate cancer and lupus.
  I would like to highlight a few of these provisions. First, H.R. 2498 
includes the provisions of the 21st Century Research Laboratories Act, 
legislation which I introduced earlier this year. There is no doubt 
that America is the worldwide leader in medical research, both at the 
National Institutes of Health and at our research facilities throughout 
the Nation. However, while Congress has worked successfully to increase 
funding for medical research, monies for building construction and 
renovation have lagged.
  Mr. Speaker, my legislation responds to this problem by authorizing 
the director of the National Center for Research Resources at the NIH 
to make grants or enter into contracts to expand or renovate existing 
research facilities and construct new research facilities. It also 
authorizes grants for the purchase of state-of-the-art laboratory 
instrumentation.
  In addition, H.R. 2498 includes the provisions of the Lupus Research 
Act, which was originally introduced by the gentlewoman from Florida 
(Mrs. Meek). She has been a tireless advocate for this proposal, and it 
was overwhelmingly approved by the House earlier this month.
  Today, over 1.4 million Americans have lupus, a devastating disease 
that causes the immune system to attack the body's own cells and 
organs. Ninety percent of the victims of lupus are women, and the 
disease is more common among women of color. By the time some lupus 
patients are diagnosed, especially in poor or rural communities, 
irreversible damage to vital organs has already occurred.
  The bill before us expands Federal lupus research activities through 
the NIH, and it authorizes the Secretary of Health and Human Services 
to make project grants for the delivery of essential services. These 
projects will help identify innovative ways to respond to this terrible 
disease.
  H.R. 2498, Mr. Speaker, also includes the provisions of the Cardiac 
Arrest Survival Act, which was authored by the gentleman from Florida 
(Mr. Stearns). I want to truly commend him for his leadership in 
advancing this initiative, which passed the House in May with strong 
support.
  Each year, a quarter million Americans die due to cardiac arrest. 
Many of these victims could be saved if portable medical devices called 
automated external defibrillators, or AEDs, were used. AEDs can analyze 
heart rhythms for abnormalities, and if warranted, deliver a life-
saving shock to the heart. An estimated 20,000 to 100,000 lives could 
be saved annually by greater access to AEDs.

[[Page 25023]]

  H.R. 2498 directs the Secretary of Health and Human Services to issue 
regulations to provide for the placement of AEDs in Federal buildings. 
The bill also establishes protections from civil liability arising from 
the emergency use of these devices.
  Mr. Speaker, the proposals incorporated in this legislative package 
will literally save lives, and I am grateful to the many Members of 
both sides of the aisle who worked so hard to advance this cause.
  In that regard, I want to thank the gentleman from Virginia (Mr. 
Bliley), chairman of the Committee on Commerce, the gentleman from 
Michigan (Mr. Dingell), ranking member, and in particular the gentleman 
from Ohio (Mr. Brown), a ranking member of the Subcommittee on Health 
and Environment.
  I also want to recognize and thank the gentleman from Pennsylvania 
(Mr. Greenwood) and the gentleman from North Carolina (Mr. Burr) for 
their contributions to this legislation.
  The bill before us is a critical public health measure worthy of 
bipartisan support. I urge every Member to support H.R. 2498.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BROWN of Ohio. Mr. Speaker I yield myself such time as I may 
consume.
  Mr. Speaker, in 1906, Upton Sinclair wrote a book called ``The 
Jungle,'' documenting problems in the unsafe working conditions and 
unsafe food production in the Chicago slaughterhouses.
  In the year 1906, when Upton Sinclair's book was published, which 
resulted later in the creation soon after of the Food and Drug 
Administration, which has guaranteed food safety in this country for 9 
decades, in that year in 1906, a boy born that year had a life 
expectancy of 46 years. A girl born in 1906 had a life expectancy of 48 
years.
  Nine-plus decades later, life expectancy in this country has been 
lengthened 30 years. Boys and girls born in this country have 30 years 
more life expectancy than they did just a century ago.
  That is not mostly from high-tech medicine. It is mostly from public 
health, everything from pure food to safe drinking water, from 
immunizations to antibiotics, from seat belts to a knowledge that 
alcohol and tobacco cause health problems, to issue after issue after 
issue of pure food laws and environmental laws and public health laws 
and worker safety laws and all the things that we in this body and in 
State legislatures across the country and in public health agencies 
across the country have done to together to enhance public health.
  That is why it is a pleasure, from my perspective, a pleasure to 
support this bill, to be a cosponsor of this bill, and support the 
gentleman from Florida (Mr. Bilirakis) in his efforts to promote public 
health, which does make such a difference in the lives of every 
American.
  This legislation includes the 21st Century Research Laboratories Act, 
a bill that I joined the gentleman from Florida (Mr. Bilirakis) in 
sponsoring. I also want to commend Senator Harkin for his leadership on 
this bill.
  The U.S. invests generously in medical research through the National 
Institutes of Health, reflecting the public's strong interest in 
reducing the burden of disease here and abroad. But to secure the most 
benefit of that investment, it makes sense to couple dollars for 
research grants with funding to bolster the Nation's research 
infrastructure. The two go hand in hand.
  Our bill would put that principle into practice by enabling NIH to 
devote additional resources to state-of-the-art research laboratories 
and instrumentations.
  Like laboratory research, clinical research is invaluable. It is a 
bridge between the laboratory and new methods of diagnosis, treatment, 
and prevention. Despite the benefits of clinical research, the current 
level of training and support for health professionals in clinical 
research is too often inadequate to the task.
  I am pleased to be an original cosponsor of the bill that is now 
incorporated into this bill from the gentleman from Pennsylvania (Mr. 
Greenwood) that supports and expands NIH involvement in clinical 
research and increases resources available for the clinical research 
community.
  This package of bills also contains legislation put forward by 
Senators Frist and Kennedy and my colleagues on the Committee on 
Commerce and the Subcommittee on Health and Environment, the gentleman 
from North Carolina (Mr. Burr) and the gentleman from Michigan (Mr. 
Stupak), on public health threats and emergencies.
  Our Nation faces grave new threats in the 21st century that imperil 
the extraordinary progress we have made on public health in the 20th 
century.
  New or resurgent infectious diseases, West Nile virus, lyme disease 
and others are on the upswing. Microbes that cause infectious diseases 
are evolving to become resistant, resisting antibiotics so that 
formerly treatable infections, such as TB, as I mentioned in an earlier 
talk tonight, may become incurable.
  We are also vulnerable to terrorist attacks using biological weapons 
that could spread deadly diseases, such as small pox or anthrax.
  This title authorizes steps that are widely agreed to be essential to 
prepare for emerging threats to public health.
  I am particularly pleased the bill authorizes perhaps its most 
important feature, funding to revitalize Centers for Disease Control 
facilities. The gentleman from Florida (Mr. Bilirakis) and I saw the 
absolute amazingly poor conditions under which employees of the CDC, 
some of the greatest scientists and public health experts in the 
country, the conditions under which they labor in Atlanta. We can do so 
much better than that.
  The provisions on combatting antimicrobial resistance are a good step 
towards addressing one of the most serious threats to public health 
that we face. They lay the groundwork for addressing the misuse and 
overuse of antibiotics, both in human medicine and in the agriculture 
sector.
  I would add that this Congress went on record a couple of months ago 
in support of an amendment I had to direct the FDA's veterinary 
medicine office to get more serious about antibiotic resistance in farm 
animals. Fifty percent of the antibiotics used in this country are used 
for nonmedicinal purposes in farm animals, something that we probably 
cannot afford to do as a Nation much longer.

                              {time}  2015

  I am also pleased this package includes important public health 
initiatives that would help the Nation combat diseases that take a 
tremendous toll on patients and their families, including lupus, 
prostate cancer, and Alzheimer's, as well as measures promoting access 
to defibrillators, an issue the gentleman from Wisconsin (Mr. Kind) has 
worked hard on, in Federal buildings and rural communities to aid 
victims of sudden heart attacks.
  Prostate cancer is the most commonly diagnosed form of cancer, other 
than skin cancer, and second only to lung cancer as a cause of cancer-
related death among men. This bill recognizes the immense toll that 
prostate cancer has taken on our country. I commend my colleague, the 
gentlewoman from Florida (Mrs. Meek), for her endless dedication to 
raising awareness about lupus. Her tireless work has made a difference 
in this bill's efforts to treat lupus.
  The American Heart Association estimates that more than 50,000 
American deaths a year could be prevented if defibrillators were 
available to designated responders. Nothing can be more frightening 
than watching someone suffer a heart attack. With proper use of a 
defibrillator and proper training, communities can respond quickly and 
effectively to a victim and improve that victim's chances of survival 
immensely.
  Like so many of these illnesses we have discussed today, Alzheimer's 
is a complicated disease afflicted by more questions than answers. 
Alzheimer's is characteristically more difficult for the family to 
bear; a person's slow deterioration in health begins with common 
forgetfulness and progresses slowly until the family is faced with no

[[Page 25024]]

choice but to move their loved one to another facility. I commend my 
colleagues, the gentleman from New Jersey (Mr. Smith) and the gentleman 
from Massachusetts (Mr. Markey), for their leadership on this measure.
  Overall, Mr. Speaker, I again thank the gentleman from Florida (Mr. 
Bilirakis) because this bipartisan legislation covers a lot of 
important ground. It bolsters public health, something this body has 
not done nearly enough of in the past, an infrastructure that has been 
neglected for too many years, the public health infrastructure; it 
invests in the fight against lupus, Alzheimer's and other traumatic 
health care conditions; it brings attention to the life-saving 
potential of portable defibrillators and the invaluable gift of organ 
donation.
  This bill reflects the breadth and complexity of health and health 
care in the U.S., and it sets in motion practical steps to improve 
both. In my mind, this may be the most important health issue this 
Congress has passed. It does so much for so many in this country.
  I wish this body would get as serious about dealing with the 
prescription drug issue and dealing with the Patients' Bill of Rights 
as it has this issue, but I particularly extend my thanks to the 
gentleman from Florida (Mr. Bilirakis), to the gentleman from Virginia 
(Mr. Bliley), to the gentleman from Michigan (Mr. Dingell), and all who 
have played a major role in this bill.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BILIRAKIS. Mr. Speaker, I yield 6 minutes to the gentleman from 
Florida (Mr. Stearns), a gentleman about whom people many not now know 
this, but people in the future will be indebted to him for his 
persistence and his perseverance in offering and sticking with this 
defibrillator legislation.
  Mr. STEARNS. Mr. Speaker, I thank the chairman of the Subcommittee on 
Health and Environment of the Committee on Commerce for yielding me 
this time.
  I think this is a very, very rewarding evening, to have had the 
Senate pass the original 2498, which was the Cardiac Arrest Survival 
Act of 2000, which now has been amended to include different sections 
of what we have tonight and is now called the Public Health Improvement 
Act of 2000.
  My portion of the bill, which is section 4, is something I am very 
proud of because, Mr. Speaker, between 200,000 to 300,000 Americans are 
lost every year to sudden cardiac arrest in the United States. Many of 
these victims could be simply saved if they had access to immediate 
medical response, including defibrillation. Just today, Mr. Speaker, 
the New England Journal of Medicine released the results of two recent 
studies in which nearly half of the victims of cardiac arrest were 
saved with the help of an automatic external defibrillator. That 
represents 10 times the usual survival rate of 5 percent for people who 
suffer cardiac arrest in a nonhospital setting.
  For the last several years, I have been working closely with the 
American Heart Association, the American Red Cross, and local emergency 
medical systems to develop bipartisan support to encourage the 
widespread use of automatic external defibrillator devices to help save 
lives. These devices, AEDs, are small portable medical devices. They 
are regulated by the Food and Drug Administration and can measure a 
victim's heart rate, determine whether the victim is suffering from 
ventricular fibrillation and, if electric shock is necessary, can 
instruct the lay user how to use it and when to use it to shock the 
victim, and even tell them when to use CPR. So these devices are safe, 
effective and do not allow a shock to be administered until after the 
device has measured the victim's heart and determined whether a shock 
is really required.
  Do my colleagues know that for every minute of delay in returning the 
heart to its normal pattern of beating it decreases the chance of that 
person's survival by 10 percent? And let me tell my colleagues tonight, 
because we all feel, probably, that we are in good health, that Robert 
Adams felt he was in good health. He was 42 years old and was an 
attorney working in Manhattan. On the weekends he was an NCAA referee. 
Obviously, he was in great condition. He had recently passed several 
extensive physical exams with flying colors; yet he suffered sudden 
cardiac arrest on July 3rd, a weekend, in Grand Central Station in New 
York City.
  Fortunately, by the grace of God, the station had just received 
delivery of an AED the day before. A couple of nearby construction 
workers saw Mr. Adams fall to the ground. They grabbed the AED, which 
was still in its package. They prayed and hoped that the batteries were 
installed and charged. And, sure enough, they were. They shocked Mr. 
Adams back to life.
  Now, Mr. Speaker, unfortunately, AEDs are not being widely employed 
because of the perception among would-be purchasers and users of these 
devices that if they do use them they are going to be sued. Our 
legislation removes this barrier to adopting AED programs with a Good 
Samaritan clause. If a Good Samaritan or building owner or renter acts 
in good faith to purchase or use an AED to help save someone's life, 
this bill will protect them from unfair lawsuits. We may not want to 
force people to provide medical care to someone having a heart attack; 
but if they are willing to do so, if they are volunteers, we should not 
put them at risk of being sued for unlimited damages if something went 
wrong.
  So this legislation also directs the Secretary of Health and Human 
Services to develop guidelines for the placement of defibrillators in 
Federal buildings. It is a moment in our history when we have to have 
these accessible throughout all the Federal and State and local 
buildings. It is inexcusable that we do not have these life-saving 
devices widely available today. We need to be a role model for the 
private sector by demonstrating our commitment to protecting the lives 
of our Federal employees.
  H.R. 2498 does not impose any new regulations or obligations on the 
private sector, and it does not preempt State law where the State has 
provided immunity for the person being sued. My colleagues, let us help 
save 250,000 American lives who are lost annually to sudden cardiac 
arrest. It could be any one of us on any day in the 365 days. The 
Senate passed this bill, as I mentioned, earlier today; and I urge my 
colleagues to support and pass this bill.
  Lastly, Mr. Speaker, it has been a long journey for all of us to get 
this bill passed through Congress. I want to thank the chairman, the 
gentleman from Florida (Mr. Bilirakis), for his support and 
encouragement all during this process and for the work he and his staff 
do; and also the gentleman from Virginia (Mr. Bliley) for his help in 
moving this legislation to where we are tonight.
  I also want to thank those who have worked so hard on the bill, 
including my staff, Veronica Crowe; as well as the folks on the 
Committee on Commerce, Marc Wheat, Robert Gordon, and Brent Delmonte; 
and Pete Goodloe, who was legislative counsel; and, of course, Mr. 
Speaker, the American Heart Association and the American Red Cross.
  This is a red letter day, and I think all Americans will benefit. I 
urge the passage of this valuable legislation.
  Mr. BROWN of Ohio. Mr. Speaker, I yield such time as he may consume 
to the gentleman from Wisconsin (Mr. Kind), who has helped to lead the 
charge in support of the defibrillator part of this legislation.
  Mr. KIND. Mr. Speaker, I thank my friend from Ohio for yielding me 
this time, and I too want to rise in support of H.R. 2498, and I want 
to commend the chairman, the gentleman from Virginia (Mr. Bliley), the 
ranking member, the gentleman from Michigan (Mr. Dingell), the chairman 
and ranking member on the subcommittee, and the bipartisan support that 
this legislation received and the work product that went into it from 
the Committee on Commerce.
  Obviously, this was a work in progress with a lot of input from a lot 
of areas, and it is nice to be on the floor here tonight with a true 
bipartisan form of health care legislation. I

[[Page 25025]]

think many Americans will reap dividends throughout our country in 
future years.
  I am happy to support the bill not only because placing automatic 
external defibrillators, AEDs for short, in Federal buildings will help 
save lives for those who live in urban areas, as the gentleman from 
Florida (Mr. Stearns) has just pointed out, and I also commend him for 
the work and the leadership he has provided in recognizing the 
importance to have access to AEDs for more Americans, but also because 
this bill includes the language of H.R. 4953, the Rural Access to 
Emergency Devices Act, which I along with the gentleman from Georgia 
(Mr. Deal) introduced earlier this year.
  In my home State of Wisconsin, nearly 200,000 people are afflicted 
with heart disease. It is the number one killer throughout the State, 
the number one killer in every county throughout the State, taking the 
lives of nearly 20,000 Wisconsonites every year. New technology, such 
as AEDs, can improve survival rates, but only if the devices are 
accessible and available.
  Unfortunately, in rural areas, the availability of AEDs is limited. 
Hospitals are often located far from the scene of an emergency, and 
fewer than half of all ambulances in the United States actually carry 
AEDs. By giving grants to emergency responders and community 
partnerships to purchase AEDs and to train people on how to administer 
CPR, citizens in rural areas especially will benefit and will have a 
better chance of surviving cardiac arrest.
  In western Wisconsin, we have seen the benefits of AED access 
already. Thanks to Scott Wuerch, an American Heart Association 
volunteer, all Eau Claire County sheriffs are now trained to use and 
are equipped with AEDs, and it is my hope that with passage of this 
bill that citizens in rural America will have a better chance of 
surviving cardiac arrest.
  The gentleman from Florida (Mr. Stearns) already indicated the 
article that appeared in the New England Journal of Medicine, the two 
studies showing the benefits in the use of AEDs. Most of the major 
newspaper publications this week have been printing stories in regard 
to the effectiveness of AEDs and the need to increase access for it. In 
fact, this week I hope a lot of my colleagues were able to capture the 
article in USA Today on Wednesday titled ``The Prescription to Save 
Lives.'' It provides a condensed, but very good, account of the 
important role that AEDs are now performing throughout America and 
increased access to it, but also the work that needs to be done.
  The gentleman from Florida already indicated that during cardiac 
arrest every minute of failed treatment results in a 10 percent less 
chance of survival. Ten minutes usually results in fatality. But what 
this article also pointed out was how simple the training of AEDs can 
be. In fact, after a few short minutes, even children can be trained to 
use it. Most of these devices now have computerized voices that 
actually walk the people through on how to effectively use AEDs. In 
fact, recent studies show that 50 percent of even untrained people can 
successfully use AEDs in emergency situations.
  So I think the evidence, the studies that have come out now, also the 
support that we are seeing here tonight on the floor, is indication 
enough of just how important this legislation is and being able to 
provide access to automatic external defibrillators for more people in 
the country, but especially in rural areas, Mr. Speaker.
  So again I commend the leadership on the committee. I commend the 
gentleman from Georgia (Mr. Deal) for introducing the rural access bill 
earlier this year, and I would encourage all my colleagues to support 
this good bipartisan piece of health care legislation before us.
  Mr. BROWN of Ohio. Mr. Speaker, I have no further requests for time, 
and I yield back the balance of my time.
  Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, I wish to add my gratitude to the many staff members on 
the Committee on Commerce, particularly for their hard work on this 
legislation; as well as people on our personal staffs, Anne Esposito of 
my personal staff and others who have helped out.
  Mr. DINGELL. Mr. Speaker, I rise in support of H.R. 2498, the Public 
Health Improvement Act. This is an excellent package of public health 
measures, and I am pleased to see this Congress act on this legislation 
before it adjourns. H.R. 2498 contains several broadly supported, non-
controversial provisions that amend the Public Health Service Act.
  Title I, ``Emerging Threats to Public Health,'' is of particular 
interest to my colleague from Michigan, Mr. Stupak. This provision 
strengthens America's capacity to detect and respond to serious public 
health threats and emergencies through several initiatives. On a local 
level, public health departments and agencies will be provided the 
resources to update their laboratory and electronic communication 
equipment, readying them to combat an infectious disease outbreak. They 
will also be able to engage in planning rapid response strategies and 
train personnel. On a national level, the often antiquated facilities 
at the Centers for Disease Control and Prevention--our nation's first 
line of defense against biological threats--will be revitalized to meet 
the demands of the 21st century. This legislation also authorizes 
activities to combat antimicrobial resistance and protect the nation 
from bioterrorist attacks, both of which are issues of long-standing 
interest to my colleague Mr. Brown of Ohio. The World Health 
Organization, and more recently the CIA's National Intelligence Council 
have named resistant infections and bioterrorism as major threats to 
global security. This provision will put the public health 
infrastructure of the United States in the best defensive position, 
should such an outbreak occur.
  Title II, ``Clinical Research Enhancement,'' directs NIH to expand 
the nation's clinical research capacity in response to a documented 
need for such activities. Clinical research translates basic science 
discoveries into medical interventions that can be used for patient 
care. This provision strengthens America's clinical research 
infrastructure by expanding facilities and faculty of the NIH-supported 
General Clinical Research Centers. It also sets forth three career 
investigator grant award programs, and provides a loan repayment option 
for young investigators wishing to dedicate their careers to clinical 
research. This provision endorses no specific clinical research agendas 
or priorities; rather, it facilitates a breadth of activities that can 
be carried out by a variety of scientists and health professionals, 
including qualified social science researchers and nurses. A separate 
provision in H.R. 2498 authorizes specific clinical research and 
training award programs in Alzheimer's disease. We are grateful to our 
colleague, Mr. Markey, for his work on this matter.
  While a number of provisions in this bill respond to the research and 
treatment needs of our nation, advances in these areas are often 
hampered by the facilities in which the activities occur. Title III, 
known as the ``Twenty-First Century Research Laboratories Act,'' 
authorizes funds for construction and modernization of our nation's 
biomedical and behavioral research laboratories and facilities, 
including the purchase of new laboratory equipment.
  Title IV of this bill, the ``Cardiac Arrest Survival Act'' passed the 
House on May 23rd. This provision directs the Secretary to develop 
guidelines for the placement of automated external defibrillators in 
Federal buildings. It also promotes public and health professional 
education in cardiopulmonary resuscitation and the use of 
defibrillators in order to save the lives. I commend my colleague from 
California, Ms. Capps, for managing this bill when the House passed it 
earlier this year. I also commend my colleague from Wisconsin, Mr. 
Kind, for shepherding through a related provision providing access to 
defibrillators and emergency devises to residents of rural areas.
  Title V is based on the H.R. 762, the ``Lupus Research and Care 
Amendments,'' introduced by my colleague from Florida, Mrs. Meek. Lupus 
is a debilitating and sometimes fatal autoimmune disease that 
disproportionately afflicts women, particularly women of color. This 
title addresses research on this disease and it authorizes 
appropriations to expand and intensify activities that focus on earlier 
diagnosis, better treatment, and an eventual cure. Significantly, a 
companion section of the provision addresses on-going primary care and 
treatment needs of poor and uninsured individuals with this expensive-
to-treat and debilitating disease. It authorizes the Secretary to award 
care grants to local governments, community hospitals, health centers, 
and other non-profit health facilities for the provision of out-patient 
care and a breadth of support services to affected individuals and the 
family members

[[Page 25026]]

who are involved in their care. This bill previously passed the House 
by a vote of 385-2.
  Title VI, addresses the growing problem of prostate cancer in 
Americans males by revising and extending the CDC's prostrate cancer 
screening preventing health program, and reauthorizing the National 
Institutes of Health prostate cancer research programs. I am pleased to 
see this provision also addresses the needs of underserved and minority 
populations with prostate cancer.
  H.R. 2498 concludes with an organ donation provision that includes 
asking all Americans to recognize this Thanksgiving day as ``Give 
Thanks, Give Life Day.'' As families sit down together this 
Thanksgiving day, they are encouraged to spend a moment thinking about 
the thousands of Americans in need of organ transplants, and discuss 
openly their own decisions to donate organs or tissue in a forum where 
relatives can be made aware of their wishes.
  There are many more things I had hoped to do for the health of the 
American people during the 106th Congress. These include: enactment of 
a real Patients' Bill of Rights; restoration of federal jurisdiction to 
control tobacco use by America's children; access to prescription drugs 
for senior citizens; long-term care for the elderly; access for 
America's children with rare and/or serious health problems to 
pediatric specialists, medications and clinical trials; adequate 
protection for human research subjects; protection of predictive 
genetic information from discrimination by health insurers and 
employers; and enhanced protection of confidential medical records. For 
those of my colleagues who will be returning next year, I look forward 
to working with you on these issues.
  Mr. MARKEY. Mr. Speaker, I rise in support of H.R. 2498, The Cardiac 
Arrest Survivors Act which includes language based on a bill I 
introduced in March together with my colleague from New Jersey and Co-
Chairman of the Bipartisan Task Force on Alzheimer's Disease, Chris 
Smith. Our bill, ``The Alzheimer's Clinical Research and Training 
Awards Act of 2000'' creates a new clinical research program at NIH to 
improve the diagnosis and treatment of Alzheimer's Disease.
  Mr. Speaker, I want to say a special word of thanks to Commerce 
Committee Chairman Tom Bliley for accepting the Alzheimer's provision 
as part of this legislation. This important public health bill is a 
feather in his health care cap as he prepares to retire from this body, 
and I thank him. I would also like to thank the Ranking Member of the 
Commerce Committee John Dingell, and Senators Kennedy and Frist in the 
other body, for constructing a strong bipartisan public health bill.
  Alzheimer's Disease is on track to become the epidemic of the 21st 
Century. Today 4 million Americans are afflicted and by 2050 it is 
estimated that this number will increase to 14 million.
  That's right Mr. Speaker, 14 million Americans will face the 
devastation of losing their independence, their personality, and their 
memory--the very threads of life that gives one his or her identity.
  Funding for basic research to find a cure for Alzheimer's Disease is 
important and I'm pleased that this year's funding levels will increase 
to over $550 million. But there's no way to know when a cure will 
present itself--it could be in two years or ten years or twenty years. 
In the meantime people are suffering.
  A recent study conducted at the Oregon Health Sciences University 
indicated that 65% of patients with probable dementia are going 
undiagnosed. This study highlights the crucial need to improve 
recognition and assessment of dementia patients.
  The language included in H.R. 2498 addresses this need. The 
Alzhiemer's Clinical Research and Training Awards program is designed 
to compliment the 30 Alzheimer's Research Centers across our nation 
which currently focus on basic research and are administered through 
the National Institutes on Aging at NIH. During my own personal 
experience with my mother's Alzheimer's disease, top Alzheimer's 
researchers and clinicians underscored the crucial need for providing a 
bridge between Alzheimer's laboratory research and new methods of 
diagnosis, treatment and prevention. This program provides awards to 
junior and mid-level physicians to focus their careers on Alzheimer's 
and to train as physician scientist specialists to improve and apply 
cutting edge research to Alzheimer's patients.
  Researching a cure for tomorrow is critical, but we also need to do 
better in treating those suffering with Alzheimer's Disease today.
  The Alzheimer's Clinical Research and Training Awards program takes a 
first step in doing the very best we can in providing cutting edge 
diagnosis, treatment and prevention for those who are and will be 
effected by the epidemic of the 21st century.

                              {time}  2030

  Mr. BILIRAKIS. Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore (Mr. Thune). The question is on the motion 
offered by the gentleman from Florida (Mr. Bilirakis) that the House 
suspend the rules and concur in the Senate amendment to the bill, H.R. 
2498.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds of 
those present have voted in the affirmative.
  Mr. BROWN of Ohio. Mr. Speaker, I object to the vote on the ground 
that a quorum is not present and make the point of order that a quorum 
is not present.
  The SPEAKER pro tempore. Pursuant to clause 8, rule XX and the 
Chair's prior announcement, further proceedings on this motion will be 
postponed.
  The point of no quorum is considered withdrawn.

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