Public Health Improvement Act
PL 106-505 (H.R.2498), enacted 11/13/2000

114 STAT. 2314 
PUBLIC LAW 106-505—NOV. 13, 2000 
Public Law 106-505 
106th Congress 
An Act 
To amend the Public Health Service Act to provide for recommendations of the 
N 
1^ 9ftnft 
Secretary of Health and Human Services regarding the placement of automatic 
°^' 
' 
external defibrillators in Federal buildings in order to improve survival rates 
[H.R. 2498] 
of individuals who experience cardiac arrest in such biiildings, and to establish 
protections from civU liability arising from the emergency use of the devices. 
Be it enacted by the Senate and House of Representatives 
of 
PubUc Health 
the United States of America in Congress assembled, 
Improvement 
^^^^^^ 
^ ^^^^^ 
^ ^ ^ ^ ^ ^ ^ ^ CONT^NT^. 
42 use 201 note. 
(a) gnoRT TiTLE.—This Act may be cited as the "PubHc 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 cUnical 
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. 3t)4. 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 build-
ings. 
Sec. 404. Good Samaritan protections regarding emergency use of automated exter-
nal defibrillators. 
Subtitle B—Rural Access to Emergency Devices 
Sec. 411. Short title. 
Sec. 412. Findings. 
Sec. 413. Grants. 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2315 
TITLE V—LUPUS RESEARCH AND CARE 
Sec. 501. Short title. 
Sec. 502. Findings. 
Subtitle A—Research on Lupus 
Sec. 511. Expansion and intensification of activities. 
Subtitle B—DeUvery of Services Regarding Lupus 
Sec. 521. Establishment of program of grants. 
Sec. 522. Certain requirements. 
Sec. 523. Technical assistance. 
Sec. 524. Definitions. 
Sec. 525. Authorization of appropriations. 
TITLE VI—PROSTATE CANCER RESEARCH AND PREVENTION 
Sec. 601. Short title. 
Sec. 602. Amendments to the Public Health Service Act. 
TITLE VII—ORGAN PROCUREMENT AND DONATION 
Sec. 701. Organ procurement organization certification. 
Sec. 702. Designation of Give Thanks, Give Life Day. 
TITLE VIII—ALZHEIMER'S CLINICAL RESEARCH AND TRAINING 
Sec. 801. Alzheimer's clinical research and training awards. 
TITLE K—SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH AND 
TRAINING 
Sec. 901. Sexually transmitted disease cUnical 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 
Public Health 
Threats and 
Emergencies Act. 
SEC. 101. SHORT TITLE. 
This title may be cited as the "PubHc 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 consulta-
tion with such public health officials as may be necessary, that— 
"(1) a disease or disorder presents a public health emer-
gency; or 
"(2) a public health emergency, including significant out-
breaks 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 inves-
tigations 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 fimd to be designated as the 'Public Health Emergency Fund' 
42 u s e 201 note. 
42 u s e 247d. 
114 STAT. 2316 
PUBLIC LAW 106-505—NOV. 13, 2000 
Deadline. 
42 use 247d-l. 
Deadline. 
to be made available to the Secretary without fiscal year limita-
tion 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 Com-
mittee 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 sup-
ported by expenditures from the Fund. 
"(c) SUPPLEMENT NOT SUPPLANT.—^Funds appropriated under 
this section shall be used to supplement and not supplant other 
Federal, State, and local public funds provided for activities under 
this section. 
"SEC. 319A. NATIONAL NEEDS TO COMBAT THREATS TO PUBLIC 
HEALTH. 
"(a) CAPACITIES.— 
"(1) IN GENERAL.—^Not later than 1 year after the date 
of the enactment of this section, the Secretary, and such 
Administrators, Directors, or Commissioners, as may be appro-
priate, and in collaboration with State and local health officisds, 
shall establish reasonable capacities that are appropriate for 
national. State, and local public health systems and the per-
sonnel 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 anti-
microbial 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) commvmicate 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 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2317 
Federal, State, and local public funds provided for activities under 
this section. 
"(c) TECHNICAL ASSISTANCE.—The Secretary shall provide tech-
nical 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. 
42 USC 247d-2. 
"(a) PROGRAM AUTHORIZED.—Not later than 1 year after the DeadUne. 
date of the enactment of this section and every 10 years thereafter, 
the Secretary shall award grants to States, or consortia of two 
or more States or political subdivisions of States, to perform, in 
collaboration with local public health agencies, an evaluation to 
determine the extent to which the States or local public health 
agencies can achieve the capacities applicable to State and local 
public health agencies described in subsection (a) of section 319A, 
The Secretary shall provide technical assistance to States, or con-
sortia of two or more States or political subdivisions of States, 
in addition to awarding such grants. 
"(b) PROCEDURE.— 
"(1) IN GENERAL.—A State, or a consortium of two or more 
States or political subdivisions of States, may contract with 
an outside entity to perform the evaluation described in sub-
' • section (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 Deadline. 
a State, or a consortium of two or more States or political subdivi-
sions of States, receives a grant under this subsection, such State, 
or a consortium of two or more States or political subdivisions 
of States, shall prepare and submit to the Secretary a report 
describing the results of the evaluation described in subsection 
(a) with respect to such State, or consortia of two or more States 
or political subdivisions of States. 
"(d) SUPPLEMENT NOT SUPPLANT.—Funds appropriated under 
this section shall be used to supplement and not supplant other 
Federal, State, and local public funds provided for activities under 
this section. 
"(e) AUTHORIZATION OF APPROPRLVTIONS.—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. 
42 USC 247d-3. 
114 STAT. 2318 
PUBLIC LAW 106-505—NOV. 13, 2000 
"(b) ELIGIBLE ENTITIES.—^A State or political subdivision of 
a State, or a consortium of two or more States or political subdivi-
sions of States, that has completed an evaluation under section 
319B(a), or an evaluation that is substantially equivalent as deter-
mined 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 emer-
gencies, 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 ^-roviders; and 
"(4) enhance laboratory capacity gmd facilities. 
Deadline. 
"(d) REPORT.—^No later than January 1, 2005, the Secretary 
shall prepare £md 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. 
42 use 247d-4. 
"SEC. 319D. REVITALIZING THE CENTERS FOR DISEASE CONTROL AND 
PREVENTION. 
"(a) FINDINGS.—Congress finds that the Centers for Disease 
Control and Prevention have an essential role in defending against 
and combatting public health threats of the 21st century and 
requires secure and modem 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 labora-
tories, laboratory support buildings, health communication facilities, 
office buildings and other facilities and infrastructure, for better 
conducting the capacities described in section 319A, and for sup-
porting 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. 
42 use 247d-5. 
"SEC. 319E. COMBATING ANTIMICROBIAL RESISTANCE. 
"(a) TASK FORCE.— 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2319 
"(1) IN GENERAL.—The Secretary shall establish an Anti- Establishment. 
microbial Resistance Task Force to provide advice and rec-
ommendations to the Secretary and coordinate Federal pro-
grams relating to antimicrobial resistance. The Secretary may 
appoint or select a committee, or other organization in existence 
as of the date of the enactment of this section, to serve as 
such a task force, if such committee, or other organization 
meets the requirements of this section. 
"(2) MEMBERS OF TASK FORCE.—The task force described 
in paragraph (1) shall be composed of representatives from 
such Federal agencies, and shall seek input from public health 
constituencies, manufacturers, veterinary and medical profes-
sional 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 para-
graph (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 patho-
gens presenting a threat to the public health; and 
"(vi) any other issues which the Secretary deter-
mines are relevant to antimicrobial resistance. 
"(B) DETECTION AND CONTROL.—The Secretary, in con-
sultation 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 mon-
itor emerging antimicrobial resistance; and 
"(ii) develop, improve, coordinate or enhance 
participation in an integrated information system to 
assimilate, analyze, and exchange antimicrobial resist-
ance 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 DL\GNOSTICS.—^The Secretary and the Director of Agri-
cultural 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 vac-
cines 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; 
79-194 O - 00 - 9: QL 3 Part 4 
114 STAT. 2320 
PUBLIC LAW 106-505—NOV. 13, 2000 
"(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 Qusility, 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 anti-
biotics; £md 
"(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 shgill award competitive 
grants to eligible entities to enable such entities to increase 
the capacity to detect, monitor, and combat antimicrobial resist-
ance. 
"(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 activi-
ties that are consistent with the factors identified by the task 
force under subsection (aX3), 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 participa-
tion 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. 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2321 
"(3) TECHNICAL ASSISTANCE.—^The Secretary shall provide 
appropriate technical assistance to eligible entities that receive 
grants under paragraph (1). 
"(f) SUPPLEMENT NOT SUPPLANT.—Funds appropriated under 
this section shall be used to supplement and not supplant other 
Federal, State, and local public funds provided for activities under 
this section. 
"(g) AUTHORIZATION OF APPROPRIATIONS.—^There are authorized 
to be appropriated to carry out this section, $40,000,000 for fiscal 
year 2001, and such sums as may be necessary for each subsequent 
fiscal year through 2006. 
"SEC. 319F. PUBLIC HEALTH COUNTERMEASURES TO A BIOTERRORIST 42 USC 247D-6. 
ATTACK 
"(a) WORKING GROUP ON PREPAREDNESS FOR ACTS OF BIOTER-
RORISM.—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 proce-
dures 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 estab-
lish 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 prepared-
ness 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 
114 STAT. 2322 
PUBLIC LAW 106-505—NOV. 13, 2000 
"(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 coordina-
tion and communication between the working groups estab-
lished 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 sub-
section, such entity must be a State, political subdivision of 
a State, a consortium of two or more States or political subdivi-
sions of States, or a hospitsil, clinic, or primary care facility. 
"(3) USE OF FUNDS.—An entity that receives a grant under 
this subsection shall use such ftinds 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 characteris-
tics of exposure to a potential bioweapon; 
"(B) addressing rapid and accurate identification of 
potential bioweapons; 
"(C) coordinating medicsil care for individuals exposed 
to bioweapons; and 
"(D) facilitating and coordinating rapid communication 
of data generated from a bioterrorist attack between 
national. State, £ind local health agencies, and health care 
providers. 
"(4) COORDINATION.—^The Secretary, in awarding grants 
under this subsection, shall— 
"(A) notify the Director of the Office of Justice Pro-
grams, and the Director of the National Domestic Prepared-
ness 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 Prepared-
ness 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 bioter-
rorist attacks on the civilian population. 
"(5) ACTIVITIES.—^An entity that receives a grant under 
this sulDsection shall, to the greatest extent practicable, coordi-
nate 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. 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2323 
"(e) EDUCATION.—^The Secretary, in collaboration with members 
of the working group described in subsection (b), and professional 
organizations and societies, shall— 
"(1) develop and implement educational programs to 
instruct public health officials, medical professionals, and other 
personnel working in healtk 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 
Dioweapon. 
"(f) FUTURE RESOURCE DEVELOPMENT.—The Secretary shall 
consult with the working group described in subsection (a), to 
develop priorities for and conduct research, investigations, experi-
ments, demonstrations, and studies in the health sciences related 
to— 
"(1) the epidemiology and pathogenesis of potential bio-
weapons; 
"(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 poten-
tial bio 
weapons; and 
"(4) other relevant research areas. 
"(g) GENERAL ACCOUNTING OFFICE REPORT.—^Not later than DeadUne. 
180 days after the date of the enactment of this section, the Comp-
troller Greneral 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 APPROPRLVTIONS.—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 
42 USC 247D-7. 
TRAINING, COORDINATION, AND READINESS. 
"(a) IN GENERAL.—^The Secretary shall make grants to not 
more than three eligible entities to carry out demonstration pro-
grams 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 
114 STAT. 2324 
PUBLIC LAW 106-505—NOV. 13, 2000 
Deadline. 
involved with the various responsibiUties and capabiHties 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 sub-
section (a) are States, political siAdivisions 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 exper-
tise 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 pasonents 
are made under a grant under subsection (a) may not exceed 
5 years. The provision of such payments shall be subject to annual 
approval by the Secretary of the pajnnents and subject to the 
availability of appropriations for the fiscal year involved to make 
the pajnnents. 
"(e) SUPPLEMENT NOT SUPPLANT.—Grants under subsection (a) 
shall be used to supplement, and not supplant, other FedergJ, 
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 Appropria-
tions 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.". 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2325 
TITLE II—CLINICAL RESEARCH 
ENHANCEMENT 
Clinical Research 
Enhancement 
Act of 2000. 
SEC. 201. SHORT TITLE. 
42 USC 201 note. 
This title may be cited as the "Clinical Research Enhancement 
Act of 2000". 
SEC. 202. FINDINGS AND PURPOSE. 
42 USC 284k 
(a) FINDINGS.—Congress makes the following findings: 
(1) Clinical research is critical to the advancement of sci-
entific 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 dis-
ease, 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 sup-
port 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 enter-
prise. 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 Col-
leges (AAMC). 
114 STAT. 2326 
PUBLIC LAW 106-505—NOV. 13, 2000 
(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 difficul-
ties 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 estab-
lished under the Office of the Director of the National Institutes 
of Health with an initial appropriation of $3,000,000. 
(11) Appropriations for general clinical research centers 
in fiscal year 1999 equaled $200,500,000. 
(12) Since the late 1960s, spending for general clinical 
research centers has declined from approximately 3 percent 
to 1 percent of the National Institutes of Health budget. 
(13) In fiscal year 1999, there were 77 general clinical 
research centers in operation, supplying patients in the areas 
in which such centers operate with access to the most modem 
clinical research and clinical research facilities and tech-
nologies. 
(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: 
42 use 284k. 
«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 rec-
ommendations 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 shsdl establish peer review mechanisms to evaluate applica-
tions for the awards and fellowships provided for in subsection 
(b)(2) and section 409D. Such review mechanisms shall include 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2327 
individuals who are exceptionally qualified to appraise the merits 
of potential clinical research training and research grant pro-
posals.". 
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. 
42USC287a-4. 
"(a) GRANTS.—^The Director of the National Center for Research 
Resources shall award grants for the establishment of general clin-
ical research centers to provide the infrastructure for clinical 
research including clinical research training and career enhance-
ment. Such centers shall support clinical studies and career develop-
ment in all settings of the hospital or academic medical center 
involved. 
"(b) ACTIVITIES.—In canying 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 tele-
communications 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. 
42 USC 2841. 
"(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 Develop-
ment 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 
3f 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 
114 STAT. 2328 
PUBLIC LAW 106-505—NOV. 13, 2000 
at general clinical research centers or at other institutions 
that have the infrastructure and resources deemed appro-
priate 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 individ-
uals pursuing master's or doctoral degrees in clinical investiga-
tion. 
"(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 pro-
grams in clinical investigation. 
"(4) DEFINITION.—As used in this subsection, the term 
'advanced degree programs in clinical investigation' megms pro-
grams that award a master's or Ph.D. degree in clinical inves-
tigation 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 pharmaco-
kinetics. 
"(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 cgirrying 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 develop-
ment 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 pharmaco-
kinetics. 
"(C) Clinical epidemiology. 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2329 
"(D) 
Computer 
data 
management 
and medical 
informatics. 
"(E) Ethical and regulatory issues. 
- • • 
"(F) Biomedical writing. 
"(2) APPLICATIONS.—An application for a grant under this 
subsection shall be submitted by an individual institution or 
a consortium of institutions at such time as the Director may 
require. An institution may submit only one such application. 
"(3) LIMITATIONS.—Grants under this subsection shall be 
for terms of up to 5 years and may be renewable. 
"(4) AUTHORIZATION OF APPROPRIATIONS.—^For the purpose 
of carrying out this subsection, there are authorized to be 
appropriated such sums as may be necessary for each fiscal 
year.", 
SEC. 205. LOAN REPAYMENT 
PROGRAM 
REGARDING 
CLINICAL 
RESEARCHERS. 
Part G of title IV of the Public Health Service Act is amended 
by inserting after section 487E (42 U.S.C. 288-5) the following: 
"SEC. 487F. LOAN REPAYMENT PROGRAM REGARDING 
CLINICAL 
42USC28&-5a. 
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 Repa3mrient Pro-
gram 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 appro-
priated 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 'clin-
ical research' means patient oriented clinical research conducted 
with human subjects, or research on the causes and consequences 
of disease in human populations involving material of human origin 
(such as tissue specimens and cognitive phenomena) for which 
an investigator or colleague directly interacts with human subjects 
in an outpatient or inpatient setting to clarify a problem in human 
114 STAT. 2330 
PUBLIC LAW 106-505—NOV. 13, 2000 
physiology, pathophysiology or disease, or epidemiologic or behav-
ioral studies, outcomes research or hesdth services research, or 
developing new technologies, therapeutic interventions, or clinical 
trials. . 
DeadUne. 
SEC. 207. OVERSIGHT BY GENERAL ACCOUNTING OFFICE. 
note. 
Not later than 18 months after the date of the enactment 
of this Act, the Comptroller General of the United States shall 
submit to the Congress a reporting describing the extent to which 
the National Institutes of Health has complied with the amend-
ments made by this title. 
TITLE III—RESEARCH LABORATORY 
INFRASTRUCTURE 
Twenty-First 
Century 
Research 
Laboratories Act. 
42 use 201 note. SEC. 301. SHORT TITLE. 
This title may be cited as the "Twenty-First Century Research 
Laboratories Act". 
42 use 287a-2 
SEC. 302. FINDINGS, 
note. 
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 substan-
tial 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 labora-
tory 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.— 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2331 
"(1) IN GENERAL.—The Director of NIH, acting through 
the Director of the Center, may make grants or contracts to 
pubhc and nonprofit private entities to expand, remodel, ren-
ovate, or alter existing research facilities or construct new 
research facilities, subject to the provisions of this section. 
"(2) CONSTRUCTION AND COST OF CONSTRUCTION.—For pur-
poses 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 Bio-
medical 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 luider 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 require-
ments 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 estab-
lished 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 t3T)es, numbers, 
and amoiuits 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.— 
114 STAT. 2332 
PUBLIC LAW 106-505—NOV. 13, 2000 
"(A) IN GENERAL.—Subject to subparagraph (B), the 
Board shall be composed of 15 members to be appointed 
by the Director of the Center, and such ad-hoc or temporary 
members as the Director of the Center determines to be 
appropriate. All members of the Board, including temporary 
and ad-hoc members, shall be voting members. 
"(B) LIMITATION.—Not more than three individuals who 
are officers or employees of the Federal Government may 
serve as members of the Board. 
"(4) CERTAIN REQUIREMENTS REGARDING MEMBERSHIP.—In 
selecting individuals for membership on the Board, the Director 
of the Center shall ensure that the members are individuals 
who, by virtue of their training or experience, are eminently 
qualified to perform peer review functions. In selecting such 
individuals for such membership, the Director of the Center 
shall ensure that the members of the Board collectively— 
"(A) are experienced in the planning, construction, 
financing, and administration of entities that conduct bio-
medical 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 prior-
ities 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 excel-
lence, as described in subsection (c)(2). 
"(5) CERTAIN AUTHORITIES.— 
"(A) WORKSHOPS AND CONFERENCES.—In carrying out 
paragraph (2), the Board may convene workshops and con-
ferences, and collect data as the Board considers appro-
priate. 
"(B) SUBCOMMITTEES.—In carrying out paragraph (2), 
the Board may establish subcommittees within the Board. 
Such subcommittees may hold meetings as determined nec-
essary 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 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2333 
received by members of other national advisory councils estab-
lished under this title. 
"(c) REQUIREMENTS FOR GRANTS.— 
"(1) IN GENERAL.—The Director of the Center may make 
a gr£int 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 con-
structed; 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 bio-
medical or behavioral research and in improving the 
quality of such research; 
"(ii) the quality of the research or training, or 
both, to be carried out in the facilities involved; 
"(iii) the congruence of the research activities to 
be carried out within the facility with the research 
and investigator manpower needs of the United States; 
and 
"(iv) the age and condition of existing research 
facilities. 
"(D) The applicant has demonstrated a commitment 
to enhancing and expanding the research productivity of 
the applicant. 
"(2) 
INSTITUTIONS OF EMERGING EXCELLENCE.—^From 
the 
amount appropriated under subsection (i) for a fiscal year up 
to $50,000,000, the Director of the Center shall make available 
25 percent of such amount, and from the amount appropriated 
under such subsection for a fiscal year that is over $50,000,000, 
the Director of the Center shall make available up to 25 percent 
of such amount, for grants under subsection (a) to applicants 
that in addition to meeting the requirements established in 
paragraph (1), have demonstrated emerging excellence in bio-
medical 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. 
114 STAT. 2334 
PUBLIC LAW 106-505—NOV. 13, 2000 
"(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 popu-
lation 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 pro-
tecting 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 agree-
ments, 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 amoiuit 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 con-
templated 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. 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2335 
"(4) WAIVER OF LIMITATIONS.—The limitations imposed 
under paragraph (1) may be waived at the discretion of the 
Director for appHcants meeting the conditions described in sub-
section (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 Deadline, 
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 behav-
ioral research facilities and the availability and condition of techno-
logically 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 facili-
ties 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 nec-
essary 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. 
42 USC 287 note. 
(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 
at seq.)). 
114 STAT. 2336 
PUBLIC LAW 106-505—NOV. 13, 2000 
(b) REQUIREMENTS FOR GRANTS.—In determining whether to 
award a grant to an appHcant 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). 
Cardiac Arrest 
T I T L E 
I V — C A R D I A C A R R E S T 
S U R V I V A L 
Survival Act of 
Subtitle A—^Recommendations for Federal 
Buildings 
42 u s e 201 note. 
SEC. 401. SHORT TITLE. 
This subtitle may be cited as the "Cardiac Arrest Survival 
Act of 2000". 
42 use 238p 
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 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2337 
a chaotic rhythm that prevents the heart from pumping oxygen 
to the victim's brain and body. 
(7) Communities that have implemented programs ensuring 
widespread pubHc access to defibrillators, combined with appro-
priate training, maintenance, arid coordination with local emer-
gency medical systems, have dramatically improved the sur-
vival rates from cardiac arrest. 
(8) Automated external defibrillator devices have been dem-
onstrated 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 Fed-
eral buildings will greatly facilitate their adoption. 
(10) Limiting the liability of Good Samaritans and acquirers 
of automated external defibrillator devices in emergency situa-
tions may encourage the use of automated external defibrillator 
devices, and result in saved lives. 
SEC. 403. 
RECOMMENDATIONS 
AND 
GUIDELINES 
OF 
SECRETARY 
OF 
HEALTH AND HUMAN SERVICES REGARDING AUTO-
MATED 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 
42 use 238p. 
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 Federal Register, 
in the Federal Register the recommendations of the Secretary on publication, 
the appropriate implementation of the placement of automated 
external defibrillator devices under subsection (a), including proce-
dures for the following: 
"(1) Implementing appropriate training courses in the use 
of such devices, including the role of cardiopulmonary resuscita-
tion. 
"(2) Proper maintenance and testing of the devices. 
"(3) Ensuring coordination with appropriate licensed profes-
sionals 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 
REC-
OMMENDATIONS.—In carrying out this section, the Secretary shall— 
"(1) consult with appropriate public and private entities; 
114 STAT. 2338 
PUBLIC LAW 106-505—NOV. 13, 2000 
"(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. 
Deadline. 
"(d) DATE CERTAIN FOR ESTABLISHING GUIDELINES AND REC-
OMMENDATIONS.—^The Secretary shall comply with this section not 
later thsm 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 
42USC238q. 
"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 h£irm 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 engage-
ment of the person as an employee or agent and the occur-
rence 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 per-
son) was not a reasonably sufficient period in which to 
provide the training. 
"(b) INAPPLICABILITY OF' IMMUNITY.—Immunity under sub-
section (a) does not apply to a person if— 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2339 
"(1) the harm involved was caused by willful or criminal 
misconduct, gross negligence, reckless misconduct, or a con-
scious, flagrant indifference to the rights or safety of the victim 
who was harmed; 
"(2) the person is a licensed or certified health professional 
who used the automated external defibrillator device while 
acting within the scope of the license or certification of the 
professional and within the scope of the employment or agency 
of the professional; 
"(3) the person is a hospital, clinic, or other entity whose 
purpose is providing health care directly to patients, and the 
harm was caused by an employee or agent of the entity who 
used the device while acting within the scope of the employment 
or agency of the employee or agent; or 
"(4) the person is an acquirer of the device who leased 
the device to a health care entity (or who otherwise provided 
the device to such entity for compensation without selling the 
device to the entity), and the harm was caused by an employee 
or agent of the entity who used the device while acting within 
the scope of the emplo3mient 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 pro-
vided 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. 
114 STAT. 2340 
PUBLIC LAW 106-505—NOV. 13, 2000 
"(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 cir-
cumstances in which the behavior of an individual leads a 
reasonable person to believe that the individusil 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 non-
pecuniary losses of any kind or nature.". 
R
u
r
a
l A
c
c
e
s
s t
o 
Subtltle B—^Rural Access to Emergency 
Emergency 
i-^ 
• 
Devices Act. 
DeVlCCS 
42 u s e 254c 
SEC. 411. SHORT TITLE. 
This subtitle may be cited as the "Rural Access to Emergency 
Devices Act" or the "Rural AED Act". 
42 u s e 254c 
SEC. 412. FINDINGS. 
Congress makes the following findings: 
(1) Heart disease is the leading cause of death in the 
United States. 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2341 
(2) The American Heart Association estimates that 250,000 
Americans die from sudden cardiac arrest each year. 
(3) A cardiac arrest victim's chance of survival drops 10 
percent for every minute that passes before his or her heart 
is returned to normal rh3^hm. 
(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 auto-
mated 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 commu-
nities across the United States. 
SEC. 413. GRANTS. 
42USC254c 
(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, locsd emergency responders, 
fire and rescue departments, police, community hospitals, and 
local non-profit entities and for-profit entities concerned about 
cardiac arrest survival rates; 
(2) evaluates the local community emergency response 
times to assess whether they meet the standards established 
by national public health organizations such as the American 
Heart Association and the American Red Cross; and 
(3) submits to the Secretary of Health and Human Services 
an application at such time, in such manner, and containing 
such information as the Secretary may require. 
(c) USE OF FUNDS.—Amounts provided under a grant under 
this section shall be used— 
(1) to purchase automated external defibrillators that have 
been approved, or cleared for marketing, by the Food and 
Drug Administration; and 
(2) to provide defibrillator and basic life support training 
in automated external defibrillator usage through the American 
Heart Association, the American Red Cross, or other nationally 
recognized training courses. 
(d) REPORT.—^Not later than 4 years after the date of the Deadline, 
enactment of this Act, the Secretary of Health and Human Services 
114 STAT. 2342 
PUBLIC LAW 106-505—NOV. 13, 2000 
shall prepare and submit to the appropriate committees of Congress 
a report containing data relating to whether the increased avail-
ability of defibrillators has affected survival rates in the commu-
nities 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. 
L
u
p
u
s R
e
s
e
a
r
c
h 
TITLE V—LUPUS RESEARCH AND CARE 
up 
and Care 
Amendments of 
2000. 
42 use 201 note. 
42 use 285d-6a 
note. 
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 tjrpes 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: 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2343 
"LUPUS 
"SEC. 441A. (a) IN GENERAL.—^The Director of the Institute 
42 tJSC 285d-6a. 
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 underljdng the ele-
vated prevalence of lupus in women, including African-Amer-
ican 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 APPROPRL^TIONS.—^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. 621. ESTABLISHMENT OF PROGRAM OF GRANTS. 
42 USC 254c-9. 
(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 effec-
tive 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 organiza-
tion, hospice, ambulatory care facility, community health center, 
migrant health center, or homeless health center; or other appro-
priate public or nonprofit private entity. 
(c) CERTAIN ACTIVITIES.—^To the extent practicable and appro-
priate, 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: 
114 STAT. 2344 
PUBLIC LAW 106-505—NOV. 13, 2000 
(1) Delivering or enhancing outpatient, ambulatory, and 
home-based health and 
support services, including case 
management and comprehensive treatment services, for individ-
uals 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 expe-
dite discharge, as medically appropriate, from inpatient facili-
ties 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 prac-
ticable 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. 
42 use 254C-10. 
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 over-
sight 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 serv-
ices. 
(4) The grant will not be expended to make payment for 
services authorized under section 521(a) to the extent that 
payment has been made, or can reasonably be expected to 
be made, with respect to such services— 
(A) under any State compensation program, under an 
insuremce 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 imposi-
tion of charges on such individuals. 
42 use 254C-H. 
SEC. 523. TECHNICAL ASSISTANCE. 
The Secretary may provide technical assistance to assist enti-
ties in complying with the requirements of this subtitle in order 
to make such entities eligible to receive grants under section 521. 
42 use 254C-12. 
SEC. 524. DEFINITIONS. 
For purposes of this subtitle: 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2345 
(1) OFFICIAL POVERTY LINE.—The term "official poverty 
line" means the poverty line established by the Director of 
the Office of Management and Budget and revised by the 
Secretary in accordance with section 673(2) of the Omnibus 
Budget Reconciliation Act of 1981. 
(2) SECRETARY.—The term "Secretary" means the Secretary 
of Health and Human Services. 
SEC. 525. AUTHORIZATION OF APPROPRIATIONS. 
For the purpose of carrying out this subtitle, there are author-
ized to be appropriated such sums as may be necessary for each 
of the fiscal years 2001 through 2003. 
42 u s e 254C-13. 
TITLE VI—PROSTATE CANCER 
RESEARCH AND PREVENTION 
Prostate Cancer 
Research and 
Prevention Act. 
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 foUowup. 
"(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 shsdl 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; 
42 u s e 201 note. 
Public 
information. 
114 STAT. 2346 
PUBLIC LAW 106-505—NOV. 13, 2000 
"(B) to provide appropriate referrals for the medical 
treatment of men who have been screened under subpara-
graph (A) and to ensure, to the extent practicable, the 
provision of appropriate followup services and support serv-
ices 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 appro-
priate allied health professionals) in the detection and con-
trol of prostate cancer. 
"(8) To evaluate activities conducted under paragraphs (1) 
through (7) through appropriate surveillance or program moni-
toring activities."; and 
(2) in subsection (1)(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". 
Organ 
TITLE VII—ORGAN PROCUREMENT AND 
SSTSon 
DONATION 
Certification Act 
of 2000. 
g g ^ ^^J ORGAN PROCUREMENT ORGANIZATION CERTIFICATION. 
42 use 201 note. 
(a) SHORT TiTLE.—^This section may be cited as the "Organ 
Procurement Organization Certification Act of 2000". 
42 use 273 note. 
(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 recertifi-
cation 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 dona-
tion. 
(3) The General Accounting Office, the Institute of Medi-
cine, 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 consid-
eration of other outcome and process standards that would 
more accurately reflect the relative capability and perform-
ance 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)(l)(A)(i) of the Social Security 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2347 
Act (42 U.S.C. 13201>-8(bXl)(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 recertifi-
cation 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 procure-
ment organizations; and 
(B) improve the overall certification process by incor-
porating process as well as outcome performance measures, 
and developing equitable processes for appeals. 
(c) CERTIFICATION AND RECERTIFICATION OF ORGAN PROCURE-
MENT 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 
"(H) the completion of recertification under the 
requirements of clause (ii); or 
"(ii) is defined through regulations that are promul- Deadline, 
gated by the Secretary by not later than January 1, 2002, 
t h a t -
'll) 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— 
114 STAT. 2348 
PUBLIC LAW 106-505—NOV. 13, 2000 
(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 
orgEin 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 develop-
ments, prolonged life expectancy, and increased prevalence of 
diseases that may lead to organ damage and failure, including 
hypertension, alcoholism, and hepatitis C infection; 
(9) the need for a more diverse donor pool, including a 
variety of racial and ethnic minorities, will continue to grow 
in the coming years; 
(10) the final decision on whether a potential donor can 
share the gift of life usually is made by surviving family mem-
bers 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" I and to 
discuss organ and tissue donation with other family members so 
that informed decisions can be made if the occasion to donate 
arises. 
PUBLIC LAW 106-505—NOV. 13, 2000 
114 STAT. 2349 
TITLE VIII—ALZHEIMER'S CLINICAL 
RESEARCH AND TRAINING 
SEC. 801. ALZHEIMER'S CLINICAL RESEARCH AND TRAINING AWARDS. 
Subpart 5 of part C of title IV of the Public Health Service 
Act (42 U.S.C. 285e et seq.) is amended— 
(1) by redesignating section 4451 as section 445J; and 
42 USC 285e-ll. 
(2) by inserting after section 445H the following: 
"SEC. 445L ALZHEIMER'S CLINICAL RESEARCH AND TRAINING 
42 USC 285e-
AWARDS. 
10a. 
"(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: 
'«EC. 447B. SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH 
42 USC 285f-3. 
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, 
114 STAT. 2350 
PUBLIC LAW 106-505—NOV. 13, 2000 
pathogenesis, diagnosis, prevention and treatment of sexually trans-
mitted 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. 
42 use 289 note. 
(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". 
42 use 289 note. 
(b) EFFECTIVE DATE.—^The amendment made by subsection (a) 
takes effect on the date of the enactment of the Children's Health 
Act of 2000. 
Approved November 13, 2000. 
LEGISLATIVE HISTORY—H.R. 2498: 
HOUSE REPORTS: No. 106-634 (Comm. on Commerce). 
CONGRESSIONAL RECORD, Vol. 146 (2000): 
May 23, considered and passed House. 
Oct. 26, considered and passed Senate, amended. 
Oct. 27, House concurred in Senate amendment.