[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2498 Enrolled Bill (ENR)]
H.R.2498
One Hundred Sixth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Monday,
the twenty-fourth day of January, two thousand
An Act
To amend the Public Health Service Act to provide for recommendations of
the Secretary of Health and Human Services regarding the placement of
automatic external defibrillators in Federal buildings in order to
improve survival rates of individuals who experience cardiac arrest in
such buildings, and to establish protections from civil liability
arising from the emergency use of the devices.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

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

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0a4b0aa814c2fa6d816361b067fc50307d5a87e64bfa1a26ea1a37623f878555

TITLE II

-CLINICAL RESEARCH ENHANCEMENT

Subtitle A--Recommendations for Federal Buildings

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TITLE III

-RESEARCH LABORATORY INFRASTRUCTURE

Human Services regarding automated external defibrillators for
Federal buildings.

22e51c3a12ba0e736faf1c2fd62aea9849e95625564d5dcd93c066de93399992

TITLE IV

-CARDIAC ARREST SURVIVAL

automated external defibrillators.
Subtitle B--Rural Access to Emergency Devices

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40b03a5a777103308d333042ab0af5a716087646a1310ec2876973045093fc69

TITLE V

-LUPUS RESEARCH AND CARE

Subtitle B--Delivery of Services Regarding Lupus

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TITLE IX

-SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH AND TRAINING

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

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TITLE I

-EMERGING THREATS TO PUBLIC HEALTH

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

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

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HEALTH IN CLINICAL RESEARCH.
Part B of title IV of the Public Health Service Act (42 U.S.C. 284
et seq.) is amended by adding at the end the following:
``SEC. 409C. CLINICAL RESEARCH.
``(a) In General.--The Director of National Institutes of Health
shall undertake activities to support and expand the involvement of the
National Institutes of Health in clinical research.
``(b) Requirements.--In carrying out subsection (a), the Director
of National Institutes of Health shall--
``(1) consider the recommendations of the Division of Research
Grants Clinical Research Study Group and other recommendations for
enhancing clinical research; and
``(2) establish intramural and extramural clinical research
fellowship programs directed specifically at medical and dental
students and a continuing education clinical research training
program at the National Institutes of Health.
``(c) Support for the Diverse Needs of Clinical Research.--The
Director of National Institutes of Health, in cooperation with the
Directors of the Institutes, Centers, and Divisions of the National
Institutes of Health, shall support and expand the resources available
for the diverse needs of the clinical research community, including
inpatient, outpatient, and critical care clinical research.
``(d) Peer Review.--The Director of National Institutes of Health
shall establish peer review mechanisms to evaluate applications for the
awards and fellowships provided for in subsection (b)(2) and section
409D. Such review mechanisms shall include individuals who are
exceptionally qualified to appraise the merits of potential clinical
research training and research grant proposals.''.

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(a) Grants.--Subpart 1 of part E of title IV of the Public Health
Service Act (42 U.S.C. 287 et seq.) is amended by adding at the end the
following:
``SEC. 481C. GENERAL CLINICAL RESEARCH CENTERS.
``(a) Grants.--The Director of the National Center for Research
Resources shall award grants for the establishment of general clinical
research centers to provide the infrastructure for clinical research
including clinical research training and career enhancement. Such
centers shall support clinical studies and career development in all
settings of the hospital or academic medical center involved.
``(b) Activities.--In carrying out subsection (a), the Director of
National Institutes of Health shall expand the activities of the
general clinical research centers through the increased use of
telecommunications and telemedicine initiatives.
``(c) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated such sums as
may be necessary for each fiscal year.''.
(b) Enhancement Awards.--Part B of title IV of the Public Health
Service Act (42 U.S.C. 284 et seq.), as amended by section 203, is
further amended by adding at the end the following:
``SEC. 409D. ENHANCEMENT AWARDS.
``(a) Mentored Patient-Oriented Research Career Development
Awards.--
``(1) Grants.--
``(A) In general.--The Director of the National Institutes
of Health shall make grants (to be referred to as `Mentored
Patient-Oriented Research Career Development Awards') to
support individual careers in clinical research at general
clinical research centers or at other institutions that have
the infrastructure and resources deemed appropriate for
conducting patient-oriented clinical research.
``(B) Use.--Grants under subparagraph (A) shall be used to
support clinical investigators in the early phases of their
independent careers by providing salary and such other support
for a period of supervised study.
``(2) Applications.--An application for a grant under this
subsection shall be submitted by an individual scientist at such
time as the Director may require.
``(3) Authorization of appropriations.--For the purpose of
carrying out this subsection, there are authorized to be
appropriated such sums as may be necessary for each fiscal year.
``(b) Mid-Career Investigator Awards in Patient-Oriented
Research.--
``(1) Grants.--
``(A) In general.--The Director of the National Institutes
of Health shall make grants (to be referred to as `Mid-Career
Investigator Awards in Patient-Oriented Research') to support
individual clinical research projects at general clinical
research centers or at other institutions that have the
infrastructure and resources deemed appropriate for conducting
patient-oriented clinical research.
``(B) Use.--Grants under subparagraph (A) shall be used to
provide support for mid-career level clinicians to allow such
clinicians to devote time to clinical research and to act as
mentors for beginning clinical investigators.
``(2) Applications.--An application for a grant under this
subsection shall be submitted by an individual scientist at such
time as the Director requires.
``(3) Authorization of appropriations.--For the purpose of
carrying out this subsection, there are authorized to be
appropriated such sums as may be necessary for each fiscal year.
``(c) Graduate Training in Clinical Investigation Award.--
``(1) In general.--The Director of the National Institutes of
Health shall make grants (to be referred to as `Graduate Training
in Clinical Investigation Awards') to support individuals pursuing
master's or doctoral degrees in clinical investigation.
``(2) Applications.--An application for a grant under this
subsection shall be submitted by an individual scientist at such
time as the Director may require.
``(3) Limitations.--Grants under this subsection shall be for
terms of 2 years or more and shall provide stipend, tuition, and
institutional support for individual advanced degree programs in
clinical investigation.
``(4) Definition.--As used in this subsection, the term
`advanced degree programs in clinical investigation' means programs
that award a master's or Ph.D. degree in clinical investigation
after 2 or more years of training in areas such as the following:
``(A) Analytical methods, biostatistics, and study design.
``(B) Principles of clinical pharmacology and
pharmacokinetics.
``(C) Clinical epidemiology.
``(D) Computer data management and medical informatics.
``(E) Ethical and regulatory issues.
``(F) Biomedical writing.
``(5) Authorization of appropriations.--For the purpose of
carrying out this subsection, there are authorized to be
appropriated such sums as may be necessary for each fiscal year.
``(d) Clinical Research Curriculum Awards.--
``(1) In general.--The Director of the National Institutes of
Health shall make grants (to be referred to as `Clinical Research
Curriculum Awards') to institutions for the development and support
of programs of core curricula for training clinical investigators,
including medical students. Such core curricula may include
training in areas such as the following:
``(A) Analytical methods, biostatistics, and study design.
``(B) Principles of clinical pharmacology and
pharmacokinetics.
``(C) Clinical epidemiology.
``(D) Computer data management and medical informatics.
``(E) Ethical and regulatory issues.
``(F) Biomedical writing.
``(2) Applications.--An application for a grant under this
subsection shall be submitted by an individual institution or a
consortium of institutions at such time as the Director may
require. An institution may submit only 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.''.

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Part G of title IV of the Public Health Service Act is amended by
inserting after section 487E (42 U.S.C. 288-5) the following:
``SEC. 487F. LOAN REPAYMENT PROGRAM REGARDING CLINICAL RESEARCHERS.
``(a) In General.--The Secretary, acting through the Director of
the National Institutes of Health, shall establish a program to enter
into contracts with qualified health professionals under which such
health professionals agree to conduct clinical research, in
consideration of the Federal Government agreeing to repay, for each
year of service conducting such research, not more than $35,000 of the
principal and interest of the educational loans of such health
professionals.
``(b) Application of Provisions.--The provisions of sections 338B,
338C, and 338E shall, except as inconsistent with subsection (a) of
this section, apply to the program established under subsection (a) to
the same extent and in the same manner as such provisions apply to the
National Health Service Corps Loan Repayment Program established in
subpart III of part D of title III.
``(c) Funding.--
``(1) Authorization of appropriations.--For the purpose of
carrying out this section, there are authorized to be appropriated
such sums as may be necessary for each fiscal year.
``(2) Availability.--Amounts appropriated for carrying out this
section shall remain available until the expiration of the second
fiscal year beginning after the fiscal year for which the amounts
were made available.''.

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

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

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

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

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Section 481A of the Public Health Service Act (42 U.S.C. 287a-2 et
seq.) is amended to read as follows:
``SEC. 481A. BIOMEDICAL AND BEHAVIORAL RESEARCH FACILITIES.
``(a) Modernization and Construction of Facilities.--
``(1) In general.--The Director of NIH, acting through the
Director of the Center, may make grants or contracts to public and
nonprofit private entities to expand, remodel, renovate, or alter
existing research facilities or construct new research facilities,
subject to the provisions of this section.
``(2) Construction and cost of construction.--For purposes of
this section, the terms `construction' and `cost of construction'
include the construction of new buildings and the expansion,
renovation, remodeling, and alteration of existing buildings,
including architects' fees, but do not include the cost of
acquisition of land or off-site improvements.
``(b) Scientific and Technical Review Boards for Merit-Based Review
of Proposals.--
``(1) In general: approval as precondition to grants.--
``(A) Establishment.--There is established within the
Center a Scientific and Technical Review Board on Biomedical
and Behavioral Research Facilities (referred to in this section
as the `Board').
``(B) Requirement.--The Director of the Center may approve
an application for a grant under subsection (a) only if the
Board has under paragraph (2) recommended the application for
approval.
``(2) Duties.--
``(A) Advice.--The Board shall provide advice to the
Director of the Center and the advisory council established
under section 480 (in this section referred to as the `Advisory
Council') in carrying out this section.
``(B) Determination of merit.--In carrying out subparagraph
(A), the Board shall make a determination of the merit of each
application submitted for a grant under subsection (a), after
consideration of the requirements established in subsection
(c), and shall report the results of the determination to the
Director of the Center and the Advisory Council. Such
determinations shall be conducted in a manner consistent with
procedures established under section 492.
``(C) Amount.--In carrying out subparagraph (A), the Board
shall, in the case of applications recommended for approval,
make recommendations to the Director and the Advisory Council
on the amount that should be provided under the grant.
``(D) Annual report.--In carrying out subparagraph (A), the
Board shall prepare an annual report for the Director of the
Center and the Advisory Council describing the activities of
the Board in the fiscal year for which the report is made. Each
such report shall be available to the public, and shall--
``(i) summarize and analyze expenditures made under
this section;
``(ii) provide a summary of the types, numbers, and
amounts of applications that were recommended for grants
under subsection (a) but that were not approved by the
Director of the Center; and
``(iii) contain the recommendations of the Board for
any changes in the administration of this section.
``(3) Membership.--
``(A) In general.--Subject to subparagraph (B), the Board
shall be composed of 15 members to be appointed by the Director
of the Center, and such ad-hoc or temporary members as the
Director of the Center determines to be appropriate. All
members of the Board, including temporary and ad-hoc members,
shall be voting members.
``(B) Limitation.--Not more than three individuals who are
officers or employees of the Federal Government may serve as
members of the Board.
``(4) Certain requirements regarding membership.--In selecting
individuals for membership on the Board, the Director of the Center
shall ensure that the members are individuals who, by virtue of
their training or experience, are eminently qualified to perform
peer review functions. In selecting such individuals for such
membership, the Director of the Center shall ensure that the
members of the Board collectively--
``(A) are experienced in the planning, construction,
financing, and administration of entities that conduct
biomedical or behavioral research sciences;
``(B) are knowledgeable in making determinations of the
need of entities for biomedical or behavioral research
facilities, including such facilities for the dentistry,
nursing, pharmacy, and allied health professions;
``(C) are knowledgeable in evaluating the relative
priorities for applications for grants under subsection (a) in
view of the overall research needs of the United States; and
``(D) are experienced with emerging centers of excellence,
as described in subsection (c)(2).
``(5) Certain authorities.--
``(A) Workshops and conferences.--In carrying out paragraph
(2), the Board may convene workshops and conferences, and
collect data as the Board considers appropriate.
``(B) Subcommittees.--In carrying out paragraph (2), the
Board may establish subcommittees within the Board. Such
subcommittees may hold meetings as determined necessary to
enable the subcommittee to carry out its duties.
``(6) Terms.--
``(A) In general.--Except as provided in subparagraph (B),
each appointed member of the Board shall hold office for a term
of 4 years. Any member appointed to fill a vacancy occurring
prior to the expiration of the term for which such member's
predecessor was appointed shall be appointed for the remainder
of the term of the predecessor.
``(B) Staggered terms.--Members appointed to the Board
shall serve staggered terms as specified by the Director of the
Center when making the appointments.
``(C) Reappointment.--No member of the Board shall be
eligible for reappointment to the Board until 1 year has
elapsed after the end of the most recent term of the member.
``(7) Compensation.--Members of the Board who are not officers
or employees of the United States shall receive for each day the
members are engaged in the performance of the functions of the
Board compensation at the same rate received by members of other
national advisory councils established under this title.
``(c) Requirements for Grants.--
``(1) In general.--The Director of the Center may make a grant
under subsection (a) only if the applicant for the grant meets the
following conditions:
``(A) The applicant is determined by such Director to be
competent to engage in the type of research for which the
proposed facility is to be constructed.
``(B) The applicant provides assurances satisfactory to the
Director that--
``(i) for not less than 20 years after completion of
the construction involved, the facility will be used for
the purposes of the research for which it is to be
constructed;
``(ii) sufficient funds will be available to meet the
non-Federal share of the cost of constructing the facility;
``(iii) sufficient funds will be available, when
construction is completed, for the effective use of the
facility for the research for which it is being
constructed; and
``(iv) the proposed construction will expand the
applicant's capacity for research, or is necessary to
improve or maintain the quality of the applicant's
research.
``(C) The applicant meets reasonable qualifications
established by the Director with respect to--
``(i) the relative scientific and technical merit of
the applications, and the relative effectiveness of the
proposed facilities, in expanding the capacity for
biomedical or behavioral research and in improving the
quality of such research;
``(ii) the quality of the research or training, or
both, to be carried out in the facilities involved;
``(iii) the congruence of the research activities to be
carried out within the facility with the research and
investigator manpower needs of the United States; and
``(iv) the age and condition of existing research
facilities.
``(D) The applicant has demonstrated a commitment to
enhancing and expanding the research productivity of the
applicant.
``(2) Institutions of emerging excellence.--From the amount
appropriated under subsection (i) for a fiscal year up to
$50,000,000, the Director of the Center shall make available 25
percent of such amount, and from the amount appropriated under such
subsection for a fiscal year that is over $50,000,000, the Director
of the Center shall make available up to 25 percent of such amount,
for grants under subsection (a) to applicants that in addition to
meeting the requirements established in paragraph (1), have
demonstrated emerging excellence in biomedical or behavioral
research, as follows:
``(A) The applicant has a plan for research or training
advancement and possesses the ability to carry out the plan.
``(B) The applicant carries out research and research
training programs that have a special relevance to a problem,
concern, or unmet health need of the United States.
``(C) The applicant has been productive in research or
research development and training.
``(D) The applicant--
``(i) has been designated as a center of excellence
under section 739;
``(ii) is located in a geographic area whose population
includes a significant number of individuals with health
status deficit, and the applicant provides health services
to such individuals; or
``(iii) is located in a geographic area in which a
deficit in health care technology, services, or research
resources may adversely affect the health status of the
population of the area in the future, and the applicant is
carrying out activities with respect to protecting the
health status of such population.
``(d) Requirement of Application.--The Director of the Center may
make a grant under subsection (a) only if an application for the grant
is submitted to the Director and the application is in such form, is
made in such manner, and contains such agreements, assurances, and
information as the Director determines to be necessary to carry out
this section.
``(e) Amount of Grant; Payments.--
``(1) Amount.--The amount of any grant awarded under subsection
(a) shall be determined by the Director of the Center, except that
such amount shall not exceed--
``(A) 50 percent of the necessary cost of the construction
of a proposed facility as determined by the Director; or
``(B) in the case of a multipurpose facility, 40 percent of
that part of the necessary cost of construction that the
Director determines to be proportionate to the contemplated use
of the facility.
``(2) Reservation of amounts.--On the approval of any
application for a grant under subsection (a), the Director of the
Center shall reserve, from any appropriation available for such
grants, the amount of such grant, and shall pay such amount, in
advance or by way of reimbursement, and in such installments
consistent with the construction progress, as the Director may
determine appropriate. The reservation of any amount by the
Director under this paragraph may be amended by the Director,
either on the approval of an amendment of the application or on the
revision of the estimated cost of construction of the facility.
``(3) Exclusion of certain costs.--In determining the amount of
any grant under subsection (a), there shall be excluded from the
cost of construction an amount equal to the sum of--
``(A) the amount of any other Federal grant that the
applicant has obtained, or is assured of obtaining, with
respect to construction that is to be financed in part by a
grant authorized under this section; and
``(B) the amount of any non-Federal funds required to be
expended as a condition of such other Federal grant.
``(4) Waiver of limitations.--The limitations imposed under
paragraph (1) may be waived at the discretion of the Director for
applicants meeting the conditions described in subsection (c).
``(f) Recapture of Payments.--If, not later than 20 years after the
completion of construction for which a grant has been awarded under
subsection (a)--
``(1) the applicant or other owner of the facility shall cease
to be a public or non profit private entity; or
``(2) the facility shall cease to be used for the research
purposes for which it was constructed (unless the Director
determines, in accordance with regulations, that there is good
cause for releasing the applicant or other owner from obligation to
do so),
the United States shall be entitled to recover from the applicant or
other owner of the facility the amount bearing the same ratio to the
current value (as determined by an agreement between the parties or by
action brought in the United States District Court for the district in
which such facility is situated) of the facility as the amount of the
Federal participation bore to the cost of the construction of such
facility.
``(g) Guidelines.--Not later than 6 months after the date of the
enactment of this section, the Director of the Center, after
consultation with the Advisory Council, shall issue guidelines with
respect to grants under subsection (a).
``(h) Report to Congress.--The Director of the Center shall prepare
and submit to the appropriate committees of Congress a biennial report
concerning the status of the biomedical and behavioral research
facilities and the availability and condition of technologically
sophisticated laboratory equipment in the United States. Such reports
shall be developed in concert with the report prepared by the National
Science Foundation on the needs of research facilities of universities
as required under section 108 of the National Science Foundation
Authorization Act for Fiscal Year 1986 (42 U.S.C. 1886).
``(i) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $250,000,000
for fiscal year 2001, and such sums as may be necessary for each of the
fiscal years 2002 and 2003.''.

0bd6c6bd706a77858c621619c119ac8062c07be26386a58837361ff46c4a8a28

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''.

bde51b04d2038960c31275fe7b10dd44e6dde0820641f9e9b8024e5bfa7e74c8

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

5a89a3c643bcdb8a7edfc8c749fb1122ba4d4c034790a9551f6860ac0b62b6d3

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

b12195384ae719a44e91ba0ed0496b5a319b7fc0b13f5119ec80c3da842f0bb9

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

c20938e9b0252774557b407f1ee25067180e2d8194559fe4ccebec7edf5404d6

HUMAN SERVICES REGARDING AUTOMATED EXTERNAL
DEFIBRILLATORS FOR FEDERAL BUILDINGS.
Part B of title II of the Public Health Service Act (42 U.S.C. 238
et seq.) is amended by adding at the end the following:
``recommendations and guidelines regarding automated external
defibrillators for federal buildings
``Sec. 247. (a) Guidelines on Placement.--The Secretary shall
establish guidelines with respect to placing automated external
defibrillator devices in Federal buildings. Such guidelines shall take
into account the extent to which such devices may be used by lay
persons, the typical number of employees and visitors in the buildings,
the extent of the need for security measures regarding the buildings,
buildings or portions of buildings in which there are special
circumstances such as high electrical voltage or extreme heat or cold,
and such other factors as the Secretary determines to be appropriate.
``(b) Related Recommendations.--The Secretary shall publish in the
Federal Register the recommendations of the Secretary on the
appropriate implementation of the placement of automated external
defibrillator devices under subsection (a), including procedures for
the following:
``(1) Implementing appropriate training courses in the use of
such devices, including the role of cardiopulmonary resuscitation.
``(2) Proper maintenance and testing of the devices.
``(3) Ensuring coordination with appropriate licensed
professionals in the oversight of training of the devices.
``(4) Ensuring coordination with local emergency medical
systems regarding the placement and incidents of use of the
devices.
``(c) Consultations; Consideration of Certain Recommendations.--In
carrying out this section, the Secretary shall--
``(1) consult with appropriate public and private entities;
``(2) consider the recommendations of national and local
public-health organizations for improving the survival rates of
individuals who experience cardiac arrest in nonhospital settings
by minimizing the time elapsing between the onset of cardiac arrest
and the initial medical response, including defibrillation as
necessary; and
``(3) consult with and counsel other Federal agencies where
such devices are to be used.
``(d) Date Certain for Establishing Guidelines and
Recommendations.--The Secretary shall comply with this section not
later than 180 days after the date of the enactment of the Cardiac
Arrest Survival Act of 2000.
``(e) Definitions.--For purposes of this section:
``(1) The term `automated external defibrillator device' has
the meaning given such term in section 248.
``(2) The term `Federal building' includes a building or
portion of a building leased or rented by a Federal agency, and
includes buildings on military installations of the United
States.''.

2b3e37503b81d4cf21a402f567c347dc165a2ed0827792e05fe6d11c1b128d7d

AUTOMATED EXTERNAL DEFIBRILLATORS.
Part B of title II of the Public Health Service Act, as amended by
section 403, is amended by adding at the end the following:
``liability regarding emergency use of automated external
defibrillators
``Sec. 248. (a) Good Samaritan Protections Regarding AEDs.--Except
as provided in subsection (b), any person who uses or attempts to use
an automated external defibrillator device on a victim of a perceived
medical emergency is immune from civil liability for any harm resulting
from the use or attempted use of such device; and in addition, any
person who acquired the device is immune from such liability, if the
harm was not due to the failure of such acquirer of the device--
``(1) to notify local emergency response personnel or other
appropriate entities of the most recent placement of the device
within a reasonable period of time after the device was placed;
``(2) to properly maintain and test the device; or
``(3) to provide appropriate training in the use of the device
to an employee or agent of the acquirer when the employee or agent
was the person who used the device on the victim, except that such
requirement of training does not apply if--
``(A) the employee or agent was not an employee or agent
who would have been reasonably expected to use the device; or
``(B) the period of time elapsing between the engagement of
the person as an employee or agent and the occurrence of the
harm (or between the acquisition of the device and the
occurrence of the harm, in any case in which the device was
acquired after such engagement of the person) was not a
reasonably sufficient period in which to provide the training.
``(b) Inapplicability of Immunity.--Immunity under subsection (a)
does not apply to a person if--
``(1) the harm involved was caused by willful or criminal
misconduct, gross negligence, reckless misconduct, or a conscious,
flagrant indifference to the rights or safety of the victim who was
harmed;
``(2) the person is a licensed or certified health professional
who used the automated external defibrillator device while acting
within the scope of the license or certification of the
professional and within the scope of the employment or agency of
the professional;
``(3) the person is a hospital, clinic, or other entity whose
purpose is providing health care directly to patients, and the harm
was caused by an employee or agent of the entity who used the
device while acting within the scope of the employment or agency of
the employee or agent; or
``(4) the person is an acquirer of the device who leased the
device to a health care entity (or who otherwise provided the
device to such entity for compensation without selling the device
to the entity), and the harm was caused by an employee or agent of
the entity who used the device while acting within the scope of the
employment or agency of the employee or agent.
``(c) Rules of Construction.--
``(1) In general.--The following applies with respect to this
section:
``(A) This section does not establish any cause of action,
or require that an automated external defibrillator device be
placed at any building or other location.
``(B) With respect to a class of persons for which this
section provides immunity from civil liability, this section
supersedes the law of a State only to the extent that the State
has no statute or regulations that provide persons in such
class with immunity for civil liability arising from the use by
such persons of automated external defibrillator devices in
emergency situations (within the meaning of the State law or
regulation involved).
``(C) This section does not waive any protection from
liability for Federal officers or employees under--
``(i) section 224; or
``(ii) sections 1346(b), 2672, and 2679 of title 28,
United States Code, or under alternative benefits provided
by the United States where the availability of such
benefits precludes a remedy under section 1346(b) of title
28.
``(2) Civil actions under federal law.--
``(A) In general.--The applicability of subsections (a) and
(b) includes applicability to any action for civil liability
described in subsection (a) that arises under Federal law.
``(B) Federal areas adopting state law.--If a geographic
area is under Federal jurisdiction and is located within a
State but out of the jurisdiction of the State, and if,
pursuant to Federal law, the law of the State applies in such
area regarding matters for which there is no applicable Federal
law, then an action for civil liability described in subsection
(a) that in such area arises under the law of the State is
subject to subsections (a) through (c) in lieu of any related
State law that would apply in such area in the absence of this
subparagraph.
``(d) Federal Jurisdiction.--In any civil action arising under
State law, the courts of the State involved have jurisdiction to apply
the provisions of this section exclusive of the jurisdiction of the
courts of the United States.
``(e) Definitions.--
``(1) Perceived medical emergency.--For purposes of this
section, the term `perceived medical emergency' means circumstances
in which the behavior of an individual leads a reasonable person to
believe that the individual is experiencing a life-threatening
medical condition that requires an immediate medical response
regarding the heart or other cardiopulmonary functioning of the
individual.
``(2) Other definitions.--For purposes of this section:
``(A) The term `automated external defibrillator device'
means a defibrillator device that--
``(i) is commercially distributed in accordance with
the Federal Food, Drug, and Cosmetic Act;
``(ii) is capable of recognizing the presence or
absence of ventricular fibrillation, and is capable of
determining without intervention by the user of the device
whether defibrillation should be performed;
``(iii) upon determining that defibrillation should be
performed, is able to deliver an electrical shock to an
individual; and
``(iv) in the case of a defibrillator device that may
be operated in either an automated or a manual mode, is set
to operate in the automated mode.
``(B)(i) The term `harm' includes physical, nonphysical,
economic, and noneconomic losses.
``(ii) The term `economic loss' means any pecuniary loss
resulting from harm (including the loss of earnings or other
benefits related to employment, medical expense loss,
replacement services loss, loss due to death, burial costs, and
loss of business or employment opportunities) to the extent
recovery for such loss is allowed under applicable State law.
``(iii) The term `noneconomic losses' means losses for
physical and emotional pain, suffering, inconvenience, physical
impairment, mental anguish, disfigurement, loss of enjoyment of
life, loss of society and companionship, loss of consortium
(other than loss of domestic service), hedonic damages, injury
to reputation and all other nonpecuniary losses of any kind or
nature.''.
Subtitle B--Rural Access to Emergency Devices

2b3dc11e9162c8f1777f1ec5c75026b51ee87553c98135129fe983b41a8cca4e

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

a58b4a1407b75ea6d6c72779f43802901619c7fd5b16a4c51d6de5a6d1d111dd

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

c13e7812a57e55f9d6d43f1a9f4972117efdd4fe96026c77d57757d4a8301f49

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

ac632870802a636e17f16dea54eb8057fe9d21faffa38365a68a3f7c8440a460

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

65c7efa156dc7121a571976daa13309cdba06d45fbe8ccba5b2ca5bf14267efe

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

3dad2a4b1c1375580e96a78e06c704c503189a7cbaf2c6e30a988503e19c7036

Subpart 4 of part C of title IV of the Public Health Service Act
(42 U.S.C. 285d et seq.) is amended by inserting after section 441 the
following:
``lupus
``Sec. 441A. (a) In General.--The Director of the Institute shall
expand and intensify research and related activities of the Institute
with respect to lupus.
``(b) Coordination With Other Institutes.--The Director of the
Institute shall coordinate the activities of the Director under
subsection (a) with similar activities conducted by the other national
research institutes and agencies of the National Institutes of Health
to the extent that such Institutes and agencies have responsibilities
that are related to lupus.
``(c) Programs for Lupus.--In carrying out subsection (a), the
Director of the Institute shall conduct or support research to expand
the understanding of the causes of, and to find a cure for, lupus.
Activities under such subsection shall include conducting and
supporting the following:
``(1) Research to determine the reasons underlying the elevated
prevalence of lupus in women, including African-American women.
``(2) Basic research concerning the etiology and causes of the
disease.
``(3) Epidemiological studies to address the frequency and
natural history of the disease and the differences among the sexes
and among racial and ethnic groups with respect to the disease.
``(4) The development of improved diagnostic techniques.
``(5) Clinical research for the development and evaluation of
new treatments, including new biological agents.
``(6) Information and education programs for health care
professionals and the public.
``(d) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated such sums as
may be necessary for each of the fiscal years 2001 through 2003.''.
Subtitle B--Delivery of Services Regarding Lupus

9e47a108ced2f9c67203f5443a773c2714d528df98fa2fad94515f7a85be1783

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

12f73b12a47ed8ebf209dcbb0f4a1de626dfdd1ce08cbd90ae30920c39d01eaa

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

483c96a26e146a63f66ef86fb522e1b865951551722a3f448bd6a84c859a9139

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

f6383d6b0776a2fc2abcf9662a8384540f20200ae08c25bd0b380571e6e54f61

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

081235121d02981cb61dda4e8626660bc49fbef452a13b0e6f606c1eb79234bf

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

3a378f96a4e06253b1ed62f60c0019018a36fe1ce226991528a271264e86efe8

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

c5de070ddb6cd46b7cd8bbeebdd43cc6ae9965ed717db2328f93a4a6773f338e

TITLE VI

-PROSTATE CANCER RESEARCH AND PREVENTION

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

abc2141802a754d3a82a9f7e9001d53ce430293bfcf5c37ad283235c3f520502

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

e21ac79ee630cc9142cc87e17e369e7110c7df2a388b7febff759fb8c395f68e

TITLE VII

-ORGAN PROCUREMENT AND DONATION

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

c7b282553fc289326ceb4a70c4b7c74830ef1664bef7e9edf688b0e0042f020c

Subpart 5 of part C of title IV of the Public Health Service Act
(42 U.S.C. 285e et seq.) is amended--
(1) by redesignating section 445I as section 445J; and
(2) by inserting after section 445H the following:
``SEC. 445I. ALZHEIMER'S CLINICAL RESEARCH AND TRAINING AWARDS.
``(a) In General.--The Director of the Institute is authorized to
establish and maintain a program to enhance and promote the translation
of new scientific knowledge into clinical practice related to the
diagnosis, care and treatment of individuals with Alzheimer's disease.
``(b) Support of Promising Clinicians.--In order to foster the
application of the most current developments in the etiology,
pathogenesis, diagnosis, prevention and treatment of Alzheimer's
disease, amounts made available under this section shall be directed to
the support of promising clinicians through awards for research, study,
and practice at centers of excellence in Alzheimer's disease research
and treatment.
``(c) Excellence in Certain Fields.--Research shall be carried out
under awards made under subsection (b) in environments of demonstrated
excellence in neuroscience, neurobiology, geriatric medicine, and
psychiatry and shall foster innovation and integration of such
disciplines or other environments determined suitable by the Director
of the Institute.
``(d) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $2,250,000
for fiscal year 2001, and such sums as may be necessary for each of
fiscal years 2002 through 2005.''.

ec2191426c2c8eb2e11ec0d55a9c1291f4e300ebca4ff3195146b82ab6dae605

TITLE VIII

-ALZHEIMER'S CLINICAL RESEARCH AND TRAINING

AWARDS.
Subpart 6 of part C of title IV of the Public Health Service Act
(42 U.S.C. 285f et seq.) is amended by adding at the end the following:
``SEC. 447B. SEXUALLY TRANSMITTED DISEASE CLINICAL RESEARCH AND
TRAINING AWARDS.
``(a) In General.--The Director of the Institute is authorized to
establish and maintain a program to enhance and promote the translation
of new scientific knowledge into clinical practice related to the
diagnosis, care and treatment of individuals with sexually transmitted
diseases.
``(b) Support of Promising Clinicians.--In order to foster the
application of the most current developments in the etiology,
pathogenesis, diagnosis, prevention and treatment of sexually
transmitted diseases, amounts made available under this section shall
be directed to the support of promising clinicians through awards for
research, study, and practice at centers of excellence in sexually
transmitted disease research and treatment.
``(c) Excellence in Certain Fields.--Research shall be carried out
under awards made under subsection (b) in environments of demonstrated
excellence in the etiology and pathogenesis of sexually transmitted
diseases and shall foster innovation and integration of such
disciplines or other environments determined suitable by the Director
of the Institute.
``(d) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated $2,250,000
for fiscal year 2001, and such sums as may be necessary for each of
fiscal years 2002 through 2005.''.

608e637f63d6f027cca755db095f95b88f1e0a9649a1916af05e01140a381ddb

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

Public Health Threats and Emergencies Act — HR. 2498

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