IIB
106TH CONGRESS
2D SESSION
H. R. 4365
IN THE SENATE OF THE UNITED STATES
MAY 10, 2000
Received; read twice and referred to the Committee on Health, Education,
Labor, and Pensions
AN ACT
To amend the Public Health Service Act with respect to
children’s health.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Children’s Health Act
of 2000’’.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I—AUTISM
Subtitle A—Surveillance and Research Regarding Prevalence and Pattern of
Autism
Sec. 101. Short title.
Sec. 102. Surveillance and research programs; clearinghouse; advisory com-
mittee.
Subtitle B—Expansion, Intensification, and Coordination of Autism Activities
of National Institutes of Health
Sec. 111. Short title.
Sec. 112. Expansion, intensification, and coordination; information and edu-
cation; interagency coordinating committee.
TITLE II—RESEARCH AND DEVELOPMENT REGARDING
FRAGILE X
Sec. 201. Short title.
Sec. 202. National Institute of Child Health and Human Development; re-
search on fragile X.
Sec. 203. National Institute of Child Health and Human Development; loan re-
payment program regarding research on fragile X.
TITLE III—JUVENILE ARTHRITIS AND RELATED CONDITIONS
Sec. 301. National Institute of Arthritis and Musculoskeletal and Skin Dis-
eases; research on juvenile arthritis and related conditions.
Sec. 302. Information clearinghouse.
TITLE IV—REDUCING BURDEN OF DIABETES AMONG CHILDREN
AND YOUTH
Sec. 401. Programs of Centers for Disease Control and Prevention.
Sec. 402. Programs of National Institutes of Health.
TITLE V—ASTHMA TREATMENT SERVICES FOR CHILDREN
Sec. 501. Short title.
Subtitle A—Treatment Services
Sec. 511. Grants for children’s asthma relief.
Sec. 512. Technical and conforming amendments.
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Sec. 1011. Childhood immunizations.
Sec. 1012. Screenings, referrals, and education regarding lead poisoning.
TITLE XI—CHILDHOOD SKELETAL MALIGNANCIES
Sec. 1101. Programs of Centers for Disease Control and Prevention and Na-
tional Institutes of Health.
TITLE XII—ADOPTION AWARENESS
Subtitle A—Infant Adoption Awareness
Sec. 1201. Short title.
Sec. 1202. Grants regarding infant adoption awareness.
Subtitle B—Special Needs Adoption Awareness
Sec. 1211. Short title.
Sec. 1212. Special needs adoption programs; public awareness campaign and
other activities.
TITLE XIII—TRAUMATIC BRAIN INJURY
Sec. 1301. Short title.
Sec. 1302. Programs of Centers for Disease Control and Prevention.
Sec. 1303. Programs of National Institutes of Health.
Sec. 1304. Programs of Health Resources and Services Administration.
TITLE XIV—PREVENTION AND CONTROL OF INJURIES
Sec. 1401. Authorization of Appropriations for programs of Centers for Disease
Control and Prevention.
TITLE XV—HEALTHY START INITIATIVE
Sec. 1501. Short title.
Sec. 1502. Continuation of healthy start program.
TITLE XVI—ORAL HEALTH PROMOTION AND DISEASE
PREVENTION
Sec. 1601. Oral health promotion and disease prevention.
TITLE XVII—VACCINE COMPENSATION PROGRAM
Sec. 1701. Short title.
Sec. 1702. Content of petitions.
TITLE XVIII—HEPATITIS C
Sec. 1801. Short title.
Sec. 1802. Surveillance and education regarding hepatitis C.
TITLE XIX—NIH INITIATIVE ON AUTOIMMUNE DISEASES
Sec. 1901. Short title.
Sec. 1902. Juvenile diabetes, juvenile arthritis, lupus, multiple sclerosis, and
other autoimmune-diseases; initiative through Directior of Na-
tional Institutes of Health.
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TITLE XX—GRADUATE MEDICAL EDUCATION PROGRAMS IN
CHILDREN’S HOSPITALS
Sec. 2001. Extension of authorization of appropriations.
TITLE XXI—SPECIAL NEEDS OF CHILDREN REGARDING ORGAN
TRANSPLANTATION
Sec. 2101. Short title.
Sec. 2102. Organ Procurement and Transplantation Network; amendments re-
garding needs of children.
TITLE XXII—MISCELLANEOUS PROVISIONS
Sec. 2201. Report regarding research on rare diseases in children.
TITLE XXIII—EFFECTIVE DATE
Sec. 2301. Effective date.
TITLE I—AUTISM
Subtitle A—Surveillance and Re-
search 
Regarding 
Prevalence
and Pattern of Autism
SEC. 101. SHORT TITLE.
This subtitle may be cited as the ‘‘Autism Statistics,
Surveillance, Research, and Epidemiology Act of 2000
(ASSURE)’’.
SEC. 102. SURVEILLANCE AND RESEARCH PROGRAMS;
CLEARINGHOUSE; ADVISORY COMMITTEE.
Part B of title III of the Public Health Service Act
(42 U.S.C. 243 et seq.) is amended by inserting after sec-
tion 317G the following section:
‘‘SURVEILLANCE AND RESEARCH REGARDING AUTISM
AND PERVASIVE DEVELOPMENTAL DISORDERS
‘‘SEC. 317H. (a) IN GENERAL.—The Secretary , act-
ing through the Director of the Centers for Disease Con-
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trol and Prevention, may make awards of grants and coop-
erative agreements for the collection, analysis, and report-
ing of data on autism and pervasive developmental dis-
orders. An entity may receive such an award only if the
entity is a public or nonprofit private entity ‘‘(including
health departments of States and political subdivisions of
States, and including universities and other educational
entities). In making such awards, the Secretary may pro-
vide direct technical assistance in lieu of cash.
‘‘(b) CENTERS
OF EXCELLENCE
IN AUTISM
AND
PERVASIVE
DEVELOPMENTAL
DISORDERS
EPIDEMI-
OLOGY.—
‘‘(1) IN
GENERAL.—The Secretary, acting
through the Director of the Centers for Disease
Control and Prevention, shall (subject to the extent
of amounts made available in appropriations Acts)
establish not less than three, and not more than five,
regional centers of excellence in autism and perva-
sive developmental disorders epidemiology for the
purpose of collecting and analyzing information on
the number, incidence, correlates, and causes of au-
tism and related developmental disorders.
‘‘(2) RECIPIENTS OF AWARDS FOR ESTABLISH-
MENT OF CENTERS.—Centers under paragraph (1)
shall be established and operated through the award
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of grants or cooperative agreements to public or
nonprofit private entities that conduct research, in-
cluding health departments of States and political
subdivisions of States, and including universities and
other educational entities.
‘‘(3) CERTAIN REQUIREMENTS.—An award for
a center under paragraph (1) may be made only if
the entity involved submits to the Secretary an ap-
plication containing such agreements and informa-
tion as the Secretary may require, including an
agreement that the center involved will operate in
accordance with the following:
‘‘(A) The center will collect, analyze, and
report autism and pervasive developmental dis-
orders data according to guidelines prescribed
by the Director, after consultation with relevant
State and local public health officials, private
sector developmental disorder researchers, and
advocates for those with developmental dis-
orders;
‘‘(B) The center will assist with the devel-
opment and coordination of State autism and
pervasive developmental disorders surveillance
efforts within a region;
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‘‘(C) The center will provide education,
training, and clinical skills improvement for
health professionals aimed at better under-
standing and treatment of autism and related
developmental disorders; and
‘‘(D) The center will identify eligible cases
and controls through its surveillance systems
and conduct research into factors which may
cause autism and related developmental dis-
orders; each program will develop or extend an
area of special research expertise (including,
but not limited to, genetics, environmental ex-
posure to contaminants, immunology, and other
relevant research specialty areas).
‘‘(c) 
CLEARINGHOUSE.—The 
Secretary, 
acting
through the Director of the Centers for Disease Control
and Prevention, shall carry out the following:
‘‘(1) The Centers for Disease Control and Pre-
vention shall serve as the coordinating agency for
autism and pervasive developmental disorders sur-
veillance activities through the establishment of a
clearinghouse for the collection and storage of data
generated from the monitoring programs created by
this section. The functions of such a clearinghouse
shall include facilitating the coordination of research
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and policy development relating to the epidemiology
of autism and other pervasive developmental dis-
orders.
‘‘(2) The Secretary shall coordinate the Federal
response to requests for assistance from State health
department officials regarding potential or alleged
autism or developmental disorder clusters.
‘‘(d) ADVISORY COMMITTEE.—
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish an Advisory Committee for Autism and Perva-
sive developmental disorders Epidemiology Research
(in this section referred to as the ‘Committee’). The
Committee shall provide advice and recommenda-
tions to the Director of the Centers for Disease Con-
trol and Prevention on—
‘‘(A) the establishment of a national au-
tism and pervasive developmental disorders sur-
veillance program;
‘‘(B) the establishment of centers of excel-
lence in autism and pervasive developmental
disorders epidemiology;
‘‘(C) methods and procedures to more ef-
fectively coordinate government and non-gov-
ernment programs and research on autism and
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pervasive developmental disorders epidemiology;
and
‘‘(D) the effective operation of autism and
pervasive developmental disorders epidemiology
research activities.
‘‘(2) COMPOSITION.—
‘‘(A) IN GENERAL.—The Committee shall
be composed of ex officio members in accord-
ance with subparagraph (B) and 11 appointed
members in accordance with subparagraph (C).
‘‘(B) EX
OFFICIO
MEMBERS.—The fol-
lowing officials shall serve as ex officio members
of the Committee:
‘‘(i) The Director of the National
Center for Environmental Health.
‘‘(ii) The Assistant Administrator of
the Agency for Toxic Substances and Dis-
ease Registry.
‘‘(iii) The Director of the National In-
stitute of Child Health and Human Devel-
opment.
‘‘(iv) The Director of the National In-
stitute of Neurological Disorders and
Stroke.
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‘‘(C) 
APPOINTED
MEMBERS.—Appoint-
ments to the Committee shall be made in ac-
cordance with the following:
‘‘(i) Two members shall be research
scientists with demonstrated achievements
in research related to autism and related
developmental disorders. The scientists
shall be appointed by the Secretary in con-
sultation with the National Academy of
Sciences.
‘‘(ii) Five members shall be represent-
atives of the five national organizations
whose primary emphasis is on research
into autism and other pervasive develop-
mental disorders. One representative from
each of such organizations shall be ap-
pointed by the Secretary in consultation
with the National Academy of Sciences.
‘‘(iii) Two members shall be clinicians
whose practice is primarily devoted to the
treatment of individuals with autism and
other pervasive developmental disorders.
The clinicians shall be appointed by the
Secretary in consultation with the Institute
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of Medicine and the National Academy of
Sciences.
‘‘(iv) Two members shall be individ-
uals who are the parents or legal guardians
of a person or persons with autism or
other pervasive developmental disorders.
The individuals shall be appointed by the
Secretary in consultation with the ex offi-
cio members under subparagraph (B) and
the five national organizations referred to
in clause (ii).
‘‘(3) ADMINISTRATIVE
SUPPORT; TERMS
OF
SERVICE; OTHER PROVISIONS.—The following apply
with respect to the Committee:
‘‘(A) The Committee shall receive nec-
essary and appropriate administrative support
from the Department of Health and Human
Services.
‘‘(B) Members of the Committee shall be
appointed for a term of three years, and may
serve for an unlimited number of terms if re-
appointed.
‘‘(C) The Committee shall meet no less
than two times per year.
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‘‘(D) Members of the Committee shall not
receive additional compensation for their serv-
ice. Such members may receive reimbursement
for appropriate and additional expenses that are
incurred through service on the Committee
which would not have incurred had they not
been a member of the Committee.
‘‘(e) REPORT TO CONGRESS.—The Secretary shall
prepare and submit to the Congress, after consultation
with and comment by the advisory committee under sub-
section (d), an annual report regarding the prevalence and
incidence of autism and other pervasive developmental dis-
orders, the results of research into the etiology of autism
and other pervasive developmental disorders, public health
responses to known or preventable causes of autism and
other pervasive developmental disorders, and the need for
additional research into promising lines of scientific in-
quiry.
‘‘(f) 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 2005.’’.
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Subtitle B—Expansion, Intensifica-
tion, and Coordination of Au-
tism Activities of National Insti-
tutes of Health With Respect to
Autism
SEC. 111. SHORT TITLE.
This subtitle may be cited as the ‘‘Advancement in
Pediatric Autism Research Act of 2000’’.
SEC. 112. EXPANSION, INTENSIFICATION, AND COORDINA-
TION; 
INFORMATION 
AND 
EDUCATION;
INTERAGENCY COORDINATING COMMITTEE.
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 section:
‘‘AUTISM
‘‘SEC. 409C. (a) IN GENERAL.—
‘‘(1) EXPANSION OF ACTIVITIES.—The Director
of NIH (in this section referred to as the ‘Director’)
shall expand, intensify, and coordinate the activities
of the National Institutes of Health with respect to
research on autism.
‘‘(2) ADMINISTRATION OF PROGRAM; COLLABO-
RATION AMONG AGENCIES.—The Director shall carry
out this section (other than subsection (b)) acting
through the Director of the National Institute of
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Mental Health and in collaboration with any other
agencies that the Director determines appropriate.
‘‘(b) INTERAGENCY COORDINATING COMMITTEE.—
‘‘(1) IN GENERAL.—The Secretary shall ensure
that there is in operation an interagency committee
to be known as the ‘Autism Coordinating Com-
mittee’ (referred to in this subsection as the ‘Com-
mittee’) to coordinate all efforts within the Depart-
ment of Health and Human Services concerning au-
tism, including activities carried out through the Na-
tional Institutes of Health under this section and ac-
tivities carried out through the Centers for Disease
Control and Prevention under section 317H.
‘‘(2) MEMBERSHIP.—The Committee shall be
composed of such directors of the national research
institutes, such directors of centers within the Cen-
ters for Disease Control and Prevention, and such
other officials within the Department of Health and
Human Services as the Secretary determines to be
appropriate. The Committee may include representa-
tives of other Federal agencies that serve children
with autism, such as the Department of Education.
‘‘(3) MEETINGS.—The Committee shall meet
not less than twice per year.
‘‘(c) CENTERS OF EXCELLENCE.—
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‘‘(1) IN GENERAL.—The Director shall under
subsection (a)(1) make awards of grants and con-
tracts to public or nonprofit private entities to pay
all or part of the cost of planning, establishing, im-
proving, and providing basic operating support for
centers of excellence regarding research on autism.
‘‘(2) RESEARCH.—Each center under para-
graph (1) shall conduct basic and clinical research
into autism. Such research should include investiga-
tions into the cause, diagnosis, early detection, pre-
vention, control, and treatment of autism. These
centers, as a group, shall conduct research including
but not limited to the fields of developmental
neurobiology, genetics, and psychopharmacology.
‘‘(3) SERVICES FOR PATIENTS.—A center under
paragraph (1) may expend amounts provided under
such paragraph to carry out a program to make in-
dividuals aware of opportunities to participate as
subjects in research conducted by the centers. The
program may, in accordance with such criteria as
the Director may establish, provide to such subjects
referrals for health and other services, and such pa-
tient care costs as are required for research. The ex-
tent to which the center can demonstrate availability
and access to clinical services shall be considered by
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the Director in decisions about awarding the grants
to applicants which meet the scientific criteria for
funding.
‘‘(4) COORDINATION OF CENTERS; REPORTS.—
The Director shall, as appropriate, provide for the
coordination of information among centers under
paragraph (1) and ensure regular communication
between such centers, and may require the periodic
preparation of reports on the activities of the centers
and the submission of the reports to the Director.
‘‘(5) ORGANIZATION OF CENTERS.—Each cen-
ter under paragraph (1) shall use the facilities of a
single institution, or be formed from a consortium of
cooperating institutions, meeting such requirements
as may be prescribed by the Director.
‘‘(6) NUMBER OF CENTERS; DURATION OF SUP-
PORT.—The Director shall provide for the establish-
ment of not less than five centers under paragraph
(1), subject to the extent of amounts made available
in appropriations Acts. Support of such a center
may be for a period not exceeding 5 years. Such pe-
riod may be extended for one or more additional pe-
riods not exceeding 5 years if the operations of such
center have been reviewed by an appropriate tech-
nical and scientific peer review group established by
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the Director and if such group has recommended to
the Director that such period should be extended.
‘‘(d) FACILITATION
OF RESEARCH.—The Director
shall under subsection (a)(1) provide for a program under
which samples of tissues and genetic materials that are
of use in research on autism are donated, collected, pre-
served, and made available for such research. The pro-
gram shall be carried out in accordance with accepted sci-
entific and medical standards for the donation, collection,
and preservation of such samples.
‘‘(e) INFORMATION AND EDUCATION.—
‘‘(1) IN GENERAL.—The Director shall establish
and implement a program to provide information
and education on autism to health professionals and
the general public, including information and edu-
cation on advances in the diagnosis and treatment of
autism and training and continuing education
through programs for scientists, physicians, and
other health professionals who provide care for pa-
tients with autism.
‘‘(2) 
STIPENDS.—The 
Director 
may 
use
amounts made available under this section to pro-
vide stipends for health professionals who are en-
rolled in training programs under this section.
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‘‘(f) PUBLIC INPUT.—The Director shall under sub-
section (a)(1) provide for means through which the public
can obtain information on the existing and planned pro-
grams and activities of the National Institutes of Health
with respect to autism and through which the Director can
receive comments from the public regarding such pro-
grams and activities.
‘‘(g) ANNUAL REPORT TO CONGRESS.—The Director
shall prepare and submit to the appropriate committees
of the Congress reports regarding the activities carried out
under this section. The first report shall be submitted not
later than January 10, 2002, and subsequent reports shall
be submitted annually thereafter.
‘‘(h) FUNDING.—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 2005. Such authorizations of appropriations are
in addition to any other authorizations of appropriations
that are available for such purpose.’’.
TITLE II—RESEARCH AND DE-
VELOPMENT 
REGARDING
FRAGILE X
SEC. 201. SHORT TITLE.
This title may be cited as the ‘‘Fragile X Research
Breakthrough Act of 2000’’.
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SEC. 202. NATIONAL INSTITUTE OF CHILD HEALTH AND
HUMAN DEVELOPMENT; RESEARCH ON FRAG-
ILE X.
Subpart 7 of part C of title IV of the Public Health
Service Act is amended by adding at the end the following
section:
‘‘FRAGILE X
‘‘SEC. 452E. (a) EXPANSION AND COORDINATION OF
RESEARCH ACTIVITIES.—The Director of the Institute,
after consultation with the advisory council for the Insti-
tute, shall expand, intensify, and coordinate the activities
of the Institute with respect to research on the disease
known as fragile X.
‘‘(b) RESEARCH CENTERS.—
‘‘(1) IN GENERAL.—The Director of the Insti-
tute, after consultation with the advisory council for
the Institute, shall make grants to, or enter into
contracts with, public or nonprofit private entities
for the development and operation of centers to con-
duct research for the purposes of improving the di-
agnosis and treatment of, and finding the cure for,
fragile X.
‘‘(2) NUMBER OF CENTERS.—In carrying out
paragraph (1), the Director of the Institute shall, to
the extent that amounts are appropriated, provide
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for the establishment of at least three fragile X re-
search centers.
‘‘(3) ACTIVITIES.—
‘‘(A) IN GENERAL.—Each center assisted
under paragraph (1) shall, with respect to frag-
ile X—
‘‘(i) conduct basic and clinical re-
search, which may include clinical trials
of—
‘‘(I) new or improved diagnostic
methods; and
‘‘(II) drugs or other treatment
approaches; and
‘‘(ii) conduct research to find a cure.
‘‘(B) FEES.—A center may use funds pro-
vided under paragraph (1) to provide fees to in-
dividuals serving as subjects in clinical trials
conducted under subparagraph (A).
‘‘(4) COORDINATION
AMONG
CENTERS.—The
Director of the Institute shall, as appropriate, pro-
vide for the coordination of the activities of the cen-
ters assisted under this section, including providing
for the exchange of information among the centers.
‘‘(5) 
CERTAIN
ADMINISTRATIVE
REQUIRE-
MENTS.—Each center assisted under paragraph (1)