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Calendar No. 578
109th Congress Report
SENATE
2d Session 109-318
======================================================================
COMBATING AUTISM ACT OF 2005
_______
August 3, 2006.--Ordered to be printed
_______
Mr. Enzi, from the Committee on Health, Education, Labor, and Pensions,
submitted the following
R E P O R T
[To accompany S. 843]
The Committee on Health, Education, Labor, and Pensions, to
which was referred the bill (S. 843) to amend the Public Health
Service Act to combat autism through research, screening,
intervention and education, having considered the same, reports
favorably thereon with an amendment in the nature of a
substitute and recommends that the bill (as amended) do pass.
CONTENTS
Page
I. Purpose and Summary..............................................1
II. Background and Need for Legislation..............................2
III. History of Legislation and Committee Action.....................12
IV. Explanation of Bill and Committee Views.........................12
V. Cost Estimate...................................................18
VI. Application of Law to the Legislative Branch....................18
VII. Regulatory Impact Statement.....................................18
VIII.Section-by-Section Analysis.....................................18
IX. Changes in Existing Law.........................................20
I. Purpose and Summary
As part of the reauthorization of Title 1 of the Children's
Health Act of 2000 (P.L. 106-310), the purpose of S. 843, the
Combating Autism Act of 2006, is to improve upon our previous
activities with respect to autism. Specifically, the
legislation focuses on expanding research and coordination at
the National Institutes of Health (NIH); increasing awareness
through the Centers for Disease Control and Prevention (CDC);
integrating health, education, and disability programs; and
ensuring that citizens have a voice in governmental activities.
With up to 1 in 166 children being diagnosed with autism
within the United States, we need to understand more about the
spectrum disorder to better differentiate the conglomerate of
individuals identified with the disorder. In addition, given
the increased demand on services for these individuals, we need
to provide better integration of the health, education, and
disability programs already available.
II. Background and Need for Legislation
Autism spectrum disorder (ASD) is a group of developmental
disabilities caused by atypical brain development. People with
ASD tend to have challenges and difficulties with social and
communication skills. Many people with ASD also have unique
ways of learning, paying attention, or reacting to different
sensations. ASD begins during early childhood and lasts
throughout a person's life.
As the name autism spectrum disorder implies, ASD covers a
continuum of behaviors and abilities. Individuals with ASD,
like all people, differ greatly in their skills abilities, and
talents. They also differ in how their disability impacts their
social, emotional, behavioral, and academic domains. No two
people with ASD will have the same symptoms. A symptom might
have a mild impact in one person and a significant impact in
another person. Some examples of the types of challenges and
behaviors a child or adult with an ASD might have include:
Social skills: People with ASD might not interact with
others the way most people do, or they might not demonstrate
interest in other people. People with ASD might not make eye
contact and appear to want to be alone. They might have
difficulty understanding other people's feelings, talking about
their own feelings, or picking up on non-verbal social cues.
Children with ASD might not like to be held or cuddled, or
might cuddle only when they want to due to sensory integration
sensitivities or difficulties. Some people with ASD might not
seem to notice when other people talk to them. Others might be
very interested in people, but not know how to interact with
others due to a lack of understanding of verbal and non-verbal
social cues, difficulty integrating sensory information from
multiple modalities, and lack of predictability.
Speech, language, and communication: About 40 percent of
children with ASD do not talk. Others have echolalia, which is
when they repeat something that was said to them. The repeated
words might be said right away or at a later time. For example,
if you ask someone with an ASD, ``Do you want some juice?'' he
or she may repeat ``Do you want some juice?'' instead of
answering your question. Or a person might repeat a television
ad heard sometime in the past. People with ASD might not
understand gestures such as waving goodbye. They might say
``I'' when they mean ``you'', or vice versa. Their voices might
sound flat and it might seem as though they cannot control how
loudly or softly they speak. People with ASD might stand too
close to people (according to acceptable western culture social
norms) they are talking to, or might stick with one topic of
conversation for a long period of time. Some people with ASD
are very articulate, but have a hard time listening to what
other people say. They might talk a lot about something they
really enjoy, or perseverate on a specific topic rather than
engage in a conversation with someone.
Repetitive behaviors and routines: People with ASD might
repeat actions multiple times, such as rocking back and forth.
They might want to have routines where things stay the same so
they have a sense of predictability of what will happen, for
how long, and in what sequence or to meet sensory-based needs
they may have. If a person with ASD does not have an effective
approach or tool to predict and prepare for transitions or
changes in family routines, and a coping strategy to
effectively cope with unexpected changes in their routine, he
or she may engage in challenging behavior. For example, if a
child is accustomed to washing his or her face before dressing
for bed, he or she might become very upset if asked to change
the order, by getting dressed first and then washing his or her
face, if he or she was not prepared for the change, the reason
why the change occurred, or if he or she does not have a
strategy to effectively cope with changes in routines.
Children with ASD may develop at different rates from
children without ASD or other developmental disabilities.
Children without ASD or other developmental disabilities
develop at about the same rate in areas of development such as
language, cognitive, and social skills. Children with ASD
develop at different rates in different areas of growth. They
might have significant delays in language, social, cognitive,
and gross motor skills, while their fine motor skills might be
about the same as other children their age. They might be very
good at activities such as putting puzzles together or solving
computer problems, but have difficulty with activities most
people think are easy, such as talking or making friends.
Children with ASD might also learn a hard skill or task before
they learn an easy one. For example, a child might be able to
read long words, but not be able to tell you what sound a ``b''
makes. A child might also learn a skill and then lose it. For
example, a child may be able to say many words, but later stop
talking altogether.
Data from several studies that used the current criteria
for diagnosing autism and autism spectrum disorder (ASD), such
as Asperger's disorder and pervasive developmental disabilities
(PDD-NOS), found prevalence rates for ASD between 2 and 6 per
1,000 individuals. Therefore, it can be summarized that between
1 in 500 (2/1,000) to 1 in 166 children (6/1,000) have an ASD.
Currently, there is not a full population count of all
individuals with an ASD in the United States. However, using
the prevalence data stated above, it is estimated that if 4
million children are born in the United States every year,
approximately 24,000 of these children will eventually be
diagnosed with an ASD. Assuming a constant prevalence rate over
the past 2 decades, we can estimate that up to 500,000
individuals between the ages of 0 to 21 have an ASD. However,
many of these individuals may not be classified as having an
ASD until school-age or later. Since behaviors related to
theASD usually present before the age of 3 years, it is important to
make sure that young children are screened, and if the individual is at
high-risk of developing an ASD that they receive an interdisciplinary,
comprehensive evaluation to confirm or rule out the diagnosis. If the
diagnosis is confirmed subsequently, the individual should receive
evidence-based interventions as early as practicable.
In a study conducted by the Centers for Disease Control and
Prevention, the Metropolitan Atlanta Developmental Disabilities
Surveillance Program found the rate of autism for children ages
3 to 10 years to be 3.4 per 1,000 children which is lower than
the rate for mental retardation/intellectual disability (9.7
per 1,000 children); but higher than the rates for cerebral
palsy (2.8 per 1,000 children), hearing loss (1.1 per 1,000
children) and vision impairment (0.9 per 1,000 children) found
in the same study.
Approximately 2 percent of children under the age of 18
have a significant developmental disability (DD) and these
include intellectual disability, cerebral palsy, hearing loss
and vision impairment. Of these significant DDs, intellectual
disability (in the past referred to as mental retardation) is
the most common. A genetic disorder often associated with
having an intellectual disability (ID) that many people
recognize is Down syndrome. Current information indicates that
having Down syndrome occurs in 1 out of 800 births and is
slightly less common than ASD. Approximately 17 percent of
children have some type of developmental disability, including
more mild challenges such as speech and language disorders,
learning disabilities, and ADHD, which appear to be more common
than ASD.
While developmental disabilities may affect a child's
speech or language, physical growth, psychological growth,
self-care, or learning, diseases that impact adults may also
affect children's health. A common childhood disease, juvenile
diabetes, is prevalent in approximately 1 in every 400 to 500
children and adolescents, which is in a similar range as ASD.
However, ASD is more common than childhood cancer, which has a
prevalence rate of 1.5 per 10,000 children (1 in 300 males and
1 in 333 females have a probability of developing cancer by age
20 according to the National Cancer Institute).
In 2004, approximately 166,424 children received supports,
services, and intervention under the ``Autism'' classification
for special education services. Not all children with an ASD
receive special education services under the classification of
``Autism,'' often they are classified as ``other'' health
impaired (OHI), so the education data may underestimate the
actual prevalence of ASD. Autism was added as a special
education exceptionality in 1991 and is now the 6th most
commonly classified disability in the United States. The most
common disability classifications in 2004 were: specific
learning disabilities (2,838,694 children served), speech or
language impairments (1,151,260 children served), intellectual
disability (567,780 children served), emotional disturbance
(484,488 children served), and other health impairments, which
often includes children diagnosed with Attention Deficit
Hyperactivity Disorder (ADHD) (511,869 children served).
Using current standards, ASD is the second most common
significant developmental disability after intellectual
disability, but is still less common than other challenges that
affect children's development, such as speech and language
impairments, learning disabilities, and ADHD. The impact of
having a developmental disability is immense for the families
affected and for communities that provide services,
interventions and supports for these families. It is important
that we treat common DDs, and especially ASD, as areas of
urgent public health concern, do all we can to identify
children's learning needs, and begin intervention as early as
practicable to enable all children to reach their full
potential.
There is no known cure for ASD. However, early and
intensive intervention is important to improving the outcomes
so that individuals can grow and learn new skills. The goal of
these efforts is to provide interventions and supports to
individuals with ASD and their families to improve the
individuals' language development, social interaction and play,
learning potential, and activities of daily living skills.
Medicines can relieve some symptoms and be helpful for some
individuals with ASD, but interdisciplinary interventions that
meet the comprehensive needs of individuals with ASD are
currently the most effective intervention. The ideal
intervention plan integrates therapies and interventions that
target the core symptoms of autism: delayed social interaction,
challenges with expressive and receptive verbal and non-verbal
communication, sensory integration dysfunction, challenging
behavior, and obsessive or repetitive routines and interests.
There is general consensus among most professionals that the
earlier implementation of interdisciplinary intervention, the
better. For many children, autism symptoms improve with
interventions and with age. Some children with autism grow up
to lead typical lives.
During adolescence, some children with autism may develop,
or show signs of depression, or experience a change or increase
in challenging behavior. These changes may occur due to
hormonal changes and increased social demands that typically
occur during adolescence. Parents of children entering and
throughout adolescence should be ready to adjust and alter the
type, frequency and intensity of supports, services and
interventions that their child receives as his or her needs
change. One key fact to keep in mind is that oftentimes young
adolescents with ASD, especially Asperger's Syndrome, will
become more aware of the social relationships their non-
disabled peers are forming with others and develop a strong
sense of isolation, socially and emotionally.
According to data from the National Health Interview
Survey, children with parent-reported autism were more likely
than children without autism to have moderate or high levels of
emotional symptoms, exhibit challenging behaviors,
hyperactivity, peer problems, and overall difficulties.
Approximately 83 percent of children reported with autism had
moderate or high levels of overall difficulties compared with
15 percent of children without autism. The most notable
differences were for peer problems (82.0 percent versus 15.9
percent) and hyperactivity (65.2 percent versus 11.9 percent).
Substantially fewer children reported with autism had a high
level of social skills (39.6 percent) compared with children
without autism (82.3 percent).
The National Survey of Children's Health found that 93.8
percent of children with parent-reported autism were classified
as having special health-care needs lasting or expected to last
*12 months; 90.1 percent were reported as needing more medical,
mental health, or educational services than usual for a child
of the same age, or needing therapies or counseling for an
emotional, developmental, or behavioralchallenge. These
percentages compared with 19.6 percent and 10.5 percent, respectively,
for children reported without autism.
NATIONAL INSTITUTES OF HEALTH (NIH)
NIH-sponsored research on autism spectrum disorder covers
domains including: interventions, diagnosis, genetics,
neurobiology, neuropsychology and services. In addition to
individual grants for research projects, NIH sponsors training,
small grants, career support, and program projects that involve
autism research. NIH has also developed several networks of
autism research centers.
There are several network activities in autism research
sponsored by different Institutes including:
Collaborative Programs of Excellence in
Autism (CPEA) Network
The Studies to Advance Autism Research and
Treatment (STAART) Network
Children's Environmental Health Centers
(NIEHS)
In 1997, the National Institute of Child Health and Human
Development (NICHD) and the National Institute on Deafness and
Other Communication Disorders (NIDCD), started a 5-year, $45
million, International Network on the Neurobiology and Genetics
of Autism. The Network included 10 Collaborative Programs of
Excellence in Autism (CPEAs) that would conduct research to
learn about the possible causes of autism, including genetic,
immunological, and environmental factors.
In 2002, the NICHD and NIDCD renewed funding for the CPEA
Network, agreeing to provide $60 million over a period of 5
years. The CPEAs link 129 scientists from 23 universities in
the United States, Canada, Britain, and five other countries,
and more than 2,000 families of people with autism. In fact, as
a result of the CPEAs, researchers now have data on the
genetics and outward characteristics of the largest group of
diagnosed persons with autism in the world.
In 2003, the CPEA Network launched a Data Coordinating
Center in Medford, Massachusetts, to provide data management
and statistical support for Network activities. The Center will
also maintain a Web site to ease communication and coordinate
activities among the CPEAs. Three groups are managing different
tasks in the Data Coordinating Center: DMSTAT, Inc.; the Boston
University Statistics and Consulting Unit; and the Department
of Biostatistics at the Boston University School of Public
Health.
The Data Coordinating Center will provide combined support
for the CPEA Network and for the eight sites of the Studies to
Advance Autism Research and Treatment (STAART) Centers Program,
a 5-year, $65 million effort supported by five NIH Institutes,
including the NICHD. Such support will increase the volume and
speed in which data are processed and compared, which may
increase the speed of uncovering findings resulting from these
research efforts.
The STAART Network is comprised of eight centers across the
country. Most of these centers are evaluating and treating
patients, as well as enrolling them into NIH-funded clinical
trials.
In 2001, the National Institute of Environmental Health
Sciences and the Environmental Protection Agency jointly
announced four new children's environmental health research
centers that will focus research on childhood autism and
attention deficit disorder. The centers were funded at $5
million, or approximately $1 million per year for 5 years
(fiscal year 01 through fiscal year 05).
CENTERS FOR DISEASE CONTROL AND PREVENTION
The Children's Health Care Act of 2000 required the Centers
for Disease Control and Prevention (CDC) to establish Centers
of Excellence. The National Center on Birth Defects and
Developmental Disabilities (NCBDDD) at CDC funded five Centers
for Autism and Developmental Disabilities Research and
Epidemiology (CADDRE).
The Centers have:
Worked with the Autism and Developmental
Disabilities Monitoring Network (discussed further below) to
monitor the number of children with an ASD and other
developmental disabilities.
Improved community and service provider awareness
of ASD and other developmental disabilities, or improved access
to comprehensive, community-based, family-centered care for
children with an ASD and other developmental disabilities.
Conducted epidemiologic research related to ASD
and other developmental disabilities. These studies will
address topics such as what factors (genetic, environment, and
others) make it more likely that a child will have an ASD, what
other disabilities children with an ASD have, biomarkers, and
the economic costs of ASD.
In addition to CADDRE, the CDC also funds 10 Autism and
Developmental Disabilities Monitoring Network (ADDM) projects.
These projects are developing or improving programs to track
the number of children with an ASD in their States. The goal of
the ADDM Network is to provide comparable, population-based
estimates of the prevalence rates of autism and related
disorders in different sites over time.
Other CDC-funded activities related to autism include the
following:
The Marshall University Autism Training Center, in
West Virginia, is conducting an intervention study with
families of children who have an ASD. Marshall University staff
developed an in-depth program that helps reduce stress factors
that have a negative effect on children with an ASD and their
families. The program includes the development of family
support plans. These plans coordinate the activities of the
different professionals who work with the children, provide
positive behavior support training for parents and teachers,
and help create community partnerships, usually with another
family who has a child with an ASD.
CDC funds SAFE, Inc., in Pennsylvania, to enhance
their community-based ASD outreach and educational activities
to help individuals with ASD live a full and independent life.
The Christian Sarkine Autism Treatment Center
(CSATC) and Clarian Health Partners at Riley Hospital for
Children have joined together to develop the HANDS in Autism
(Helping Answer Needs by Developing Specialists in Autism)
Program through a grant provided by the Centers for Disease
Control and Prevention (CDC).
EDUCATION, EARLY DETECTION, AND INTERVENTION
Education: The NIH, CDC, and the Health Resources and
Services Administration (HRSA) all provide a variety of
activities to expand information and education to the general
public and health care providers specific to autism spectrum
disorder.
Beyond activities which have already been described, HRSA
supports a program to train health professionals to work with
children who have neurodevelopmental or related disabilities,
such as cerebral palsy, autism or spina bifida, or who may be
at high risk of developing such disabilities. The Leadership
Education in Neurodevelopmental and Related Disabilities (LEND)
grants provide interdisciplinary training to improve the
clinical expertise and leadership skills of health
professionals who serve children with disabilities. The grants
encourage doctors, nurses and psychologists to work together to
prevent disabilities in children resulting from genetic or
metabolic conditions and to identify signs of disability early
enough for effective intervention. In addition, social workers,
speech pathologists, pediatric dentists, dietitians,
occupational therapists, physical therapists and genetics
experts promote practice models that encourage cultural
competence by health professionals and the involvement of
families in making decisions about their children's supports
and services. Parents and youth consultants with disabilities
provide leadership training through the program.
HRSA supports a network of statewide centers run by
families of children with special health care needs (CSHCN) to
help other families with special needs children. These centers,
called Family-To-Family Health Care Information and Education
Centers for Families of Children with Special Health Care
Needs, will be designed and supervised by families in
partnership with State Title V CSHCN programs and other
providers.
They offer:
Health and related information to families
and providers for improving health decision-making;
Assistance on gaining greater access to and
making better use of services within communities; and
Educational and leadership opportunities to
family members.
Finally, HRSA also supports the developmental-behavioral
pediatrics training program that focuses on (1) supporting
fellows in behavioral pediatrics to help prepare them for
leadership roles as teachers, researchers, and clinicians; and
(2) providing pediatric practitioners, residents, and medical
students with essential biopsychosocial knowledge and clinical
expertise. The purpose of the program is to enhance behavioral,
psychosocial, and developmental aspects of general pediatric
care. This program has three main aspects:
Faculty and Fellows. Training grant funds support
faculty who demonstrate leadership and expertise in behavioral
pediatrics teaching, scholarship, and community service and
fellows who have completed training to be board-eligible in
pediatrics.
Curriculum. The 3-year residency program
curriculum includes course work and clinical exposure to
psychosocial and biological sciences, growth and development,
adaptation, injury prevention, disease prevention, and health
promotion. Projects are also encouraged to cosponsor, with
child psychiatry, an ongoing Collaborative Office Rounds (COR)
group as a training experience for fellows and a continuing
education experience for community providers.
Continuing Education and Technical Assistance.
Grantees must also provide continuing education activities for
practicing physicians and are encouraged to offer technical
assistance and consultation to pediatric residency training
programs that are in the early stages of developing their own
behavioral program components.
To increase awareness about the early warning signs of
developmental disabilities, such as autism, and help ensure
that children get services at the youngest age possible, the
Centers for Disease Control and Prevention (CDC), in
partnership with Porter Novelli, developed a targeted social
marketing campaign: ``Learn the Signs. Act Early.'' In its
first year, this innovative campaign has educated parents and
doctors about the developmental milestones that every young
child should reach, the warning signs of a developmental delay,
and the need to act early when a problem is suspected.
Recent studies have shown that developmental disabilities,
such as autism spectrum disorder, can be diagnosed as early as
18 months; however, in an estimated 50 percent of children,
disabilities remain unidentified until age 5 years, when most
enter kindergarten. Why is this important? Although there are
no cures for these disabilities, early detection and early
intervention services have demonstrated significant improvement
in outcomes and functioning for affected children. Early
intervention is a child's best hope for reaching his or her
full potential.
The campaign targets parents of children ages 4 and younger
and health care professionals, including pediatricians, family
physicians, physician assistants, and nurses. These audiences
tend to monitor a child's physical growth--height, weight and
milestones such as crawling and walking--but pay less attention
to the social, emotional, cognitive and language milestones
that mark a child's overall development. To increase awareness
of the milestones and the importance of early action when a
delay is suspected, the campaign employed the following
strategies:
Build on the familiar physical developmental
milestones, adding in information on social, emotional,
language and cognitive milestones.
Work with health care professionals to ensure they
are able to initiate and respond to parent requests for
information.
Partner with trusted medical associations and
leverage the CDC brand to build trust and credibility with
providers.
Distribute materials to parents through provider
offices, empowering parents with questions to ask the doctor at
the point of service.
The first phase of the social marketing campaign launched
in October 2004 and focused on educating health care
professionals, arming them with information and resources to
initiate discussions and respond to increased queries from
parents. The second phase, launched in February 2005, focused
on increasing awareness among parents.
Evaluations have shown rather promising results.
EARLY DETECTION
Many children with developmental disabilities, such as
autism spectrum disorder, are missing critical opportunities
for early detection and intervention. In the United States,17
percent of children have a developmental disability such as autism,
intellectual disability, or Attention-Deficit/Hyperactivity Disorder.
In addition, many children have delays in language or other areas,
which impacts school readiness, success in school and quality of life.
However, less than 50 percent of these children are identified before
starting school, by which time significant delays may have already
occurred and opportunities for early intervention have been missed.
Recent surveys indicate that parents want information and
guidance from their health care provider about their child's
development, but studies sponsored by the American Academy of
Pediatrics show that 65 percent of pediatricians feel
inadequately trained in assessing children's developmental
status. Although developmental screening is widely recommended,
there are currently no national data tracking the state of this
practice and how it is integrated into primary care.
Developmental screenings such as the Modified Checklist for
Autism in Toddlers (M-CHAT)--a brief assessment designed to
identify children who should receive more intensive evaluation
or assessment for autism spectrum disorder--can improve child
health and well-being, especially for children with autism
spectrum disorders and other developmental disabilities or
delays.
Research has demonstrated that early detection of
developmental disabilities and evidence-based intervention can
significantly improve short- and long-term outcomes and reduce
the need for lifelong interventions. For example, children with
autism spectrum disorder identified early and enrolled in early
intervention programs show significant improvements in their
language, cognitive, social, and motor skills, as well as in
their future educational attainment and decreased need for
special education services. Thus, the committee encourages the
Department of HHS to develop and implement activities so that
all children are screened for autism spectrum disorder and
other developmental disabilities before their second birthday.
Also, children with an autism spectrum disorder diagnosis or
who are at high risk for autism should receive evidence-based
interdisciplinary interventions as early as practicable.
Interventions include referral and services provided by school
and agencies (including community, consumer, and parent-based
agencies), along with organizations and other programs required
by the Individuals with Disabilities Education Act (which
offers programs specifically designed to meet the unique needs
of children with autism and their families).
Given this, the CDC has established the following goals to
help children reach their full potential:
Develop and evaluate community-based model
programs in primary care settings (and potentially other
settings that care for young children) to provide early
screening for children to identify those at risk for autism and
other developmental disabilities or delays, and ensure that
children are referred to local and State resources, and receive
evidence based interventions.
Increase health care providers' knowledge and
skills in developmental screening by incorporating
developmental screening into professional health care training.
Monitor the use of screening for autism and other
developmental disabilities or delays in primary care settings.
Raise awareness about the need for and benefits of
developmental screening to identify and meet the needs for
children with autism and other developmental disabilities or
delays.
Complementing the activities at the CDC, HRSA administers
the Maternal and Child Health Services Title V Block Grant
(title V). The goal of the title V program is to improve the
health of all mothers and children consistent with the
applicable health status goals and national health objectives
established by the Secretary of the U.S. Department of Health
and Human Services.
The title V program has operated as a Federal-State
partnership for more than 65 years. When the Social Security
Act was passed in 1935, the Federal Government, through title
V, pledged its support of State efforts to extend and improve
health and welfare services for mothers and children. Title V
has been amended many times over the years to reflect the
expansion of the national interest in maternal and child
health. It was converted to a block grant program as part of
the Omnibus Budget Reconciliation Act (OBRA) of 1981. Congress
later sought to balance the flexibility of the block grant with
greater accountability by the States. Through the 1989 OBRA
States were required to report on progress made toward key
maternal and child health indicators and to provide other
program information.
States and jurisdictions use title V funds to design and
implement a wide range of maternal and child health programs
that meet national and State needs. Although specific
initiatives may vary among the 59 States and jurisdictions
utilizing title V funds, all programs work to do the following:
Reduce infant mortality and incidence of
disability among children.
Increase the number of children appropriately
immunized against disease.
Increase the number of children in low-income
households who receive assessments and follow-up diagnostic and
treatment services.
Provide and ensure access to comprehensive
perinatal care for women; preventative and child care services;
comprehensive care, including long-term care services, for
children with special health care needs; and rehabilitation
services for blind and disabled children under 16 years of age
who are eligible for Supplemental Security Income.
Facilitate the development of comprehensive,
family-centered, community-based, culturally competent,
coordinated systems of care for children with special health
care needs.
As part of title V's focus on children with special health
care needs, the goal of that program is to support development
and implementation of comprehensive, culturally competent,
coordinated systems of care for the estimated 18 million U.S.
children who have or are at risk for chronic physical,
developmental, behavioral or emotional disorders and who also
require health and related services of a type or amount beyond
that required by children generally. Children with an ASD are
specifically included within these programs.
IACC
The Children's Health Act of 2000 (P.L. 106-310), Title I,
Section 104, mandated the establishment of an Interagency
Autism Coordinating Committee (IACC) to coordinate autism
research and other efforts within the Department of Health and
Human Services (DHHS). In April 2001, Secretary Tommy Thompson
delegated the authority toestablish the IACC to the National
Institutes of Health (NIH). The National Institute of Mental Health
(NIMH) at the NIH has been designated the lead for this activity.
The IACC's primary mission is to facilitate the efficient
and effective exchange of information on autism activities
among the member agencies, and to coordinate autism-related
programs and initiatives. P.L. 106-310 specifies that parents
or legal guardians of individuals with autism or other
pervasive developmental disorders be appointed to the
committee. The Secretary retained the authority to select such
public members. Such appointments are necessary and vital to
the conduct of the committee's mission. Public members of the
IACC will help bring to DHHS the concerns and interests of
members of the autism community. The IACC will serve as a forum
and assist in increasing public understanding of the member
agencies' activities, programs, policies, and research and in
bringing important matters of interest forward for discussion.
III. History of Legislation and Committee Action
On April 19, 2005, Senator Santorum and Senator Dodd
introduced S. 843, the ``Combating Autism Act of 2005.'' Since
that introduction, the bill has been cosponsored by 40 other
members of Congress. After accepting a substitute amendment
offered by Senator Enzi and cosponsored by Senators Dodd,
Frist, Kennedy, Burr, Clinton, DeWine, Harkin, Hatch, Gregg,
Mikulski, and Jeffords, the Committee on Health, Education,
Labor, and Pensions reported the bill favorably by unanimous
voice vote on July 19, 2006.
IV. Explanation of Bill and Committee Views
The bill has a variety of provisions, the explanation of
and committee views on which follow below:
Throughout the bill, the committee uses the term
``intervention.'' In using this term, the committee believes
that such a term encompasses a broad range of activities,
including biomedical interventions (such as pharmaceuticals),
behavioral interventions and therapies. Thus, it is the intent
of the committee that the term ``intervention'' be very broadly
construed as any activity which improves the overall health
outcome of the individual diagnosed with autism spectrum
disorder or other developmental disabilities.
In addition, the committee paired language related to
``diagnosing'' an individual with autism spectrum disorder with
the need to also ``rule out'' a diagnosis. As with any
determination of whether an individual has a particular
disorder, it is important that the individual assisting with
such process is able to distinguish between the particular
disorder and other potential issues, hence, the need to pair
``diagnosis'' with ``rule out.''
Finally, the committee uses the term ``evidence-based'' at
various points throughout the legislation. In doing so, the
committee expects the term ``evidence-based'' to be the
conscientious, explicit, and judicious use of current best
evidence in making decisions about care and services for
individuals. The practice of evidence-based care and services
means integrating individual expertise with the best available
external evidence from systematic research.
To increase the accountability and focus on autism spectrum
disorder at the National Institutes of Health (NIH), the
committee specifically authorizes a strategic plan related to
autism spectrum disorder. In requiring the Director of the NIH
to develop a strategic plan for autism spectrum disorder, the
committee wants to ensure that this plan provides not only an
outline of key research activities and questions but also ties
those activities to specific budgetary outlays to improve the
transparency of the planning process. The goal of this planning
process is to ensure broader coordination of activities among
the Institutes and Centers (ICs) within the NIH. This is
particularly important given the number of ICs at NIH which
have a role to play on research related to autism spectrum
disorder. However, the Committee committee does not expect the
strategic plan process to deviate from similar processes that
NIH uses during the budgetary process by putting together their
professional judgment of the funds required for particular
activities, recognizing that those professional judgments
cannot be tied to obligating such funds to the research
outlined under the strategic plan.
In reporting on the expected spending and providing an
analysis of what was previously expended, the committee
strongly encourages the director to provide such dollar amounts
using clear and consistent methods for determining the monetary
allocation. At this point, various ICs have different policies
for determining the budgetary allocation for a grant that has
multiple disease impacts, and the committee would like the
information presented for this report to use one consistent
method for all of the information provided. The committee
further encourages the director to use this information on the
amount of spending on autism spectrum disorder for all of its
dissemination purposes, including the information publicly
available at http://www.nih.gov/news/fundingresearchareas.htm,
regarding spending on specific disease categories.
Further, in crafting the specific strategic plan, the
committee encourages the director to:
Determine and establish priorities among
critical scientific questions related to autism
spectrum disorder;
Specify the short and long-range objectives
to be achieved, and estimate the resources needed to
achieve these objectives;
Evaluate the sufficiency of existing
research programs on autism spectrum disorder to meet
the specified objectives and establish objectives,
timelines, and criteria for evaluating future research
programs; and
Make recommendations for changes to existing
research programs on autism spectrum disorder,
including potential consolidation of research
activities if such consolidation would improve program
efficiencies and outcomes.
In addition to the strategic plan, the committee requests
that the NIH expand, intensify, and coordinate activities at
NIH. The committee further authorizes two centers of excellence
programs--the Autism Centers of Excellence and the Centers of
Excellence in Environmental Health and Autism.
The committee is encouraged by the work that the NIH has
already performed in the past 5 years with respect to Centers
of Excellence. In providing updated authority for those Centers
of Excellence, the committee applauds the NIH for taking the
proactive step to collapse two current Centers of Excellence
programs (e.g., the Collaborative Programs of Excellence in
Autism and the Studies to Advance Autism Research andTreatment)
into one comprehensive Center of Excellence--the Autism Centers of
Excellence (or ACE). This virtual network of centers across the Nation
will build upon the work of the previous Centers of Excellence by
focusing on treatment trials, neuroimaging, and the behavioral and
biological components tied to genetic traits. In working with these
centers, the committee expects the director to continue to coordinate
activities with the directors of the National Institute of Mental
Health, the National Institute of Child Health and Human Development,
the National Institute of Neurological Disorders and Stroke, the
National Institute of Environmental Health Sciences, the National
Institute on Deafness and Other Communication Disorders, and any other
agencies that the director determines appropriate.
Given that the Centers of Excellence can utilize their
grant award for making individuals aware of opportunities to
participate as subjects in research at the Center, the
committee strongly encourages the NIH to provide appropriate
oversight and accounting of these activities to ensure that
those costs are reasonable and appropriate and tied directly to
recruitment activities. The committee allows the NIH to request
justification from grantees for such expenditures.
The committee also authorizes the collection of storage of
data, including samples of tissues and genetic and other
biological materials, to improve the availability of
information to individuals examining questions related to
autism spectrum disorder. Given that the NIH has already
developed a genetic repository as part of the Autism Genome
Resource Exchange, which includes DNA extracted from blood
samples from families with a child with autism, the committee
expects that the Centers of Excellence will have the
opportunity to perform research on high-risk infant siblings.
The committee further commends the NIH for developing the
National Database for Autism Research. This collaboration among
sites allows for data sharing, additional analysis, queries
across disparate systems and data stories, and additional data
resources. By using common reference architectures of data
standards, vocabularies, web services, and application
solutions, this network can link the Autism Speaks Registry,
the Autism Treatment Network, and the Centers of Excellence at
the Centers for Disease Control, and other autism researchers.
In making this information available to the public and other
autism researchers, the committee expects the NIH to share this
information using standard protocols to appropriately protect
patient confidentiality.
Given that the NIH is already working to establish a
virtual data center, the committee expects the CDC to share
relevant data and samples of tissues and other biological
material with the NIH so that there can be a single point of
access within the Federal Government for all autism data-
sharing purposes.
To ensure the maximum amount of efficiency, while still
focusing on outcomes, the committee gives the NIH the authority
to consolidate program activities under the direction of NIH if
such consolidation would improve program efficiencies and
outcomes. In promoting any consolidation, the committee expects
the NIH to retain a separate, distinct focus on environmental
health factors as they potentially relate to autism spectrum
disorder.
In addition, beyond the authorization of appropriations,
the committee further clarifies that NIH can use up to 5
percent of the grant amounts for administrative and other
expenses. Although the committee understands the need for the
NIH to have such taps, the committee is concerned about those
taps being too high and diverting scarce resources to
administrative expenses.
In an effort to clarify the committee's intent that these
provisions do indeed sunset at the end of the authorization
period, the committee has provided specific sunset language. In
providing this language, the committee intends to reauthorize
this critical law within the timeframe specified to ensure that
the committee provides appropriate oversight of these issues.
Except for the provisions related to biomedical research at
the NIH, the committee does not separate autism spectrum
disorder from other developmental disabilities because the
committee recognizes how necessary it is to continue to provide
such services and epidemiological research in a comprehensive
manner. However, given how little is known about ASD in
biomedical research, the committee consciously decided to focus
solely on ASD in that particular context.
The committee appreciates the work that the director of the
Centers for Disease Control and Prevention (CDC) has already
done in implementing the provisions of section 1 of the
Children's Health Act of 2000. Recognizing that, the committee
updated the language related to the State epidemiological
studies, as well as additional Centers of Excellence for Autism
Spectrum Disorder Epidemiology.
In continuing to implement the State epidemiology program
and centers of excellence for autism research focused on
epidemiological questions, the committee encourages the CDC to
examine specific trends of autism spectrum disorder over time.
While examining the incidence and prevalence of ASD, the
committee encourages the CDC to use the diagnostic criteria
established within the current edition of the Diagnostic and
Statistical Manual (DSM) of Mental Disorders published by the
American Psychiatric Association. If there is a change in the
diagnostic criteria over time, due to new insights into ASD,
then the committee expects CDC to provide a sufficient
crosswalk between the various definitions so that it is
possible to still follow the trends over time. Further, to
ensure that there are standard methods for data collection, the
committee specifically requires the CDC to provide such
guidelines, after consultation with relevant State and local
public health officials, for both the State epidemiology
program and centers of excellence.
The committee commends the CDC for continuing to coordinate
the Federal response to requests for assistance from State
health departments regarding potential or alleged autism
spectrum disorder clusters. For instance, in late 1997, a
citizen's group in Brick Township, New Jersey, told the New
Jersey Department of Health and Senior Services (DHSS) of their
concerns about what seemed to be a larger-than-expected number
of children with autism in Brick Township. Because of the
complexity of the disorder and the citizens' concern that
environmental factors might play a role, the New Jersey DHSS
contacted CDC and the Agency for Toxic Substances and Disease
Registry (ATSDR) for help. CDC and ATSDR worked together on a
project to find out how common ASD was in Brick Township and to
study the possible relationship of environmental factors toASD
in the community. After much review, it was determined that the
prevalence of autism in Brick Township seems to be higher than that in
other studies, particularly studies conducted in the United States, but
within the range of a few recent studies in smaller populations that
used more thorough case-finding methods.
To truly address the issues surrounding the need for
additional education, early detection, diagnosis, and
intervention for individuals with autism spectrum disorder and
other developmental disorders, there must be an
interdisciplinary approach, combining key resources from
health, education, and disability programs. With that in mind,
the committee made the largest number of changes in section
399BB autism education, early detection, and intervention to
the original draft of S. 843. In particular, the committee
included specific requirements for data coordination, as well
as the designation by the Governor of a State lead agency.
The committee added language requesting the Governor to
designate a lead agency to coordinate activities designated to
provide information regarding risk factors, characteristics,
identification, diagnosis, and interventions for individuals
with autism spectrum disorder and other developmental
disabilities and their families through specific Federal, State
and local programs. Methods of delivery of such information may
include websites, toll-free numbers, pamphlets and other means
that the Governor may require. The committee recognizes that
such activities are occurring throughout the United States,
however, there are often multiple points of entry to access
such information and families have indicated difficulties
locating beneficial information in a timely fashion. Hence, the
committee requests the Governor to designate a lead agency to
seek, collect, and publicize information related to services
that are available to individuals with autism spectrum disorder
and other developmental disabilities, and their families.
The committee has modified the language from the original
text of the Children's Health Act of 2000 to specify that the
information should include information relevant to individuals
with autism spectrum disorder and other developmental
disabilities across the lifespan, especially transition age
youth and adults, and with regard to college, vocational and
labor accommodations. The committee further encourages that
funding provided under this section include funding for
information and education on advances in the early detection,
diagnosis and intervention for individuals with autism spectrum
disorder and other developmental disabilities as well as
training and continuing education through programs for
scientists, physicians, and other health professionals, social
workers, and child care and education professionals and
assistants who provide supports and services to, or are likely
to come into professional contact with, people with autism
spectrum disorder and other developmental disabilities, and
their families. Activities under this section should place
special emphasis on early identification of autism spectrum
disorder and other developmental disabilities and those at high
risk for ASD and other developmental disabilities, and prompt
referral for appropriate services.
In addition to these activities, the committee specifically
encourages the Secretary to develop evidence-based models for
the comprehensive medical care of individuals with autism
spectrum disorder. Comprehensive medical care models should
include diagnosis and evaluation of disabilities identified
during a complete history and physical examination and through
appropriate laboratory evaluations. When outlining the
comprehensive medical models, the committee encourages the
Secretary to examine these models in the context of the
individual, not just the potential diagnosis of autism spectrum
disorder but in the context of the other potential co-
occurring conditions and other health aspects. Therefore,
evaluation and diagnosis could consider all of the health
aspects of an individual, including developmental,
psychosocial, behavioral, nutritional, neurological,
immunological, endocrinological, gastrointestinal, metabolic,
and toxicological parameters.
As part of the informational process, the committee
requested that the Secretary, in collaboration with the
Secretary of Education and the Secretary of Agriculture,
provide culturally competent information regarding autism
spectrum disorder and other developmental disabilities through
a variety of Federal programs. In doing so, the committee
recognizes that nutrition services are the mission of the
Special Supplemental Nutrition Program for Women, Infants and
Children (WIC) and is concerned that placing additional
responsibilities upon WIC that are not central to this mission
may potentially result in a diminished quality of nutrition
services. At the same time, the committee recognizes the access
that WIC provides to a significant number of children up to the
age of 5. It is the committee's intention that the information
and education activities carried out through WIC under
subsection (c) be limited to the basic provision and
dissemination of information, such as providing pamphlets or
other materials that can easily be passed along to or picked up
by WIC clients, rather than activities that would require WIC
staff to actively perform duties such as providing screening,
education, interventions, administering information surveys,
etc., for individuals with autism spectrum disorder, that are
unrelated to the core mission of WIC.
The committee further re-examined the Interagency Autism
Coordinating Committee (IACC). In particular, the committee
wanted to increase the amount of public participation (from two
individuals) to at least six. In addition, the IACC has been
tasked to make recommendations to the Secretary regarding the
public participation in decisions relating to autism spectrum
disorder. For instance, the committee notes that the IACC may
recommend providing other, additional, formal mechanisms, such
as an Autism Advisory Board, to provide additional public
feedback and interaction. Further, the Secretary may opt to
provide such a mechanism without the recommendation of the
IACC.
The committee expects that the IACC will be the primary
mechanism for the coordination of all research, surveillance,
and early detection activities within the Department of Health
and Human Services. As agencies implement specific activities
related to autism spectrum disorder, they should strongly
consider those activities outlined in the Autism Research
Matrix.
To provide the necessary information for an appropriate
committee analysis of activities outlined in this legislation,
the committee requires a specific report 4 years after the date
of enactment of the ``Combating Autism Act of 2006.''
Finally, the committee repeals sections of the ``Children's
Health Act of 2000'' that were updated by the ``Combating
Autism Act of 2006.''
V. Cost Estimate
Due to time constraints the Congressional Budget Office
estimate was not included in the report. When received by the
committee, it will appear in the Congressional Record at a
later time.
VI. Application of Law to the Legislative Branch
The committee has determined that there is no impact of
this law on the Legislative Branch.
VII. Regulatory Impact Statement
In accordance with paragraph 11(b) of rule XXVI of the
Standing Rules of the Senate, the committee has determined that
there will be minimal increases in the regulatory burden
imposed by this bill.
VIII. Section-by-Section Analysis
Section 2--Activities to improve autism-related research
Section 409C--This section authorizes the director of NIH
to develop and implement a strategic plan for research related
to autism spectrum disorder. The director will take into
consideration the recommendations of the Interagency Autism
Coordinating Committee (IACC). Oversight of the strategic plan
and budget for research is based on the existing Autism
Research Roadmap and Matrix developed by the IACC. The
strategic plan shall require identification of the total
expenditures of NIH research activities related to autism
spectrum disorder.
This section promotes the expansion, intensification and
coordination of activities at NIH related to autism spectrum
disorder. It reauthorizes the Autism Centers of Excellence
which were originally created in the Children's Health Act of
2000. The funding may support both basic and clinical research
in the fields of developmental neurobiology, genetics,
epigenetics, pharmacology, nutrition, immunology,
neuroimmunology, neurobehavioral development, endocrinology,
gastroenterology, psychopharmacology or toxicology. It will
also support continued investigations into the causation,
diagnosis, early detection, prevention, control, intervention
and cure for autism spectrum disorder. Centers of Excellence
will also receive funding for coordination of services and
information for patients. The director of NIH shall promote
research to determine evidence-based best practices for
diagnosis and intervention strategies for individuals with
autism spectrum disorder.
This section authorizes $500 million for NIH research
funding over 5 years ($68 million for 2007, $82 million for
2008, $96 million for 2009, $120 million for 2010 and $134
million for 2011) and $195 million for funding the Autism
Centers of Excellence over 5 years ($26 million for 2007, $32.5
million for 2008, $38 million for 2009, $45.5 million for 2010,
$52 million for 2011).
This section promotes research initiatives for basic and
clinical research of a broad array of environmental factors.
The research will be coordinated through the Centers of
Excellence in Environmental Health and will have the same
requirements concerning coordinating, reporting and
organization as applied to the other Centers of Excellence.
It authorizes $45 million in funding for the National
Institutes of Environmental Health over 5 years ($6 million for
2007, $7.5 million for 2008, $9 million for 2009, $10.5 million
for 2010, and $12 million for 2011).
This section also authorizes the Secretary to establish and
provide funding for the collection, storage, coordination, and
public availability of data generated from public and private
research partnerships. It will also establish a program under
which tissue samples, genetic material or biological materials
are available for research.
Section 3--Developmental disabilities surveillance and research
programs
Section 399AA--This section reauthorizes CDC's
epidemiologic surveillance programs and establishes regional
Centers of Excellence for collection, analysis and reporting of
epidemiological data on autism spectrum disorder and other
developmental disabilities. The Centers will also assist with
the development and coordination of State autism spectrum
disorder and other developmental disabilities efforts within a
region. This section authorizes CDC to promote research to
determine evidence-based best practices for diagnosis and
interventions for individuals with autism spectrum disorder and
other developmental disabilities. This section authorizes $75
million for years 2007 through 2011.
Section 399BB--This section increases awareness, reduces
barriers to screening and diagnosis, and promotes evidence-
based early interventions for individuals with autism spectrum
disorder and other developmental disabilities. It also promotes
the training of professionals to utilize valid and reliable
screening tools to diagnose and provide evidence based
interventions. Information will be provided through Federal
programs that target individuals and their families (such as
Head Start, Early Start, Healthy Start and Medicaid and SCHIP).
This section also requires the designation of a lead agency
with demonstrated experience and expertise in autism by the
Governor of each State to coordinate and provide comprehensive
information, education and referral services regarding autism
spectrum disorder and other developmental disabilities. It also
promotes the development and implementation of valid and
reliable screening tools for autism spectrum disorder and other
developmental disabilities. Both the Secretary of HHS and the
Secretary of Education shall collaborate to provide collection,
storage, and coordination of screening tools, educational
materials and other products used by Federal programs. The
Secretary of HHS shall also expand the interdisciplinary
training opportunities through the Health Resources and
Services Administration (HRSA) grants to public and non-profit
agencies and promote grants to determine the evidence-based
practices for interventions for autism spectrum disorder and
other developmental disabilities. They shall also develop
guidelines for these interventions and disseminate such
information. It authorizes $210 million in funding over 5 years
($32 million for 2007, $37 million for 2008, $42 million for
2009, $47 million for 2010, and $52 million for 2011).
Section 399CC--This section reauthorizes the ``Autism
Coordinating Committee'' established in the Children's Health
Act of 2000. The Interagency Autism Coordinating Committee
(IACC) shall make recommendations concerning the strategic plan
for the Autism Matrix. The IACC will also develop and annually
update advances in autism spectrum disorder research related to
causes, early screening, diagnosis, intervention and access to
services for individuals with autism spectrum disorder. The
public member participation in the IACC will be comprised of 1/
3 (or 6 members) of the committee. The IACC will be funded by
such sums as necessary each year through 2011.
Section 399DD--This section requires a report from the
Secretary of HHS in coordination with the Secretary of
Education no later than 4 years after the date of enactment of
this bill. The report shall be submitted to the Health,
Education, Labor, and Pension Committee in the Senate and
Energy and Commerce Committee of the House of Representatives
on the progress of activities related to autism spectrum
disorder and other developmental disabilities.
Repeals--The respective sections of the Children's Health
Act of 2000 are repealed.
IX. Changes in Existing Law
In compliance with rule XXVI paragraph 12 of the Standing
Rules of the Senate, the following provides a print of the
statute or the part or section thereof to be amended or
replaced (existing law proposed to be omitted is enclosed in
black brackets, new matter is printed in italic, existing law
in which no change is proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE
PART A--RESEARCH AND INVESTIGATION
IN GENERAL
Sec. 301 * * *
* * * * * * *
PART Q--PROGRAMS TO IMPROVE THE HEALTH OF CHILDREN
SEC. 399W. [280H] GRANTS TO PROMOTE CHILDHOOD NUTRITION AND PHYSICAL
ACTIVITY.
(a) In General.--* * *
* * * * * * *
PART R--PROGRAMS RELATING TO AUTISM
SEC. 399AA. DEVELOPMENTAL DISABILITIES SURVEILLANCE AND RESEARCH
PROGRAM.
(a) Autism Spectrum Disorder and Other Developmental
Disabilities.--
(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and
Prevention, may award grants or cooperative agreements
to eligible entities for the collection, analysis, and
reporting of State epidemiological data on autism
spectrum disorder and other developmental disabilities.
An eligible entity shall assist with the development
and coordination of State autism spectrum disorder and
other developmental disability surveillance efforts
within a region. In making such awards, the Secretary
may provide direct technical assistance in lieu of
cash.
(2) Data standards.--In submitting epidemiological
data to the Secretary pursuant to subsection (a), an
eligible entity shall report data according to
guidelines prescribed by the Director of the Centers
for Disease Control and Prevention, after consultation
with relevant State and local public health officials,
private sector developmental disability researchers,
and advocates for individuals with autism spectrum
disorder or other developmental disabilities.
(3) Eligibility.--To be eligible to receive an award
under paragraph (1), an entity shall be a public or
nonprofit private entity (including a health department
of a State or a political subdivision of a State, a
university, or any other educational institution), and
submit to the Secretary an application at such time, in
such manner, and containing such information as the
Secretary may require.
(b) Centers of Excellence in Autism Spectrum Disorder
Epidemiology.--
(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and
Prevention, shall, subject to the availability of
appropriations, award grants or cooperative agreements
for the establishment of regional centers of excellence
in autism spectrum disorder and other developmental
disabilities epidemiology for the purpose of collecting
and analyzing information on the number, incidence,
correlates and causes of autism spectrum disorder and
other developmental disabilities.
(2) Requirements.--To be eligible to receive a grant
or cooperative agreement under paragraph (1), an entity
shall submit to the Secretary an application containing
such agreements and information as the Secretary may
require, including an agreementthat the center to be
established under the grant or cooperative agreement shall operate in
accordance with the following:
(A) The center will collect, analyze, and
report autism spectrum disorder and other
developmental disability data according to
guidelines prescribed by the Director of the
Centers for Disease Control and Prevention,
after consultation with relevant State and
local public health officials, private sector
developmental disability researchers, and
advocates for individuals with developmental
disabilities.
(B) The center will develop or extend an area
of special research expertise (including
genetics, epigenetics, epidemiological research
related to environmental exposures),
immunology, and other relevant research
specialty areas.
(C) The center will identify eligible cases
and controls through its surveillance system
and conduct research into factors which may
cause or increase the risk of autism spectrum
disorder and other developmental disabilities.
(c) Federal Response.--The Secretary shall coordinate the
Federal response to requests for assistance from State health,
mental health, and education department officials regarding
potential or alleged autism spectrum disorder or developmental
disability clusters.
(d) Definitions.--In this part:
(1) Other developmental disabilities.--The term
``other developmental disabilities'' has the meaning
given the term ``developmental disability'' in section
102(8) of the Developmental Disabilities Assistance and
Bill of Rights Act of 2000 (42 U.S.C. 15002(8)).
(2) State.--The term ``State'' means each of the
several States, the District of Columbia, the
Commonwealth of Puerto Rico, American Samoa, Guam, the
Commonwealth of the Northern Mariana Islands, the
Virgin Islands, and the Trust Territory of the Pacific
Islands.
(e) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated, $15,000,000
for fiscal year 2007, and such sums as may be necessary for
each of fiscal years 2008 through 2011.
(f) Sunset.--This section shall not apply after September
30, 2011.
SEC. 399BB. AUTISM EDUCATION, EARLY DETECTION, AND INTERVENTION .
(a) Purpose.--It is the purpose of this section--
(1) to increase awareness, reduce barriers to
screening and diagnosis, promote evidence-based
interventions for individuals with autism spectrum
disorder or other developmental disabilities, and train
professionals to utilize valid and reliable screening
tools to diagnose or rule out and provide evidence-
based interventions for children with autism spectrum
disorder and other developmental disabilities; and
(2) to conduct activities under this section with a
focus on an interdisciplinary approach (as defined in
programs developed under section 501(a)(2) of the
Social Security Act) that will also focus on specific
issues for children who are not receiving an early
diagnosis and subsequent interventions.
(b) In General.--The Secretary shall, subject to the
availability of appropriations, establish and evaluate
activities to--
(1) provide information and education on autism
spectrum disorder and other developmental disabilities
to increase public awareness of developmental
milestones;
(2) promote research into the development and
validation of reliable screening tools for autism
spectrum disorder and other developmental disabilities
and disseminate information regarding those screening
tools;
(3) promote early screening of individuals at higher
risk for autism spectrum disorder and other
developmental disabilities as early as practicable,
given evidence-based screening techniques and
interventions;
(4) increase the number of individuals who are able
to confirm or rule out a diagnosis of autism spectrum
disorder and other developmental disabilities;
(5) increase the number of individuals able to
provide evidence-based interventions for individuals
diagnosed with autism spectrum disorder or other
developmental disabilities; and
(6) promote the use of evidence-based interventions
for individuals at higher risk for autism spectrum
disorder and other developmental disabilities as early
as practicable.
(c) Information and Education.--
(1) In general.--In carrying out subsection (b)(1),
the Secretary, in collaboration with the Secretary of
Education and the Secretary of Agriculture, shall,
subject to the availability of appropriations, provide
culturally competent information regardingautism
spectrum disorder and other developmental disabilities, risk factors,
characteristics, identification, diagnosis or rule out, and evidence-
based interventions to meet the needs of individuals with autism
spectrum disorder or other developmental disabilities and their
families through--
(A) Federal programs, including--
(i) the Head Start program;
(ii) the Early Start program;
(iii) the Healthy Start program;
(iv) programs under the Child Care
and Development Block Grant Act of
1990;
(v) programs under title XIX of the
Social Security Act (particularly the
Medicaid Early and Periodic Screening,
Diagnosis and Treatment Program);
(vi) the program under title XXI of
the Social Security Act (the State
Children's Health Insurance Program);
(vii) the program under title V of
the Social Security Act (Maternal and
Child Health Block Grant Program);
(viii) the program under parts B and
C of the Individuals with Disabilities
Education Act;
(ix) the special supplemental
nutrition program for women, infants,
and children established under section
17 of the Child Nutrition Act of 1966
(42 U.S.C. 1786); and
(x) the State grant program under the
Rehabilitation Act of 1973.
(B) State licensed child care facilities; and
(C) other community-based organizations or
points of entry for individuals with autism
spectrum disorder and other developmental
disabilities to receive services.
(2) Lead agency.--
(A) Designation.--The governor of a State
shall designate a public agency as a lead
agency to coordinate the activities provided
for under paragraph (1) in the State at the
State level.
(B) Information.--The Governor or a State,
acting through the lead agency under
subparagraph (A), shall make available to
individuals and their family members,
guardians, advocates, or authorized
representatives, providers, and other
appropriate individuals in the State,
comprehensive culturally competent information
about State and local resources regarding
autism spectrum disorder and other
developmental disabilities, risk factors,
characteristics, identification, diagnosis or
rule out, available services and supports, and
evidence-based interventions. Such information
shall be provided through--
(i) toll-free telephone numbers;
(ii) Internet websites;
(iii) mailings; or
(iv) other means as the Governor may
require.
(C) Requirements of agency.--In designating
the lead agency under subparagraph (A), the
Governor shall--
(i) select an agency that has
demonstrated experience and expertise
in--
(I) autism spectrum disorder
and other developmental
disability issues; and
(II) developing,
implementing, conducting, and
administering programs and
delivering education,
information, and referral
services (including technology-
based curriculum-development
services) to individuals with
developmental disabilities and
their family members,
guardians, advocates or
authorized representatives,
providers, and other
appropriate individuals locally
and across the State; and
(ii) consider input from individuals
with developmental disabilities and
their family members, guardians,
advocates or authorized
representatives, providers, and other
appropriate individuals.
(d) Tools.--
(1) In general.--To promote the use of valid and
reliable screening tools for autism spectrum disorder
and other developmental disabilities, the Secretary
shall develop a curriculum for continuing education to
assist individuals in recognizing the need for valid
and reliable screening tools and the use of such tools.
(2) Collection, storage, coordination, and
availability.--The Secretary, in collaboration with the
Secretary of Education, shall provide for the
collection, storage, coordination, and public
availability of tools described in paragraph (1),
educational materials and other products that are used
by the Federalprograms referred to in subsection
(c)(1)(A), as well as--
(A) programs authorized under the
Developmental Disabilities Assistance
and Bill of Rights Act of 2000;
(B) early intervention programs or
interagency coordinating council's
authorized under part C of the
Individuals with Disabilities Education
Act; and
(C) children with special health care
needs programs authorized under title V
of the Social Security Act.
(3) Required sharing.--In establishing
mechanisms and entities under this subsection,
the Secretary, and the Secretary of Education,
shall ensure the sharing of tools, materials,
and products developed under this subsection
among entities receiving funding under this
section.
(e) Diagnosis.--
(1) Training.--The Secretary, in coordination with
activities conducted under title V of the Social
Security Act, shall, subject to the availability of
appropriations, expand existing interdisciplinary
training opportunities or opportunities to increase the
number of sites able to diagnose or rule out
individuals with autism spectrum disorder or other
developmental disabilities and ensure that--
(A) competitive grants or cooperative
agreements are awarded to public or non-profit
agencies, including institutions of higher
education, to expanding existing or develop new
maternal and child health interdisciplinary
leadership education in neurodevelopmental and
related disabilities programs (similar to the
programs developed under section 501(a)(2) of
the Social Security Act) in States that do not
have such a program;
(B) trainees under such training programs--
(i) receive an appropriate balance of
academic, clinical, and community
opportunities;
(ii) are culturally competent;
(iii) are ethnically diverse;
(iv) demonstrate a capacity to
evaluate, diagnose or rule out,
develop, and provide evidence-based
interventions to individuals with
autism spectrum disorder and other
developmental disabilities; and
(v) demonstrate an ability to use a
family-centered approach; and
(C) program sites provide culturally
competent services.
(2) Technical assistance.--The Secretary may award
one or more grants under this section to provide
technical assistance to the network of
interdisciplinary training programs.
(3) Best practices.--The Secretary shall promote
research into additional valid and reliable tools for
shortening the time required to confirm or rule out a
diagnosis of autism spectrum disorder or other
developmental disabilities and detecting individuals
with autism spectrum disorder or other developmental
disabilities at an earlier age.
(f) Intervention.--The Secretary shall promote research,
through grants or contracts, to determine the evidence-based
practices for interventions for individuals with autism
spectrum disorder or other developmental disabilities, develop
guidelines for those interventions, and disseminate information
related to such research and guidelines.
(g) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated, $32,000,000
for fiscal year 2007, $37,000,000 for fiscal year 2008,
$42,000,000 for fiscal year 2009, $47,000,000 for fiscal year
2010, and $52,000,000 for fiscal year 2011, of which--
(1) $5,000,000 shall be made available in each fiscal
year for activities described in subsection (c); and
(2) $3,000,000 shall be made available in fiscal year
2007, $6,000,000 in fiscal year 2008, $9,000,000 in
fiscal year 2009, $12,000,000 in fiscal year 2010, and
$15,000,000 in fiscal year 2011, for activities
described in subsection (f).
(h) Sunset.--This section shall not apply after September 30,
2011.
SEC. 399CC. INTERAGENCY AUTISM COORDINATING COMMITTEE.
(a) Establishment.--The Secretary shall establish a
committee, to be known as the ``Interagency Autism Coordinating
Committee'' (in this section referred to as the ``Committee''),
to coordinate all efforts within the Department of Health and
Human Services concerning autism spectrum disorder.
(b) Responsibilities.--In carrying out its duties under this
section, the Committee shall--
(1) make recommendations concerning the strategic
plan described in section 409C(a);
(2) develop and annually update advances in autism
spectrum disorder research related to causes, early
screening, diagnosis or rule out, intervention, and
access to services and supports for individuals with
autism spectrum disorder; and
(3) make recommendations to the Secretary regarding
the public participation in decisions relating to
autism spectrum disorder.
(c) Membership.--
(1) In general.--The Committee shall be composed of--
(A) the Director of the Centers for Disease
Control and Prevention;
(B) the Director of the National Institutes
of Health, and the Directors of such national
research institutes of the National Institutes
of Health as the Secretary determines
appropriate;
(C) the heads of such other agencies as the
Secretary determines appropriate;
(D) representatives of other Federal
Governmental agencies that serve individuals
with autism spectrum disorder such as the
Department of Education; and
(E) the additional members appointed under
paragraph (2).
(2) Additional members.--Not fewer than 6 members of
the Committee, or 1/3 of the total membership of the
Committee, whichever is greater, shall be composed of
non-federal public members to be appointed by the
Secretary, of which--
(A) at least one such member shall be an
individual with a diagnosis of autism spectrum
disorder;
(B) at least one such member shall be a
parent or legal guardian of an individual with
an autism spectrum disorder; and
(C) at least one such member shall be a
representative of leading research, advocacy,
and service organizations for individuals with
autism spectrum disorder.
(d) Administrative Support; Terms of Service; Other
Provisions.--The following provisions shall apply with respect
to the Committee:
(1) The Committee shall receive necessary and
appropriate administrative support from the Secretary.
(2) Members of the Committee appointed under
subsection (c)(2) shall serve for a term of 4 years,
and may be reappointed for one or more additional 4
year term. Any member appointed to fill a vacancy for
an unexpired term shall be appointed for the remainder
of such term. A member may serve after the expiration
of the member's term until a successor has taken
office.
(3) The Committee shall meet at the call of the
chairperson or upon the request of the Secretary. The
Committee shall meet not fewer than 2 times each year.
(4) All meetings of the Committee shall be public and
shall include appropriate time periods for questions
and presentations by the public.
(e) Compensation and Expenses.--Members of the Committee who
are officers or employees of the Federal Government shall serve
as members of the Committee without compensation in addition to
that received in their regular government employment. Other
members of the Committee shall receive compensation at rates
not to exceed the daily equivalent of the annual rate in effect
for grade GS-18 of the General Schedule for each day (including
travel time) they are engaged in the performance of their
duties as members of the Committee.
(f) Subcommittees; Establishment and Membership.--In carrying
out its functions, the Committee may establish subcommittees
and convene workshops and conferences. Such subcommittees shall
be composed of Committee members and may hold such meetings as
are necessary to enable the subcommittees to carry out their
duties.
(g) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated, such sums as
may be necessary for each of fiscal years 2007 through 2011.
(h) Sunset.--This section shall not apply after September 30,
2011 and the Committee shall be terminated on such date.
SEC. 399DD. REPORT TO CONGRESS.
(a) In General.--Not later than 4 years after the date of
enactment of the Combating Autism Act of 2006, the Secretary,
in coordination with the Secretary of Education, shall prepare
and submit to the Health, Education, Labor, and Pensions
Committee of the Senate and the Energy and Commerce Committee
of the House of Representatives a progress report on activities
related to autism spectrum disorder and other developmental
disabilities.
(b) Contents.--The report submitted under subsection (a)
shall contain--
(1) a description of the progress made in
implementing the provisions of the Combating Autism Act
of 2006;
(2) a description of the amounts expended on the
implementation of the particular provisions of
Combating Autism Act of 2006;
(3) information on the incidence of autism spectrum
disorder and trend data of such incidence since the
date of enactment of the Combating Autism Act of 2006;
(4) information on the average age of diagnosis for
children with autism spectrum disorder and other
disabilities, including how that age may have changed
over the 4-year period beginning on the date of
enactment of this Act;
(5) information on the average age for intervention
for individuals diagnosed with autism spectrum disorder
and other developmental disabilities, including how
that age may have changed over the 4-year period
beginning on the date of enactment of this Act;
(6) information on the average time between initial
screening and then diagnosis or rule out for
individuals with autism spectrum disorder or other
developmental disabilities, as well as information on
the average time between diagnosis and evidence-based
intervention for individuals with autism spectrum
disorder or other developmental disabilities;
(7) information on the effectiveness and outcomes of
interventions for individuals diagnosed with autism
spectrum disorder, including by various subtypes, and
other developmental disabilities and how the age of the
child may affect such effectiveness;
(8) information on the effectiveness and outcomes of
innovative and newly developed intervention strategies
for individuals with autism spectrum disorder or other
developmental disabilities; and
(9) information on services and supports provided to
individuals with autism spectrum disorder and other
developmental disabilities who have reached the age of
majority (as defined for purposes of section 615(m) of
the Individuals with Disabilities Education Act (20
U.S.C. 1415(m)).
* * * * * * *
EXPANSION, INTENSIFICATION, AND COORDINATION OF ACTIVITIES OF NATIONAL
INSTITUTES OF HEALTH WITH RESPECT TO RESEARCH ON AUTISM
[Sec. 409C. [284g] (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; collaboration among
agencies.--The Director shall carry out this section
acting through the Director of the National Institute
of Mental Health and in collaboration with any other
agencies that the Director determines appropriate.
[(b) Centers of Excellence.--
[(1) In general.--The Director shall under subsection
(a)(1) make awards of grants and contracts to public or
non-profit private entities to pay all or part of the
cost of planning, establishing, improving, and
providing basic operating support for centers of
excellence regarding research on autism.
[(2) Research.--Each center under paragraph (1) shall
conduct basic and clinical research into autism. Such
research should include investigations into the cause,
diagnosis, early detection, prevention, control, and
treatment of autism. The centers, as a group, shall
conduct research including he fields of developmental
neurobiology, genetics, and psychopharmacology.
[(3) Services for patients.--
[(A) In general.--A center under paragraph
(1) may expend amounts provided under such
paragraph to carry out a program to make
individuals aware of opportunities to
participate as subjects in research conducted
by the centers.
[(B) Referrals and costs.--A program under
subparagraph (A) may, in accordance with such
criteria as the Director may establish, provide
to the subjects described in such subparagraph,
referrals for health and other services, and
such patient care costs as are required for
research.
[(C) Availability and access.--The extent to
which a center can demonstrate availability and
access to clinical services shall be considered
by the Director in decisions about awarding
grants to applicants which meet the scientific
criteria for funding under this section.
[(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 center 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 support.--
[(A) In general.--The Director shall provide
for the establishment of not less than five
centers under paragraph (1).
[(B) Duration.--Support for a center
established under paragraph (1) may be provided
under this section for a period of not to
exceed 5 years. Such period may be extended for
one or more additional periods not exceeding 5
years if the operations of such center have
been reviewed by an appropriate technical and
scientific peer review group established by the
Director and if such group has recommended to
the Director that such period should be
extended.
[(c) 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, preserved, and made available
for such research. The program shall be carried out in
accordance with accepted scientific and medical standards for
the donation, collection, and preservation of such samples.
[(d) Public Input.--The Director shall under subsection
(a)(1) provide for means through which the public can obtain
information on the existing and planned programs 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 programs and activities.
[(e) Funding.--There are authorized to be appropriated such
sums as may be necessary to carry out this section. Amounts
appropriated under this subsection are in addition to any other
amounts appropriated for such purpose.]
SEC. 409C. AUTHORITY OF THE DIRECTOR OF THE NATIONAL INSTITUTES OF
HEALTH RELATING TO AUTISM.
(a) Strategic Plan for Autism Research.--
(1) In general.--The Secretary, acting through the
Director, shall develop and implement a strategic plan
for the conduct and support of research related to
autism spectrum disorder.
(2) Requirements.--The strategic plan developed under
paragraph (1)--
(A) shall--
(i) be updated annually;
(ii) take into account the research
recommendations of the Interagency
Autism Coordinating Committee under
section 399CC; and
(iii) using professional judgment,
outline the proposed budgetary
requirements of the strategic plan,
including specific funding expectations
for continued multi-year program
activities, as well as new and
complementary program activities,
subject to the availability of
appropriations; and
(B) may include investigator-initiated
research.
(3) Report.--Not later than April 1, 2008, and
annually thereafter, the Secretary, acting through the
Director, shall prepare and submit to the appropriate
committees of Congress a report that contains--
(A) the strategic plan under paragraph (1)
that will be applicable to the upcoming fiscal
year; and
(B) a description of the actual dollar
expenditures for autism spectrum disorder
during the previous fiscal year.
(b) Expansion, Intensification, and Coordination of
Activities.--The Secretary, acting through the Director, shall,
subject to the availability of appropriations, expand,
intensify, and coordinate the activities of the National
Institutes of Health with respect to autism spectrum disorder.
(c) Centers of Excellence.--
(1) Autism centers of excellence.--
(A) In general.--The Secretary, acting
through the Director, shall, subject to the
availability of appropriations, award grants or
contracts to public or nonprofit private
entities to assist such entities in paying all
or part of the costs of planning, establishing,
improving, and providing basic operating
support for centers of excellence concerning
research on autism spectrum disorder.
(B) Research activities.--A center of
excellence that receives funding under this
paragraph shall conduct basic and clinical
research into autism spectrum disorder. Such
research shall--
(i) be conducted in the fields of
developmental neurobiology, genetics,
epigenetics, pharmacology, nutrition,
immunology, neuroimmunology,
neurobehavioral development,
endocrinology, gastroenterology,
psychopharmacology, or toxicology; and
(ii) include investigations into the
causation, diagnosis or rule out, early
detection, prevention, services,
supports, or intervention of autism
spectrum disorder.
(C) Services.--
(i) In general.--A center of
excellence that receives funding under
this paragraph may expend amounts
provided under a grant or contract
under such paragraph to carry out a
program to make individuals aware of
opportunities to participate as
subjects in research conducted by the
center.
(ii) Referrals and costs.--A program
carried out under clause (i) may, in
accordance with such criteria as the
Director may establish, provide to the
subjects described in such clause,
referrals for health and other services
and reimbursement of care for
individuals as are required for such
research.
(iii) Availability and access.--The
extent to which a center of excellence
that receives funding under this
paragraph can demonstrate the
availability of and access to clinical
services shall be considered by the
Director in making decisions concerning
the awarding of grants or contracts to
applicants that meet the scientific
criteria for funding under this
section.
(D) Coordination of centers of excellence.--
The Director shall provide for the appropriate
coordination of information among centers of
excellence that receive funding under this
paragraph and ensure regular communication
between such centers.
(E) Organization.--A center of excellence
that receives funding under this paragraph
shall use the facilities of a single
institution, or be formed through a consortium
of cooperating institutions, that meets such
requirements as may be required by the
Director.
(F) Duration.--The term of a grant or
contract awarded under this paragraph shall not
exceed a period of 5 years. Such period may be
extended for 1 or more additional periods not
exceeding 5 years if the operations of the
center of excellence involved have been
reviewed by an appropriate technical and
scientific peer review group established by the
Director and the group has recommended to the
Director the extension of such period.
(G) Geographic diversity.--The Director shall
consider geographic diversity in awarding
centers of excellence.
(2) Centers of excellence in environmental health and
autism.--
(A) In general.--The Director shall, subject
to the availability of appropriations, award
grants or contracts to public or nonprofit
private entities to pay all or part of the cost
of planning, establishing, improving, and
providing basic operating support for centers
of excellence regarding environmental health
and autism spectrum disorder.
(B) Research.--A center of excellence
established under this paragraph shall conduct
basic and clinical research of a broad array of
environmental factors that may have a possible
role in autism spectrum disorder.
(C) Coordination and organization.--The
Secretary, acting through the Director of NIH,
shall apply to the centers under this paragraph
the same requirements concerning coordination,
reporting, and organization as the requirements
applied to the centers of excellence under
subparagraphs (D), (E), (F), and (G) of
paragraph (1).
(d) Collection and Storage of Data.--
(1) In general.--The Secretary, acting though the
Director and in coordination with the Director of the
Centers for Disease Control and Prevention, shall,
subject to the availability of appropriations,
establish and provide funding for mechanisms and
entities that provide for the collection, storage,
coordination, and public availability of data that is
collected by the centers of excellence under this
section, under section 399AA(b), and under section
409C(c) and, to the extent possible, data generated
from public and private research partnerships. In
establishing such mechanisms and entities, the
Secretary--
(A) shall ensure that there is data sharing
among autism spectrum disorder researchers; and
(B) may utilize existing facilities.
(2) Facilitation of research.--
(A) Establishment of program.--The Secretary
shall establish a program under which samples
of tissues and genetic and other biological
materials that are of use in research on autism
spectrum disorder are donated, collected,
preserved, and made available for such
research.
(B) Accepted scientific standards.--The
program established under paragraph (1) shall
be--
(i) carried out in accordance with
accepted scientific and medical
standards for the donation, collection,
and preservation of such samples; and
(ii) conducted so that the tissues
and other materials saved, as well as
any database compiled from such tissues
and materials, are available to
researchers at a reasonable cost and on
an expedited basis.
(e) Consolidation.--The Secretary, acting through the
Director, may consolidate program activities under this section
if such consolidation would improve program efficiencies and
outcomes.
(f) Authorization of Appropriations.--
(1) In general.--There is authorized to be
appropriated--
(A) $68,000,000 for fiscal year 2007,
$82,000,000 for fiscal year 2008, $96,000,000
for fiscal year 2009, $120,000,000 for fiscal
year 2010, and $134,000,000 for fiscal year
2011, to carry out subsections (a), (b), and
(d);
(B) $26,000,000 for fiscal year 2007,
$32,500,000 for fiscal year 2008, $39,000,000
for fiscal year 2009, $45,500,000 for fiscal
year 2010, and $52,000,000 for fiscal year
2011, to carry out subsection (c)(1); and
(C) $6,000,000 for fiscal year 2007,
$7,500,000 for fiscal year 2008, $9,000,000 for
fiscal year 2009, $10,500,000 for fiscal year
2010, and $12,000,000 for fiscal year 2011, to
carry out subsection (c)(2).
(2) General usage.--Of the amounts appropriated under
subparagraphs (B) and (C) of paragraph (1), not to
exceed 5 percent of such amounts may be utilized by the
National Institutes of Health for administrative and
other expenses.
(g) Sunset.--This section shall not apply after September 30,
2011.
* * * * * * *
