[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 1762 Introduced in Senate (IS)]
111th CONGRESS
1st Session
S. 1762
To amend the Public Health Service Act to expand and intensify programs
of the National Institutes of Health and the Centers for Disease
Control and Prevention with respect to translational research and
related activities concerning Down syndrome, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
October 7, 2009
Mr. Brownback (for himself and Mr. Brown) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to expand and intensify programs
of the National Institutes of Health and the Centers for Disease
Control and Prevention with respect to translational research and
related activities concerning Down syndrome, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Trisomy 21 Translational Research
Parity Act of 2009'' or the ``21 Act''.
SEC. 2. FINDINGS.
The Congress makes the following findings:
(1) Down syndrome was named after John Langdon Down, the
first physician to identify the syndrome.
(2) Down syndrome is the most frequent genetic cause of
mild to moderate intellectual disabilities (mental retardation)
and associated medical problems and occurs in one out of 733
live births, in all races and economic groups. Intellectual
disability is a disability characterized by significant
limitations both in intellectual functioning and in adaptive
behavior, which covers many everyday social and practical
skills. This disability originates before the age of 18.
(3) Down syndrome is a chromosomal condition caused by an
error in cell or chromosome division that usually results in
the presence of an additional third chromosome 21 or ``trisomy
21''. Three other forms of Down syndrome exist: translocation
Down syndrome (where cells have two copies of chromosome 21 and
a third hybrid copy of chromosome 21 and another chromosome),
mosaic Down syndrome (where some but not all, cells have three
copies of chromosome 21), and segmental trisomy Down syndrome
(where cells have an extra copy of a part of chromosome 21
either added to an otherwise normal 21 or as a hybrid copy of a
part of chromosome 21 and another chromosome).
(4) There are more than 400,000 people living with Down
syndrome in the United States.
(5) Down syndrome incidence increases with the age of the
mother, but due to higher fertility rates in younger women, the
majority of children with Down syndrome are born to women under
35 years of age.
(6) Life expectancy for people with Down syndrome has
increased dramatically in recent decades, but varies
significantly across various ethnic groups. People with Down
syndrome attend school, work, participate in decisions that
concern them, and contribute to society in many meaningful
ways.
(7) The Children's Health Act of 2000 (Public Law 106-310)
amended the Public Health Service Act (42 U.S.C. 201 et seq.)
and included a number of provisions that addressed the research
and surveillance needs of many disabilities such as autism,
traumatic brain injury, Fragile X, juvenile diabetes, asthma,
epilepsy, and others. However, this landmark legislation did
not address the significant research, surveillance, and
clinical care needs of Down syndrome and thus has been an
impediment to progress in the Down syndrome research community
over the last decade. This Act attempts to incorporate Down
syndrome as an area of permissible research and surveillance at
the National Institutes of Health and the Centers for Disease
Control and Prevention and will foster a better understanding
of Down syndrome.
SEC. 3. NIH DOWN SYNDROME TRANSLATIONAL RESEARCH AND SERVICE
DEVELOPMENT ACTIVITIES.
Part B of title IV of the Public Health Service Act (42 U.S.C. 284
et seq.) is amended by adding at the end the following:
``SEC. 409J. DOWN SYNDROME TRANSLATIONAL RESEARCH AND SERVICE
DEVELOPMENT ACTIVITIES.
``(a) Expansion, Intensification, and Coordination of Activities.--
``(1) In general.--The Director of NIH, in coordination
with the directors of the National Institute of Child Health
and Human Development, the National Heart, Lung, and Blood
Institute, the National Institute of Allergy and Infectious
Diseases, the National Institute of Neurological Disorders and
Stroke, the National Cancer Institute, the National Institute
on Aging, the National Institute of Mental Health, and the
other national research institutes as appropriate, shall expand
and intensify programs of the National Institutes of Health
with respect to translational research and related activities
concerning Down syndrome.
``(2) Coordination.--The directors referred to in paragraph
(1) shall jointly coordinate the programs referred to in such
paragraph and consult with the Down Syndrome Coordinating
Committee established under subsection (d).
``(3) Allocations by director of nih.--The Director of NIH
shall allocate the amounts appropriated to carry out this
section for each fiscal year among the national research
institutes referred to in paragraph (1).
``(b) Centers of Excellence.--
``(1) In general.--The Director of NIH shall award grants
and contracts under subsection (a)(1) 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 translational research on
Down syndrome. To the extent and in the amount of
appropriations made in advance, the Director of NIH shall
provide for the establishment of at least 6 such centers of
excellence.
``(2) Translational research.--Each center under paragraph
(1) shall contribute to a comprehensive research portfolio for
Down syndrome building upon the recommendations set forth in
the NIH Research Plan on Down Syndrome published in October
2007, have a primary focus on Down syndrome, provide an optimal
venue and infrastructure for patient-oriented research, and
conduct basic, clinical, and translational research on Down
syndrome, including, but not limited to, research on the
following:
``(A) Early detection, diagnosis, and treatment of
Down syndrome.
``(B) The biological mechanisms responsible for
structural and functional anomalies in cells and
tissues affected by Down syndrome.
``(C) The biological mechanisms responsible for
cognitive and behavioral dysfunction resulting from
Down syndrome.
``(D) Novel biomedical and pharmacological
interventions designed to promote or enhance cognition
and related brain functions and activities of daily
living (ADLs).
``(E) Co-occurrence of and treatments for
associated medical and neurobehavioral disorders.
``(F) Developmental disorders, interventions for
congenital heart disease, obstructive sleep apnea,
coronary heart disease, obesity, and metabolism.
``(G) Contributions of genetic variation to
clinical presentation as targets for therapy.
``(H) Identification of biomarkers for complex
phenotypes.
``(I) Accessibility of health care, evidence-based
health practice research and support services, referral
patterns, and complications.
``(J) Noninvasive imaging in support of efforts to
other genotype and phenotypes of Down syndrome.
``(K) Pharmacological and other therapies for
common features of Down syndrome including Alzheimer
disease and other Down syndrome related disorders.
``(3) Services for patients.--
``(A) In general.--A center under paragraph (1)
shall 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) shall, 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.--In awarding grants
under this section, the Director of NIH shall require
the applicant to demonstrate, and shall take into
consideration, the availability of and access to health
and medical services described in subparagraph (B).
``(4) Training program for clinician and scientists.--Each
center under paragraph (1) shall establish or expand training
programs for medical and allied health clinicians and
scientists in research relevant to Down syndrome.
``(5) Coordination of centers; reports.--The Director of
NIH shall--
``(A) provide for the coordination of information
sharing among the centers under paragraph (1) and
ensure regular communication among such centers; and
``(B) require the centers to submit periodic
reports to the Director on their activities.
``(6) Organization of centers.--Each center under paragraph
(1) shall use the facilities of a single institution meeting
such requirements as may be prescribed by the Director of NIH,
be formed from a consortium or network of such institutions, or
both.
``(7) Duration of support.--
``(A) In general.--Subject to subparagraph (B), the
Director of NIH may not provide support to a center
established under paragraph (1) for a period of more
than 5 years.
``(B) Extension.--The period referred to in
subparagraph (A) may be extended for 1 or more
additional periods not exceeding 5 years if--
``(i) the operations of the center have
been reviewed by an appropriate technical and
scientific peer review group established by the
Director of NIH; and
``(ii) such group has recommended to the
Director that such period be extended.
``(c) Facilitation and Coordination of Research.--The Director of
NIH shall, in coordination of the National Down Syndrome Patient
Registry and Biobank established under section 317U, provide for a
program under subsection (a)(1) under which samples of tissues and
genetic materials that are of use in research on Down syndrome are
donated, collected, preserved, and made available for such research.
The program shall--
``(1) be carried out in accordance with accepted scientific
and medical standards for the donation, collection, and
preservation of such samples; and
``(2) be linked with the National Down Syndrome Patient
Registry and Biobank established under section 317U to allow
for systematic searches of information.
``(d) Coordinating Committee.--
``(1) In general.--The Secretary shall establish the Down
Syndrome Coordinating Committee (referred to in this section as
the `Coordinating Committee') to coordinate activities across
the National Institutes of Health and with other Federal health
programs and activities relating to Down syndrome.
``(2) Composition.--The Coordinating Committee shall
consist of not more than 15 members, of which--
``(A) \2/3\ of such members shall represent
governmental agencies, including--
``(i) the directors or their designees of
each of the national research institutes
involved in research with respect to Down
syndrome;
``(ii) representatives of all other Federal
departments and agencies whose programs involve
health functions or responsibilities relevant
to such diseases, including the Centers for
Disease Control and Prevention, the Health
Resources and Services Administration, and the
Food and Drug Administration; and
``(iii) representatives of other
governmental agencies that serve children and
adults with Down syndrome, such as the
Department of Education, the Department of
Labor, and the Department of Housing and Urban
Development; and
``(B) \1/3\ of such members shall be public
members, including a broad cross section of persons
with Down syndrome, parents or legal guardians of
persons with Down syndrome, researchers, and
clinicians.
``(3) Appointment; terms.--
``(A) In general.--The Secretary, in consultation
with Down syndrome stakeholder organizations, shall
appoint the members of the Coordinating Committee.
``(B) Public members.--Members of the Coordinating
Committee appointed under paragraph (2)(B) shall be
appointed for a term of 3 years, and may serve for an
unlimited number of terms if reappointed. At least two
such public members shall be persons who are actively
engaged in research or clinical practice on Down
syndrome. At least one such public member shall be a
person with Down syndrome, and an additional, non-
voting member, whose sole role shall be to support the
member with Down syndrome, shall be identified with
direct input from the member with Down syndrome.
``(4) Chair.--
``(A) Duties.--With respect to Down syndrome, the
Chair of the Coordinating Committee shall--
``(i) serve as the principal advisor to the
Secretary, the Assistant Secretary for Health,
and the Director of NIH; and
``(ii) provide advice to the Director of
the Centers for Disease Control and Prevention,
the Commissioner of Food and Drugs, and to the
heads of other relevant agencies.
``(B) Appointment; term.--The Chair of the
Coordinating Committee--
``(i) shall be selected by the Coordinating
Committee from among its members; and
``(ii) shall be selected to serve a term
not to exceed 2 years.
``(5) Administrative support.--The Secretary of Health and
Human Services shall provide, or arrange for an appropriate
office or agency of the Department of Health and Human Services
to provide, necessary and appropriate administrative support to
the Coordinating Committee.
``(6) Meetings.--The Coordinating Committee shall meet as
appropriate, as determined by the Secretary in consultation
with the Chair of the Coordinating Committee.
``(e) Plan for HHS Activities.--
``(1) In general.--Not later than 1 year after the date of
enactment of this section, the Coordinating Committee shall
develop a plan for conducting and supporting research and
education on Down syndrome through the national research
institutes and shall periodically review and revise the plan.
The plan shall--
``(A) provide for a broad range of research and
education activities relating to biomedical,
epidemiological, public perception, psychosocial, and
rehabilitative issues, including studies of the impact
of such conditions in rural and underserved
communities;
``(B) identify priorities among the programs and
activities of the National Institutes of Health
regarding such conditions; and
``(C) reflect input from a broad range of
scientists, patients, and advocacy groups.
``(2) Certain elements of plan.--The plan under paragraph
(1) shall, with respect to Down syndrome, provide for the
following as appropriate:
``(A) Basic research concerning the etiology and
genetic contributions to the potential causes and
consequences of the chromosomal disorder.
``(B) Basic and clinical research for the
development and evaluation of new treatments, including
new biological agents.
``(C) Specific programs for identifying potential
therapeutic agents and moving them into clinical trials
in a timely manner.
``(D) Research to determine the reasons underlying
the incidence and prevalence of various forms of Down
syndrome.
``(E) Information and education programs for health
care professionals and the public.
``(f) Reports to Congress.--The Coordinating Committee shall
biennially submit to the Committee on Energy and Commerce of the House
of Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate a report that describes the research, education,
and other activities on Down syndrome being conducted or supported
through the Department of Health and Human Services. Each such report
shall include the following:
``(1) The plan under subsection (e)(1) (or revisions to the
plan, as the case may be).
``(2) Provisions specifying the amounts expended by the
Department of Health and Human Services with respect to Down
syndrome.
``(3) Provisions identifying particular projects or types
of projects that should in the future be considered by the
national research institutes or other entities in the field of
research on Down syndrome.
``(g) Public Input.--The Secretary shall, under subsection (a)(1),
provide for a means through which the public can obtain information on
the existing and planned programs and activities of the Department of
Health and Human Services with respect to Down syndrome and through
which the Secretary can receive comments from the public regarding such
programs and activities.
``(h) Definition.--The term `translational research' means
rigorous, evidence-based basic or clinical research with an emphasis on
accelerating the development and delivery of effective new therapies to
patients.
``(i) Authorization of Appropriations.--For the purpose of carrying
out this section, there are authorized to be appropriated such sums as
may be necessary for each of fiscal years 2011 through 2015. The
authorization of appropriations established in the preceding sentence
is in addition to any other authorization of appropriations that is
available for conducting or supporting through the National Institutes
of Health research and other activities with respect to Down
syndrome.''.
SEC. 4. CDC DOWN SYNDROME SURVEILLANCE AND RESEARCH PROGRAMS.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended by inserting after section 317T the following:
``SEC. 317U. DOWN SYNDROME SURVEILLANCE AND RESEARCH PROGRAMS.
``(a) In General.--The Secretary, acting through the Director of
the Centers for Disease Control and Prevention, may award grants and
cooperative agreements to public or nonprofit private entities
(including State health departments, political subdivisions of States,
universities, and other educational entities) for the collection,
analysis, and reporting of data on Down syndrome. In making such
awards, the Secretary may provide direct technical assistance,
including personnel support, in lieu of cash.
``(b) National Down Syndrome Epidemiology Program.--
``(1) Grants.--The Secretary, acting through the Director
of the Centers for Disease Control and Prevention, may award
grants to public or nonprofit private entities (including State
health departments, political subdivisions of States,
universities, and other educational entities) for the purpose
of carrying out epidemiological activities regarding Down
syndrome, including collecting and analyzing information on the
number, incidence, correlates, and symptoms of cases and the
clinical utility (including costs and benefits) of specific
practice patterns. In making such awards, the Secretary may
provide direct technical assistance, including personnel
support, in lieu of cash.
``(2) National surveillance program.--In carrying out
subsection (a), the Secretary shall--
``(A) provide for a national surveillance program;
and
``(B) where possible, ensure that the surveillance
program is coordinated with the data and sample
collection activities of the National Down Syndrome
Patient Registry and Biobank.
``(c) National Down Syndrome Patient Registry and Biobank.--
``(1) In general.--The Secretary, acting through the
Director of the Centers for Disease Control and Prevention and
in collaboration with an eligible national organization and
patient advocacy organization, shall establish a National Down
Syndrome Patient Registry and Biobank.
``(2) Requirements.--The National Down Syndrome Patient
Registry and Biobank--
``(A) shall be used, building upon the multi-
disease bank of brain and other tissue of the National
Institute of Child Health and Human Development--
``(i) to establish a centralized or
distributed brain, cell, tissue, DNA, and RNA
bank;
``(ii) to well-characterize a cohort of
patients for genotype-phenotype investigations
to inter-operate with the bank; and
``(iii) to correlate the nature and
severity of cognitive deficits and age of onset
and severity of dementia;
``(B) shall be used as a resource to prepare
therapies and treatments for clinical trials of ongoing
treatments for individuals with Down syndrome,
including the encouragement to include participants
with Down syndrome in National Institutes of Health-
funded clinical trials; and
``(C) shall include the collection and analysis of
longitudinal data related to individuals of all ages
with Down syndrome, including infants, young children,
adolescents, and adults of all ages including older
Americans.
``(d) Centers of Excellence.--
``(1) Cooperative agreements.--In carrying out this
section, the Secretary shall enter into cooperative agreements
with an eligible national organization, a patient advocacy
organization, and appropriate academic health institutions to
develop, implement, and manage Down Syndrome Centers of
Excellence for the purpose of--
``(A) providing clinical care for patients with
Down syndrome;
``(B) coordinating research and clinical activities
with the activities of the National Down Syndrome
Registry and Biobank; and
``(C) participating in a system for Down syndrome
patient data collection and analysis, including the
creation and use of a common data entry and management
system.
``(2) Eligible national organization.--In this subsection,
the term `eligible national organization' means a national
organization that--
``(A) has expertise in the epidemiology of Down
syndrome; and
``(B) has the capacity to maintain a patient
registry or Biobank.
``(e) Advisory Committee.--
``(1) Establishment.--Not later than 90 days after the date
of the enactment of this section, the Secretary, acting through
the Director of the Centers for Disease Control and Prevention,
shall establish a committee to be known as the Advisory
Committee on the National Down Syndrome Registry and Biobank
(referred to in this section as the `Advisory Committee').
``(2) Membership.--The Advisory Committee shall be composed
of at least one member, to be appointed by the Secretary,
acting through the Director of the Centers for Disease Control
and Prevention, representing each of the following:
``(A) National voluntary health associations that
focus solely on Down syndrome and have demonstrated
experience in Down syndrome research, care, and patient
services.
``(B) The National Institutes of Health, to
include, upon the recommendation of the Director of the
National Institutes of Health, representatives from the
Directors of the National Institute of Child Health and
Human Development, National Heart, Lung, and Blood
Institute, National Institute of Allergy and Infectious
Diseases, National Institute of Neurological Disorders
and Stroke, National Cancer Institute, National
Institute on Aging, and National Institute of Mental
Health.
``(C) The Agency for Toxic Substances and Disease
Registry.
``(D) The Centers for Disease Control and
Prevention.
``(E) Down Syndrome Centers of Excellence developed
under subsection (d).
``(F) Individuals with Down syndrome and, for the
sole purpose of supporting such individuals, their
family members.
``(G) Clinicians with expertise on Down syndrome.
``(H) Epidemiologists with experience in data
registries.
``(I) Geneticists or experts in genetics who have
experience with the genetics of Down syndrome.
``(J) Statisticians.
``(K) Ethicists.
``(L) Attorneys.
``(M) Researchers with expertise on Down syndrome.
``(N) Research scientists with experience
conducting translational research or creating systems
that support translating basic discoveries into
treatments.
``(O) Experts in additional neurological diseases,
as appropriate, based on development and implementation
of national surveillance systems for other neurological
diseases and disorders.
``(P) Other individuals with an interest in
developing and maintaining the National Down Syndrome
Registry and Biobank.
For purposes of this paragraph, the Secretary may appoint a
member to represent more than one category described in
subparagraphs (A) through (P).
``(3) Duties.--The Advisory Committee shall review and make
recommendations to the Secretary concerning--
``(A) the establishment, operation, and maintenance
of the National Down Syndrome Registry and Biobank;
``(B) the type of information to be collected and
stored in the Registry and Biobank;
``(C) the manner in which such data is to be
collected; and
``(D) the use and availability of such data
including guidelines for such use.
``(4) Administrative support.--The Director of the Centers
for Disease Control and Prevention shall provide administrative
support that is necessary and appropriate, as determined by the
Director, to the Advisory Committee.
``(5) Meetings.--The Advisory Committee shall meet as
appropriate, as determined by the Director of the Centers for
Disease Control and Prevention.
``(6) Report.--Not later than 2 years after the date on
which the Advisory Committee is established, the Advisory
Committee shall submit a report concerning the review conducted
under paragraph (3) that contains the recommendations of the
Advisory Committee with respect to the results of such review.
``(f) Coordination With Centers of Excellence.--The Secretary shall
ensure that epidemiological and registry information under subsections
(a), (b), (c), and (d) are made available to centers of excellence
supported under section 409C(b) by the Director of NIH.
``(g) Definition.--The term `translational research' means
rigorous, evidence-based basic or clinical research with an emphasis on
accelerating the development and delivery of effective new therapies to
patients.
``(h) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $3,000,000 for fiscal year 2010
and $500,000 for each of fiscal years 2011 through 2015.''.
SEC. 5. REPORT TO CONGRESS.
Not later than January 1, 2011, and each January 1 thereafter, the
Secretary of Health and Human Services shall prepare and submit to the
appropriate committees of Congress a report concerning the
implementation of this Act and the amendments made by this Act.
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