[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[S. 621 Introduced in Senate (IS)]

111th CONGRESS
  1st Session
                                 S. 621

To amend the Public Health Service Act to coordinate Federal congenital 
  heart disease research efforts and to improve public education and 
     awareness of congenital heart disease, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 17, 2009

Mr. Durbin (for himself and Mr. Cochran) 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 coordinate Federal congenital 
  heart disease research efforts and to improve public education and 
     awareness of congenital heart disease, 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 ``Congenital Heart Futures Act''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Congenital heart defects are the most common and most 
        deadly group of birth defects and affect nearly 1 percent of 
        all live births, approximately 36,000 births a year. A child is 
        born with a congenital heart defect every 15 minutes.
            (2) Congenital heart disease is a rapidly growing national 
        health problem. Childhood survival has risen from below 20 
        percent in 1950 to more than 90 percent today. Due to the 
        increase in childhood survival, the congenital heart disease 
        population increases by an estimated 5 percent every year.
            (3) Approximately 800,000 children and 1,000,000 adults in 
        the United States are now living with congenital heart disease 
        and require highly specialized life-long cardiac care.
            (4) There is no cure for congenital heart disease. Even 
        survivors of successful childhood treatment can face life-long 
        risks from congenital heart disease, including heart failure, 
        rhythmic disorders, stroke, renal dysfunction, and 
        neurocognitive dysfunction.
            (5) Less than 10 percent of adults living with complex 
        congenital heart disease currently receive recommended cardiac 
        care. Many individuals with congenital heart disease are 
        unaware that they require life-long specialized health 
        surveillance. Delays in care can result in premature death and 
        disability.
            (6) The estimated life expectancy for those with congenital 
        heart disease is significantly lower than for the general 
        population. The life expectancy for those born with moderately 
        complex heart defects is 55, while the estimated life 
        expectancy for those born with highly complex defects is 
        between 35 and 40.
            (7) Despite the prevalence and seriousness of the disease, 
        Federal research, data collection, education, and awareness 
        activities are limited.
            (8) The strategic plan of the National Heart, Lung, and 
        Blood Institute completed in 2007 notes that ``successes over 
        several decades have enabled people with congenital heart 
        diseases to live beyond childhood, but too often inadequate 
        data are available to guide their treatment as adults''.
            (9) The strategic plan for the Division of Cardiovascular 
        Diseases at the National Heart, Lung and Blood Institute, 
        completed in 2008, set goals for congenital heart disease 
        research, including understanding the development and genetic 
        basis of congenital heart disease, improving evidence-based 
        care and treatment of children with congenital and acquired 
        pediatric heart disease, and improving evidence-based care and 
        treatment of adults with congenital heart disease.

SEC. 3. PUBLIC EDUCATION AND AWARENESS OF CONGENITAL HEART DISEASE.

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) 
is amended by adding at the end the following:

        ``PART S--PROGRAMS RELATING TO CONGENITAL HEART DISEASE

``SEC. 399HH. PUBLIC EDUCATION AND AWARENESS OF CONGENITAL HEART 
              DISEASE.

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention and in collaboration 
with appropriate congenital heart disease patient organizations and 
professional organizations, may directly or through grants, cooperative 
agreements, or contracts to eligible entities conduct, support, and 
promote a comprehensive public education and awareness campaign to 
increase public and medical community awareness regarding congenital 
heart disease, including the need for life-long treatment of congenital 
heart disease survivors.
    ``(b) Eligibility for Grants.--To be eligible to receive a grant, 
cooperative agreement, or contract under this section, an entity shall 
be a State or private nonprofit entity and shall submit to the 
Secretary an application at such time, in such manner, and containing 
such information as the Secretary may require.''.

SEC. 4. NATIONAL CONGENITAL HEART DISEASE REGISTRY.

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.), 
as amended by section 3, is further amended by adding at the end the 
following:

``SEC. 399II. NATIONAL CONGENITAL HEART DISEASE REGISTRY.

    ``(a) In General.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, may--
            ``(1) enhance and expand infrastructure to track the 
        epidemiology of congenital heart disease and to organize such 
        information into a comprehensive, nationwide registry of actual 
        occurrences of congenital heart disease, to be known as the 
        `National Congenital Heart Disease Registry'; or
            ``(2) award a grant to one eligible entity to undertake the 
        activities described in paragraph (1).
    ``(b) Purpose.--The purpose of the Congenital Heart Disease 
Registry shall be to facilitate further research into the types of 
health services patients use and to identify possible areas for 
educational outreach and prevention in accordance with standard 
practices of the Centers for Disease Control and Prevention.
    ``(c) Content.--The Congenital Heart Disease Registry--
            ``(1) may include information concerning the incidence and 
        prevalence of congenital heart disease in the United States;
            ``(2) may be used to collect and store data on congenital 
        heart disease, including data concerning--
                    ``(A) demographic factors associated with 
                congenital heart disease, such as age, race, ethnicity, 
                sex, and family history of individuals who are 
                diagnosed with the disease;
                    ``(B) risk factors associated with the disease;
                    ``(C) causation of the disease;
                    ``(D) treatment approaches; and
                    ``(E) outcome measures, such that analysis of the 
                outcome measures will allow derivation of evidence-
                based best practices and guidelines for congenital 
                heart disease patients; and
            ``(3) may ensure the collection and analysis of 
        longitudinal data related to individuals of all ages with 
        congenital heart disease, including infants, young children, 
        adolescents, and adults of all ages, including the elderly.
    ``(d) Coordination With Federal, State, and Local Registries.--In 
establishing the National Congenital Heart Registry, the Secretary may 
identify, build upon, expand, and coordinate among existing data and 
surveillance systems, surveys, registries, and other Federal public 
health infrastructure, including--
            ``(1) State birth defects surveillance systems;
            ``(2) the State birth defects tracking systems of the 
        Centers for Disease Control and Prevention;
            ``(3) the Metropolitan Atlanta Congenital Defects Program; 
        and
            ``(4) the National Birth Defects Prevention Network.
    ``(e) Public Access.--The Congenital Heart Disease Registry shall 
be made available to the public, including congenital heart disease 
researchers.
    ``(f) Patient Privacy.--The Secretary shall ensure that the 
Congenital Heart Disease Registry is maintained in a manner that 
complies with the regulations promulgated under section 264 of the 
Health Insurance Portability and Accountability Act of 1996.
    ``(g) Eligibility for Grant.--To be eligible to receive a grant 
under subsection (a)(2), an entity shall--
            ``(1) be a public or private nonprofit entity with 
        specialized experience in congenital heart disease; and
            ``(2) submit to the Secretary an application at such time, 
        in such manner, and containing such information as the 
        Secretary may require.''.

SEC. 5. ADVISORY COMMITTEE ON CONGENITAL HEART DISEASE.

    Title III of the Public Health Service Act (42 U.S.C. 241 et seq.), 
as amended by section 4, is further amended by adding at the end the 
following:

``SEC. 399JJ. ADVISORY COMMITTEE ON CONGENITAL HEART DISEASE.

    ``(a) Establishment.--The Secretary, acting through the Director of 
the Centers for Disease Control and Prevention, may establish an 
advisory committee, to be known as the `Advisory Committee on 
Congenital Heart Disease' (referred to in this section as the `Advisory 
Committee').
    ``(b) Membership.--The members of the Advisory Committee may be 
appointed by the Secretary, acting through the Centers for Disease 
Control and Prevention, and shall include--
            ``(1) at least one representative from--
                    ``(A) the National Institutes of Health;
                    ``(B) the Centers for Disease Control and 
                Prevention; and
                    ``(C) a national patient advocacy organization with 
                experience advocating on behalf of patients living with 
                congenital heart disease;
            ``(2) at least one epidemiologist who has experience 
        working with data registries;
            ``(3) clinicians, including--
                    ``(A) at least one with experience diagnosing or 
                treating congenital heart disease; and
                    ``(B) at least one with experience using medical 
                data registries; and
            ``(4) at least one publicly or privately funded researcher 
        with experience researching congenital heart disease.
    ``(c) Duties.--The Advisory Committee may review information and 
make recommendations to the Secretary concerning--
            ``(1) the development and maintenance of the National 
        Congenital Heart Disease Registry established under section 
        399II;
            ``(2) the type of data to be collected and stored in the 
        National Congenital Heart Disease Registry;
            ``(3) the manner in which such data is to be collected;
            ``(4) the use and availability of such data, including 
        guidelines for such use; and
            ``(5) other matters, as the Secretary determines to be 
        appropriate.
    ``(d) Report.--Not later than 180 days after the date on which the 
Advisory Committee is established and annually thereafter, the Advisory 
Committee shall submit a report to the Secretary concerning the 
information described in subsection (c), including recommendations with 
respect to the results of the Advisory Committee's review of such 
information.''.

SEC. 6. CONGENITAL HEART DISEASE RESEARCH.

    Subpart 2 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 285b et seq.) is amended by adding at the end the following:

``SEC. 425. CONGENITAL HEART DISEASE.

    ``(a) In General.--The Director of the Institute may expand, 
intensify, and coordinate research and related activities of the 
Institute with respect to congenital heart disease, which may include 
congenital heart disease research with respect to--
            ``(1) causation of congenital heart disease, including 
        genetic causes;
            ``(2) long-term outcomes in individuals with congenital 
        heart disease, including infants, children, teenagers, adults, 
        and elderly individuals;
            ``(3) diagnosis, treatment, and prevention;
            ``(4) studies using longitudinal data and retrospective 
        analysis to identify effective treatments and outcomes for 
        individuals with congenital heart disease; and
            ``(5) identifying barriers to life-long care for 
        individuals with congenital heart disease.
    ``(b) Coordination of Research Activities.--The Director of the 
Institute may coordinate research efforts related to congenital heart 
disease among multiple research institutions and may develop research 
networks.
    ``(c) Minority and Medically Underserved Communities.--In carrying 
out the activities described in this section, the Director of the 
Institute shall consider the application of such research and other 
activities to minority and medically underserved communities.''.

SEC. 7. AUTHORIZATION OF APPROPRIATIONS.

    There are authorized to be appropriated to carry out the amendments 
made by this Act such sums as may be necessary for each of fiscal years 
2010 through 2014.
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