I 

111TH CONGRESS 

1ST SESSION H. R. 1570 

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 HOUSE OF REPRESENTATIVES 

MARCH 17, 2009 

Mr. SPACE (for himself and Mr. BILIRAKIS) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Congenital Heart Fu5 tures Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 


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1 (1) Congenital heart defects are the most com2 mon and most deadly group of birth defects and af3 fect nearly 1 percent of all live births, approximately 

4 36,000 births a year. A child is born with a con5 genital heart defect every 15 minutes. 

6 (2) Congenital heart disease is a rapidly grow7 ing national health problem. Childhood survival has 

8 risen from below 20 percent in 1950 to more than 

9 90 percent today. Due to the increase in childhood 

10 survival, the congenital heart disease population in11 creases by an estimated 5 percent every year. 

12 (3) Approximately 800,000 children and 

13 1,000,000 adults in the United States are now living 

14 with congenital heart disease and require highly spe15 cialized life-long cardiac care. 

16 (4) There is no cure for congenital heart dis17 ease. Even survivors of successful childhood treat18 ment can face life-long risks from congenital heart 

19 disease, including heart failure, rhythmic disorders, 

20 stroke, renal dysfunction, and neurocognitive dys21 function. 

22 (5) Less than 10 percent of adults living with 

23 complex congenital heart disease currently receive 

24 recommended cardiac care. Many individuals with 

25 congenital heart disease are unaware that they reVerDate Nov 24 2008 01:23 Mar 19, 2009 Jkt 079200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1570.IH H1570

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1 quire life-long specialized health surveillance. Delays 

2 in care can result in premature death and disability. 

3 (6) The estimated life expectancy for those with 

4 congenital heart disease is significantly lower than 

5 for the general population. The life expectancy for 

6 those born with moderately complex heart defects is 

7 55, while the estimated life expectancy for those 

8 born with highly complex defects is between 35 and 

9 40. 

10 (7) Despite the prevalence and seriousness of 

11 the disease, Federal research, data collection, edu12 cation, and awareness activities are limited. 

13 (8) The strategic plan of the National Heart, 

14 Lung, and Blood Institute completed in 2007 notes 

15 that ‘‘successes over several decades have enabled 

16 people with congenital heart diseases to live beyond 

17 childhood, but too often inadequate data are avail18 able to guide their treatment as adults’’. 

19 (9) The strategic plan for the Division of Car20 diovascular Diseases at the National Heart, Lung, 

21 and Blood Institute, completed in 2008, set goals for 

22 congenital heart disease research, including under23 standing the development and genetic basis of con24 genital heart disease, improving evidence-based care 

25 and treatment of children with congenital and acVerDate Nov 24 2008 01:23 Mar 19, 2009 Jkt 079200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1570.IH H1570

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1 quired pediatric heart disease, and improving evi2 dence-based care and treatment of adults with con3 genital heart disease. 

4 SEC. 3. PUBLIC EDUCATION AND AWARENESS OF CON5 GENITAL HEART DISEASE. 

6 Title III of the Public Health Service Act (42 U.S.C. 

7 241 et seq.) is amended by adding at the end the fol8 lowing: 

9 ‘‘PART S—PROGRAMS RELATING TO CONGENITAL 

10 HEART DISEASE 

11 ‘‘SEC. 399HH. PUBLIC EDUCATION AND AWARENESS OF 

12 CONGENITAL HEART DISEASE. 

13 ‘‘(a) IN GENERAL.—The Secretary, acting through 

14 the Director of the Centers for Disease Control and Pre15 vention and in collaboration with appropriate congenital 

16 heart disease patient organizations and professional orga17 nizations, may, directly or through grants, cooperative 

18 agreements, or contracts to eligible entities, conduct, sup19 port, and promote a comprehensive public education and 

20 awareness campaign to increase public and medical com21 munity awareness regarding congenital heart disease, in22 cluding the need for life-long treatment of congenital heart 

23 disease survivors. 

24 ‘‘(b) ELIGIBILITY FOR GRANTS.—To be eligible to re25 ceive a grant, cooperative agreement, or contract under 


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1 this section, an entity shall be a State or private nonprofit 

2 entity and shall submit to the Secretary an application at 

3 such time, in such manner, and containing such informa4 tion as the Secretary may require.’’. 

5 SEC. 4. NATIONAL CONGENITAL HEART DISEASE REGISTRY. 

6 Title III of the Public Health Service Act (42 U.S.C. 

7 241 et seq.), as amended by section 3, is further amended 

8 by adding at the end the following: 

9 ‘‘SEC. 399II. NATIONAL CONGENITAL HEART DISEASE REG10 ISTRY. 

11 ‘‘(a) IN GENERAL.—The Secretary, acting through 

12 the Director of the Centers for Disease Control and Pre13 vention, may— 

14 ‘‘(1) enhance and expand infrastructure to 

15 track the epidemiology of congenital heart disease 

16 and to organize such information into a comprehen17 sive, nationwide registry of actual occurrences of 

18 congenital heart disease, to be known as the ‘Na19 tional Congenital Heart Disease Registry’; or 

20 ‘‘(2) award a grant to one eligible entity to un21 dertake the activities described in paragraph (1). 

22 ‘‘(b) PURPOSE.—The purpose of the Congenital 

23 Heart Disease Registry shall be to facilitate further re24 search into the types of health services patients use and 

25 to identify possible areas for educational outreach and preVerDate Nov 24 2008 01:23 Mar 19, 2009 Jkt 079200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1570.IH H1570

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1 vention in accordance with standard practices of the Cen2 ters for Disease Control and Prevention. 

3 ‘‘(c) CONTENT.—The Congenital Heart Disease Reg4 istry— 

5 ‘‘(1) may include information concerning the in6 cidence and prevalence of congenital heart disease in 

7 the United States; 

8 ‘‘(2) may be used to collect and store data on 

9 congenital heart disease, including data con10 cerning— 

11 ‘‘(A) demographic factors associated with 

12 congenital heart disease, such as age, race, eth13 nicity, sex, and family history of individuals 

14 who are diagnosed with the disease; 

15 ‘‘(B) risk factors associated with the dis16 ease; 

17 ‘‘(C) causation of the disease; 

18 ‘‘(D) treatment approaches; and 

19 ‘‘(E) outcome measures, such that analysis 

20 of the outcome measures will allow derivation of 

21 evidence-based best practices and guidelines for 

22 congenital heart disease patients; and 

23 ‘‘(3) may ensure the collection and analysis of 

24 longitudinal data related to individuals of all ages 

25 with congenital heart disease, including infants, 


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1 young children, adolescents, and adults of all ages, 

2 including the elderly. 

3 ‘‘(d) COORDINATION WITH FEDERAL, STATE, AND

4 LOCAL REGISTRIES.—In establishing the National Con5 genital Heart Registry, the Secretary may identify, build 

6 upon, expand, and coordinate among existing data and 

7 surveillance systems, surveys, registries, and other Federal 

8 public health infrastructure, including— 

9 ‘‘(1) State birth defects surveillance systems; 

10 ‘‘(2) the State birth defects tracking systems of 

11 the Centers for Disease Control and Prevention; 

12 ‘‘(3) the Metropolitan Atlanta Congenital De13 fects Program; and 

14 ‘‘(4) the National Birth Defects Prevention 

15 Network. 

16 ‘‘(e) PUBLIC ACCESS.—The Congenital Heart Dis17 ease Registry shall be made available to the public, includ18 ing congenital heart disease researchers. 

19 ‘‘(f) PATIENT PRIVACY.—The Secretary shall ensure 

20 that the Congenital Heart Disease Registry is maintained 

21 in a manner that complies with the regulations promul22 gated under section 264 of the Health Insurance Port23 ability and Accountability Act of 1996. 

24 ‘‘(g) ELIGIBILITY FOR GRANT.—To be eligible to re25 ceive a grant under subsection (a)(2), an entity shall— 


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1 ‘‘(1) be a public or private nonprofit entity with 

2 specialized experience in congenital heart disease; 

3 and 

4 ‘‘(2) submit to the Secretary an application at 

5 such time, in such manner, and containing such in6 formation as the Secretary may require.’’. 

7 SEC. 5. ADVISORY COMMITTEE ON CONGENITAL HEART 

8 DISEASE. 

9 Title III of the Public Health Service Act (42 U.S.C. 

10 241 et seq.), as amended by section 4, is further amended 

11 by adding at the end the following: 

12 ‘‘SEC. 399JJ. ADVISORY COMMITTEE ON CONGENITAL 

13 HEART DISEASE. 

14 ‘‘(a) ESTABLISHMENT.—The Secretary, acting 

15 through the Director of the Centers for Disease Control 

16 and Prevention, may establish an advisory committee, to 

17 be known as the ‘Advisory Committee on Congenital Heart 

18 Disease’ (referred to in this section as the ‘Advisory Com19 mittee’). 

20 ‘‘(b) MEMBERSHIP.—The members of the Advisory 

21 Committee may be appointed by the Secretary, acting 

22 through the Centers for Disease Control and Prevention, 

23 and shall include— 

24 ‘‘(1) at least one representative from— 

25 ‘‘(A) the National Institutes of Health; 


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1 ‘‘(B) the Centers for Disease Control and 

2 Prevention; and 

3 ‘‘(C) a national patient advocacy organiza4 tion with experience advocating on behalf of pa5 tients living with congenital heart disease; 

6 ‘‘(2) at least one epidemiologist who has experi7 ence working with data registries; 

8 ‘‘(3) clinicians, including— 

9 ‘‘(A) at least one with experience diag10 nosing or treating congenital heart disease; and 

11 ‘‘(B) at least one with experience using 

12 medical data registries; and 

13 ‘‘(4) at least one publicly or privately funded re14 searcher with experience researching congenital 

15 heart disease. 

16 ‘‘(c) DUTIES.—The Advisory Committee may review 

17 information and make recommendations to the Secretary 

18 concerning— 

19 ‘‘(1) the development and maintenance of the 

20 National Congenital Heart Disease Registry estab21 lished under section 399II; 

22 ‘‘(2) the type of data to be collected and stored 

23 in the National Congenital Heart Disease Registry; 

24 ‘‘(3) the manner in which such data is to be 

25 collected; 


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1 ‘‘(4) the use and availability of such data, in2 cluding guidelines for such use; and 

3 ‘‘(5) other matters, as the Secretary determines 

4 to be appropriate. 

5 ‘‘(d) REPORT.—Not later than 180 days after the 

6 date on which the Advisory Committee is established and 

7 annually thereafter, the Advisory Committee shall submit 

8 a report to the Secretary concerning the information de9 scribed in subsection (c), including recommendations with 

10 respect to the results of the Advisory Committee’s review 

11 of such information.’’. 

12 SEC. 6. CONGENITAL HEART DISEASE RESEARCH. 

13 Subpart 2 of part C of title IV of the Public Health 

14 Service Act (42 U.S.C. 285b et seq.) is amended by adding 

15 at the end the following: 

16 ‘‘SEC. 425. CONGENITAL HEART DISEASE. 

17 ‘‘(a) IN GENERAL.—The Director of the Institute 

18 may expand, intensify, and coordinate research and re19 lated activities of the Institute with respect to congenital 

20 heart disease, which may include congenital heart disease 

21 research with respect to— 

22 ‘‘(1) causation of congenital heart disease, in23 cluding genetic causes; 


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1 ‘‘(2) long-term outcomes in individuals with 

2 congenital heart disease, including infants, children, 

3 teenagers, adults, and elderly individuals; 

4 ‘‘(3) diagnosis, treatment, and prevention; 

5 ‘‘(4) studies using longitudinal data and retro6 spective analysis to identify effective treatments and 

7 outcomes for individuals with congenital heart dis8 ease; and 

9 ‘‘(5) identifying barriers to life-long care for in10 dividuals with congenital heart disease. 

11 ‘‘(b) COORDINATION OF RESEARCH ACTIVITIES.— 

12 The Director of the Institute may coordinate research ef13 forts related to congenital heart disease among multiple 

14 research institutions and may develop research networks. 

15 ‘‘(c) MINORITY AND MEDICALLY UNDERSERVED

16 COMMUNITIES.—In carrying out the activities described in 

17 this section, the Director of the Institute shall consider 

18 the application of such research and other activities to mi19 nority and medically underserved communities.’’. 

20 SEC. 7. AUTHORIZATION OF APPROPRIATIONS. 

21 There are authorized to be appropriated to carry out 

22 the amendments made by this Act such sums as may be 

23 necessary for each of fiscal years 2010 through 2014. 

Æ 


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