I 

114TH CONGRESS 

1ST SESSION H. R. 3952 

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 

NOVEMBER 5, 2015 

Mr. BILIRAKIS (for himself, Mr. SCHIFF, and Ms. NORTON) 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 Reauthorization Act of 2015’’. 


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1 SEC. 2. NATIONAL CONGENITAL HEART DISEASE SURVEIL2 LANCE SYSTEM. 

3 Section 399V–2 of the Public Health Service Act (42 

4 U.S.C. 280g–13) is amended to read as follows: 

5 ‘‘SEC. 399V–2. NATIONAL CONGENITAL HEART DISEASE RE6 SEARCH, SURVEILLANCE, AND AWARENESS. 

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

8 the Director of the Centers for Disease Control and Pre9 vention, shall— 

10 ‘‘(1) enhance and expand research and surveil11 lance infrastructure to study and track the epidemi12 ology of congenital heart disease (in this section re13 ferred to as ‘CHD’); 

14 ‘‘(2) plan and implement a public outreach and 

15 education campaign regarding CHD across the life16 span; and 

17 ‘‘(3) award grants to eligible entities to under18 take the activities described in subsections (b) and 

19 (c). 

20 ‘‘(b) NATIONAL CONGENITAL HEART DISEASE CO21 HORT STUDY.— 

22 ‘‘(1) IN GENERAL.—The Director of the Cen23 ters for Disease Control and Prevention shall plan, 

24 develop, implement, and submit one or more reports 

25 to the Congress on a cohort study to improve under26 standing of the epidemiology of CHD across the lifeVerDate Sep 11 2014 23:10 Nov 07, 2015 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3952.IH H3952

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1 span, from birth to adulthood, with particular inter2 est in the following: 

3 ‘‘(A) Health care utilization and natural 

4 history of those affected by CHD. 

5 ‘‘(B) Demographic factors associated with 

6 CHD, such as age, race, ethnicity, gender, and 

7 family history of individuals who are diagnosed 

8 with the disease. 

9 ‘‘(C) Outcome measures, such that analysis 

10 of the outcome measures will allow derivation of 

11 evidence-based best practices and guidelines for 

12 CHD patients. 

13 ‘‘(2) PERMISSIBLE CONSIDERATIONS.—The 

14 study under this subsection may— 

15 ‘‘(A) gather data on the health outcomes of 

16 a diverse population of those affected by CHD; 

17 ‘‘(B) consider health disparities among 

18 those affected by CHD which may include the 

19 consideration of prenatal exposures; and 

20 ‘‘(C) incorporate behavioral, emotional, 

21 and educational outcomes of those affected by 

22 CHD. 

23 ‘‘(3) PUBLIC ACCESS.—Subject to paragraph 

24 (4), the data generated from the study under this 


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1 subsection shall be made available to the public, in2 cluding CHD researchers. 

3 ‘‘(4) PATIENT PRIVACY.—The Secretary shall 

4 ensure that the study under this subsection is car5 ried out in a manner that complies with the require6 ments applicable to a covered entity under the regu7 lations promulgated pursuant to section 264(c) of 

8 the Health Insurance Portability and Accountability 

9 Act of 1996. 

10 ‘‘(c) CONGENITAL HEART DISEASE AWARENESS

11 CAMPAIGN.— 

12 ‘‘(1) IN GENERAL.—The Director of the Cen13 ters for Disease Control and Prevention shall estab14 lish and implement an awareness, outreach, and 

15 education campaign regarding CHD across the life16 span. The information expressed through such cam17 paign shall— 

18 ‘‘(A) emphasize that CHD is the most 

19 prevalent birth defect; 

20 ‘‘(B) identify CHD as a condition that af21 fects those diagnosed throughout their lives; 

22 and 

23 ‘‘(C) promote the need for pediatric, ado24 lescent, and adult individuals with CHD to seek 

25 and maintain lifelong, specialized care. 


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1 ‘‘(2) PERMISSIBLE ACTIVITIES.—The campaign 

2 under this subsection may— 

3 ‘‘(A) utilize collaborations or partnerships 

4 with other agencies, health care professionals, 

5 and patient advocacy organizations that spe6 cialize in the needs of individuals with CHD; 

7 and 

8 ‘‘(B) include the use of print, film, and 

9 electronic materials distributed via television, 

10 radio, Internet, and other commercial mar11 keting venues. 

12 ‘‘(d) ELIGIBILITY FOR GRANTS.—To be eligible to re13 ceive a grant under subsection (a)(3), an entity shall— 

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

15 specialized experience in CHD; and 

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

17 such time, in such manner, and containing such in18 formation as the Secretary may require. 

19 ‘‘(e) AUTHORIZATION OF APPROPRIATIONS.—To 

20 carry out this section, there is authorized to be appro21 priated $4,000,000 for each of fiscal years 2016 through 

22 2020.’’. 

23 SEC. 3. CONGENITAL HEART DISEASE RESEARCH. 

24 Section 425 of the Public Health Service Act (42 

25 U.S.C. 285b–8) is amended to read as follows: 


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1 ‘‘SEC. 425. CONGENITAL HEART DISEASE. 

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

3 may expand, intensify, and coordinate research and re4 lated activities of the Institute with respect to congenital 

5 heart disease, which may include congenital heart disease 

6 research with respect to— 

7 ‘‘(1) causation of congenital heart disease, in8 cluding genetic causes; 

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

10 congenital heart disease, including infants, children, 

11 teenagers, adults, and elderly individuals; 

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

13 ‘‘(4) studies using longitudinal data and retro14 spective analysis to identify effective treatments and 

15 outcomes for individuals with congenital heart dis16 ease; and 

17 ‘‘(5) identifying barriers to lifelong care for in18 dividuals with congenital heart disease. 

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

20 The Director of the Institute may coordinate research ef21 forts related to congenital heart disease among multiple 

22 research institutions and may develop research networks. 

23 ‘‘(c) MINORITY AND MEDICALLY UNDERSERVED

24 COMMUNITIES.—In carrying out the activities described in 

25 this section, the Director of the Institute shall consider 


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1 the application of such research and other activities to mi2 nority and medically underserved communities. 

3 ‘‘(d) REPORT FROM NIH.—Not later than 1 year 

4 after the date of enactment of the Congenital Heart Fu5 tures Reauthorization Act of 2015, the Director of NIH, 

6 acting through the Director of the Institute, shall provide 

7 a report to Congress— 

8 ‘‘(1) outlining the ongoing research efforts of 

9 the National Institutes of Health regarding con10 genital heart disease; and 

11 ‘‘(2) identifying— 

12 ‘‘(A) future plans for research regarding 

13 congenital heart disease; and 

14 ‘‘(B) the areas of greatest need for such 

15 research.’’. 

Æ 


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