I 

114TH CONGRESS 

1ST SESSION H. R. 3284 

To amend the Public Health Service Act to provide for the establishment 

of a mesothelioma patient registry, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JULY 29, 2015 

Mr. KATKO (for himself, Ms. SCHAKOWSKY, Mr. COLLINS of New York, Mr. 

KING of New York, Mr. KENNEDY, Ms. MCCOLLUM, and Mr. LANCE) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Public Health Service Act to provide for 

the establishment of a mesothelioma patient registry, 

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 ‘‘Mary Jo Lawyer Spano 

5 Mesothelioma Patient Registry Act of 2015’’. 


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1 SEC. 2. PATIENT REGISTRY FOR MESOTHELIOMA DATA 

2 COLLECTION AND RESEARCH. 

3 Title III of the Public Health Service Act is amended 

4 by inserting after section 399V–5 of such Act (42 U.S.C. 

5 280g–16) the following: 

6 ‘‘SEC. 399V–6. PATIENT REGISTRY FOR MESOTHELIOMA 

7 DATA COLLECTION AND RESEARCH. 

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

9 the Administrator of the Agency for Toxic Substances and 

10 Disease Registry, shall develop a patient registry to collect 

11 data on mesothelioma, including information with respect 

12 to the incidence and prevalence of the disease in the 

13 United States. 

14 ‘‘(b) USES.—The Secretary shall use the registry 

15 under subsection (a)— 

16 ‘‘(1) to enhance and expand infrastructure and 

17 activities for tracking the epidemiology of mesothe18 lioma patients; 

19 ‘‘(2) to collect, consolidate, and report on health 

20 information on patients who have been diagnosed 

21 with mesothelioma, including with respect to— 

22 ‘‘(A) treatment outcomes, including patient 

23 longevity; and 

24 ‘‘(B) the number of patients receiving 

25 treatment for mesothelioma disaggregated by 

26 hospital; 


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1 ‘‘(3) to better describe the incidence and preva2 lence of mesothelioma in the United States; 

3 ‘‘(4) to facilitate further research on mesothe4 lioma; 

5 ‘‘(5) to examine factors, such as environmental 

6 and occupational factors, that may be associated 

7 with mesothelioma; 

8 ‘‘(6) to better outline key demographic factors 

9 (such as age, race or ethnicity, gender, and family 

10 history) associated with mesothelioma; and 

11 ‘‘(7) to make the information in such registry, 

12 other than individually identifiable information, 

13 available to the public to facilitate and enhance re14 search on, and prevention and treatment of, meso15 thelioma. 

16 ‘‘(c) CONTENT.—In carrying out this section, the 

17 Secretary— 

18 ‘‘(1) shall provide for the collection and storage 

19 of information on the incidence and prevalence of 

20 mesothelioma in the United States; 

21 ‘‘(2) when scientifically possible, shall provide 

22 for the collection and storage of other available in23 formation on mesothelioma, such as information con24 cerning— 


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1 ‘‘(A) demographics and other information 

2 associated or possibly associated with mesothe3 lioma, such as age, race, ethnicity, sex, geo4 graphic location, and family history; 

5 ‘‘(B) risk factors associated or possibly as6 sociated with mesothelioma, including genetic 

7 and environmental risk factors; and 

8 ‘‘(C) diagnosis and progression markers; 

9 and 

10 ‘‘(3) may provide for the collection and storage 

11 of information relevant to analysis on mesothelioma, 

12 such as information concerning— 

13 ‘‘(A) the epidemiology of the disease; 

14 ‘‘(B) the natural history of the disease; 

15 ‘‘(C) the prevention of the disease; 

16 ‘‘(D) the detection, management, and 

17 treatment approaches for the disease; and 

18 ‘‘(E) the development of outcomes meas19 ures. 

20 ‘‘(d) CONSULTATION.—In carrying out this section, 

21 the Secretary shall consult with individuals with appro22 priate expertise, including non-Federal mesothelioma ex23 perts including— 

24 ‘‘(1) epidemiologists with experience in disease 

25 surveillance or registries; 


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1 ‘‘(2) representatives of national voluntary asso2 ciations that focus on mesothelioma or have dem3 onstrated experience in research, care, or patient 

4 service for mesothelioma; 

5 ‘‘(3) health information technology experts or 

6 other information management specialists; 

7 ‘‘(4) clinicians with expertise in mesothelioma; 

8 and 

9 ‘‘(5) research scientists with experience con10 ducting translational research or utilizing surveil11 lance systems for scientific research purposes. 

12 ‘‘(e) COORDINATION WITH OTHER FEDERAL AGEN13 CIES.—The Secretary shall make information in and anal14 ysis derived from the registry under this section available, 

15 as appropriate, to Federal departments and agencies, such 

16 as the National Institutes of Health, the Food and Drug 

17 Administration, the Centers for Medicare & Medicaid 

18 Services, the Agency for Healthcare Research and Quality, 

19 the Department of Veterans Affairs, and the Department 

20 of Defense. 

21 ‘‘(f) PUBLIC ACCESS.—Subject to subsection (g), the 

22 Secretary shall make information in, and analysis derived 

23 from, the registry under this section available, as appro24 priate, to the public, including researchers. 


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1 ‘‘(g) PRIVACY.—The Secretary shall ensure that pri2 vacy and security protections applicable to the registry 

3 under this section are at least as stringent as the privacy 

4 and security protections under HIPAA privacy and secu5 rity law (as defined in section 3009). 

6 ‘‘(h) REPORTS TO CONGRESS.— 

7 ‘‘(1) INITIAL REPORT.—Not later than 18 

8 months after the date of enactment of the Mary Jo 

9 Lawyer Spano Mesothelioma Patient Registry Act of 

10 2015, the Secretary shall submit to the Congress a 

11 report that— 

12 ‘‘(A) shall outline— 

13 ‘‘(i) the findings in the mesothelioma 

14 patient registry under subsection (a); 

15 ‘‘(ii) future plans for expansion or re16 vision of such registry; and 

17 ‘‘(iii) the scope of such registry; and 

18 ‘‘(B) may include a description of the ac19 tivities undertaken by the Secretary to establish 

20 partnerships with research and patient advocacy 

21 communities to expand such registry. 

22 ‘‘(2) SUBSEQUENT REPORT.—Not later than 4 

23 years after the date of enactment of the Mary Jo 

24 Lawyer Spano Mesothelioma Patient Registry Act of 

25 2015, the Secretary shall submit a report to the 


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1 Congress concerning the implementation of this sec2 tion. Such report should include information on— 

3 ‘‘(A) the development and maintenance of 

4 the mesothelioma patient registry under sub5 section (a); 

6 ‘‘(B) the type of information collected and 

7 stored in the registry; 

8 ‘‘(C) the use and availability of such infor9 mation, including guidelines for such use; and 

10 ‘‘(D) the use and coordination of databases 

11 that collect or maintain information on meso12 thelioma.’’. 

Æ 


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