II 

112TH CONGRESS 

1ST SESSION S. 1350 

To expand the research, prevention, and awareness activities of the Centers 

for Disease Control and Prevention and the National Institutes of Health 

with respect to pulmonary fibrosis, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JULY 12, 2011 

Mr. COONS (for himself, Mr. CRAPO, Mrs. MURRAY, and Mr. KIRK) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To expand the research, prevention, and awareness activities 

of the Centers for Disease Control and Prevention and 

the National Institutes of Health with respect to pulmonary fibrosis, 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 ‘‘Pulmonary Fibrosis 

5 Research Enhancement Act’’. 

6 SEC. 2. FINDINGS. 

7 Congress makes the following findings: 


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1 (1) Pulmonary fibrosis (in this section referred 

2 to as ‘‘PF’’) is a relentlessly progressive, ultimately 

3 fatal disease that affects the lungs, gradually rob4 bing a person of the ability to breathe. 

5 (2) More than 200,000 individuals may be liv6 ing with PF in the United States, 48,000 individuals 

7 in the United States are diagnosed with PF annu8 ally, and as many as 40,000 die annually. 

9 (3) Prevalence of PF has increased more than 

10 150 percent since 2001, and is expected to continue 

11 rising. 

12 (4) The median survival rate for a person with 

13 PF is 2.8 years. 

14 (5) The cause of PF is not well understood, and 

15 in most cases is unknown, though there is growing 

16 evidence that one cause of PF may be environmental 

17 or occupational exposure to pollutants. 

18 (6) There is no Food and Drug Administration19 approved treatment or cure for PF. 

20 (7) Public awareness of PF remains low com21 pared to rare diseases of lesser prevalence, despite 

22 PF’s increasing prevalence. 

23 (8) There has been no federally funded national 

24 awareness or educational effort to improve under25 standing of PF in the public or medical commuVerDate Mar 15 2010 00:26 Jul 13, 2011 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1350.IS S1350

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1 nities, though nonprofit patient education and re2 search groups have begun to increase awareness. 

3 The first Federal legislation expressing Congress’s 

4 support for PF research, H. Con. Res. 182, was 

5 agreed to by both Houses of Congress in 2007. 

6 SEC. 3. PULMONARY FIBROSIS ADVISORY BOARD AND REG7 ISTRY. 

8 Part B of title III of the Public Health Service Act 

9 (42 U.S.C. 243 et seq.) is amended by inserting after sec10 tion 317T the following: 

11 ‘‘SEC. 317U. PULMONARY FIBROSIS ADVISORY BOARD AND 

12 REGISTRY. 

13 ‘‘(a) ADVISORY BOARD.— 

14 ‘‘(1) ESTABLISHMENT.—Not later than 90 days 

15 after the date of the enactment of this section, the 

16 Secretary, acting through the Director of the Cen17 ters for Disease Control and Prevention, shall estab18 lish a board to be known as the National Pulmonary 

19 Fibrosis Advisory Board (in this section referred to 

20 as the ‘Advisory Board’). The Advisory Board shall 

21 be composed of at least one member, to be appointed 

22 by the Secretary, acting through the Director of the 

23 Centers for Disease Control and Prevention, rep24 resenting each of the following: 

25 ‘‘(A) The National Institutes of Health. 


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1 ‘‘(B) The National Institute of Environ2 mental Health Sciences. 

3 ‘‘(C) The Department of Veterans Affairs. 

4 ‘‘(D) The Agency for Toxic Substances 

5 and Disease Registry. 

6 ‘‘(E) The Centers for Disease Control and 

7 Prevention. 

8 ‘‘(F) Patients with PF or their family 

9 members and other individuals with an interest 

10 in developing and maintaining the National PF 

11 Registry. 

12 ‘‘(G) Patient advocates, including organi13 zations representing such advocates. 

14 ‘‘(H) Clinicians with expertise on PF and 

15 related diseases. 

16 ‘‘(I) Epidemiologists with experience work17 ing with data registries. 

18 ‘‘(J) Geneticists or experts in genetics who 

19 have experience with the genetics of PF or 

20 other interstitial lung diseases. 

21 ‘‘(2) DUTIES.—The Advisory Board shall— 

22 ‘‘(A) review information and make rec23 ommendations to the Secretary concerning— 

24 ‘‘(i) the development and maintenance 

25 of the National PF Registry; 


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1 ‘‘(ii) the type of information to be col2 lected and stored in the National PF Reg3 istry; 

4 ‘‘(iii) the manner in which such data 

5 is to be collected; 

6 ‘‘(iv) the use and availability of such 

7 data, including guidelines for such use; and 

8 ‘‘(v) the collection of information 

9 about diseases and disorders that primarily 

10 affect the lungs that are considered essen11 tial to furthering the study and cure of 

12 PF; and 

13 ‘‘(B) consult with the Director of the Cen14 ters for Disease Control and Prevention regard15 ing preparation of the National Pulmonary Fi16 brosis Education and Awareness Plan under 

17 section 4(a) of the Pulmonary Fibrosis Re18 search Enhancement Act. 

19 ‘‘(3) REPORT.—Not later than 1 year after the 

20 date of enactment of this section, the Advisory 

21 Board shall submit to the Secretary, the Committee 

22 on Energy and Commerce of the House of Rep23 resentatives, and the Health, Education, Labor, and 

24 Pensions Committee of the Senate a report on the 

25 review conducted under paragraph (2), including the 


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1 recommendations of the Advisory Board resulting 

2 from such review. 

3 ‘‘(b) ESTABLISHMENT OF REGISTRY.— 

4 ‘‘(1) IN GENERAL.—Not later than 1 year after 

5 the receipt of the report required by subsection 

6 (a)(3), the Secretary, acting through the Director of 

7 the Centers for Disease Control and Prevention and 

8 in consultation with patients, patient advocates, and 

9 others with expertise in research and care of pul10 monary fibrosis (referred to in this section as ‘PF’), 

11 shall— 

12 ‘‘(A) develop a system to collect data on 

13 PF and other interstitial lung diseases that are 

14 related to PF, including information with re15 spect to the incidence and prevalence of the dis16 ease in the United States; and 

17 ‘‘(B) establish a national registry (in this 

18 section referred to as the ‘National PF Reg19 istry’) that— 

20 ‘‘(i) is used for the collection and stor21 age of data described in subparagraph (A); 

22 and 

23 ‘‘(ii) includes a population-based reg24 istry of cases in the United States of PF 


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1 and other interstitial lung diseases that are 

2 related to PF. 

3 ‘‘(2) PURPOSE.—The purpose of the National 

4 PF Registry shall be to gather available data con5 cerning— 

6 ‘‘(A) PF, including the incidence and prev7 alence of PF in the United States; 

8 ‘‘(B) environmental and occupational fac9 tors that may be associated with the disease; 

10 ‘‘(C) age, race or ethnicity, gender, and 

11 family history of individuals who are diagnosed 

12 with the disease; 

13 ‘‘(D) pathogenesis of PF; and 

14 ‘‘(E) other matters as determined appro15 priate by the Secretary. 

16 ‘‘(c) COORDINATION WITH STATE, LOCAL, AND FED17 ERAL REGISTRIES.— 

18 ‘‘(1) IN GENERAL.—In establishing the Na19 tional PF Registry under subsection (b), the Sec20 retary shall— 

21 ‘‘(A) identify, build upon, expand, and co22 ordinate among existing data and surveillance 

23 systems, surveys, registries, and other Federal 

24 public health and environmental infrastructure 

25 wherever possible, including— 


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1 ‘‘(i) existing systems in place at uni2 versities, medical centers, and government 

3 agencies; 

4 ‘‘(ii) State-based PF registries, Na5 tional Institutes of Health registries, and 

6 Department of Veterans Affairs registries, 

7 as available; and 

8 ‘‘(iii) any other relevant databases 

9 that collect or maintain information on in10 terstitial lung diseases; and 

11 ‘‘(B) provide for research access to PF 

12 data in accordance with applicable statutes and 

13 regulations, including those protecting personal 

14 privacy. 

15 ‘‘(2) COORDINATION WITH NIH AND DEPART16 MENT OF VETERANS AFFAIRS.—Consistent with ap17 plicable privacy statutes and regulations, the Sec18 retary shall ensure that epidemiological and other 

19 types of information obtained under subsection (b) is 

20 made available to the National Institutes of Health 

21 and the Department of Veterans Affairs. 

22 ‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 

23 are authorized to be appropriated to carry out this section 

24 $5,000,000 for fiscal year 2012 and $2,500,000 for each 

25 of the fiscal years 2013 through 2016.’’. 


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1 SEC. 4. NATIONAL PULMONARY FIBROSIS EDUCATION AND 

2 AWARENESS PLAN. 

3 (a) IN GENERAL.— 

4 (1) PREPARATION OF PLAN.—The Director of 

5 the Centers for Disease Control and Prevention, in 

6 consultation with the National Pulmonary Fibrosis 

7 Advisory Board established under section 317U of 

8 the Public Health Service Act, as added by section 

9 3 of this Act, shall prepare a comprehensive plan (in 

10 this section referred to as the ‘‘National Pulmonary 

11 Fibrosis Education and Awareness Plan’’). 

12 (2) REPORT TO CONGRESS.—Not later than one 

13 year after the date of the enactment of this Act, and 

14 at the same time as the report is submitted under 

15 section 317U(a)(3) of the Public Health Service Act, 

16 the Director of the Centers for Disease Control and 

17 Prevention shall submit the National Pulmonary Fi18 brosis Education and Awareness Plan to the Com19 mittee on Energy and Commerce and the Committee 

20 on Appropriations of the House of Representatives 

21 and to the Committee on Health, Education, Labor, 

22 and Pensions and the Committee on Appropriations 

23 of the Senate. 

24 (b) CONTENT.—The National Pulmonary Fibrosis 

25 Education and Awareness Plan shall— 


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1 (1) focus on strategies to increase public edu2 cation and awareness of pulmonary fibrosis; 

3 (2) accelerate patient education strategies, with 

4 respect to pulmonary fibrosis, nationwide; 

5 (3) address the need for new physician edu6 cation strategies to improve diagnosis and treatment 

7 standards with respect to pulmonary fibrosis; 

8 (4) assess and monitor the costs of pulmonary 

9 fibrosis and its burden on patients and families; and 

10 (5) develop such strategies in partnership with 

11 patients, patient advocates, and others with exper12 tise in research and care of pulmonary fibrosis. 

13 (c) AUTHORIZATION OF APPROPRIATIONS.—There 

14 are authorized to be appropriated to carry out this section 

15 $1,000,000 for fiscal year 2012. 

16 SEC. 5. PULMONARY FIBROSIS RESEARCH EXPANSION. 

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

18 Service Act (42 U.S.C. 285b et seq.) is amended by insert19 ing after section 424C the following: 

20 ‘‘SEC. 424D. PULMONARY FIBROSIS RESEARCH EXPANSION. 

21 ‘‘The Director of the Institute is encouraged to ex22 pand, intensify, and coordinate the activities of the Insti23 tute with respect to research on pulmonary fibrosis, as ap24 propriate.’’. 

Æ 


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