I 
112TH CONGRESS 
1ST SESSION H. R. 2505 
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 HOUSE OF REPRESENTATIVES 
JULY 12, 2011 
Mr. PAULSEN (for himself, Ms. BALDWIN, and Mr. MARKEY) introduced the 
following bill; which was referred to the Committee on Energy and Commerce 
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 pul-
monary fibrosis, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Pulmonary Fibrosis 
Research Enhancement Act’’. 
SEC. 2. FINDINGS. 
Congress makes the following findings: 
VerDate Mar 15 2010 
03:05 Jul 13, 2011
Jkt 099200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H2505.IH
H2505
jbell on DSKDVH8Z91PROD with BILLS
(1) Pulmonary fibrosis (in this section referred 
to as ‘‘PF’’) is a relentlessly progressive, ultimately 
fatal disease that affects the lungs, gradually rob-
bing a person of the ability to breathe. 
(2) More than 200,000 individuals may be liv-
ing with PF in the United States, 48,000 individuals 
in the United States are diagnosed with PF annu-
ally, and as many as 40,000 die annually. 
(3) Prevalence of PF has increased more than 
150 percent since 2001, and is expected to continue 
rising. 
(4) The median survival rate for a person with 
PF is 2.8 years. 
(5) The cause of PF is not well understood, and 
in most cases is unknown, though there is growing 
evidence that one cause of PF may be environmental 
or occupational exposure to pollutants. 
(6) There is no Food and Drug Administration- 
approved treatment or cure for PF. 
(7) Public awareness of PF remains low com-
pared to rare diseases of lesser prevalence, despite 
PF’s increasing prevalence. 
(8) There has been no federally funded national 
awareness or educational effort to improve under-
standing of PF in the public or medical commu-
VerDate Mar 15 2010 
03:05 Jul 13, 2011
Jkt 099200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H2505.IH
H2505
jbell on DSKDVH8Z91PROD with BILLS
nities, though nonprofit patient education and re-
search groups have begun to increase awareness. 
The first Federal legislation expressing Congress’s 
support for PF research, H. Con. Res. 182, was 
agreed to by both Houses of Congress in 2007. 
SEC. 3. PULMONARY FIBROSIS ADVISORY BOARD AND REG-
ISTRY. 
Part B of title III of the Public Health Service Act 
(42 U.S.C. 243 et seq.) is amended by inserting after sec-
tion 317T the following: 
‘‘SEC. 317U. PULMONARY FIBROSIS ADVISORY BOARD AND 
REGISTRY. 
‘‘(a) ADVISORY BOARD.— 
‘‘(1) ESTABLISHMENT.—Not later than 90 days 
after the date of the enactment of this section, the 
Secretary, acting through the Director of the Cen-
ters for Disease Control and Prevention, shall estab-
lish a board to be known as the National Pulmonary 
Fibrosis Advisory Board (in this section referred to 
as the ‘Advisory Board’). The Advisory Board shall 
be composed of at least one member, to be appointed 
by the Secretary, acting through the Director of the 
Centers for Disease Control and Prevention, rep-
resenting each of the following: 
‘‘(A) The National Institutes of Health. 
VerDate Mar 15 2010 
03:05 Jul 13, 2011
Jkt 099200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H2505.IH
H2505
jbell on DSKDVH8Z91PROD with BILLS
‘‘(B) The National Institute of Environ-
mental Health Sciences. 
‘‘(C) The Department of Veterans Affairs. 
‘‘(D) The Agency for Toxic Substances 
and Disease Registry. 
‘‘(E) The Centers for Disease Control and 
Prevention. 
‘‘(F) Patients with PF or their family 
members and other individuals with an interest 
in developing and maintaining the National PF 
Registry. 
‘‘(G) Patient advocates, including organi-
zations representing such advocates. 
‘‘(H) Clinicians with expertise on PF and 
related diseases. 
‘‘(I) Epidemiologists with experience work-
ing with data registries. 
‘‘(J) Geneticists or experts in genetics who 
have experience with the genetics of PF or 
other interstitial lung diseases. 
‘‘(2) DUTIES.—The Advisory Board shall— 
‘‘(A) review information and make rec-
ommendations to the Secretary concerning— 
‘‘(i) the development and maintenance 
of the National PF Registry; 
VerDate Mar 15 2010 
03:05 Jul 13, 2011
Jkt 099200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H2505.IH
H2505
jbell on DSKDVH8Z91PROD with BILLS
‘‘(ii) the type of information to be col-
lected and stored in the National PF Reg-
istry; 
‘‘(iii) the manner in which such data 
is to be collected; 
‘‘(iv) the use and availability of such 
data, including guidelines for such use; and 
‘‘(v) the collection of information 
about diseases and disorders that primarily 
affect the lungs that are considered essen-
tial to furthering the study and cure of 
PF; and 
‘‘(B) consult with the Director of the Cen-
ters for Disease Control and Prevention regard-
ing preparation of the National Pulmonary Fi-
brosis Education and Awareness Plan under 
section 4(a) of the Pulmonary Fibrosis Re-
search Enhancement Act. 
‘‘(3) REPORT.—Not later than 1 year after the 
date of enactment of this section, the Advisory 
Board shall submit to the Secretary, the Committee 
on Energy and Commerce of the House of Rep-
resentatives, and the Health, Education, Labor, and 
Pensions Committee of the Senate a report on the 
review conducted under paragraph (2), including the 
VerDate Mar 15 2010 
03:05 Jul 13, 2011
Jkt 099200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H2505.IH
H2505
jbell on DSKDVH8Z91PROD with BILLS
recommendations of the Advisory Board resulting 
from such review. 
‘‘(b) ESTABLISHMENT OF REGISTRY.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the receipt of the report required by subsection 
(a)(3), the Secretary, acting through the Director of 
the Centers for Disease Control and Prevention and 
in consultation with patients, patient advocates, and 
others with expertise in research and care of pul-
monary fibrosis (referred to in this section as ‘PF’), 
shall— 
‘‘(A) develop a system to collect data on 
PF and other interstitial lung diseases that are 
related to PF, including information with re-
spect to the incidence and prevalence of the dis-
ease in the United States; and 
‘‘(B) establish a national registry (in this 
section referred to as the ‘National PF Reg-
istry’) that— 
‘‘(i) is used for the collection and stor-
age of data described in subparagraph (A); 
and 
‘‘(ii) includes a population-based reg-
istry of cases in the United States of PF 
VerDate Mar 15 2010 
03:05 Jul 13, 2011
Jkt 099200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H2505.IH
H2505
jbell on DSKDVH8Z91PROD with BILLS
and other interstitial lung diseases that are 
related to PF. 
‘‘(2) PURPOSE.—The purpose of the National 
PF Registry shall be to gather available data con-
cerning— 
‘‘(A) PF, including the incidence and prev-
alence of PF in the United States; 
‘‘(B) environmental and occupational fac-
tors that may be associated with the disease; 
‘‘(C) age, race or ethnicity, gender, and 
family history of individuals who are diagnosed 
with the disease; 
‘‘(D) pathogenesis of PF; and 
‘‘(E) other matters as determined appro-
priate by the Secretary. 
‘‘(c) COORDINATION WITH STATE, LOCAL, AND FED-
ERAL REGISTRIES.— 
‘‘(1) IN
GENERAL.—In establishing the Na-
tional PF Registry under subsection (b), the Sec-
retary shall— 
‘‘(A) identify, build upon, expand, and co-
ordinate among existing data and surveillance 
systems, surveys, registries, and other Federal 
public health and environmental infrastructure 
wherever possible, including— 
VerDate Mar 15 2010 
03:05 Jul 13, 2011
Jkt 099200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H2505.IH
H2505
jbell on DSKDVH8Z91PROD with BILLS
‘‘(i) existing systems in place at uni-
versities, medical centers, and government 
agencies; 
‘‘(ii) State-based PF registries, Na-
tional Institutes of Health registries, and 
Department of Veterans Affairs registries, 
as available; and 
‘‘(iii) any other relevant databases 
that collect or maintain information on in-
terstitial lung diseases; and 
‘‘(B) provide for research access to PF 
data in accordance with applicable statutes and 
regulations, including those protecting personal 
privacy. 
‘‘(2) COORDINATION WITH NIH AND DEPART-
MENT OF VETERANS AFFAIRS.—Consistent with ap-
plicable privacy statutes and regulations, the Sec-
retary shall ensure that epidemiological and other 
types of information obtained under subsection (b) is 
made available to the National Institutes of Health 
and the Department of Veterans Affairs.’’. 
SEC. 4. NATIONAL PULMONARY FIBROSIS EDUCATION AND 
AWARENESS PLAN. 
(a) IN GENERAL.— 
VerDate Mar 15 2010 
03:05 Jul 13, 2011
Jkt 099200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H2505.IH
H2505
jbell on DSKDVH8Z91PROD with BILLS
(1) PREPARATION OF PLAN.—The Director of 
the Centers for Disease Control and Prevention, in 
consultation with the National Pulmonary Fibrosis 
Advisory Board established under section 317U of 
the Public Health Service Act, as added by section 
3 of this Act, shall prepare a comprehensive plan (in 
this section referred to as the ‘‘National Pulmonary 
Fibrosis Education and Awareness Plan’’). 
(2) REPORT TO CONGRESS.—Not later than one 
year after the date of the enactment of this Act, and 
at the same time as the report is submitted under 
section 317U(a)(3) of the Public Health Service Act, 
the Director of the Centers for Disease Control and 
Prevention shall submit the National Pulmonary Fi-
brosis Education and Awareness Plan to the Com-
mittee on Energy and Commerce and the Committee 
on Appropriations of the House of Representatives 
and to the Committee on Health, Education, Labor, 
and Pensions and the Committee on Appropriations 
of the Senate. 
(b) CONTENT.—The National Pulmonary Fibrosis 
Education and Awareness Plan shall— 
(1) focus on strategies to increase public edu-
cation and awareness of pulmonary fibrosis; 
VerDate Mar 15 2010 
03:05 Jul 13, 2011
Jkt 099200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H2505.IH
H2505
jbell on DSKDVH8Z91PROD with BILLS
(2) accelerate patient education strategies, with 
respect to pulmonary fibrosis, nationwide; 
(3) address the need for new physician edu-
cation strategies to improve diagnosis and treatment 
standards with respect to pulmonary fibrosis; 
(4) assess and monitor the costs of pulmonary 
fibrosis and its burden on patients and families; and 
(5) develop such strategies in partnership with 
patients, patient advocates, and others with exper-
tise in research and care of pulmonary fibrosis. 
SEC. 5. PULMONARY FIBROSIS RESEARCH EXPANSION. 
Subpart 2 of part C of title IV of the Public Health 
Service Act (42 U.S.C. 285b et seq.) is amended by insert-
ing after section 424C the following: 
‘‘SEC. 424D. PULMONARY FIBROSIS RESEARCH EXPANSION. 
‘‘The Director of the Institute is encouraged to ex-
pand, intensify, and coordinate the activities of the Insti-
tute with respect to research on pulmonary fibrosis, as ap-
propriate.’’. 
Æ 
VerDate Mar 15 2010 
03:05 Jul 13, 2011
Jkt 099200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6301
E:\BILLS\H2505.IH
H2505
jbell on DSKDVH8Z91PROD with BILLS