355 
(C) recommendations for an interprofes-
sional research agenda at the National Insti-
tutes of Health aimed at reducing and ulti-
mately eliminating mental and behavioral health 
disparities in such racial and ethnic minority 
groups. 
TITLE VII—ADDRESSING HIGH 
IMPACT MINORITY DISEASES 
Subtitle A—Cancer 
SEC. 701. LUNG CANCER MORTALITY REDUCTION. 
(a) SHORT TITLE.—This section may be cited as the 
‘‘Lung Cancer Mortality Reduction Act of 2011’’. 
(b) FINDINGS.—Congress makes the following find-
ings: 
(1) Lung cancer is the leading cause of cancer 
death for both men and women, accounting for 28 
percent of all cancer deaths. 
(2) Lung cancer kills more people annually 
than breast cancer, prostate cancer, colon cancer, 
liver cancer, melanoma, and kidney cancer combined. 
(3) Since the National Cancer Act of 1971 
(Public Law 92–218; 85 Stat. 778), coordinated and 
comprehensive research has raised the 5-year sur-
vival rates for breast cancer to 88 percent, for pros-
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tate cancer to 99 percent, and for colon cancer to 
64 percent. 
(4) However, the 5-year survival rate for lung 
cancer is still only 15 percent and a similar coordi-
nated and comprehensive research effort is required 
to achieve increases in lung cancer survivability 
rates. 
(5) Sixty percent of lung cancer cases are now 
diagnosed nonsmokers or former smokers. 
(6) Two-thirds of nonsmokers diagnosed with 
lung cancer are women. 
(7) Certain minority populations, such as Afri-
can-American males, have disproportionately high 
rates of lung cancer incidence and mortality, not-
withstanding their similar smoking rate. 
(8) Members of the baby boomer generation are 
entering their sixties, the most common age at which 
people develop lung cancer. 
(9) Tobacco addiction and exposure to other 
lung cancer carcinogens such as Agent Orange and 
other herbicides and battlefield emissions are serious 
problems among military personnel and war vet-
erans. 
(10) Significant and rapid improvements in 
lung cancer mortality can be expected through great-
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er use and access to lung cancer screening tests for 
at-risk individuals. 
(11) Additional strategies are necessary to fur-
ther enhance the existing tests and therapies avail-
able to diagnose and treat lung cancer in the future. 
(12) The August 2001 Report of the Lung 
Cancer Progress Review Group of the National Can-
cer Institute stated that funding for lung cancer re-
search was ‘‘far below the levels characterized for 
other common malignancies and far out of propor-
tion to its massive health impact’’. 
(13) The Report of the Lung Cancer Progress 
Review Group identified as its ‘‘highest priority’’ the 
creation of integrated, multidisciplinary, multi-insti-
tutional research consortia organized around the 
problem of lung cancer rather than around specific 
research disciplines. 
(14) The United States must enhance its re-
sponse to the issues raised in the Report of the 
Lung Cancer Progress Review Group, and this can 
be accomplished through the establishment of a co-
ordinated effort designed to reduce the lung cancer 
mortality rate by 50 percent by 2015 and targeted 
funding to support this coordinated effort. 
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(c) SENSE OF CONGRESS CONCERNING INVESTMENT 
IN LUNG CANCER RESEARCH.—It is the sense of the Con-
gress that— 
(1) lung cancer mortality reduction should be 
made a national public health priority; and 
(2) a comprehensive mortality reduction pro-
gram coordinated by the Secretary of Health and 
Human Services is justified and necessary to ade-
quately address and reduce lung cancer mortality. 
(d) LUNG CANCER MORTALITY REDUCTION PRO-
GRAM.— 
(1) IN GENERAL.—Subpart 1 of part C of title 
IV of the Public Health Service Act (42 U.S.C. 285 
et seq.) is amended by adding at the end the fol-
lowing: 
‘‘SEC. 417H. LUNG CANCER MORTALITY REDUCTION PRO-
GRAM. 
‘‘(a) IN GENERAL.—Not later than 6 months after 
the date of the enactment of this section, the Secretary, 
in consultation with the Secretary of Defense, the Sec-
retary of Veterans Affairs, the Director of the National 
Institutes of Health, the Director of the Centers for Dis-
ease Control and Prevention, the Commissioner of Food 
and Drugs, the Administrator of the Centers for Medicare 
& Medicaid Services, the Director of the National Institute 
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on Minority Health and Health Disparities, and other 
members of the Lung Cancer Advisory Board established 
under section 546 of the Lung Cancer Mortality Reduc-
tion Act of 2011, shall implement a comprehensive pro-
gram, to be known as the Lung Cancer Mortality Reduc-
tion Program, to achieve a reduction of at least 25 percent 
in the mortality rate of lung cancer by 2017. 
‘‘(b) REQUIREMENTS.—The Program shall include at 
least the following: 
‘‘(1) With respect to the National Institutes of 
Health— 
‘‘(A) a strategic review and prioritization 
by the National Cancer Institute of research 
grants to achieve the goal of the Lung Cancer 
Mortality Reduction Program in reducing lung 
cancer mortality; 
‘‘(B) the provision of funds to enable the 
Airway Biology and Disease Branch of the Na-
tional Heart, Lung, and Blood Institute to ex-
pand its research programs to include pre-
dispositions to lung cancer, the interrelationship 
between lung cancer and other pulmonary and 
cardiac disease, and the diagnosis and treat-
ment of these interrelationships; 
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‘‘(C) the provision of funds to enable the 
National Institute of Biomedical Imaging and 
Bioengineering to expedite the development of 
computer assisted diagnostic, surgical, treat-
ment, and drug-testing innovations to reduce 
lung cancer mortality, such as through expan-
sion of the Institute’s Quantum Grant Program 
and Image-Guided Interventions programs; and 
‘‘(D) the provision of funds to enable the 
National Institute of Environmental Health 
Sciences to implement research programs rel-
ative to the lung cancer incidence. 
‘‘(2) With respect to the Food and Drug Ad-
ministration— 
‘‘(A) activities under section 529 of the 
Federal Food, Drug, and Cosmetic Act; and 
‘‘(B) activities under section 561 of the 
Federal Food, Drug, and Cosmetic Act to ex-
pand access to investigational drugs and devices 
for the diagnosis, monitoring, or treatment of 
lung cancer. 
‘‘(3) With respect to the Centers for Disease 
Control and Prevention, the establishment of an 
early disease research and management program 
under section 1511. 
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‘‘(4) With respect to the Agency for Healthcare 
Research and Quality, the conduct of a biannual re-
view of lung cancer screening, diagnostic, and treat-
ment protocols, and the issuance of updated guide-
lines. 
‘‘(5) The cooperation and coordination of all 
minority and health disparity programs within the 
Department of Health and Human Services to en-
sure that all aspects of the Lung Cancer Mortality 
Reduction Program under this section adequately 
address the burden of lung cancer on minority and 
rural populations. 
‘‘(6) The cooperation and coordination of all to-
bacco control and cessation programs within agen-
cies of the Department of Health and Human Serv-
ices to achieve the goals of the Lung Cancer Mor-
tality Reduction Program under this section with 
particular emphasis on the coordination of drug and 
other cessation treatments with early detection pro-
tocols.’’. 
(2) FEDERAL
FOOD, DRUG, AND
COSMETIC 
ACT.—Subchapter B of chapter V of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360aaa et 
seq.) is amended by adding at the end the following: 
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‘‘DRUGS RELATING TO LUNG CANCER 
‘‘SEC. 529. (a) IN GENERAL.—The provisions of this 
subchapter shall apply to a drug described in subsection 
(b) to the same extent and in the same manner as such 
provisions apply to a drug for a rare disease or condition. 
‘‘(b) QUALIFIED DRUGS.—A drug described in this 
subsection is— 
‘‘(1) a chemoprevention drug for precancerous 
conditions of the lung; 
‘‘(2) a drug for targeted therapeutic treat-
ments, including any vaccine, for lung cancer; and 
‘‘(3) a drug to curtail or prevent nicotine addic-
tion. 
‘‘(c) BOARD.—The Board established under the Lung 
Cancer Mortality Reduction Act of 2011 shall monitor the 
program implemented under this section.’’. 
(3) ACCESS TO UNAPPROVED THERAPIES.—Sec-
tion 561(e) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360bbb(e)) is amended by in-
serting before the period the following: ‘‘and shall 
include expanding access to drugs under section 
529, with substantial consideration being given to 
whether the totality of information available to the 
Secretary regarding the safety and effectiveness of 
an investigational drug, as compared to the risk of 
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morbidity and death from the disease, indicates that 
a patient may obtain more benefit than risk if treat-
ed with the drug’’. 
(4) CDC.—Title XV of the Public Health Serv-
ice Act (42 U.S.C. 300k et seq.) is amended by add-
ing at the end the following: 
‘‘SEC. 1511. EARLY DISEASE RESEARCH AND MANAGEMENT 
PROGRAM. 
‘‘The Secretary shall establish and implement an 
early disease research and management program targeted 
at the high incidence and mortality rates of lung cancer 
among minority and low-income populations.’’. 
(e) DEPARTMENT OF DEFENSE AND THE DEPART-
MENT OF VETERANS AFFAIRS.—The Secretary of Defense 
and the Secretary of Veterans Affairs shall coordinate 
with the Secretary of Health and Human Services— 
(1) in the development of the Lung Cancer 
Mortality Reduction Program under section 417H; 
(2) in the implementation within the Depart-
ment of Defense and the Department of Veterans 
Affairs of an early detection and disease manage-
ment research program for military personnel and 
veterans whose smoking history and exposure to car-
cinogens during active duty service has increased 
their risk for lung cancer; and 
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(3) in the implementation of coordinated care 
programs for military personnel and veterans diag-
nosed with lung cancer. 
(f) LUNG CANCER ADVISORY BOARD.— 
(1) IN GENERAL.—The Secretary of Health and 
Human Services shall convene a Lung Cancer Advi-
sory Board (referred to in this section as the 
‘‘Board’’)— 
(A) to monitor the programs established 
under this section (and the amendments made 
by this section); and 
(B) to provide annual reports to the Con-
gress concerning benchmarks, expenditures, 
lung cancer statistics, and the public health im-
pact of such programs. 
(2) COMPOSITION.—The Board shall be com-
posed of— 
(A) the Secretary of Health and Human 
Services; 
(B) the Secretary of Defense; 
(C) the Secretary of Veterans Affairs; and 
(D) two representatives each from the 
fields of clinical medicine focused on lung can-
cer, lung cancer research, imaging, drug devel-
opment, and lung cancer advocacy, to be ap-
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pointed by the Secretary of Health and Human 
Services. 
(g) AUTHORIZATION OF APPROPRIATIONS.— 
(1) IN
GENERAL.—To carry out this section 
(and the amendments made by this section), there 
are authorized to be appropriated such sums as may 
be necessary for each of fiscal years 2012 through 
2016. 
(2) LUNG CANCER MORTALITY REDUCTION PRO-
GRAM.—Of the amounts authorized to be appro-
priated by subsection (a), there are authorized to be 
appropriated— 
(A) $25,000,000 for fiscal year 2012, and 
such sums as may be necessary for each of fis-
cal years 2013 through 2016, for the activities 
described in section 417H(b)(1)(B) of the Pub-
lic Health Service Act, as added by subsection 
(d)(1); 
(B) $25,000,000 for fiscal year 2012, and 
such sums as may be necessary for each of fis-
cal years 2013 through 2016, for the activities 
described in section 417H(b)(1)(C) of such Act; 
(C) $10,000,000 for fiscal year 2012, and 
such sums as may be necessary for each of fis-
cal years 2013 through 2016, for the activities 
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described in section 417H(b)(1)(D) of such Act; 
and 
(D) $15,000,000 for fiscal year 2012, and 
such sums as may be necessary for each of fis-
cal years 2013 through 2016, for the activities 
described in section 417H(b)(3) of such Act. 
SEC. 702. EXPANDING PROSTATE CANCER RESEARCH, OUT-
REACH, SCREENING, TESTING, ACCESS, AND 
TREATMENT EFFECTIVENESS. 
(a) SHORT TITLE.—This section may be cited as the 
‘‘Prostate Research, Outreach, Screening, Testing, Access, 
and Treatment Effectiveness Act of 2011’’ or the ‘‘PROS-
TATE Act’’. 
(b) FINDINGS.—Congress makes the following find-
ings: 
(1) Prostate cancer is the second leading cause 
of cancer death among men. 
(2) In 2010, more than 217,730 new patients 
were diagnosed with prostate cancer and more than 
32,000 men died from this disease. 
(3) Roughly 2,000,000 Americans are living 
with a diagnosis of prostate cancer and its con-
sequences. 
(4) While prostate cancer generally affects older 
individuals, younger men are also at risk for the dis-
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ease, and when prostate cancer appears in early 
middle age it frequently takes on a more aggressive 
form. 
(5) There are significant racial and ethnic dis-
parities that demand attention, namely African- 
Americans have prostate cancer mortality rates that 
are more than double those in the White population. 
(6) Underserved rural populations have higher 
rates of mortality compared to their urban counter-
parts, and innovative and cost-efficient methods to 
improve rural access to high quality care should take 
advantage of advances in telehealth to diagnose and 
treat prostate cancer when appropriate. 
(7) Certain veterans populations may have 
nearly twice the incidence of prostate cancer as the 
general population of the United States. 
(8) Urologists may constitute the specialists 
who diagnose and treat the vast majority of prostate 
cancer patients. 
(9) Although much basic and translational re-
search has been completed and much is currently 
known, there are still many unanswered questions. 
For example, it is not fully understood how much of 
known disparities are attributable to disease eti-
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ology, access to care, or education and awareness in 
the community. 
(10) Causes of prostate cancer are not known. 
There is not good information regarding how to dif-
ferentiate accurately, early on, between aggressive 
and indolent forms of the disease. As a result, there 
is significant overtreatment in prostate cancer. 
There are no treatments that can durably arrest 
growth or cure prostate cancer once it has metasta-
sized. 
(11) A significant proportion (roughly 23 to 54 
percent) of cases may be clinically indolent and 
‘‘overdiagnosed’’, resulting in significant overtreat-
ment. More accurate tests will allow men and their 
families to face less physical, psychological, financial, 
and emotional trauma and billions of dollars could 
be saved in private and public health care systems 
in an area that has been identified by the Medicare 
program as one of eight high-volume, high-cost areas 
in the Resource Utilization Report program author-
ized by Congress under the Medicare Improvements 
for Patients and Providers Act of 2008. 
(12) Prostate cancer research and health care 
programs across Federal agencies should be coordi-
nated to improve accountability and actively encour-
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age the translation of research into practice, to iden-
tify and implement best practices, in order to foster 
an integrated and consistent focus on effective pre-
vention, diagnosis, and treatment of this disease. 
(c) PROSTATE CANCER COORDINATION AND EDU-
CATION.— 
(1) INTERAGENCY PROSTATE CANCER COORDI-
NATION AND EDUCATION TASK FORCE.—Not later 
than 180 days after the date of the enactment of 
this section, the Secretary of Veterans Affairs, in co-
operation with the Secretary of Defense and the Sec-
retary of Health and Human Services, shall estab-
lish an Interagency Prostate Cancer Coordination 
and Education Task Force (in this section referred 
to as the ‘‘Prostate Cancer Task Force’’). 
(2) DUTIES.—The Prostate Cancer Task Force 
shall— 
(A) develop a summary of advances in 
prostate cancer research supported or con-
ducted by Federal agencies relevant to the diag-
nosis, prevention, and treatment of prostate 
cancer, including psychosocial impairments re-
lated to prostate cancer treatment, and compile 
a list of best practices that warrant broader 
adoption in health care programs; 
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(B) consider establishing, and advocating 
for, a guidance to enable physicians to allow 
screening of men who are over age 74, on a 
case-by-case basis, taking into account quality 
of life and family history of prostate cancer; 
(C) share and coordinate information on 
Federal research and health care program ac-
tivities, including activities related to— 
(i) determining how to improve re-
search and health care programs, including 
psychosocial impairments related to pros-
tate cancer treatment; 
(ii) identifying any gaps in the overall 
research inventory and in health care pro-
grams; 
(iii) identifying opportunities to pro-
mote translation of research into practice; 
and 
(iv) maximizing the effects of Federal 
efforts by identifying opportunities for col-
laboration and leveraging of resources in 
research and health care programs that 
serve those susceptible to or diagnosed 
with prostate cancer; 
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(D) develop a comprehensive interagency 
strategy and advise relevant Federal agencies in 
the solicitation of proposals for collaborative, 
multidisciplinary research and health care pro-
grams, including proposals to evaluate factors 
that may be related to the etiology of prostate 
cancer, that would— 
(i) result in innovative approaches to 
study emerging scientific opportunities or 
eliminate knowledge gaps in research to 
improve the prostate cancer research port-
folio of the Federal Government; 
(ii) outline key research questions, 
methodologies, and knowledge gaps; and 
(iii) ensure consistent action, as out-
lined by section 402(b) of the Public 
Health Service Act; 
(E) develop a coordinated message related 
to screening and treatment for prostate cancer 
to be reflected in educational and beneficiary 
materials for Federal health programs as such 
documents are updated; and 
(F) not later than 2 years after the date 
of the establishment of the Prostate Cancer 
Task Force, submit to the Expert Advisory 
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