I 
108TH CONGRESS 
1ST SESSION H. R. 2741
To provide for a comprehensive Federal effort relating to early detection 
of, treatments for, and the prevention of cancer, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 15, 2003
Mrs. CAPPS (for herself, Mr. GEORGE MILLER of California, Mrs. MALONEY, 
Mr. FROST, and Mr. TOWNS) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce, and in addition to 
the Committees on Education and the Workforce and Ways and Means, 
for a period to be subsequently determined by the Speaker, in each case 
for consideration of such provisions as fall within the jurisdiction of the 
committee concerned 
A BILL 
To provide for a comprehensive Federal effort relating to 
early detection of, treatments for, and the prevention 
of cancer, 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; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘National Cancer Act of 2003’’. 
(b) TABLE OF CONTENTS.—The table of contents for 
this Act is as follows:
Sec. 1. Short title; table of contents. 
Sec. 2. Findings. 
TITLE I—EXPANSION OF CANCER-RELATED RESEARCH, 
PREVENTION, DETECTION, AND TREATMENT PROGRAMS 
Sec. 101. Sense of the House of Representatives concerning investments in can-
cer research funding. 
Sec. 102. Sense of the House of Representatives concerning investments in can-
cer research to develop targeted drugs. 
Sec. 103. Expansion of cancer-related research, prevention, detection, treat-
ment, and survivorship programs. 
Sec. 104. National Institute for Environmental Health Sciences. 
Sec. 105. Comprehensive cancer control plans. 
Sec. 106. Breast, cervical, and colorectal cancer screening. 
Sec. 107. IHS grants for model community cancer and chronic disease care and 
prevention; IHS grants for patient navigators. 
TITLE II—EXPANDING ACCESS TO CANCER DRUGS AND 
TREATMENT 
Sec. 201. Acceleration of the drug treatment approval process of the Food and 
Drug Administration. 
Sec. 202. FDA amendment. 
TITLE III—CANCER-RELATED HEALTH INSURANCE COVERAGE 
Subtitle A—Clinical Trials Coverage 
Sec. 301. Coverage for clinical trials under the Public Health Service Act. 
Sec. 302. Coverage for clinical trials under the Employee Retirement Income 
Security Act of 1974. 
Sec. 303. Coverage for clinical trials under other public health insurance. 
Subtitle B—Cancer Screening and Other Coverage 
Sec. 311. Cancer screening coverage. 
Subtitle C—Physicians and Quality of Care 
Sec. 321. Managing physicians and quality of care for cancer patients under 
the Public Health Service Act. 
Sec. 322. Managing physicians and quality of care for cancer patients under 
the Employee Retirement Income Security Act of 1974. 
Sec. 323. Managing physicians and quality of care for cancer patients under 
medicare.
Sec. 324. Managing physicians and quality of care for cancer patients under 
medicaid and SCHIP. 
Subtitle D—General Provisions 
Sec. 331. Coverage under other public health insurance. 
TITLE IV—PATIENT NAVIGATOR AND CANCER CARE WITHIN THE 
HEALTH RESOURCES AND SERVICES ADMINISTRATION 
Sec. 401. HRSA grants for model community cancer and chronic disease care 
and prevention and grants for patient navigators.
SEC. 2. FINDINGS. 
Congress makes the following findings: 
(1) Each year 1,300,000 Americans are diag-
nosed with cancer. Each year 560,000 Americans die 
from cancer. Approximately 40 percent of all Ameri-
cans in the United States will be diagnosed with 
cancer at some point in their lives. 
(2) Since 1971, when the National Cancer Act 
was enacted, and the ‘‘War on Cancer’’ was de-
clared, the science of cancer has advanced dramati-
cally. The revolution in molecular and cellular biol-
ogy has created unprecedented opportunities for un-
derstanding cancer and the role of genetics, environ-
mental risk factors, and lifestyle factors in relation 
to cancer. 
(3) Since 1971, mortality rates for some can-
cers have decreased, while such rates for other can-
cers have not. 
(4) Since 1971, the Nation’s population has be-
come increasingly diverse and cancer affects various
minority, socioeconomic, and ethnic groups dis-
proportionately. 
(5) Cancer screening can reduce cancer mor-
tality, in some cases by 30 percent or more. While 
effective screening tools have yet to be developed for 
the majority of cancers, proven screening tools for 
early detection do exist for some of the more com-
mon cancers. Screening for some cancers, such as 
breast, colorectal, and cervical cancers, has improved 
dramatically; however, screening rates are still lower 
than optimal. Cancer screening rates vary by cancer 
site, population group, and health insurance cov-
erage. 
(6) Public and private health insurance cov-
erage offered in the United States has dramatically 
changed since 1971. Today, managed care coverage 
is more typical than the fee-for-service coverage that 
was more common in the past. This change in the 
form of coverage has introduced more economic con-
siderations into medical decisionmaking, which can 
affect the quality of all health care provided, includ-
ing cancer care. 
(7) Fewer than 5 percent of adult cancer pa-
tients participate in cancer trials.
(8) New translational cancer research centers 
are needed to provide the preclinical and early clin-
ical trials support required to advance scientific dis-
coveries into new drugs and technologies to prevent, 
detect, treat, and diagnose cancer. 
(9) The quality of cancer care is uneven across 
the Nation and can be based on pure coincidence of 
where one lives. Many cancer patients do not receive 
optimal care. 
(10) Cancer is a disease of aging and as the 
American population ages, cancer incidence will 
grow. It is estimated that the number of cancer di-
agnoses in 2010 will increase by 20 percent. The 
number of cancer deaths is anticipated to increase 
by 20 percent, at an annual cost of over 
$200,000,000,000. With such increases in the inci-
dence of cancer, there will be a serious shortage of 
individuals in the workforce to provide cancer care, 
particularly in long-term care settings. 
(11) The number of medical researchers is de-
clining, a decrease which will negatively affect the 
prevention, detection, and treatment of cancer. 
(12) Since 1971, there has been a shift in can-
cer care, such as the administration of chemo-
therapy, moving from inpatient to outpatient set-
tings.
(13) Since 1971, the conduct of research has 
involved more collaboration between the public and 
private sectors and more multidisciplinary ap-
proaches. The biotechnology pharmaceutical and de-
vice industry has grown and provided a broad array
of new treatment options and scientific opportunities 
for cancer patients, providers, and researchers. 
(14) Since 1971, technology and communica-
tions have expanded and increased in complexity, 
transforming research methodologies and making the 
accessing and transmitting of information more 
widespread and more readily available. 
(15) Tobacco use is the leading preventable 
cause of disease and premature death in the United 
States, resulting in 1⁄3 of all cancer deaths, including 
87 percent of lung cancer deaths. Research consist-
ently shows that smoking cessation services can be 
1 of the most cost-effective health interventions and 
can reduce smoking-related health care costs. Ces-
sation services offered as a combination of tobacco 
medication therapy and counseling effectively help 
smokers quit successfully and prevent premature 
death from tobacco-related cancers.
TITLE I—EXPANSION OF CAN-
CER-RELATED 
RESEARCH, 
PREVENTION, 
DETECTION, 
AND TREATMENT PROGRAMS 
SEC. 101. SENSE OF THE HOUSE OF REPRESENTATIVES 
CONCERNING INVESTMENTS IN CANCER RE-
SEARCH FUNDING. 
It is the sense of the House of Representatives that—
(1) past investments in cancer research have re-
sulted in better health, an improved quality of life, 
and a reduction in national health care expenditures; 
and 
(2) to build on, and sustain, the progress made 
over the past 5 years during which Congress doubled 
the budget at the National Institutes of Health, the 
National Cancer Institute requires continued in-
creases in Federal funding, as outlined in the Na-
tional Cancer Institute Directors Bypass Budget, to 
achieve a balanced research portfolio and to develop 
more targeted, more effective therapies or drugs and 
other cancer treatments and to address those rare, 
deadly cancers lacking effective early detection tests 
or treatments for a wide range of cancers, commen-
surable with the National Cancer Institute bypass 
budget.
SEC. 102. SENSE OF THE HOUSE OF REPRESENTATIVES 
CONCERNING INVESTMENTS IN CANCER RE-
SEARCH TO DEVELOP TARGETED DRUGS. 
(a) FINDINGS.—The House of Representatives finds 
that—
(1) all cells have molecular signatures, unique 
identifiable characteristics related to a cell’s function 
in the body; 
(2) as a normal cell becomes malignant, its sig-
nature changes and this change becomes a signal of 
the presence of cancer; and 
(3) with new technologies, scientists are reading 
cancer-associated signatures and using this informa-
tion to devise treatments that target specific cells. 
(b) SENSE OF THE HOUSE OF REPRESENTATIVES.—
It is the sense of the House of Representatives that to 
build on the research currently conducted by the National 
Institutes of Health, increased funding is necessary to fur-
ther develop this new generation of low toxicity, high effi-
cacy agents which target only the cancer cells leaving in 
place the healthy cells. 
SEC. 103. EXPANSION OF CANCER-RELATED RESEARCH, 
PREVENTION, DETECTION, TREATMENT, AND 
SURVIVORSHIP PROGRAMS. 
Subpart 1 of part C of title IV of the Public Health 
Service Act (42 U.S.C. 285) is amended—
(1) by inserting after the subpart heading the 
following: 
‘‘CHAPTER I—PURPOSE OF INSTITUTE AND 
NATIONAL CANCER PROGRAMS’’; 
and 
(2) by adding at the end the following: 
‘‘CHAPTER II—PROGRAMS TO PREVENT AND 
TREAT CANCER 
‘‘SEC. 417E. STUDY AND STRATEGIC PLANS. 
‘‘(a) IN GENERAL.—Not later than July 1, 2005, the 
Institute shall prepare 1 or more strategic plans to iden-
tify unmet needs and the level of funding in the areas of 
prevention, treatment, early detection, and quality of life, 
and to expand and intensify cancer research and cancer-
related research by July 1, 2006, for—
‘‘(1) behavioral research associated with caus-
ing and preventing cancer; 
‘‘(2) research regarding prevention of cancer 
other than behavioral interventions; 
‘‘(3) research to reduce disparities among racial 
and ethnic minorities and other disparity popu-
lations; 
‘‘(4) research regarding palliative care, pain 
management;
‘‘(5) research regarding preserving and restor-
ing quality-of-life for cancer patients; 
‘‘(6) research regarding environmental risk fac-
tors for cancer and gene-environment interactions; 
‘‘(7) research regarding management of symp-
toms;
‘‘(8) research regarding tools for early detec-
tion, especially for which there currently are no ade-
quate screening technologies; and 
‘‘(9) cancer survivorship. 
‘‘(b) PRIORITIES.—The Institute shall determine pri-
orities based on scientific opportunities, in consultation 
with medical, scientific, patient, and provider representa-
tives, and prepare 1 or more strategic plans by July 1, 
2005. 
‘‘SEC. 417E–1. GRANTS FOR TRANSLATIONAL CANCER RE-
SEARCH. 
‘‘(a) IN GENERAL.—The Director of the Institute 
shall carry out a program to establish translational cancer 
research centers. 
‘‘(b) DUTIES OF DIRECTOR.—In carrying out the 
program, the Director of the Institute shall—
‘‘(1) award grants to public or nonprofit private 
entities to plan and operate a national network of at 
least 20 existing or new translational cancer re-
search centers to conduct translational, multidisci-
plinary cancer research; 
‘‘(2) establish networks and partnerships link-
ing the translational cancer research centers de-
scribed in paragraph (1) to community cancer pro-
viders (hospitals, clinics, providers’ practices, par-
ticularly in underserved areas) and expand opportu-
nities for all cancer patients to participate in clinical 
trials of new agents developed by these centers; 
‘‘(3) facilitate the process to award grants, con-
tracts, and cooperative agreements to private entities 
to conduct translational cancer research in the fol-
lowing areas—
‘‘(A) cancer drugs, biologics, and devices; 
and 
‘‘(B) cancer detection diagnostic tests, 
techniques, and technology; and 
‘‘(4) develop and implement a strategic plan by 
July 1, 2005, in collaboration with translational cen-
ters as authorized in paragraph (7) for intensifying, 
expanding, and disseminating results of translational 
research to providers of cancer care. 
‘‘(c) GRANTS.—
‘‘(1) IN GENERAL.—The Director of the Insti-
tute shall award grants to public or nonprofit pri-
vate entities to establish translational cancer re-
search centers to conduct translational, multidisci-
plinary cancer research. Funds shall not be used for 
construction of new facilities. 
‘‘(2) EQUITY.—The Director of the Institute 
shall award grants under subsection (b)(1) to pro-
vide, to the greatest extent practicable, a broad dis-
tribution of such grants among geographic regions 
of the United States. 
‘‘(3) DUTIES.—A public or nonprofit entity that 
receives a grant under subsection (b)(1) shall use 
funds received through such grant to establish and 
operate a translational cancer research center. 
‘‘(4) APPLICATION.—A public or nonprofit enti-
ty desiring a grant under this subsection shall sub-
mit an application to the Director of the Institute at 
such time, in such manner, and containing such in-
formation as the Director of the Institute may rea-
sonably require. 
‘‘(d) DUTIES OF TRANSLATIONAL RESEARCH CEN-
TERS.—The translational research centers shall—
‘‘(1) perform research for discovery and pre-
clinical evaluation of drugs, biologics, devices, tech-
nologies, and strategies with potential to improve the 
prevention, detection, diagnosis, and treatment of
cancer and to improve pain and symptom manage-
ment and quality of life of cancer patients; 
‘‘(2) perform clinical research studies on prom-
ising cancer treatments or strategies, in appropriate 
human populations; 
‘‘(3) evaluate promising cancer diagnostic tests, 
techniques, or technologies in individuals being eval-
uated for the presence of cancer; 
‘‘(4) perform all phases of clinical trials of new 
drugs, devices, biologics, or other strategies for 
treating patients with cancer, in collaboration with 
the existing NCI Cooperative Groups; 
‘‘(5) develop and implement a plan to ensure 
the availability of adequate sources of patients for 
each type of clinical research study; 
‘‘(6) create systems and external relationships, 
which do not duplicate capabilities available in the 
private sector, to accelerate the findings from 
translational research to a stage that private compa-
nies can assume development and commercialization; 
and 
‘‘(7) develop and implement a plan expanding 
and disseminating the efficacious products of 
translational research to providers of cancer care, in-
cluding products approved by the Food and Drug 
Administration. 
‘‘(e) DEFINITIONS.—In this section: 
‘‘(1) CLINICAL TRIAL.—The term ‘clinical trial’ 
means a scientifically-designed clinical investigation 
in which a patient participates in examining the ef-
fects of a drug, biologic medical treatment, or med-
ical device for the prevention, early detection, or 
treatment of cancer or the potential side effects of 
treatment or of the disease. 
‘‘(2) TRANSLATIONAL
CANCER
RESEARCH.—
The term ‘translational cancer research’ means sci-
entific laboratory and clinical research and testing 
needed to transform scientific discoveries into new 
approaches and products that can prevent, detect, 
control, diagnose, and treat cancer, optimize quality 
of life, and ultimately, cure cancer. 
‘‘(f) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section, 
$100,000,000 in fiscal year 2004, and $100,000,000 for 
each of the fiscal years 2005, 2006, 2007, and 2008. 
‘‘SEC. 417E–2. GRANTS FOR DEVELOPMENT OF TARGETED 
DRUGS. 
‘‘(a) IN GENERAL.—The Director of the Institute 
shall carry out a research grant program to provide fund-
ing to projects that seek to develop cancer treatments that 
target cancer cells. 
‘‘(b) DUTIES OF DIRECTOR.—In carrying out the 
program under subsection (a), the Director of the Insti-
tute shall—
‘‘(1) award grants and facilitate the process to 
award grants to public or nonprofit private entities 
to conduct research to develop a molecularly-ori-
ented, knowledge-based approach to cancer drug dis-
covery and development; and 
‘‘(2) not later than July 1, 2005, develop and 
implement a strategic plan for intensifying and ex-
panding research conducted to increase the number 
of cancer treatments available that are low toxicity, 
high efficacy agents, and in particular, research to 
develop treatments that selectively target malignant 
or cancerous cells. 
‘‘(c) LIMITATIONS.—Amounts awarded under grants 
under this section shall not be used for the construction 
of facilities. 
‘‘(d) AUTHORIZATION OF APPROPRIATIONS.—There 
is authorized to be appropriated to carry out this section, 
$20,000,000 in fiscal year 2004, and $20,000,000 for 
each of the fiscal years 2005, 2006, 2007, and 2008.
‘‘SEC. 417E–3. CLINICAL TRIALS. 
‘‘(a) IN GENERAL.—The Director of the Institute 
shall carry out a program to increase patient and provider 
participation in clinical trials. 
‘‘(b) PROGRAM.—The program described in sub-
section (a) shall include—
‘‘(1) an outreach program; 
‘‘(2) a diversity assurance program; 
‘‘(3) an assistance program, including recom-
mending sources of funding for patients support 
costs; and 
‘‘(4) culturally appropriate materials. 
‘‘(c) OUTREACH PROGRAM.—In carrying out the out-
reach program described in subsection (a), the Director 
of the Institute shall regularly provide information to can-
cer care providers, professional and patient organizations, 
including community-based organizations, and patients to 
increase provider participation and patient enrollment in 
clinical trials. 
‘‘(d) DIVERSITY ASSURANCE PROGRAM.—In carrying 
out the diversity assurance program described in sub-
section (a), the Director of the Institute shall require that 
all research grant applications include assurances that the 
applicant will actively recruit a diverse patient population, 
including disparity populations, to participate in trials, 
when such recruitment is medically appropriate.
‘‘SEC. 417E–4. CANCER CARE RESEARCHERS. 
‘‘(a) SUPPLY OF CANCER RESEARCHERS.—In order 
to ensure a sufficient number of researchers trained in the 
prevention, early detection, diagnosis, cure, and treatment 
of cancer in future fiscal years, the Director of the Insti-
tute, in coordination with the Secretary of Veterans Af-
fairs, shall carry out activities to—
‘‘(1) increase the number and amount of insti-
tutional training grants to institutions supporting 
cancer research; and 
‘‘(2) increase the number of career development 
awards for health professionals, particularly minori-
ties, who intend to have, or who expand, careers in 
basic, clinical, and translational cancer research, in-
cluding cancer prevention, cancer information tech-
nology, bioinformatics, behavioral research, and re-
search on palliative, psychosocial, and end-of-life 
care. 
‘‘(b) LOAN REPAYMENT.—
‘‘(1) ESTABLISHMENT.—The Director of the 
Institute, in consultation with the Director of the 
National Institutes of Health, shall establish a can-
cer research loan repayment program. 
‘‘(2) CONTRACTS.—Under the program estab-
lished under paragraph (1), the Director of the In-
stitute shall enter into contracts with qualified