Sec. 1. Short title; table of contents. 
Sec. 2. Findings and purpose. 
Sec. 3. Advancement of the National Cancer Program. 
Sec. 4. Comprehensive and Responsible Access to Research, Data, and Out-
comes. 
Sec. 5. Enhanced focus and reporting on cancer research. 
Sec. 6. Continuing access to care for prevention and early detection. 
Sec. 7. Early recognition and treatment of cancer through use of biomarkers. 
Sec. 8. Extending coverage under Medicaid of counseling and pharmacotherapy 
for cessation of tobacco use. 
Sec. 9. Comprehensive cancer care and coverage under Medicare. 
Sec. 10. Targeted Cancers program. 
Sec. 11. Activities of the Food and Drug Administration. 
Sec. 12. CDC Cancer Control Programs. 
Sec. 13. NIH cancer survivorship programs. 
Sec. 14. Clinics for comprehensive long-term follow-up services for childhood 
cancer survivors. 
Sec. 15. Grants to improve access to care for childhood cancer survivors. 
SEC. 2. FINDINGS AND PURPOSE. 
(a) FINDINGS.—Congress makes the following find-
ings: 
(1) One in 2 men and one in 3 women are ex-
pected to develop cancer in their lifetimes. 
(2) Cancer is the leading cause of death for 
people under the age of 85 and is expected to claim 
more than 1,500 lives per day in 2008. 
(3) At least 30 percent of all cancer deaths and 
87 percent of lung cancer deaths are attributed to 
smoking. 
(4) The National Institutes of Health estimates 
that in 2007 alone, the overall cost of cancer to the 
United States was more than $219,000,000,000. 
(5) In recent decades, the biomedical research 
enterprise has made considerable advances in the 
knowledge required to understand, prevent, diag-
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nose, and treat cancer; however, it still takes 17 
years, on average, to translate these discoveries into 
viable treatment options. 
(6) While clinical trials are vital to the dis-
covery and implementation of new preventative, di-
agnostic, and treatment options, only 3 to 5 percent 
of the more than 10,000,000 adults with cancer in 
the United States participate in cancer clinical 
trials. 
(7) Where people reside should not determine 
whether they live, yet women in rural areas are less 
likely to obtain preventative cancer screenings than 
those residing in urban areas. 
(8) Two-thirds of childhood cancer survivors are 
likely to experience at least one late effect from 
treatment and one-fourth are expected to experience 
a late effect that is life threatening. 
(9) In 1971, there were only 3,000,000 cancer 
survivors. Today, cancer survivors account for 3 per-
cent of the United States population, approximately 
12,000,000. 
(10) The National Cancer Act of 1971 (Public 
Law 92–218) advanced the ability of the United 
States to develop new scientific leads and help in-
crease the rate of cancer survivorship. 
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(11) Yet in the 37 years since the national dec-
laration of the War on Cancer, the age adjusted 
mortality rate for cancer is still extraordinarily high. 
Eight forms of cancer have a 5-year survival rate of 
less than 50 percent (pancreatic, liver, lung, esopha-
geal, stomach, brain, multiple myeloma, and ovar-
ian). 
(12) While there have been substantial achieve-
ments since the crusade began, we are far from win-
ning the war on cancer. 
(13) Many obstacles have hindered our progress 
in cancer prevention, research, and treatment. 
(b) PURPOSES.—The purposes of this Act are as fol-
lows: 
(1) To reauthorize the National Cancer Pro-
gram in order to benefit cancer patients by enhanc-
ing and improving the cancer research conducted 
and supported by the National Cancer Institute and 
the National Cancer Program. 
(2) To recognize that with an increased under-
standing of cancer as more than 200 different dis-
eases with genetic and molecular variations, there is 
a need for increased coordination and greater flexi-
bility in how cancer research is conducted and co-
ordinated in order to maximize the return the 
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United States receives on its investment in such re-
search. 
(3) To prepare for the looming impact of an 
aging population of the United States and the an-
ticipated financial burden associated with medical 
treatment and lost productivity, along with the toll 
of human suffering that accompanies a cancer diag-
nosis. 
(4) To support the National Cancer Institute in 
establishing relationships and scientific consortia 
with an emphasis on public-private partnership de-
velopment, which will further the development of ad-
vanced technologies that will improve the prevention, 
diagnosis, and treatment of cancer. 
SEC. 3. ADVANCEMENT OF THE NATIONAL CANCER PRO-
GRAM. 
Section 411 of the Public Health Service Act (42 
U.S.C. 285a) is amended to read as follows: 
‘‘SEC. 411. NATIONAL CANCER PROGRAM. 
‘‘(a) IN GENERAL.—There shall be established a Na-
tional Cancer Program (referred to in this section as the 
‘Program’) that shall consist of— 
‘‘(1) an expanded, intensified, and coordinated 
cancer research program encompassing the research 
programs conducted and supported by the Institute 
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and the related research programs of the other na-
tional research institutes, including an expanded and 
intensified research program for the prevention of 
cancer caused by occupational or environmental ex-
posure to carcinogens; and 
‘‘(2) the other programs and activities of the 
Institute. 
‘‘(b) COLLABORATION.—In carrying out the Pro-
gram— 
‘‘(1) the Secretary and the Director of the In-
stitute shall identify relevant Federal agencies that 
shall collaborate with respect to activities conducted 
under the Program (including the Institute, the 
other Institutes and Centers of the National Insti-
tutes of Health, the Office of the Director of the Na-
tional Institutes of Health, the Food and Drug Ad-
ministration, the Centers for Medicare & Medicaid 
Services, the Centers for Disease Control and Pre-
vention, the Department of Defense, the Department 
of Energy, the Agency for Healthcare Research and 
Quality, the Office for Human Research Protections, 
the Health Resources and Services Administration, 
and the Office for Human Research Protections); 
and 
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‘‘(2) the Secretary shall ensure that the policies 
related to the promotion of cancer research of all 
agencies within the Department of Health and 
Human Services (including the Institute, the Food 
and Drug Administration, and the Centers for Medi-
care & Medicaid Services) are harmonized, and shall 
ensure that such agencies collaborate with regard to 
cancer research and development. 
‘‘(c) TRANSPARENCY AND EFFICIENCY.— 
‘‘(1) BUDGETING.—In carrying out the Pro-
gram, the Director of the Institute shall, in pre-
paring and submitting to the President the annual 
budget estimate for the Program— 
‘‘(A) develop the budgetary needs of the 
entire Program and submit the budget estimate 
relating to such needs to the National Cancer 
Advisory Board for review prior to submitting 
such estimate to the President; and 
‘‘(B) submit such budget estimate to the 
Committee on the Budget and the Committee 
on Appropriations of the Senate and the Com-
mittee on the Budget and Committee on Appro-
priations of the House of Representatives at the 
same time that such estimate is submitted to 
the President. 
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‘‘(2) NATIONAL CANCER ADVISORY BOARD.—In 
establishing the priorities of the Program, the Na-
tional Cancer Advisory Board shall provide for in-
creased coordination by increasing the participation 
of representatives (to the extent practicable, rep-
resentatives who have appropriate decision making 
authority) of appropriate Federal agencies, includ-
ing— 
‘‘(A) the Centers for Medicare & Medicaid 
Services; 
‘‘(B) the Health Resources and Services 
Administration; 
‘‘(C) the Centers for Disease Control and 
Prevention; and 
‘‘(D) the Agency for Healthcare Research 
and Quality. 
‘‘(d) PROGRAMS TO ENCOURAGE EARLY DETECTION 
RESEARCH.—The Director of the Institute shall develop 
a standard process through which Federal agencies, in-
cluding the Department of Defense, and administrators of 
federally funded programs may engage in early cancer de-
tection research. 
‘‘(e) 
IDENTIFICATION
OF
PROMISING 
TRANSLATIONAL RESEARCH OPPORTUNITIES.— 
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‘‘(1) IN GENERAL.—The Director of the Insti-
tute, acting through the Program and in accordance 
with the NIH Reform Act of 2007, shall continue to 
identify promising translational research opportuni-
ties across all disease sites, populations, and path-
ways to clinical goals through a transparent, inclu-
sive process by— 
‘‘(A) continuing to support efforts to de-
velop a robust number of public or nonprofit 
entities to carry out early translational research 
activities; 
‘‘(B) emphasizing the role of the young re-
searcher in the program under this section; and 
‘‘(C) modifying guidelines for multiproject, 
collaborative, 
early 
translational 
research 
awards to focus research and reward collabo-
rative team science. 
‘‘(2) MATCHING FUNDS FOR RESEARCH.— 
‘‘(A) IN
GENERAL.—The Secretary may 
provide assistance to eligible entities to match 
the amount of non-Federal funds made avail-
able by such entity for translational research of 
the type described in paragraph (1) relating to 
cancer. 
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‘‘(B) ELIGIBILITY.—To be eligible to re-
ceive assistance under subparagraph (A), an en-
tity shall submit to the Secretary an application 
at such time, in such manner, and containing 
such information as the Secretary may require. 
‘‘(C) 
RECOMMENDATIONS
AND 
PRIORITIZATION.—In 
providing 
assistance 
under subparagraph (A), the Secretary shall— 
‘‘(i) select entities based on the rec-
ommendations of— 
‘‘(I) the Director of NIH; and 
‘‘(II) a peer review process; and 
‘‘(ii) give priority to those entities 
submitting applications under subpara-
graph (B) that demonstrate that the re-
search involved is high risk or translational 
research (as determined by the Secretary). 
‘‘(D) AMOUNT.—The amount of assistance 
to be provided to an entity under subparagraph 
(A) shall be at the discretion of the Secretary 
but shall not exceed an amount equal to 100 
percent of the amount of non-Federal funds ($1 
for each $2 of non-Federal funds) made avail-
able for research described in subparagraph 
(A). 
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‘‘(E) DETERMINATION
OF
AMOUNT
OF 
NON-FEDERAL
CONTRIBUTION.—Non-Federal 
funds to be matched under subparagraph (A) 
may be in cash or in kind, fairly evaluated, in-
cluding plant, equipment, or services. Amounts 
provided by the Federal Government, and any 
portion of any service subsidized by the Federal 
Government, may not be included in deter-
mining the amount of such non-Federal funds. 
‘‘(f) BIOLOGICAL RESOURCE COORDINATION
AND 
ADVANCEMENT
OF TECHNOLOGIES
FOR CANCER RE-
SEARCH.— 
‘‘(1) ESTABLISHMENT.—The Director of the 
Institute, acting through the Program, shall estab-
lish an entity within the Institute to augment ongo-
ing efforts to advance new technologies in cancer re-
search, support the national collection of tissues for 
cancer research purposes, and ensure the quality of 
tissue collection. 
‘‘(2) GOALS.—The entity established under 
paragraph (1) shall— 
‘‘(A) be designed to expand the access of 
researchers to biospecimens for cancer research 
purposes; 
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‘‘(B) establish uniform standards for the 
handling and preservation of patient tissue 
specimens by entities participating in the net-
work established under paragraph (3); 
‘‘(C) require adequate annotation of all rel-
evant clinical data while assuring patient pri-
vacy; 
‘‘(D) facilitate the linkage of public and 
private entities into the national network under 
paragraph (3); 
‘‘(E) provide for the linkage of cancer reg-
istries to other administrative Federal Govern-
ment data sources, including the Centers for 
Medicare & Medicaid Services, the Social Secu-
rity Administration, and the Centers for Dis-
ease Control and Prevention, with the goal of 
understanding the determinants of cancer treat-
ment, care, and outcomes by allowing economic, 
social, genetic, and other factors to be analyzed 
in an independent manner; and 
‘‘(F) develop strategies to ensure patient 
rights and privacy, including an assessment of 
the 
regulations 
promulgated 
pursuant 
to 
HIPAA privacy and security law (as defined in 
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section 3009(a)(2)), while facilitating advances 
in medical research. 
‘‘(3) ADVANCEMENT
OF
NEW
TECHNOLOGIES 
FOR CANCER RESEARCH AND EXPANSION OF CANCER 
BIOREPOSITORY NETWORKS.— 
‘‘(A) IN GENERAL.—As part of the entity 
established under paragraph (1), the Director 
of the Institute shall build upon existing initia-
tives to establish an interconnected network of 
biorepositories (referred to in this subsection as 
the ‘Network’) with consistent, interoperable 
systems for the collection and storage of tissues 
and information, the annotation of such infor-
mation, and the sharing of such information 
through an interoperable information system. 
‘‘(B) GUIDELINES.—A biorepository in the 
Network that receives Federal funds shall adopt 
the Institute’s Best Practices for Biospecimen 
Resources for Institute-supported biospecimen 
resources (as published by the Institute and in-
cluding any successor guidelines) for the collec-
tion of biospecimens and any accompanying 
data. 
‘‘(C) REPRESENTATION.—The composition 
of any leadership entity of the Network shall be 
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determined by the Director of the Institute and 
shall, at a minimum, include a representative 
of— 
‘‘(i) private sector entities and individ-
uals, including cancer researchers and 
health care providers; 
‘‘(ii) the Centers for Disease Control 
and Prevention; 
‘‘(iii) the Agency for Healthcare Re-
search and Quality; 
‘‘(iv) the Office of National Coordina-
tion of Health Information Technology; 
‘‘(v) the National Library of Medicine; 
‘‘(vi) the Office for the Protection of 
Research Subjects; and 
‘‘(vii) the National Science Founda-
tion. 
‘‘(D) PARTNERSHIPS WITH TISSUE SOURCE 
SITES.—The Director of the Institute may 
enter into contracts with tissue source sites to 
acquire data from such sites. Any such data 
shall be acquired through the use of protocols 
and closely monitored, transparent procedures 
within appropriate ethical and legal frame-
works. 
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‘‘(4) COLLECTION OF DATA.— 
‘‘(A) HOSPITALS.—A hospital or ambula-
tory cancer center that receives Federal funds 
shall offer patients the opportunity to con-
tribute their biospecimens and clinical data to 
the entity established under paragraph (1). 
‘‘(B) CLINICAL TRIAL DATA.—Clinical trial 
data relating to cancer care and treatment shall 
be provided to the entity established under 
paragraph (1).’’. 
SEC. 4. COMPREHENSIVE AND RESPONSIBLE ACCESS TO 
RESEARCH, DATA, AND OUTCOMES. 
(a) IN GENERAL.—Not later than 180 days after the 
date of the enactment of this Act, the Director of the Of-
fice for Human Research Protections shall issue guidance 
to National Institutes of Health grantees concerning use 
of the facilitated review process in conjunction with the 
central institutional review board of the National Cancer 
Institute as the preferred mechanism to satisfy regulatory 
requirements to review ethical or scientific issues for all 
National Cancer Institute-supported translational and 
clinical research. 
(b) IMPROVED PRIVACY STANDARDS IN CLINICAL 
RESEARCH.— 
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(1) PERMITTED DISCLOSURE UNDER THE PRI-
VACY RULE.—For purposes of HIPAA privacy and 
security law (as referred to in section 411(f)(2)(F) 
of the Public Health Service Act, as amended by 
section 3), a covered entity (as defined for purposes 
of such law) shall be in compliance with such law re-
lating to the disclosure of de-identified patient infor-
mation if such disclosure is— 
(A) pursuant to a waiver that had been 
granted by an institutional review board or pri-
vacy board relating to such disclosure; and 
(B) in the case that such entity is a re-
search institution, the entity informs patients 
when they make first patient contact with the 
entity that the entity is a research institution 
that may conduct research using their de-identi-
fied medical records. 
(2) SYNCHRONIZATION OF STANDARDS.— 
(A) 
IN
GENERAL.—The 
Secretary 
of 
Health and Human Services shall study the ad-
vantages and disadvantages of the synchroni-
zation of the standards for research under the 
Common Rule (under part 46 of title 45, Code 
of Federal Regulations) and the HIPAA privacy 
and security law (as described in section 
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411(f)(2)(F) of the Public Health Service Act, 
as amended by section 3) in order to determine 
the appropriate data elements that should be 
omitted under the strict de-identification stand-
ards relating to personal information. 
(B) REVIEW OF RECOMMENDATIONS.—In 
carrying out subparagraph (A), the Secretary of 
Health and Human Services shall conduct a re-
view of recommendations made by the Advisory 
Committee on Human Research Protections as 
well as recommendations from the appropriate 
leadership of the National Committee on Vital 
and Health Statistics. 
(C) ADDITIONAL AREAS.—In carrying out 
subparagraph (A), the Secretary of Health and 
Human Services shall— 
(i) make recommendations concerning 
the conduct of international research to de-
termine the boundaries and applications of 
extraterritoriality under such HIPAA pri-
vacy and security law; and 
(ii) include biorepository storage infor-
mation when obtaining patient consent. 
(D) REPORT.—Not later than 180 days 
after the date of the enactment of this Act, the 
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Secretary of Health and Human Services shall 
submit to the appropriate committee of Con-
gress, a report concerning the recommendations 
made under this paragraph. 
(3) APPLICATION OF HIPAA PRIVACY AND SECU-
RITY LAW TO EXTERNAL RESEARCHERS.— 
(A) IN
GENERAL.—Notwithstanding any 
other provision of law, the HIPAA privacy and 
security 
law 
(as 
described 
in 
section 
411(f)(2)(F) of the Public Health Service Act, 
as amended by section 3) shall apply to external 
researchers. 
(B) DEFINITION.— 
(i) IN GENERAL.—In this paragraph, 
the term ‘‘external researcher’’ means a re-
searcher who is on the staff of a covered 
entity (as defined for purposes of the 
HIPAA privacy and security law) but who 
is not actually employed by such covered 
entity. 
(ii) INTERNAL
AND
EXTERNAL
RE-
SEARCHERS.—With respect to determining 
the distinction of whether or not a re-
searcher has the ability to use protected 
health information under the provisions of 
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