1.Short title; table of
contents
(a)This Act may be cited as the National Cancer Act of 2007
.
(b)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 Senate concerning investments in cancer
research funding.
Sec. 102. Sense of the Senate concerning investments in cancer
research to develop targeted drugs.
Sec. 103. Expansion of cancer-related research, prevention,
detection, treatment, and survivorship programs.
Sec. 104. National Institute for Environmental Health
Sciences.
Sec. 105. National Center on Minority Health and Health
Disparities.
Sec. 106. Comprehensive cancer
control plans.
Sec. 107. Lung cancer early
detection demonstration project.
Sec. 108. Colorectal cancer screening.
Sec. 109. National program of cancer registries.
Sec. 110. Other transactions authority.
TITLE II—Expanding access to cancer drugs and
treatment
Sec. 201. Drugs to prevent cancer.
Sec. 202. Compassionate access to investigational drugs and
devices.
Sec. 203. Oncology Drugs Advisory Committee.
Sec. 204. Technical amendment.
TITLE III—Payments for cancer-related services and
products
Sec. 301. Coordinating cancer care for patients.
Sec. 302. Elimination of
optional exclusion from medicaid prescription drug coverage for tobacco
cessation medications.
TITLE IV—Promoting biospecimen collection to accelerate the
genomic mapping of the most lethal cancers
Sec. 401. Adoption of National Cancer
Institute guidelines for biorepositories.
Sec. 402. MedPac report on payments for
specimen collection.
2.Congress makes the following
findings:
(1)Cancer killed
6,700,000 people around the world in 2002 and this figure is expected to rise
to 10,100,000 in 2020.
(2)In 2007, an
estimated 1,444,920 new cancer cases will be diagnosed in the United States.
More than 1,000,000 cases of skin cancer are also expected to be diagnosed this
year. Cancer accounts for one in every four deaths, and about 559,650 Americans
are expected to die from cancer this year. Approximately 40 percent of all
Americans in the United States will be diagnosed with cancer at some point in
their lives, 1 of every 2 men and 1 of every 3 women.
(3)The National
Institutes of Health estimated the overall cost of cancer for 2006 at
$206,300,000,000.
(4)Cancer can strike
at any age, but it remains largely a disease of aging. As the American
population ages, the number of cancer cases will rise. It is estimated that
between 2000 and 2010, the number of cancer diagnoses will increase by 20
percent based on this change in population dynamics and no change in cancer
risk. With such increases in the incidence of cancer, not only will costs
continue to grow, but there will be a serious shortage of individuals in the
workforce to provide cancer care, particularly in long-term care
settings.
(5)Since 1971, when
the National Cancer Act was enacted, and the War on Cancer
was
declared, the science of cancer has advanced dramatically. The revolution in
molecular and cellular biology and advances in technology have created
unprecedented opportunities for understanding cancer and the role of genetics,
environmental risk factors, and lifestyle factors in relation to cancer.
(6)Since 1971,
mortality rates for some cancers have decreased, while such rates for other
cancers remain high. The United States has seen the number of cancer deaths
drop for 2 consecutive years, despite an older and larger population. This
success is largely due to reductions in smoking prevalence over the past
several decades, improvements in cancer screening rates, and the use of
increasingly effective treatment regimens.
(7)Since 1971, the
United States population has become increasingly diverse and cancer affects
various minority, socioeconomic, and ethnic groups disproportionately. For
example, in 2003, the death rate from cancer among African American males was
35 percent higher than that among white males and for African American females,
it was 18 percent higher than white females.
(8)The quality of
cancer care is uneven across the Nation. Many cancer patients do not receive
optimal care.
(9)Cancer is the
chief cause of death by disease in children between the ages of 1 and 14. Each
year, 14,000 children and adolescents are diagnosed with cancer. However, while
nearly every childhood cancer diagnosis 20 years ago was fatal, today
approximately 80 percent of children diagnosed with cancer survive at least 5
years.
(10)Survivors of
childhood cancer are 5 times more likely to suffer moderate to severe health
problems in adulthood than their healthy siblings.
(11)Adolescents and
young adults diagnosed with cancer between ages 15 and 39 have seen little or
no improvement in cancer survival rates in decades and are the least
represented population in clinical trials. Survivors in this age range are at
risk for many long-term adverse treatments effects such as second primary
cancers, heart failure, hearing loss, and cognitive dysfunction.
(12)Cancers that can
be prevented or detected earlier by screening account for at least half of all
new cancer cases. Screening can detect cancers of the breast, colon, rectum,
cervix, prostate, oral cavity and skin at early stages, resulting in a 5-year
survival rate of about 86 percent, a reflection of real reductions in mortality
as well as earlier diagnosis because of screening. Cancer screening rates vary
by cancer site, population group, and health insurance coverage.
(13)Approximately
10,500,000 cancer survivors are living in the United States. These survivors
may experience physical, psychological, social and economic effects as a result
of cancer and its treatment.
(14)About 76 percent
of all cancers are diagnosed at age 55 and older, and 6 of every 10 cancer
diagnoses are at age 65 and above. Medicare plays a critical role in providing
cancer care for many Americans.
(15)Scientific
advances in cancer treatment since 1971 have helped shift cancer care, such as
the administration of chemotherapy, increasingly from inpatient to outpatient
settings.
(16)Clinical trials
are a critical resource for the discovery of new prevention, diagnostic, and
treatment methods for cancer. However, only 3 to 5 percent of the nearly
1,400,000 adult cancer patients each year participate in cancer clinical
trials, contrasted with the 60 percent participation rate of children with
cancer.
(17)New
translational research centers focused on cancer are needed to provide the
preclinical and early clinical trial support required to advance scientific
discoveries into new drugs and technologies to prevent, detect, treat, and
diagnose cancer.
(18)The number of
medical researchers is declining, a decrease which will negatively affect the
prevention, detection, and treatment of cancer.
(19)Since 1971, the
conduct of research has involved more collaboration between public and private
sectors and more multidisciplinary approaches. The biotechnology pharmaceutical
and device industries have grown and provided a broad array of prevention,
detection, and treatment approaches and scientific opportunities for cancer
patients, providers, and researchers.
(20)In May 2001,
Gleevec, the first in what is expected to be a number of targeted cancer
treatments, was approved for use by the Food and Drug Administration. It
appeared to be effective in stopping the growth of deadly Chronic Myeloid
Leukemia cells within 3 months of use. In 2002, Gleevec showed ability to stop
growth of gastrointestinal stromal tumors. Trials have now demonstrated that 89
percent of CML patients taking Gleevec are alive 5 years after
diagnosis.
(21)Other targeted
cancer therapies, such as Avastin, Tarceva, and Herceptin are emerging as
promising cancer treatments.
(22)In 2006, the
Food and Drug Administration approved the first vaccine to prevent the two
strains of Human Papillomavirus (HPV) responsible for 70 percent of cervical
cancer cases.
(23)Tobacco use is
the leading preventable cause of disease and premature death in the United
States, resulting in approximately 1/3 of all cancer deaths, including 87
percent of lung cancer deaths. Smoking alone causes more than $167,000,000 in
annual health related costs.
(24)The development
of molecular technology and chemopreventative agents to attack precancerous
cells before they develop into tumors is a promising way to reduce cancer
incidence and death rates.
<enum>I</enum><header>Expansion of
cancer-related research, prevention, detection, and treatment programs</header>
<section id="IDCC4A124A6B814B4E99A8463302D8DF9F"><enum>101.</enum><header>Sense of the
Senate concerning investments in cancer research funding</header><text display-inline="no-display-inline">It is the sense of the Senate that—</text>
<paragraph id="ID5B4E7C9C745F4E52A89B38B15ED054BB"><enum>(1)</enum><text>past investments
in cancer research have resulted in better health, an improved quality of life,
and new discoveries; and</text>
</paragraph><paragraph id="ID5D3A19099E604520806FE00053B0F6CB"><enum>(2)</enum><text>to build on, and
sustain, the progress made between 1998 and 2003 during which Congress doubled
the budget at the National Institutes of Health, the National Cancer Institute
requires continued Federal investment, as outlined in the National Cancer
Institute Directors Bypass Budget: The Nation's Investment in Cancer, 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, commensurable with the National Cancer Institute
bypass budget.</text>
</paragraph></section><section id="IDDB749B0172964CCC8E87887B0705C737"><enum>102.</enum><header>Sense of the
Senate concerning investments in cancer research to develop targeted
drugs</header>
<subsection id="IDDCDEE22F843A4CD5BAA610CAEDCA57BE"><enum>(a)</enum><header>Findings</header><text>The
Senate finds that—</text>
<paragraph id="ID254F26DF7CBA4777AEE5B87B9D00B561"><enum>(1)</enum><text>all cells have
molecular signatures, unique identifiable characteristics related to a cells’
function in the body;</text>
</paragraph><paragraph id="IDE47571A467FF4B22AD564B7C714FEC93"><enum>(2)</enum><text>as a normal cell
becomes malignant, its signature changes and this change becomes a signal of
the presence of cancer; and</text>
</paragraph><paragraph id="IDAA5A7694CBF74486AD2615A7FB28006D"><enum>(3)</enum><text>with new
technologies, scientists are reading cancer-associated signatures and using
this information to devise treatments that target specific cells.</text>
</paragraph></subsection><subsection id="ID2D1B9D3B988247E298DC1866BCFF19DC"><enum>(b)</enum><header>Sense of the
Senate</header><text>It is the sense of the Senate that to build on the
research currently conducted by the National Institutes of Health, continued
funding is necessary to further develop this new generation of low toxicity,
high efficacy agents which target only the cancer cells leaving in place the
healthy cells.</text>
</subsection></section><section id="ID1855DCFFAFC94CDBA343905D59D52161"><enum>103.</enum><header>Expansion of
cancer-related research, prevention, detection, treatment, and survivorship
programs</header><text display-inline="no-display-inline">Subpart 1 of part C
of title IV of the <act-name parsable-cite="PHSA">Public Health Service
Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/285">42
U.S.C. 285</external-xref>) is amended—</text>
<paragraph id="ID2EB24CA209D24BDFA114C9CA00261E9B"><enum>(1)</enum><text>by inserting
after the subpart heading the following:</text>
<quoted-block id="ID93B41624122F4EDCA0274F48F3F113C4">
<chapter id="ID2EDEED9FB8B54C5585DEEC9FBC68D4A1"><enum>I</enum><header>Purpose of
Institute and national cancer
programs</header>
</chapter><after-quoted-block>;</after-quoted-block></quoted-block>
</paragraph><paragraph id="ID7EE3AC449DD242919968564CADAB9DBA"><enum></enum><text>and</text>
</paragraph><paragraph id="ID97C44503970D4B15ACE5948F4273B4B8"><enum>(2)</enum><text>by adding at the
end the following:</text>
<quoted-block id="ID80551BECF25949D09D8F93ECD0271915">
<chapter id="ID930BBDFD4AC04016995933DD981CFC26"><enum>II</enum><header>Programs to
prevent and treat cancer</header>
<section id="IDF1780DB5AADB46D5B403B6C3125CC844"><enum>417E.</enum><header>Study and
strategic plans</header>
<subsection id="ID9D2748C6718140BFA6E550A03E920014"><enum>(a)</enum><header>In
general</header><text>Not later than 6 months after the date of enactment of
the <short-title>National Cancer Act of
2007</short-title>, the Institute shall prepare a progress report on the goal
of reducing death and suffering from cancer in the next 10 years, that
identifies unmet needs, recommends progress goals and benchmarks, recommends
programmatic restructuring, and recommends a level of funding necessary in the
following areas:</text>
<paragraph id="ID24AF82CA586B4E7990F4A62BAC267431"><enum>(1)</enum><text>Understanding the
causes of cancer.</text>
</paragraph><paragraph id="ID8B833A5BC3DC4470ABE78C45FAE84B66"><enum>(2)</enum><text>Research
regarding cancer prevention.</text>
</paragraph><paragraph id="ID0C470362E26C4950B3C188B80147C987"><enum>(3)</enum><text>Improving early
detection and diagnosis of cancer.</text>
</paragraph><paragraph id="ID99B56516BE9F4BAF0077BDC2FA74E2E6"><enum>(4)</enum><text>Developing
effective and efficient cancer treatments.</text>
</paragraph><paragraph id="IDD09757F5F6B04EE3B8852798F4580053"><enum>(5)</enum><text>Understanding the
factors that influence patient outcomes.</text>
</paragraph><paragraph id="IDA08243146D134158810833DDCA4F443B"><enum>(6)</enum><text>Improving the
quality of cancer care.</text>
</paragraph><paragraph id="IDBB28DA3F5E824322B48978D8E188CE19"><enum>(7)</enum><text>Research
regarding the quality of life for cancer patients and survivors.</text>
</paragraph><paragraph id="ID6AF0F94DA13A4C7AA709BF8CFD935C54"><enum>(8)</enum><text>Overcoming cancer
health disparities.</text>
</paragraph></subsection><subsection id="IDAA3D57773129495BBEE1EF4CD59447DC"><enum>(b)</enum><header>Detailed
report</header><text>The Institute shall include in future reports to Congress
an accounting for the manner in which Congressional funding for cancer
activities described in subsection (a) was used during the 5-fiscal year period
preceding the date of enactment of the <short-title>National Cancer Act of 2007</short-title>, that includes a
detailed description of the type of cancer and the treatment, device, tool, or
discovery that was procured and the estimated number of individuals with cancer
who benefitted from such activities.</text>
</subsection><subsection id="IDD2F7A1B6F60A4F74000253AE5BDB92B1"><enum>(c)</enum><header>Priorities</header><text>Not
later than 6 months after the date of enactment of the
<short-title>National Cancer Act of 2007</short-title>,
the Institute shall determine priorities based on scientific opportunities, in
consultation with medical, scientific, patient, and provider representatives,
and prepare 1 or more strategic plans.</text>
</subsection></section><section id="ID4F8E2DD9A52B4E62AE92E9177817638E"><enum>417E–1.</enum><header>Grants for
development of targeted drugs</header>
<subsection id="ID5E8CE6E5C48A4F10B7AABE4205A5C504"><enum>(a)</enum><header>In
general</header><text>The Director of the Institute shall carry out a research
grant program to provide funding to projects that seek to develop cancer
treatments that target cancer cells.</text>
</subsection><subsection id="IDADE2487B311E4D95A4B5C17E554CD89B"><enum>(b)</enum><header>Duties of
Director</header><text>In carrying out the program under subsection (a), the
Director of the Institute shall—</text>
<paragraph id="IDB57319BB1AA645A2BAD25B8DF14CBCAB"><enum>(1)</enum><text>award grants and
facilitate the process to award grants to public or nonprofit private entities
to conduct research to develop a molecularly-oriented, knowledge-based approach
to cancer drug discovery and development; and</text>
</paragraph><paragraph id="ID0E6D741257544BA7B8A423F428CC41C7"><enum>(2)</enum><text>not later than 6
months after the date of enactment of the <short-title>National Cancer Act of 2007</short-title>, develop and
implement a strategic plan for intensifying and expanding 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.</text>
</paragraph></subsection><subsection id="ID360D07E23F5943B6B8F600BFBA3655DC"><enum>(c)</enum><header>Limitations</header><text>Amounts
awarded under grants under this section shall not be used for the construction
of facilities.</text>
</subsection><subsection id="IDFF45830CE30F408A9289CE0287DDEA9E"><enum>(d)</enum><header>Authorization
of appropriations</header><text>There is authorized to be appropriated to carry
out this section, such sums as may be necessary for each of fiscal years 2008
through 2011.</text>
</subsection></section><section id="IDd538c10cb0024617b54fe084921b93e6"><enum>417E–2.</enum><header>Clinical
trials</header>
<subsection id="ID846ff59ef9184d4dad8301bb2b1cfae6"><enum>(a)</enum><header>In
general</header><text>For the purpose of enhancing patient access to clinical
trials and investigational therapies for the treatment or prevention of cancer,
the National Cancer Institute shall establish an education program that
provides patients and providers with—</text>
<paragraph id="IDcce1216350024d81ae813fd811d57c39"><enum>(1)</enum><text>information about
how to access and use the National Cancer Institute clinical trials database
online;</text>
</paragraph><paragraph id="ID2d52a5a574f5442888612b4031c04ada"><enum>(2)</enum><text>information about
the Food and Drug Administration process for approving the use of drugs and
biologics for a single patient;</text>
</paragraph><paragraph id="IDe20f6c37d7554c6c8b1a86a4f9157246"><enum>(3)</enum><text>information
targeted to populations of age and cultural demographics that are frequently
underrepresented in clinical trials; and</text>
</paragraph><paragraph id="ID3d3d6cb3a49f45e58d72f101eee8c3f3"><enum>(4)</enum><text>recommendations
regarding logistical support and sources of funding for patients support
costs.</text>
</paragraph></subsection><subsection id="ID5a9c435abedd4f5b8061c6b94e36c81e"><enum>(b)</enum><header>Information
dissemination</header><text>In carrying out such information dissemination
described under this section, the Director of the Institute shall regularly
provide information to cancer care providers, professional and patient
organizations, including community-based organizations, and patients to
increase provider participation and patient enrollment in clinical
trials.</text>
</subsection><subsection id="IDc9939fc837554b71a9ec65615083ee41"><enum>(c)</enum><header>Diversity
assurance</header><text>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.</text>
</subsection><subsection id="ID6C5BAF7CFB504218BEB211C78C883DB7"><enum>(d)</enum><header>Sense of the
Senate on a central institutional review board</header><text>It is the sense of
the Senate that—</text>
<paragraph id="IDE39A983198AC485CAA01ED887D7C6E06"><enum>(1)</enum><text>the current
procedure of sending 1 clinical trial through multiple local institutional
review boards may not be the most efficient method for the protection of
patients enrolled in the trial and may delay the process of bringing lifesaving
treatment to cancer patients;</text>
</paragraph><paragraph id="IDEC3C363F5CA14FACA05FCAB2A2577700"><enum>(2)</enum><text>the National
Cancer Institute should be commended for its work in centralizing the
institutional review board process and should continue to recommend and support
meaningful reform of the existing Central Institutional Review Board
Initiative; and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID596E6EECBFA34170B224E9F8EBE39211"><enum>(3)</enum><text>the research
community should continue to streamline the institutional review board process
in order to bring lifesaving treatments to patients as quickly as
possible.</text>
</paragraph></subsection></section><section id="ID8D46C6FF4A534192860506434BB29C03"><enum>417E–3.</enum><header>Cancer care
researchers</header>
<subsection id="ID07F892E29F41463782DAFE3FFD3CB95F"><enum>(a)</enum><header>Supply of
cancer researchers</header><text>In order to ensure a sufficient number of
researchers who are trained in the prevention, early detection, diagnosis,
cure, and treatment of cancer in future fiscal years, the Director of the
Institute, in coordination with the Secretary of Veterans Affairs and the
National Institute of Nursing Research, shall conduct a study as described in
section 417E–4 for the purpose of recommending activities to promote training
and education for health care professionals and institutions supporting cancer
research.</text>
</subsection><subsection id="IDEEF744F93FC341FB96B8F043E048EAA6"><enum>(b)</enum><header>Loan
repayment</header>
<paragraph id="ID3B08765716BB4A5CB28D48B0181A6108"><enum>(1)</enum><header>In
general</header><text>The Director of the Institute shall establish a program
of entering into contracts with qualified health professionals under which such
health professionals agree to engage in cancer prevention research in
consideration of the Federal Government agreeing to repay, for each year of
engaging in such research, not more than $35,000 of the principal and interest
of the educational loans of such health professionals.</text>
</paragraph><paragraph id="IDE721B553CF654A74AD698E1AB05E5A75"><enum>(2)</enum><header>Service
provisions</header><text>The provisions of sections 338B, 338C, and 338E shall,
except as inconsistent with paragraph (1), apply to the program established in
such paragraph to the same extent and in the same manner as such provisions
apply to the National Health Service Corps Loan Repayment Program established
in subpart III of part D of title III.</text>
</paragraph></subsection><subsection commented="no" id="ID1681EB160ED043418462B54EA6A500B9"><enum>(c)</enum><header>Authorization
of appropriations</header><text>There is authorized to be appropriated to carry
out this section, such sums as may be necessary for each of fiscal years 2008
through 2011.</text>
</subsection></section><section id="IDfe9a2e3b26df488f8da13cd9dbfc5fd7"><enum>417E–4.</enum><header>Cancer care
workforce</header>
<subsection id="IDba9934ca10a245c1a411ed853103aa51"><enum>(a)</enum><header>In
general</header>
<paragraph id="IDecfc5271ba59402d9b2be981e31b4e43"><enum>(1)</enum><header>Study</header><text>The
Secretary shall conduct a study on the current and future cancer care workforce
needs in the following areas:</text>
<subparagraph id="id44F38B36B75B4973BBBE204F3CB10A06"><enum>(A)</enum><text>Cancer
research.</text>
</subparagraph><subparagraph id="ID1341eace495945faae29415a3b1b2de9"><enum>(B)</enum><text>Care and
treatment of cancer patients and survivors.</text>
</subparagraph><subparagraph id="IDb01cce8805a544f58b628f07e57955dd"><enum>(C)</enum><text>Quality of life,
symptom management, and pain management.</text>
</subparagraph><subparagraph id="IDc2b827072f9244bf9805e3786b16b31e"><enum>(D)</enum><text>Early detection
and diagnosis.</text>
</subparagraph><subparagraph id="IDee80004fb53e4001921f9a6545a4e595"><enum>(E)</enum><text>Cancer
prevention.</text>
</subparagraph><subparagraph id="ID916e4dd4e0db4059a8f6322d79832d20"><enum>(F)</enum><text>Genetic testing,
counseling, and ethical considerations related to such testing.</text>
</subparagraph><subparagraph id="ID0ec624eeb7224d89a759c97971d52c97"><enum>(G)</enum><text>Diversity and
appropriate care for disparity populations.</text>
</subparagraph><subparagraph id="ID15bf8ebd73f44f2091a6ba4e92f8cf21"><enum>(H)</enum><text>Palliative and
end-of-life care.</text>
</subparagraph></paragraph><paragraph id="IDc0a32a38780d47cbbbdafda362d9695a"><enum>(2)</enum><header>Report</header><text>Not
later than 1 year after the date of enactment of the
<short-title>National Cancer Act of 2007</short-title>,
the Secretary shall submit to Congress a report that describes the findings of
the study conducted under subsection (a).</text>
</paragraph></subsection><subsection id="ID5fa1db0aaed645298c899d150270c010"><enum>(b)</enum><header>Program</header>
<paragraph id="IDf74bc1a5d728419aacb0dd5243a31b40"><enum>(1)</enum><header>Establishment</header><text>The
Secretary shall issue programmatic recommendations and establish a program to
carry out activities based on the results of the study conducted under
subsection (a).</text>
</paragraph><paragraph id="ID341ed359e3994ee98f3289d8e19e3208"><enum>(2)</enum><header>Recommendations</header><text>The
programmatic recommendations described in paragraph (1) shall—</text>
<subparagraph id="ID521cd899eaad4e478cd1b4c796fedb34"><enum>(A)</enum><text>set annual and
long-term training goals to assure an adequate cancer care workforce;</text>
</subparagraph><subparagraph id="ID49250d3983f944c5bf908e00b54b326b"><enum>(B)</enum><text>prepare and
implement a plan to assist to cancer healthcare professions with the most
severe shortages, under which awards will be made under this section to
eligible individuals to increase cancer care workforce training for individuals
to become cancer care providers, which may include such individuals who make a
commitment to serve in underserved communities or areas with disproportionately
high cancer incidence or mortality and for health professions for which there
are anticipated shortages; and</text>
</subparagraph><subparagraph id="IDee414a70ff794b20ba6195c703745ecb"><enum>(C)</enum><text>be coordinated
with existing programs to prevent duplication.</text>
</subparagraph></paragraph></subsection><subsection id="ID6c70bd021d154654ac08f588b939b792"><enum>(c)</enum><header>Eligibility</header><text>To
be eligible to receive assistance under this section, an individual shall
submit an application to the Secretary at such time, in such manner, and
containing such information as the Secretary reasonably requires. In such
application, such individual shall demonstrate the intent to seek training to
obtain a certificate, license, or postsecondary degree as the Secretary
provides in the report under subsection (a), or in the case of licensed health
care professionals, the intent to seek professional development to upgrade
skills and knowledge or to obtain specialized knowledge according to criteria
developed by the Secretary.</text>
</subsection><subsection id="ID011eb7984ffd4d908c18dd2058e3208f"><enum>(d)</enum><header>Use of
funds</header><text>The use of funds by a recipient of assistance under this
section shall be deemed by the Secretary and reported to Congress not later
than 1 year after the issuance of the report under subsection (a).</text>
</subsection><subsection id="ID41028a30a66e41dc873b80f1a0e53edd"><enum>(e)</enum><header>Authorization
of appropriations</header><text>There is authorized to be appropriated to carry
out this section, such sums as may be necessary in each year for each of fiscal
years 2008 through and 2011.</text>
</subsection></section><section id="ID3FFBE91213D34299866CD3488F5FA8A3"><enum>417F–5.</enum><header>Cancer
survivorship</header>
<subsection id="IDCDFB3857432A447FB6C3DF944E83CECB"><enum>(a)</enum><header>In
general</header><text>The Secretary, acting through the Director of the
National Cancer Institute, shall conduct a study of the unique health
challenges associated with cancer survivorship and carry out projects and
interventions to improve the long-term health status of cancer survivors. Such
projects shall be carried out directly or through the awarding of grants or
contracts.</text>
</subsection><subsection id="ID98EFAD78A22E4977B2C1121900F71D35"><enum>(b)</enum><header>Activities</header><text>Activities
that may be carried out under subsection (a) include—</text>
<paragraph id="IDFA90E348EB294B2195E4183D9E06713B"><enum>(1)</enum><text>the coordination
of a partnership between the National Cancer Institute and the Centers for
Disease Control and Prevention to assess the unique challenges associated with
cancer survivorship and the enhancement of cancer related surveillance systems
to track the status of cancer survivors and determine whether cancer survivors
are at-risk for other chronic and disabling conditions;</text>
</paragraph><paragraph id="ID7E51CB8424C34364A76BC20059AAE1CA"><enum>(2)</enum><text>the development
of a national cancer survivorship action plan, in partnership with health
organizations focused on cancer survivorship, including further support for the
Childhood Cancer Survivors Study, to be carried out in coordination with the
State-based comprehensive cancer control program of the Centers for Disease
Control and Prevention to—</text>
<subparagraph id="IDE83DDAB5EAE3494CBE4B84EA00B30542"><enum>(A)</enum><text>develop unique
and innovative post-treatment programs, services, and demonstrations designed
to support and advance cancer survivorship through—</text>
<clause id="IDC035FAC987D14384BA00DCFE469F1E6C"><enum>(i)</enum><text>promotion of
physical activity and healthy lifestyles;</text>
</clause><clause id="ID2481C642759F46D591B09EA006C76616"><enum>(ii)</enum><text>educational
outreach programs for health care providers;</text>
</clause><clause id="ID6B69F11C2C454E0B8654E81F2D57E4E8"><enum>(iii)</enum><text>support for
innovative programs to improve the quality of life among cancer
survivors;</text>
</clause><clause id="IDA33570C1D8194F4DBEC1746406614756"><enum>(iv)</enum><text>home and
community-based interventions;</text>
</clause><clause id="ID3B6191C5D67C4F4F98F0CD003DF19C2B"><enum>(v)</enum><text>peer support and
mentor programs;</text>
</clause><clause id="IDBDDABD7D04A14E2FB6036BD7097B026E"><enum>(vi)</enum><text>public awareness
and outreach campaigns; and</text>
</clause><clause id="ID1EE8E15AEE5E4BD5A120DAFF30F733E7"><enum>(vii)</enum><text>information
dissemination to inform health care providers and cancer survivors of their
health care options and available survivorship programs; and</text>
</clause></subparagraph><subparagraph id="ID7427309425F64CA19E9C41D300105116"><enum>(B)</enum><text>develop unique
cancer survivorship demonstration programs designed to address the needs of
underserved populations, including minorities, children, and individuals
residing in rural areas.</text>
</subparagraph></paragraph></subsection><subsection id="ID2AD97691424C46B7997FD4DAA556595C"><enum>(c)</enum><header>Coordination of
activities</header><text>The Secretary shall ensure that activities carried out
under this section are coordinated as appropriate with other agencies of the
Public Health Service.</text>
</subsection><subsection id="ID16BA3A5A8BEE404C8956FEE562B23072"><enum>(d)</enum><header>Report to
Congress</header><text>Not later than October 1, 2008, the Secretary shall
submit to Congress a report describing the results of the study conducted under
subsection (a), and as applicable, the strategies developed under such
subsection.</text>
</subsection><subsection id="IDD02B2082469D479499C4BE3FABF07D42"><enum>(e)</enum><header>Authorization
of appropriations</header><text>There is authorized to be appropriated to carry
out this section, such sums as may be necessary for each of fiscal years 2008
through 2011.</text>
</subsection></section><section id="IDD0FBA2D2D16E409C93008DACD923562E"><enum>417G–6.</enum><header>Monitoring
and evaluating cancer care in cancer survivorship</header>
<subsection id="IDB08AD8C1D8ED4D8B874666FCEE3F2311"><enum>(a)</enum><header>In
general</header><text>The Secretary, acting through the Director of the
Institute and the Director of the National Cancer Institute, shall make grants
to eligible entities for the purpose of enabling such entities to develop,
monitor, and evaluate information concerning quality cancer care in cancer
survivorship.</text>
</subsection><subsection id="IDE826ED217C95411FBE3BAE21D6A759C6"><enum>(b)</enum><header>Eligible
entities</header><text>An entity shall be eligible for a grant under this
section for a fiscal year if such entity—</text>
<paragraph id="ID8B600179D1EA43A695F0C6B8AF44EF2F"><enum>(1)</enum><text>operates a
statewide cancer registry with funds from a grant made under section 399B for
such fiscal year; or</text>
</paragraph><paragraph id="ID3DBC3693660444F285F8347D6E7BE4CB"><enum>(2)</enum><text>has the
capacities for ideal systems and the ability to link data on phases of cancer
care that go beyond medical record data (on initial course of cancer diagnosis
and treatment) to longer term care and to also allow for ascertaining patient’s
needs and perspectives.</text>
</paragraph></subsection><subsection id="IDB533234E3FBA413EAB85530077638E83"><enum>(c)</enum><header>Contracting
authority</header><text>In carrying the purpose described in subsection (a), an
eligible entity may expend a grant under such subsection to enter into
contracts with academic institutions, cancer centers, and other entities, when
determined appropriate by the Secretary.</text>
</subsection><subsection id="ID18E11125D5764201B459C02F17A19244"><enum>(d)</enum><header>Application</header><text>To
be eligible for a grant under subsection (a), an eligible entity shall submit
to the Secretary an application at such time, in such manner, and containing
such agreements, assurances, and information as the Secretary determines to be
necessary to carry out this section.</text>
</subsection><subsection id="ID709F80295531432CBDAAC201DDE75CD1"><enum>(e)</enum><header>Authority of
Secretary regarding use of grant funds</header><text>The Secretary shall
determine the appropriate uses of grant funds under subsection (a) to achieve
the purpose described in such subsection.</text>
</subsection><subsection id="ID9C34820A5FEF4D9D9E4DBB73BE70063E"><enum>(f)</enum><header>Authorization
of appropriations</header><text>For the purpose of carrying out this section,
there are authorized to be appropriated such sums as may be necessary for each
of fiscal years 2007 through 2011.</text>
</subsection></section><section id="IDa89b72fc05784e13bd7a93bf6c137d93"><enum>417E–7.</enum><header>Cancer care
guidelines</header><text display-inline="no-display-inline">The National Cancer
Institute shall regularly convene cancer experts, cancer care providers,
practicing oncologists, patients, representatives of disparity populations, and
other relevant experts and organizations, including representatives of the
Agency for Healthcare Research and Quality, the Health Resources
Administration, and the Centers for Disease Control and Prevention, to
coordinate the development and regularly update—</text>
<paragraph id="IDbc71baf322cf442980ef597686295465"><enum>(1)</enum><text>consensus
protocols and guidelines for optimal cancer treatments and prevention,
including palliation, symptom management, and end-of-life care; and</text>
</paragraph><paragraph id="IDf4a88b662d6e460eba81a3e0003597b2"><enum>(2)</enum><text>guidelines for
providing patients with multidisciplinary consultation before treatment is
initiated to provide overall coordination and management of cancer care among
all providers of the patient’s treatment and services.</text>
</paragraph></section><section id="IDbd8b9a682cd84aa7baa60526123cec8e"><enum>417E–8.</enum><header>Other
activities to improve outcomes of cancer care</header>
<subsection id="IDb023f7dc567f4ecdb10a0209004119b6"><enum>(a)</enum><header>In
general</header>
<paragraph id="ID846c2d5f8af345c5bd5bb81a06d4a7cc"><enum>(1)</enum><header>Research</header><text>The
Director of the Institute, in consultation with the entities described in
section 417E–8, shall conduct and support research and other activities to
build an evidence base regarding effective clinical and organizational
intervention strategies to improve the quality and outcomes of cancer care, and
access to such care, at all stages of the health care continuum.</text>
</paragraph><paragraph id="ID301d35e7b78c48ff81db572912c82d45"><enum>(2)</enum><header>Factors</header><text>In
carrying out paragraph (1), the Director of the Institute shall take into
account the breadth of the continuum of cancer care, from prevention and early
detection, through diagnosis and treatment, to rehabilitation, long term
survivorship and remission, through psychosocial, palliative, and end-of-life
care.</text>
</paragraph></subsection><subsection id="ID761c989015fb4b5ca1941c6403c68d46"><enum>(b)</enum><header>Specific
requirements</header><text>The Director of the Institute shall—</text>
<paragraph id="ID83ccd0c8c35d4daabbe41c8c16bd028b"><enum>(1)</enum><text>ensure the
targeted dissemination of the most current scientific evidence in appropriate
formats for use by organizations representing cancer patients and their
families, professional societies and organizations representing cancer care
providers, and organizations through which health care and support services are
delivered; and</text>
</paragraph><paragraph id="ID925f8dcf75584f73926b69de491c61db"><enum>(2)</enum><text>develop effective
strategies to facilitate patient communication with health care providers
regarding such protocols and guidelines and to ensure overall coordination and
management of cancer care by providers.</text>
</paragraph></subsection><subsection id="IDc89841aff63240b4b881e918bf7c5f89"><enum>(c)</enum><header>Authorization
of appropriations</header><text>There is authorized to be appropriated to carry
out this section such sums as may be necessary for each of fiscal years 2007
through
2011.</text>
</subsection></section></chapter><after-quoted-block>.</after-quoted-block></quoted-block>
</paragraph></section><section id="ID00B437370AF54D2EBB998C194F3727D7"><enum>104.</enum><header>National
Institute for Environmental Health Sciences</header>
<subsection id="IDB5B67F51E2D3467085E652C945AA5E57"><enum>(a)</enum><header>In
general</header><text>Not later than 6 months after the date of enactment of
this Act, the Director of the National Institute for Environmental Health
Sciences shall, in coordination with the National Cancer Institute, prepare and
submit to the Secretary of Health and Human Services a strategic plan that
identifies the unmet needs, progress goals and benchmarks, and the level of
funding necessary for research on environmental risk factors for cancer and
gene-environment interactions.</text>
</subsection><subsection id="ID5C05996608A44C5E8207C0AA13A86100"><enum>(b)</enum><header>Authorization
of appropriations</header><text>There is authorized to be appropriated to carry
out this section such sums as may be necessary.</text>
</subsection></section><section id="id39DBBA724F7B45AD92FBE1B1FCD4EF25"><enum>105.</enum><header>National
Center on Minority Health and Health Disparities</header><text display-inline="no-display-inline">Not later than 6 months after the date of
enactment of this Act, the Director of the National Cancer Institute, in
coordination with the National Center on Minority Health and Health
Disparities, shall prepare a strategic plan that identifies progress goals,
benchmarks, and needed resources for research on disparities in cancer
treatment, control, and prevention.</text>
</section><section id="ID132FA75AE7E74583875663450772BC7D"><enum>106.</enum><header>Comprehensive
cancer control plans</header><text display-inline="no-display-inline">Section
412 of the <act-name parsable-cite="PHSA">Public Health Service Act</act-name>
(<external-xref legal-doc="usc" parsable-cite="usc/42/285a-1">42 U.S.C.
285a–1</external-xref>) is amended—</text>
<paragraph id="ID9D446CCAD6CF4E44874ED565B76DE346"><enum>(1)</enum><text>in the first
sentence, by inserting <quote>, for survivorship,</quote> after
<quote>treatment of cancer</quote>;</text>
</paragraph><paragraph id="IDCDEAC683C70B4633B879A0A29446B519"><enum>(2)</enum><text>in paragraph
(1)(B), by striking <quote>cancer patients</quote> and all that follows and
inserting the following: <quote>cancer patients, families of cancer patients,
and cancer survivors, and</quote>; and</text>
</paragraph><paragraph id="IDBF1B4110298D40A38E2300A1DA0070F7"><enum>(3)</enum><text>in paragraph (3),
by inserting <quote>and concerning cancer survivorship programs,</quote> after
<quote>control of cancer</quote>.</text>
</paragraph></section><section id="idA05D7B46E038449BBA8EEE46A3746CFD"><enum>107.</enum><header>Lung cancer
early detection and research demonstration project</header><text display-inline="no-display-inline">Title
XV of the Public Health Service Act (42 U.S.C. 300k et seq.) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id6F479A779621405D8D03415FE55FAFE3" style="OLC">
<section id="IDc62cc8ec73d94f07bc22abcac9a6a4a1"><enum>1511.</enum><header>Lung cancer
early detection and research demonstration project</header>
<subsection id="ID9a0f232fbf664b3bbcf795931de427fb"><enum>(a)</enum><header>In
general</header><text>The Secretary, acting through the Director of the Centers
for Disease Control and Prevention, shall award not less than 10 competitive
grants to public and non-profit private entities to enable such entities to
establish demonstration programs pursuant to the general authority under title
III to carry out lung cancer early detection and research activities using
Computer Tomography (CT) scanning within a high risk population utilizing the
comprehensive protocol that encompasses pre-diagnosis and post-diagnosis, that
was developed under the best published clinical practices, and that was
established by the multi-institutional, multi-disciplinary research program
initiated in the year 1993. Such demonstration programs shall continue and
enhance the research initiated by such protocol into all aspects of early
detection and disease management, the incorporation of technological advances
in imaging and the development of computer assisted diagnostic tools, and shall
include the provision of appropriate referral and case management for the
medical treatment of individuals screened pursuant to this section to ensure
appropriate follow-up services for abnormal tests, diagnostic and therapeutic
services, and treatment for detected cancers subject to the requirements of
this section.</text>
</subsection><subsection id="IDc77aeaca49454571b91e478db24bf5d3"><enum>(b)</enum><header>Requirements</header>
<paragraph id="IDb30a2c104dc045f283237ffbe6f33b59"><enum>(1)</enum><header>In
general</header><text>To be eligible for a grant under this section, an entity
shall agree to adopt the protocol as defined in subsection (a) for the
selection of participants in the program funded under the grant, the scanning
equipment used in such program, the personnel involved in the scanning and
diagnoses provided under such program, the method of diagnosing used in the
program, the scans utilized under the program, and the follow-up procedures
used under such program.</text>
</paragraph><paragraph id="ID2417588be9204e499a400e52440b43d9"><enum>(2)</enum><header>Collection of
imaging data</header><text>To be eligible for a grant under this section, an
entity shall agree to collect, transmit, and preserve imaging data as required
under the protocol as defined in subsection (a). Prior to such collection,
transmission, and preservation of imaging data, patient consent shall be
obtained from participating entities as defined by subsection (a).</text>
</paragraph><paragraph id="ID515efc2f16ff47b5b8473ae97ccf40c2"><enum>(3)</enum><header>Relationship to
items and services under other programs</header><text>To be eligible for a
grant under this section, an entity shall agree that grant funds will not be
expended to make payments for any item or service to the extent that payment
has been made, or can reasonably be expected to be made, with respect to such
item or service—</text>
<subparagraph id="IDf3e15a8917e74813b32d78436e32a3d5"><enum>(A)</enum><text>under any State
compensation program, under an insurance policy, or under any Federal or State
health benefits program; or</text>
</subparagraph><subparagraph id="ID8cb28b188cf84b42be170c66f1720365"><enum>(B)</enum><text>by an entity that
provides health service on a prepaid basis.</text>
</subparagraph></paragraph><paragraph id="ID6011423b6b984cacb54c8e8d81f0160d"><enum>(4)</enum><header>Records and
audits</header><text>To be eligible for a grant under this section, an entity
shall—</text>
<subparagraph id="IDfaaa52729fd44aed8ec9f02699b04eb8"><enum>(A)</enum><text>establish such
fiscal control and fund accounting procedures as may be necessary to ensure
proper disbursal of, and accounting for, amounts received under this section;
and</text>
</subparagraph><subparagraph id="ID65dc55a4e0364c529da0ce6abac63673"><enum>(B)</enum><text>provide agreed
upon annual reports to the Secretary or the Comptroller General of the United
States for the purposes of auditing the expenditures of the entity.</text>
</subparagraph></paragraph><paragraph id="IDcb8ed16cd55b4061a7910a7fc59d8f62"><enum>(5)</enum><header>Reports</header><text>To
be eligible for a grant under subsection (a) an entity shall agree to submit to
the Secretary such reports as the Secretary deems appropriate.</text>
</paragraph></subsection><subsection id="IDb8a9790583c741fc942d5a070212896a"><enum>(c)</enum><header>Definition</header><text>In
this section, the term <term>high risk population</term> means those
individuals over the age of 50 with a smoking history of 20 pack years or a
family history of lung cancer, or those individuals whose occupation or
military service exposed them to asbestos, Agent Orange and other herbicides,
beryllium, radon, nuclear fuels or waste, or other lung cancer
carcinogens.</text>
</subsection><subsection id="IDd07f0096f5004b1e90d57634a879bad9"><enum>(d)</enum><header>Authorization
of appropriations</header><text>There is authorized to be appropriated to carry
out this section such sums as may be necessary for each of the fiscal years
2007 through
2011.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="IDE88A3AE3EA574E159EC48C5F9D00D1FE"><enum>108.</enum><header>Colorectal
cancer screening</header><text display-inline="no-display-inline">Title XV of
the <act-name parsable-cite="PHSA">Public Health Service Act</act-name>
(<external-xref legal-doc="usc" parsable-cite="usc/42/300k">42 U.S.C.
300k</external-xref> et seq.), as amended by section 106, is further amended by
adding at the end the following:</text>
<quoted-block act-name="Public Health Service Act" id="ID66A1EA0766774402ADC04E959990C360" style="OLC">
<section id="IDAA1AC973E20F490F8C9672412E000130"><enum>1512.</enum><header>Colorectal
cancer screening demonstration project</header>
<subsection id="ID28972015074943509C240643791083FF"><enum>(a)</enum><header>In
general</header><text>The Secretary, acting through the Director of the Centers
for Disease Control and Prevention, shall award competitive grants to public
and nonprofit private entities to enable such entities to establish
demonstration programs pursuant to the general authority of title III to carry
out colorectal screening activities including—</text>
<paragraph id="ID1A451B27E12A460FA9461823366C30AD"><enum>(1)</enum><text>screening
asymptomatic individuals for colorectal cancer as a preventive health measure
according to scientific evidence-based screening guidelines;</text>
</paragraph><paragraph id="ID77A7CA7EFB10411CBCDF6F2B8D995900"><enum>(2)</enum><text>providing the
full continuum of cancer care for individuals screened pursuant to this section
and to ensure the appropriate follow-up services for abnormal tests, diagnostic
and therapeutic services, and treatment for detected cancers, subject to the
requirements of subsection (c)(2);</text>
</paragraph><paragraph id="IDB3EFFF7FDE5E4E7D92B5E022BF760070"><enum>(3)</enum><text>activities to
improve the education, training, and skills of health professionals (including
allied health professionals) in the detection and control of colorectal
cancer;</text>
</paragraph><paragraph id="IDEAC71117EBE643778FD05CD321980002"><enum>(4)</enum><text>activities to
evaluate the programs under this section through appropriate surveillance or
program monitoring activities;</text>
</paragraph><paragraph id="IDA526A0A9B5094AD384CA47BE9B6F7257"><enum>(5)</enum><text>the development
and dissemination of findings derived through such evaluations through public
and professional education; and</text>
</paragraph><paragraph id="IDA723220899E84DD88E17C58D28D55D61"><enum>(6)</enum><text>activities to
promote participation in the colorectal cancer screening under this
section.</text>
</paragraph></subsection><subsection id="ID7C40554DEE924E39BF0679198FBDD337"><enum>(b)</enum><header>Use of certain
standards under medicare program</header><text>A grant may be awarded under
subsection (a) only if the applicant involved agrees that—</text>
<paragraph id="IDe74c36bb42eb4a42ad169a36ea692773"><enum>(1)</enum><text>screenings under
subsection (a)(1) will be carried out as preventive health measures in
accordance with evidence-based screening procedures as specified in section
1861(pp)(1) of the Social Security Act;</text>
</paragraph><paragraph id="ID6a2b40f4402749c6b16882f4a9917709"><enum>(2)</enum><text>an individual
will be considered high risk for purposes of subsection (a)(1)(B)(ii) only if
the individual is high risk within the meaning of section 1861(pp)(2) of such
Act; and</text>
</paragraph><paragraph id="ID55c40ea3d9fa4eec9ff82401f3303a8d"><enum>(3)</enum><text>the payment made
from the grant for a screening procedure under subsection (a)(1) will not
exceed the amount that would be paid under part B of title XVIII of such Act if
payment were made under such part for furnishing the procedure to an individual
enrolled under such part.</text>
</paragraph></subsection><subsection id="IDA0989B5EDE52454AB5C3C3782BF4A62F"><enum>(c)</enum><header>Requirements</header>
<paragraph id="ID1D010AB08EED42C0A2389B6173649411"><enum>(1)</enum><header>Priority</header><text>To
be eligible for a grant under subsection (a), an entity shall agree to give
priority with respect to activities and services under the grant to a
low-income—</text>
<subparagraph id="ID5CF9B9A4C62F444DA5003631DFBDD7A9"><enum>(A)</enum><text>individual who is
at least 50 years of age; or</text>
</subparagraph><subparagraph id="ID2E550C2E9CB44CEDB1A7C719EA41EEF3"><enum>(B)</enum><text>individual at
high risk for colorectal cancer (as defined in section 1861(pp)(2) of the
<act-name parsable-cite="SSA">Social Security Act</act-name>) and is under 50
years of age.</text>
</subparagraph></paragraph><paragraph id="ID8AB6489F6BC443B6A7754520DF97D23D"><enum>(2)</enum><header>Relationship to
items and services under other programs</header><text>To be eligible for a
grant under subsection (a), an entity shall agree that grant funds will not be
expended to make payments for any item or service to the extent that payment
has been made, or can reasonably be expected to be made, with respect to such
item or service—</text>
<subparagraph id="ID1B033FA7A0784603A9A91CBCAAB72B60"><enum>(A)</enum><text>under any State
compensation program, under an insurance policy, or under any Federal or State
health benefits program; or</text>
</subparagraph><subparagraph id="ID348E1B4C3D054C81BD4C21B1A9F24700"><enum>(B)</enum><text>by an entity that
provides health service on a prepaid basis.</text>
</subparagraph></paragraph><paragraph id="IDCDC3893A7506476D87E5057F7043FA97"><enum>(3)</enum><header>Records and
audits</header><text>To be eligible for a grant under subsection (a), an entity
shall agree that the entity will—</text>
<subparagraph id="ID424F01EEF9C84BBF95D7FF85DB7ED62F"><enum>(A)</enum><text>establish such
fiscal control and fund accounting procedures as may be necessary to ensure
proper disbursal of, and accounting for, amounts received under this section;
and</text>
</subparagraph><subparagraph id="ID1EE77670ACA94BC1989380AE80E9D742"><enum>(B)</enum><text>provide agreed
upon annual reports to the Secretary or the Comptroller General of the United
States for the purposes of auditing the expenditures by the entity.</text>
</subparagraph></paragraph><paragraph id="ID353532C663274B8596A7BB70B73E2C71"><enum>(4)</enum><header>Reports</header><text>To
be eligible for a grant under subsection (a), an entity shall agree to submit
to the Secretary such reports as the Secretary determines appropriate.</text>
</paragraph></subsection><subsection id="IDB00B481B6118434B89F89FB826ADE075"><enum>(d)</enum><header>Authorization
of appropriations</header><text>There is authorized to be appropriated to carry
out this section, such sums as may be necessary for each of the fiscal years
2007 through
2011.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="ID011592654D0849249F37F8012426CC79"><enum>109.</enum><header>National
program of cancer registries</header><text display-inline="no-display-inline">Part M of title III of the
<act-name parsable-cite="PHSA">Public Health Service Act</act-name>
(<external-xref legal-doc="usc" parsable-cite="usc/42/280e">42 U.S.C.
280e</external-xref> et seq.) is amended by inserting after section 399B the
following:</text>
<quoted-block act-name="Public Health Service Act" display-inline="no-display-inline" id="IDEC58C343A38C470AB3B36E4E7959EE06" style="OLC">
<section id="ID010ACB82633741B6B9C5E037792EA441"><enum>399B–1.</enum><header>Enhancing
cancer registries and preparing for the future</header><text display-inline="no-display-inline">Not later than 1 year after the date of
enactment of the <short-title>National Cancer Act of
2007</short-title> the Secretary shall develop a plan and submit a report to
Congress that outlines strategies by which the State cancer registries funded
with grants under section 399B and the Surveillance, Epidemiology, and End
Results program of the National Cancer Institute (in this section referred to
as the <quote>SEER program</quote>) can share information to ensure more
comprehensive cancer data. The report shall include ways in which the Secretary
will—</text>
<paragraph id="ID0AF935DA67D14EA2B04288D0ACF76463"><enum>(1)</enum><text>standardize data
between State cancer registries and the SEER program;</text>
</paragraph><paragraph id="ID5AB8B98BC4754915B16BF5BB1E907CAE"><enum>(2)</enum><text>increase the
portability and usability of data files from each registry for researchers and
public health planners;</text>
</paragraph><paragraph id="IDADB1D9B526E3438381C3351DE9C13B23"><enum>(3)</enum><text>ensure data
collection from the greatest number of health care facilities possible;</text>
</paragraph><paragraph id="IDE62E6E1A7EC64E22A5902F07AB841915"><enum>(4)</enum><text>maximize the use
of State registry data and data from the SEER program in State and regional
public health planning processes; and</text>
</paragraph><paragraph id="IDA9FA9186070548CB85F4E926B043FDAC"><enum>(5)</enum><text>promote the use
of data to—</text>
<subparagraph id="ID9BE6A8A812554AB9AF8836383969BF00"><enum>(A)</enum><text>improve the
health status of cancer survivors; and</text>
</subparagraph><subparagraph commented="no" display-inline="no-display-inline" id="ID26A247B6FCAD479300723045237495F2"><enum>(B)</enum><text>research quality
of cancer care and access to that care.</text>
</subparagraph></paragraph></section><section id="ID900437a8defd46a58700479eb363b491"><enum>399B–2.</enum><header>National
childhood cancer registry</header>
<subsection id="IDf718ee67a5614097a26ee500b4ff409c"><enum>(a)</enum><header>In
general</header><text>The Director of the National Institute of Health (in this
section referred to as the <quote>Director</quote>) shall, through the awarding
of a grant to, or contract or cooperative agreement with, support the existing
National Cancer Institute-designated multi-center national infrastructure for
collaborative pediatric cancer research to support a national population-based
childhood cancer database, the Childhood Cancer Research Network, in order
to—</text>
<paragraph id="IDcb4c56ea74724c15ba7138c7ea934a47"><enum>(1)</enum><text>formalize the
consent process by which pediatric cancer patients enroll on to a clinical
trial or receive treatment within the multi-center infrastructure;</text>
</paragraph><paragraph id="IDff02501e9e3c4c03824bcecc6aa279b1"><enum>(2)</enum><text>conduct
non-therapeutic studies, monitor and evaluate the incidence, survival rate, and
long-term health outcomes of childhood cancer patients, develop information
concerning best practices in pediatric cancer care; and</text>
</paragraph><paragraph id="ID37dc2ee18617485d88c0f7f8936a7274"><enum>(3)</enum><text>evaluate the
quality of pediatric cancer care, and monitor long-term pediatric cancer
survivorship.</text>
</paragraph></subsection><subsection id="ID2206b43325bf4a7a846509098710b7d8"><enum>(b)</enum><header>Coordination</header><text>The
Director shall carry out this section jointly through the Director of the
Centers for Disease Control and Prevention and the Director of the National
Cancer Institute.</text>
</subsection><subsection id="ID1b9a842ba38147d7b559bc101ae357c4"><enum>(c)</enum><header>Authorization
of appropriations</header><text>There is authorized to be appropriated, such
sums as may be necessary to carry out this
section.</text>
</subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="idA3B2CF5A9E484D2FA258AF7D839D0BF8"><enum>110.</enum><header>Other
transactions authority</header><text display-inline="no-display-inline">Section
402(i) of the Public Health Service Act (42 U.S.C. 282(i)) is amended by adding
at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id3CB1B804115642F2B675E72E3B5382EB" style="OLC">
<paragraph id="idF41C0B9ABEE046E283CF3190FD96E0DB" indent="up1"><enum>(4)</enum><text display-inline="yes-display-inline">Notwithstanding any other provision of law,
the Director of the National Cancer Institute may use amounts appropriated
under section 417B(a) to enter into transactions (other than contracts,
cooperative agreements, or grants) to carry out research in support of the
development of advanced technologies leading to the expedited delivery of
clinical products to benefit the cancer
patient.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</section><enum>II</enum><header>Expanding access
to cancer drugs and treatment</header>
<section id="idB5CB1294204944C4857214354645015F"><enum>201.</enum><header>Drugs to
prevent cancer</header>
<subsection id="id1A3FCCA3D2594BE4867103FE0FB905D7"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Chapter V of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by
adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="idE674ECEE64EA4CDA9FAC376100C5A1A7" style="OLC">
<subtitle id="id1B8A4BD065AD4430BE949903B133B870"><enum>G</enum><header>Chemoprevention
drugs</header>
<section id="idD17BB2EF9DFC42199CC42A773C9F7F9B"><enum>581.</enum><header>Recommendations
for investigations of chemoprevention drugs</header>
<subsection id="idE0EE511FF93F49918A0E7A53597EE2F2"><enum>(a)</enum><header>In
general</header><text>The sponsor of a chemoprevention drug in the States may
request the Secretary to provide written recommendations for the nonclinical
and clinical investigations which must be conducted with the drug
before—</text>
<paragraph id="id5322D9DDD68E453DB368E29EBA7D9284"><enum>(1)</enum><text>it may be
approved under section 505 for the high-risk condition that the drug is
designed to treat; or</text>
</paragraph><paragraph id="idFEA29778844D495D993928421006DB79"><enum>(2)</enum><text>if the drug is a
biological product, it may be licensed under section 351 of the Public Health
Service Act for such condition.</text>
</paragraph><continuation-text continuation-text-level="subsection">If the
Secretary has reason to believe that a drug for which a request is made under
this section is a chemoprevention drug, the Secretary shall provide the person
making the request written recommendations for the nonclinical and clinical
investigations which the Secretary believes, on the basis of information
available to the Secretary at the time of the request under this section, would
be necessary for approval under section 505 or licensing under section 351 of
the Public Health Service Act of such chemoprevention drug for the high-risk
condition that such drug is designed to treat.</continuation-text></subsection><subsection commented="no" id="idC44DF1BE13C942CFA7B22ADFCE332864"><enum>(b)</enum><header>Regulations</header><text>The
Secretary shall by regulation promulgate procedures for the implementation of
subsection (a).</text>
</subsection></section><section id="id4D25322C6BD747738BBCE23AB5F34D43"><enum>582.</enum><header>Designation of
chemoprevention drugs</header>
<subsection id="idF704164E45F6492BB1B5ECF33DECAB21"><enum>(a)</enum><header>Designation</header>
<paragraph id="idC891416906DA4361881FC130EB1348E7"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">The manufacturer or
the sponsor of a drug may request the Secretary to designate the drug as a
chemoprevention drug. A request for designation of a drug shall be made before
the submission of an application under section 505(b) for the drug or the
submission of an application for licensing of the drug under section 351 of the
Public Health Service Act. If the Secretary finds that a drug for which a
request is submitted under this subsection is a chemoprevention drug that is
being or will be investigated for a high-risk condition and—</text>
<subparagraph id="id7BA691135A0A4179ADE62080757BD046"><enum>(A)</enum><text>if an application
for such drug is approved under section 505; or</text>
</subparagraph><subparagraph id="id5DF88F8ED7A448AD866767424D612A83"><enum>(B)</enum><text>if a license for
such drug is issued under section 351 of the Public Health Service Act,</text>
</subparagraph><continuation-text continuation-text-level="paragraph">the
approval or license would be for use for such high-risk condition, the
Secretary shall designate the drug as a chemoprevention drug for such high-risk
condition. A request for a designation of a drug under this subsection shall
contain the consent of the applicant to notice being given by the Secretary
under subsection (b) respecting the designation of the drug.</continuation-text></paragraph><paragraph id="id3E6AA24F80B743449BDC4DA8DE459170"><enum>(2)</enum><header>Definitions</header><text>In
this subtitle:</text>
<subparagraph id="idAD6A645FDDED4E2583A7BF2F57A09E96"><enum>(A)</enum><header>Chemoprevention
drug</header><text>The term <term>chemoprevention drug</term> means a drug
designed to treat a high-risk condition.</text>
</subparagraph><subparagraph id="id47CAD42B3CFE43D7987DD3AF5A8DAE21"><enum>(B)</enum><header>High-risk
condition</header><text>The term <term>high-risk condition</term> means a
medical condition that—</text>
<clause id="IDeb18486043ed4923bc0f88d34a2b0e5d"><enum>(i)</enum><text>has been
diagnosed in individuals who have not been diagnosed with cancer or who do not
currently have progressive, life-threatening cancer; and</text>
</clause><clause id="ID2dcd7f038392477c9901089f5a13995b"><enum>(ii)</enum><text>unless treated,
could develop into progressive and life-threatening cancer</text>
</clause></subparagraph><subparagraph id="id7461BC52232F4AB9937DF984DF1DC99D"><enum>(C)</enum><header>Determination</header><text>Determinations
under subparagraphs (A) and (B) with respect to any drug shall be made on the
basis of the facts and circumstances as of the date the request for designation
of the drug under this subsection is made.</text>
</subparagraph></paragraph></subsection><subsection id="id0B45F0631915413C8D4F049908F8FF80"><enum>(b)</enum><header>Conditions of
designation</header><text>A designation of a drug under subsection (a) shall be
subject to the condition that—</text>
<paragraph id="idF95EFB9D52FB4D228472A3AA64E94FBB"><enum>(1)</enum><text>if an application
was approved for the drug under section 505(b) or a license was issued for the
drug under section 351 of the Public Health Service Act, the manufacturer of
the drug will notify the Secretary of any discontinuance of the production of
the drug at least 1 year before discontinuance; and</text>
</paragraph><paragraph id="idA7FA21636B304EC285B09FE408CDBC2A"><enum>(2)</enum><text>if an application
has not been approved for the drug under section 505(b) or a license has not
been issued for the drug under section 351 of the Public Health Service Act and
if preclinical investigations or investigations under section 505(i) are being
conducted with the drug, the manufacturer or sponsor of the drug will notify
the Secretary of any decision to discontinue active pursuit of approval of an
application under section 505(b) or approval of a license under section 351 of
the Public Health Service Act.</text>
</paragraph></subsection><subsection id="idC8162012635C4956971E0BBDCD716EAA"><enum>(c)</enum><header>Notice</header><text>Notice
respecting the designation of a drug under subsection (a) shall be made
available to the public.</text>
</subsection><subsection id="id6BE162F38B644A8AA6F967D81627D239"><enum>(d)</enum><header>Regulations</header><text>The
Secretary shall by regulation promulgate procedures for the implementation of
subsection (a).</text>
</subsection></section><section id="id91452A6604BF4507BD6FF314E79E87E2"><enum>583.</enum><header>Protection for
chemoprevention drugs</header>
<subsection id="idCF216E99725040968312AEA5346AF401"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Except as provided in
subsection (b), if the Secretary—</text>
<paragraph id="id3BB38B66C5824268AE95AA0BDF5BC93C"><enum>(1)</enum><text>approves an
application filed pursuant to section 505(b); or</text>
</paragraph><paragraph id="id2A25B39B69CF4AB180544AD953D64523"><enum>(2)</enum><text>issues a license
under section 351 of the Public Health Service Act,</text>
</paragraph><continuation-text continuation-text-level="subsection">for a
drug designated as a chemoprevention drug under section 582, the Secretary may
not approve another application under section 505(b) or issue another license
under section 351 of the Public Health Service Act for such drug for the
high-risk condition that such drug is designated for a person who is not the
holder of such approved application or of such license until the expiration 7
years from the date of the approval of the approved application or the issuance
of the license. Section 505(c)(2) does not apply to the refusal to approve an
application under the preceding sentence.</continuation-text></subsection><subsection id="idCA2FCB9C49A44B878E1E72B6C34BB5BF"><enum>(b)</enum><header>Other
application approval</header><text>If an application filed pursuant to section
505(b) is approved for a drug designated as a chemoprevention drug under
section 582 or if a license is issued under section 351 of the Public Health
Service Act for such a drug, the Secretary may, during the 7-year period
beginning on the date of the application approval or of the issuance of the
license, approve another application under section 505(b) or issue a license
under section 351 of the Public Health Service Act, for such drug for the
high-risk condition that such drug is designated for a person who is not the
holder of such approved application or of such license if—</text>
<paragraph id="idCDD51A7F78974120AAEF735390D88259"><enum>(1)</enum><text>the Secretary
finds, after providing the holder notice and opportunity for the submission of
views, that in such period the holder of the approved application or of the
license cannot assure the availability of sufficient quantities of the drug to
meet the needs of persons with such high-risk condition for which the drug was
designated; or</text>
</paragraph><paragraph id="id9BECE69D1643408FAC5A5AD997C2259A"><enum>(2)</enum><text>such holder
provides the Secretary in writing the consent of such holder for the approval
of other applications or the issuance of other licenses before the expiration
of such 7-year period.</text>
</paragraph></subsection><subsection id="idEBC2D4A6062042E8BBDEE61079F4E4A3"><enum>(c)</enum><header>Market
exclusivity for chemoprevention drugs designated for a high-risk
condition</header><text>If the Secretary designates a drug as a chemoprevention
drug for a high-risk condition under section 582—</text>
<paragraph id="id4D32C55427B6440094617F2C8ED58914"><enum>(1)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="idF61EF3E9A0A548EC84E3AF420B69A62D"><enum>(A)</enum><text>the period referred to
in subsection (c)(3)(E)(ii) of section 505, and in subsection (j)(5)(F)(ii) of
such section, is deemed to be twelve years rather than five years, and the
references in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to
four years, to forty-eight months, and to seven and one-half years are deemed
to be eleven years, one hundred thirty-two months, and fourteen and one-half
years, respectively; or</text>
</subparagraph><subparagraph id="idDB01B733BB954785A8CDFCF445682831" indent="up1"><enum>(B)</enum><text>the period referred to in clauses
(iii) and (iv) of subsection (c)(3)(E) of such section, and in clauses (iii)
and (iv) of subsection (j)(5)(F) of such section, is deemed to be ten years
rather than three years;</text>
</subparagraph></paragraph><paragraph id="idC3662A3344624E46AD20D44C032E8C95"><enum>(2)</enum><subparagraph commented="no" display-inline="yes-display-inline" id="idE55B99B353524457A7E86D6213EAED5E"><enum>(A)</enum><text>if the drug is the
subject of—</text>
<clause id="id2B3FBC4965BA4A7EB7A5F14CBA8A5687" indent="up1"><enum>(i)</enum><text>a listed patent for which a
certification has been submitted under subsection (b)(2)(A)(ii) or
(j)(2)(A)(vii)(II) of section 505; or</text>
</clause><clause id="id86EB592CF2F3456083F3E6C00C134700" indent="up1"><enum>(ii)</enum><text>a listed patent for which a
certification has been submitted under subsections (b)(2)(A)(iii) or
(j)(2)(A)(vii)(III) of section 505,</text>
</clause><continuation-text continuation-text-level="subparagraph">the
period during which an application may not be approved under section 505(c)(3)
or section 505(j)(5)(B) shall be extended by a period of seven years after the
date the patent expires (including any patent extensions); or</continuation-text></subparagraph><subparagraph id="idEFF083A9C97840B38DC2633A0340533A" indent="up1"><enum>(B)</enum><text>if the drug is the subject of a listed
patent for which a certification has been submitted under subsection
(b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent
infringement litigation resulting from the certification the court determines
that the patent is valid and would be infringed, the period during which an
application may not be approved under section 505(c)(3) or section 505(j)(5)(B)
shall be extended by a period of seven years after the date the patent expires
(including any patent extensions); and</text>
</subparagraph></paragraph><paragraph id="idB1278AA9C5C345DB8DFC88369346C583"><enum>(3)</enum><text>with respect to a
drug that is so designated that is also subject to market exclusivity extension
under section 505A, the extension of the periods described under paragraphs (1)
and (2) of this subsection shall be increased by six months in accordance with
such section 505A.</text>
</paragraph></subsection></section><section id="id803A6B9A783B4440B30689005567A137"><enum>584.</enum><header>Open protocols
for investigations of chemoprevention drugs</header><text display-inline="no-display-inline">If a drug is designated under section 582 as
a chemoprevention drug and if notice of a claimed exemption under section
505(i) or regulations issued thereunder is filed for such drug, the Secretary
shall encourage the sponsor of such drug to design protocols for clinical
investigations of the drug which may be conducted under the exemption to permit
the addition to the investigations of persons with the high-risk condition for
which such drug was
designated.</text>
</section></subtitle><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="id5B97832CE4B64D0F9488668E495E4854"><enum>(b)</enum><header>Grants and
contracts for development of chemoprevention drugs</header>
<paragraph id="idD6D4D0CCE3684C5FA69729B57D235F7D"><enum>(1)</enum><header>In
general</header><text display-inline="yes-display-inline">The Secretary may
make grants to and enter into contracts with public and private entities and
individuals to assist in—</text>
<subparagraph id="id93B80C8001D24F4080DFAE2FBCFD9BF4"><enum>(A)</enum><text display-inline="yes-display-inline">defraying the costs of qualified clinical
testing expenses incurred in connection with the development of chemoprevention
drugs;</text>
</subparagraph><subparagraph id="id7A250405A0DA4CA7A77BACA0DF91822C"><enum>(B)</enum><text display-inline="yes-display-inline">defraying the costs of developing
chemoprevention devices; and</text>
</subparagraph><subparagraph id="id60B5F7D216B7442181555F2E501C2A31"><enum>(C)</enum><text display-inline="yes-display-inline">defraying the costs of developing
chemoprevention foods.</text>
</subparagraph></paragraph><paragraph id="id21CD7489740841F1AA9B9666F8206561"><enum>(2)</enum><header>Definitions</header><text display-inline="yes-display-inline">For purposes of this subsection:</text>
<subparagraph commented="no" id="id0D4F9AF02725431495D264BA045AB315"><enum>(A)</enum><header>Chemoprevention
device</header><text>The term <term>chemoprevention device</term> means a
device to be approved to treat a high-risk condition.</text>
</subparagraph><subparagraph id="idF6CA0D99378B4AE1B1948BECAED71409"><enum>(B)</enum><header>Chemoprevention
drug</header><text>The term <term>chemoprevention drug</term> means a drug
designed to treat a high-risk condition.</text>
</subparagraph><subparagraph commented="no" id="idBBFDA0B8C383409FA446D69DEF76D8C9"><enum>(C)</enum><header>Chemoprevention
food</header><text>The term <term>chemoprevention food</term> means a food
which is formulated to be consumed or administered enterally under the
supervision of a physician and which is intended for the specific dietary
management of a type of high-risk condition for which distinctive nutritional
requirements, based on recognized scientific principles, are established by
medical evaluation.</text>
</subparagraph><subparagraph id="idDA03220E6F0947B9B9E4D7AA341069F5"><enum>(D)</enum><header>High-risk
condition</header>
<clause id="id8FEB25AD3C0149FE90F9A26818F888ED"><enum>(i)</enum><header>In
general</header><text>The term <term>high-risk condition</term> means, with
respect to a chemoprevention drug, chemoprevention device, or chemoprevention
food, a medical condition that—</text>
<subclause id="IDae1bd87fd2344195a06ab8b9a1772a7a"><enum>(I)</enum><text>has been
diagnosed in individuals who have not been diagnosed with cancer or who do not
currently have progressive, life-threatening cancer; and</text>
</subclause><subclause id="ID173858976ed14856b7ec64d51fc508e5"><enum>(II)</enum><text>unless treated,
could develop into progressive and life-threatening cancer.</text>
</subclause></clause><clause id="id25507726DFEA44408ACD457BA93A88F8"><enum>(ii)</enum><header>Determination</header><text>Determinations
under this subparagraph with respect to any drug, device, or food shall be made
on the basis of the facts and circumstances as of the date the request for
designation of the drug or food under section 582 of the Federal Food, Drug,
and Cosmetic Act is made.</text>
</clause></subparagraph><subparagraph id="id98FF2DA6527C401AB70568A2F36542F4"><enum>(E)</enum><header>Qualified
testing</header><text>The term <term>qualified testing</term> means—</text>
<clause id="idEDD1A47855B849EAB579D80BE8ABABEB"><enum>(i)</enum><text>human clinical
testing—</text>
<subclause id="idD1FF96A50C5C46FB8C709A1E3C11D3C4"><enum>(I)</enum><text>which is carried
out under an exemption for a chemoprevention drug under section 505(i) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)); and</text>
</subclause><subclause id="id625F2DFDA6D04398A4218CCDDC429457"><enum>(II)</enum><text>which occurs
after the date such drug is designated under section 582 of such Act (as added
by subsection (a)) and before the date on which an application with respect to
such drug is submitted under section 505(b) of such Act (21 U.S.C. 355(b)) or
under section 351 of the Public Health Service Act (42 U.S.C. 292); and</text>
</subclause></clause><clause id="id29A3B327824C488690171E8657BAA108"><enum>(ii)</enum><text>preclinical
testing involving a drug is designated under such section 582 and before the
date on which an application with respect to such drug is submitted under such
section 505(b) or under such section 351.</text>
</clause></subparagraph></paragraph><paragraph id="id5F64DAC03DE949A1B36A6D439640055D"><enum>(3)</enum><header>Authorization
of appropriations</header><text>There is authorized to be appropriated to carry
out this section such sums as may be necessary for each of fiscal years 2008
through 2010.</text>
</paragraph></subsection><subsection id="idBC1049FD84E84C4DB633D8B098A811B5"><enum>(c)</enum><header>Studies</header>
<paragraph id="id9FF801DA28EF44A4B07BAD07272069FB"><enum>(1)</enum><header>Medical devices
or medical food for high risk conditions</header><text>The Secretary of Health
and Human Services shall conduct a study to determine whether the application
of subchapter G of chapter V of the Federal Food, Drug, and Cosmetic Act (as
added by subsection (a)) to medical devices or medical foods for the high-risk
condition for which such devices or foods are designated, or to both, is needed
to encourage the development of such devices and foods. The Secretary shall
report the results of the study to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health, Education, Labor and
Pensions of the Senate not later than 1 year after the date of the enactment of
this Act.</text>
</paragraph><paragraph id="IDd781936193204d028a8efb1350b9f71e"><enum>(2)</enum><header>Chemoprevention
products</header><text>The Director of the Institute of Medicine shall conduct
a study to measure the quality and quantity of chemoprevention products
resulting from the application of subpart G of chapter V of the Federal Food,
Drug, and Cosmetic Act to drugs, medical devices, and medical foods for which
such drugs, devices, and foods are designated, or to all.</text>
</paragraph></subsection><subsection id="id1E93CCFB8E804F6096C2A8EC6857BEDC"><enum>(d)</enum><header>Chemoprevention
products board</header><text>Part A of title II of the Public Health Service
Act (42 U.S.C. 202 et seq.) is amended by adding at the end the
following:</text>
<quoted-block display-inline="no-display-inline" id="id47333B3FDBCF4B45B403CC4673E0DED5" style="OLC">
<section id="id557834B1329447D19514641F593A7BD2"><enum>229.</enum><header>Chemoprevention
products board</header>
<subsection id="id91D880A0DCCD4196B991F9E586E401A1"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">There is established
in the Department of Health and Human Services a board for the development of
chemoprevention drugs (including biologics) and devices (including diagnostic
products), to be known as the Chemoprevention Products Board (referred to in
this section as the <quote>Board</quote>). The Board shall be comprised of the
Assistant Secretary for Health of the Department of Health and Human Services
and representatives, selected by the Secretary, of the Food and Drug
Administration, the National Institutes Health, the Centers for Disease Control
and Prevention, and any other Federal department or agency which the Secretary
determines has activities relating to chemoprevention drugs and devices. The
Assistant Secretary for Health shall chair the Board.</text>
</subsection><subsection id="id0501B804137247F1BF7C6A99EEF568DF"><enum>(b)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph commented="no" id="id3582E378C3B948469DACAAB6AA40D987"><enum>(1)</enum><header>Chemoprevention
device</header><text>The term <term>chemoprevention device</term> has the
meaning given such term in section 582 of the Federal Food, Drug, and Cosmetic
Act.</text>
</paragraph><paragraph id="id0EACE59E5D274E549CAF55DF47A2AECD"><enum>(2)</enum><header>Chemoprevention
drug</header><text>The term <term>chemoprevention drug</term> has the meaning
given such term in section 582 of the Federal Food, Drug, and Cosmetic
Act.</text>
</paragraph><paragraph id="idFC100DC413B34949A52D1B623CEBB15A"><enum>(3)</enum><header>High-risk
condition</header><text>The term <term>high-risk condition</term> has the
meaning given such term in section 582 of the Federal Food, Drug, and Cosmetic
Act.</text>
</paragraph></subsection><subsection id="id727999ED1B8B481C9E13CA09AD5125E7"><enum>(c)</enum><header>Function</header><text>The
function of the Board shall be to promote the development of chemoprevention
drugs and devices and the coordination among Federal, other public, and private
agencies in carrying out their respective functions relating to the development
of such articles for such drugs to treat high-risk conditions.</text>
</subsection><subsection id="id9A7D1DFC1DC542259840A6D35AB93688"><enum>(d)</enum><header>Duties</header><text>In
the case of chemoprevention drugs, the Board shall—</text>
<paragraph id="id8B02B6B5A2E849BC96A34E1426C4DA24"><enum>(1)</enum><text>evaluate—</text>
<subparagraph id="id384DA486B59C485B82FFCD9271E116FA"><enum>(A)</enum><text>the effect of
subchapter G of chapter V of the Federal Food, Drug, and Cosmetic Act on the
development of such drugs; and</text>
</subparagraph><subparagraph id="id4960CEB0EC944191AA2D97F4519C9A7A"><enum>(B)</enum><text>the
implementation of such subchapter; and</text>
</subparagraph></paragraph><paragraph id="idAA72F23B06394575B508CF0EC6994D83"><enum>(2)</enum><text>evaluate the
activities of the National Institutes of Health and the Alcohol, Drug Abuse,
and Mental Health Administration for the development of such drugs for
high-risk conditions;</text>
</paragraph><paragraph id="idDD090AE52EFF46E69A1D4FD708A6B365"><enum>(3)</enum><text>assure
appropriate coordination among the Food and Drug Administration, the National
Institutes of Health, the Alcohol, Drug Abuse, and Mental Health
Administration, and the Centers for Disease Control and Prevention in the
carrying out of their respective functions relating to the development of drugs
for high-risk conditions to assure that the activities of each agency are
complementary;</text>
</paragraph><paragraph id="id7E0A7517C753416F9418504C02504ED8"><enum>(4)</enum><text>assure
appropriate coordination among all interested Federal agencies, manufacturers,
and organizations representing patients, in their activities relating to such
drugs;</text>
</paragraph><paragraph id="id15C2670944664720AC27BB6760CA5886"><enum>(5)</enum><text>with the consent
of the sponsor of a chemoprevention drug exempt under section 505(i) of the
Federal Food, Drug, and Cosmetic Act or regulations issued under such section,
inform physicians and the public respecting the availability of such drug for
the high-risk condition for which it is designated under section 582 of such
Act and inform physicians and the public respecting the availability of drugs
approved under section 505(c) of such Act or licensed under section 351 of this
Act for chemoprevention;</text>
</paragraph><paragraph id="id7840B547AF5F442996DCABD591C72AF4"><enum>(6)</enum><text>seek business
entities and others to undertake the sponsorship of chemoprevention drugs, seek
investigators to facilitate the development of such drugs, and seek business
entities to participate in the distribution of such drugs;</text>
</paragraph><paragraph id="idA4715C3737F44AF58C836BC2E139D850"><enum>(7)</enum><text>reorganize and
incentivize collaborative efforts between public and private entities and
efforts by individuals seeking the development of chemoprevention drugs in
developing such drugs; and</text>
</paragraph><paragraph id="id3E7582457243463FA4E644D77C0C8E57"><enum>(8)</enum><text>promote healthy
competition to support the steady movement of chemoprevention products through
the research and development process.</text>
</paragraph></subsection><subsection id="idA942BCD41B274169AE7C62FF681A66EE"><enum>(e)</enum><header>Consultation</header><text>The
Board shall consult with interested persons respecting the activities of the
Board under this section and as part of such consultation shall provide the
opportunity for the submission of oral views.</text>
</subsection><subsection id="id443479CFA7F9465084E9D73647846637"><enum>(f)</enum><header>Annual
report</header>
<paragraph id="id075CE7FC69A7479BBD3C6C2C50D3D587"><enum>(1)</enum><header>In
general</header><text>Not later than June 1 of each year, the Board shall
submit to the Committee on Health, Education, Labor and Pensions of the Senate
and the Committee on Energy and Commerce of the House of Representatives an
annual report, that, with respect to the preceding calendar year—</text>
<subparagraph id="id2020484618BC412199DAE8839CDB75A1"><enum>(A)</enum><text>identifies the
drugs which have been designated under section 582 of the Federal Food, Drug,
and Cosmetic Act as chemoprevention drugs;</text>
</subparagraph><subparagraph id="id9CB272DC1E7A46BF9E94F9757B26CC18"><enum>(B)</enum><text>describes the
activities of the Board; and</text>
</subparagraph><subparagraph id="idA3A0FA1BE29B43549B9714A1886FF375"><enum>(C)</enum><text>contains the
results of the evaluations carried out by the Board.</text>
</subparagraph></paragraph><paragraph id="id90D937A830DB46DAA103767400A722DC"><enum>(2)</enum><header>Additional
information for inclusion in annual report</header>
<subparagraph id="id84F5155015364072871C654A96705394"><enum>(A)</enum><header>Research
activities</header><text>The Director of the National Institutes of Health and
the Administrator of the Alcohol, Drug Abuse, and Mental Health Administration
shall submit to the Board for inclusion in the annual report under paragraph
(1) a report on the chemoprevention research activities of the Institutes of
the National Institutes of Health and the Alcohol, Drug Abuse, and Mental
Health Administration.</text>
</subparagraph><subparagraph id="idF2B350E3F9604981B3C756E36349CF20"><enum>(B)</enum><header>Effect of
provisions</header><text>The Secretary shall submit to the Board for inclusion
in the annual report under paragraph (1) a report on the program of assistance
under section __(c) of the <short-title>National Cancer
Act of 2007</short-title> for the development of chemoprevention
drugs.</text>
</subparagraph></paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="idF76ED14049494D5CAF8B8DD7277EFF45"><enum>(e)</enum><header>Sense of the
Senate on chemoprevention drugs</header><text display-inline="yes-display-inline">It is the sense of the Senate that—</text>
<paragraph id="idE93E77E36E01455890DFB7653DC98CC7"><enum>(1)</enum><text>adequate
chemoprevention drugs have not been developed;</text>
</paragraph><paragraph id="id4E2F1ED3F3E746CC8E7BAEB7884E4A35"><enum>(2)</enum><text>there is reason
to believe that promising chemoprevention drugs will not be developed unless
changes are made in the applicable Federal laws to reduce the costs of
developing such drugs and to provide incentives to develop such drugs;
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="idD0B310CAC59C433399B67B3E0B86CCF5"><enum>(3)</enum><text>it is in the
public interest to provide such changes and incentives for the development of
chemoprevention drugs.</text>
</paragraph></subsection></section><section id="ID42ec270c0e574f3f9723ae14ec810638"><enum>202.</enum><header>Compassionate
access to investigational drugs and devices</header>
<subsection id="ID26a9d97643a64187b070fa43fe25e9e8"><enum>(a)</enum><header>In
general</header><text>Section 561 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id3083DF91329249EA9A05BA579853FF86" style="OLC">
<subsection id="ID7eb6a73f14274c598cb12e727d871658"><enum>(f)</enum><header>Oncologic
compassionate access program</header><text>Acting under the existing expanded
access program, the Secretary shall establish a new program to expand access to
investigational treatments for individuals diagnosed with cancer who have
exhausted all treatment options approved by Secretary for the condition or
disease for which the patient is a reasonable candidate, and have
unsuccessfully sought treatment, or obtained treatment that was not effective,
with an investigational drug, biological product, or device for which such
individual is a reasonable candidate. In carrying out this compassionate access
program, the Secretary shall publish and broadly disseminate written guidance
to health care providers and organizations representative of patients diagnosed
with cancer that—</text>
<paragraph id="ID71cb30f0dab8422fb61f1c524bc5a28b"><enum>(1)</enum><text>describes such
compassionate access programs for investigational drugs, biological products,
and devices intended to treat cancer;</text>
</paragraph><paragraph id="IDad9a307946f549bc9efbd2b8609895ca"><enum>(2)</enum><text>facilitates the
provision of investigational drugs and devices to seriously ill cancer patients
without unreasonable delay by recognizing that the use of available
investigational products for treatment is the responsibility of the physician
and the patient; and</text>
</paragraph><paragraph id="ID50055bc6cba843c09d08822c3cf5c86c"><enum>(3)</enum><text>facilitates the
contribution of safety and efficacy data of investigational treatments from
participants in such compassionate access program.</text>
</paragraph></subsection><subsection id="IDfbf23ec515824fcbaa5e55f40fbc651a"><enum>(g)</enum><header>Implementation
of compassionate access programs</header>
<paragraph id="ID1ebf59bb4d5444f1a093859210b661ad"><enum>(1)</enum><header>Training of
personnel</header><text>Not later than 90 days after the date of enactment of
this subsection, the Secretary shall implement training programs at the Food
and Drug Administration with respect to existing expanded access program
established under this section.</text>
</paragraph><paragraph id="IDe1c84d65386b40febd87c0ce17129900"><enum>(2)</enum><header>Policies,
regulations, and guidance</header><text>The Secretary shall establish policies,
regulations, and guidance designed to most directly benefit seriously ill
cancer
patients.</text>
</paragraph></subsection><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="id700FEE76461C4100ADAD47585054EDF5"><enum>(b)</enum><header>Development of
surrogate endpoints and biomarkers</header><text>The Federal Food, Drug, and
Cosmetic Act is amended by inserting after section 561 (21 U.S.C. 360bbb) the
following:</text>
<quoted-block display-inline="no-display-inline" id="id42E1EF68B4344454A3B3DD507EE7CD56" style="OLC">
<section id="idC4F5C36E19B94A76AEED2E5F54424A2A"><enum>561A.</enum><header>Development
of surrogate endpoints and biomarkers</header><text display-inline="no-display-inline">The Secretary shall—</text>
<paragraph id="IDd25942cb95f5454eb0a4222c86bcf84d"><enum>(1)</enum><text>establish a
program to encourage the development of surrogate endpoints and biomarkers,
which shall include medical images, that are reasonably likely to
predict—</text>
<subparagraph id="id93E5229537D84FED96522DE1CA3A0885"><enum>(A)</enum><text>clinical benefit
for cancer-related conditions for which there exist significant unmet medical
needs; and</text>
</subparagraph><subparagraph id="id5E633B71A56A47BB9693F4038DFD5C25"><enum>(B)</enum><text>individual risk
for cancer-related conditions for which there exist unmet medical needs;</text>
</subparagraph></paragraph><paragraph id="ID0b19337c57ef489ebeaa0cd1f6eac6d1"><enum>(2)</enum><text>request the
Institute of Medicine to undertake a study to identify validated surrogate
endpoints and biomarkers, which shall include medical images, and recommend
research to validate such surrogate endpoints and biomarkers, that may support
approvals for products intended for the treatment of cancer;</text>
</paragraph><paragraph id="ID20ff23c575024f8e82339cf417e1c1b4"><enum>(3)</enum><text>request the
Institute of Medicine to undertake a study to evaluate the practicality of
expanding the use of large, community-based simple trials designed to identify
product safety and efficacy in a larger and more representative patient
population of individuals diagnosed with cancer prior to approving the product
for widespread use; and</text>
</paragraph><paragraph id="IDc82d1884ccb2403bb33b809abe92abb7"><enum>(4)</enum><text>make available to
the public a list of drugs, biological products, and devices that are being
investigated for cancer and that are in no earlier than the Phase II stage of
clinical
trials.</text>
</paragraph></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="IDcbdb5ed3c9d64ac0bce8eb46c81f73b6"><enum>(c)</enum><header>Conforming
amendment</header><text>Section 561(c) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bbb(c)) is amended by striking the heading and inserting
<quote><header-in-text level="subsection" style="OLC">Compassionate Access to
Investigational Drugs and Devices for Cancer
Patients.—</header-in-text></quote>.</text>
</subsection></section><section id="ID1bbef8079ec54173b828694d227c8464"><enum>203.</enum><header>Oncology Drugs
Advisory Committee</header><text display-inline="no-display-inline">Subchapter
E of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et
seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="id73ED23A765AF46CDB361A28E5ADBFF03" style="OLC">
<section id="ID46c3f736db574b16ab124d49712bc495"><enum>566.</enum><header>Membership of
Oncology Drugs Advisory Committee</header><text display-inline="no-display-inline">Membership of the Oncology Drugs Advisory
Committee of the Food and Drug Administration shall consist of no less than 2
patient representatives who are voting members of the
committee.</text>
</section><after-quoted-block>.</after-quoted-block></quoted-block>
</section><section id="ID1194B262EDC94C55B21D9F88655C6E26"><enum>204.</enum><header>Technical
amendment</header><text display-inline="no-display-inline">Section 526(a)(2) of
the <act-name parsable-cite="FFDCA">Federal Food, Drug, and Cosmetic
Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/21/360bb(a)(2)">21 U.S.C. 360bb(a)(2)</external-xref>) is
amended by inserting <quote>or targets and mechanisms of pathogenesis of
diseases</quote> after <quote>disease or condition</quote>.</text>
</section><enum>III</enum><header>Payments for
cancer-related services and products</header>
<section id="ID5AC5A5F2E1214679ABC814637D1DD574"><enum>301.</enum><header>Coordinating
cancer care for patients</header>
<subsection id="ID0C7DFA56B7664C50B6CD3BC8AFAF24D5"><enum>(a)</enum><header>Cancer coverage
requirements</header><text>Part B of title XVIII of the
<act-name parsable-cite="SSA">Social Security Act</act-name> (<external-xref legal-doc="usc" parsable-cite="usc/42/1395j">42 U.S.C. 1395j</external-xref> et
seq.) is amended by adding at the end the following:</text>
<quoted-block act-name="Social Security Act" id="IDFC885E302D55414A973D29689B307935" style="traditional">
<section id="ID2B1B10D7A67B4D40AD90C81C23E7AE62"><enum>1849.</enum><header>Cancer coverage requirements</header><subsection commented="no" display-inline="yes-display-inline" id="id1039154ABFD74D2DA42BE7B061C8073B"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">The following
provisions shall apply to a participating cancer care coordinator treating an
individual who has been diagnosed with cancer and who is covered under the
insurance program established under this part.</text>
</subsection><subsection id="idD0A9533A6FAF4505A55E44809419D99C"><enum>(b)</enum><header>Definitions</header><text>In
this section:</text>
<paragraph id="ID52b6f9dd2c364405a5b572981d1172c6"><enum>(1)</enum><header>Cancer care
coordinator</header>
<subparagraph id="id2DECF370D7994384B996D4A94749F9FD"><enum>(A)</enum><header>In
general</header><text>The term <quote>cancer care coordinator</quote> means,
with respect to items or services provided under the coverage related to the
treatment of cancer, a lead managing physician, nurse practitioner with an
oncology certification (as provided by a nationally accredited organization),
or registered nurse (as provided by a nationally accredited organization) that
is designated at the time of cancer diagnosis by the provider, in consultation
with the participant or beneficiary, and other providers involved to provide
for the overall coordination and management of the cancer care of the
individual among all providers who provide items or services to the individual,
and who otherwise meet the requirements of this paragraph.</text>
</subparagraph><subparagraph id="IDb09cd463af044927be4ddd3894f4947d"><enum>(B)</enum><header>Responsibilities</header><text>A
designee under subparagraph (A) shall be responsible for the overall
coordination and management of the medical, nursing, and other health services
provided to the individual during the period in which the individual is
undergoing treatment for such cancer.</text>
</subparagraph><subparagraph id="ID12b1796c1c3a445191a2b50ab25677b2"><enum>(C)</enum><header>Coordination
and management</header>
<clause id="id3F752BBC5C7548A4A13C7CC92CB6CA2E"><enum>(i)</enum><header>In
general</header><text>The overall coordination and management under
subparagraph (A) shall include the development of a plan of care that—</text>
<subclause id="id9A7652E5FD1A46898EF674851FF6D5D0"><enum>(I)</enum><text>details, to the
greatest extent practicable, all aspects of the care to be provided to the
individual, with respect to the treatment of such cancer, including any
curative treatment and comprehensive symptom management (such as palliative
care) involved;</text>
</subclause><subclause id="ID331409e160ef45fa89d9b435db487f6d"><enum>(II)</enum><text>is furnished in
written form to the individual in person within a period specified by the
Secretary that is as soon as practicable after the date on which the individual
is so diagnosed;</text>
</subclause><subclause id="ID7ff9ff64ae7044778193744733913fc2"><enum>(III)</enum><text>is furnished in
a form that is appropriate for use by disparity populations, to the extent
practicable; and</text>
</subclause><subclause id="ID964c3204d3e14470b876c5c8df7e9e07"><enum>(IV)</enum><text>is in accordance
with standards determined by the Secretary to be appropriate;</text>
</subclause></clause><clause id="ID2624b6e8278c4b34ac1c601a0643792b"><enum>(ii)</enum><header>Covered
individual</header><text>With respect to an individual for whom the plan of
care has been developed under clause (i), such plan shall be revised as
necessary to account for any substantial change in the condition of the
individual, if such revision—</text>
<subclause id="IDd368fe51803d46ffa3004f5d8d7874cf"><enum>(I)</enum><text>is in accordance
with subclauses (I) and (III) of such clause; and</text>
</subclause><subclause id="IDa004c9e3920c468d9fffaa8588ea7b7b"><enum>(II)</enum><text>is furnished in
written form to the individual within a period specified by the Secretary that
is as soon as practicable after the date of such revision.</text>
</subclause></clause><clause id="ID984fc3e4f8ec48358a5568b7aab065d1"><enum>(iii)</enum><header>Follow-up
plan</header><text>With respect to an individual who has completed the primary
treatment for cancer, as defined by the Secretary (such as completion of
chemotherapy or radiation treatment), the development of a follow-up cancer
care plan that—</text>
<subclause id="ID6ab0fc0887f44a0eb373250d4b4a8079"><enum>(I)</enum><text>describes the
elements of the primary treatment, including symptom management, furnished to
such individual;</text>
</subclause><subclause id="IDeed05495aa6a4f16b8cf49e7a8450e42"><enum>(II)</enum><text>provides
recommendations for the subsequent care of the individual with respect to the
cancer involved;</text>
</subclause><subclause id="ID17cd4bbb42b24514b30a1d9cbe09bda8"><enum>(III)</enum><text>is furnished in
written form to the individual in person within a period specified by the
Secretary that is as soon as practicable after the completion of such primary
treatment;</text>
</subclause><subclause id="ID736f52442973419ea187ff8e23fa56ed"><enum>(IV)</enum><text>is furnished in
a form that is appropriate for use by disparity populations to the extent
practicable; and</text>
</subclause><subclause id="ID27ffb0cd52b54952bd84be29b9cf33c3"><enum>(V)</enum><text>is in accordance
with standards determined by the Secretary to be appropriate.</text>
</subclause></clause><clause id="IDff02ba584525489b8c2840dfbbd39fc0"><enum>(iv)</enum><header>Revisions to
follow up plan</header><text>With respect to an individual for whom a follow-up
cancer care plan has been developed under clause (iii), the revision of such
plan as necessary to account for any substantial change in the condition of the
individual, if such revision—</text>
<subclause id="ID9d49d2a983b04e27988621c26637b652"><enum>(I)</enum><text>is in accordance
with subclauses (I), (II), and (IV) of such clause; and</text>
</subclause><subclause id="IDe0e7889bec23452689bef6f65febe2af"><enum>(II)</enum><text>is furnished in
written form to the individual within a period specified by the Secretary that
is as soon as practicable after the date of such revision.</text>
</subclause></clause></subparagraph><subparagraph id="ID71478df1de63470fa346f5c857fec060"><enum>(D)</enum><header>Standards</header><text>The
Secretary shall establish standards to carry out this paragraph in consultation
with appropriate organizations that represent providers of services related to
cancer treatment and organizations representing survivors of cancer. Such
standards shall include standards for determining the need and frequency for
revisions of the plans of care and follow-up plans based on changes in the
condition of the individual and standards for the communication of the plan to
the patient.</text>
</subparagraph></paragraph><paragraph id="ID2d9f2f51cc5a491992033f18f1f8f585"><enum>(2)</enum><header>Individual</header><text>The
term <term>individual</term> means a person who has been diagnosed with cancer
and who is covered under the insurance program established under this
part.</text>
</paragraph></subsection></section><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection><subsection id="idF149C2FA6F6C4A1282DF2B3C4E0529B0"><enum>(b)</enum><header>Additional
payment</header><text>Section 1833(m) of the Social Security Act (42 U.S.C.
1395 l(m)) is amended by adding at the end the following new paragraph:</text>
<quoted-block display-inline="no-display-inline" id="idBB58D188A74847BE846B84D5C2D279E4" style="OLC">
<paragraph id="ID3c1b98e033284c499d7c940efc9a8f6e"><enum>(5)</enum><text>In the case of
physician or nursing services furnished to an individual under this section who
receives care for such cancer, there shall be paid to the cancer care
coordinator of that individual during the period in which that individual is
undergoing treatment for such cancer from the Federal Supplementary Medical
Insurance Trust Fund, a separate and additional payment amount for the services
under this part in addition to any amount otherwise paid under this
part.</text>
</paragraph><after-quoted-block>.</after-quoted-block></quoted-block>
</subsection></section><section id="ID7D0BA963F8764C188191F12CB9275A22"><enum>302.</enum><header>Elimination of
Optional Exclusion From Medicaid Prescription Drug Coverage for Tobacco
Cessation Medications</header>
<subsection id="id8DE67731C14541FB8611492C39C0859F"><enum>(a)</enum><header>In
general</header><text display-inline="yes-display-inline">Section 1927(d)(2) of
the <act-name parsable-cite="SSA">Social Security Act</act-name> (42 U.S.C.
1396r–8(d)(2)) is amended—</text>
<paragraph id="IDC62638968B194560AF082308F94493DF"><enum>(1)</enum><text>by striking
subparagraph (E);</text>
</paragraph><paragraph id="ID3632DE7DBC0742ACA39A90D64F678A7B"><enum>(2)</enum><text>by redesignating
subparagraphs (F) through (K) as subparagraphs (E) through (J), respectively;
and</text>
</paragraph><paragraph commented="no" display-inline="no-display-inline" id="ID1486FF66EF9C434EA2D3126C6F008834"><enum>(3)</enum><text>in subparagraph
(F) (as redesignated by paragraph (2)), by inserting before the period at the
end the following: <quote>, other than agents approved by the Food and Drug
Administration for purposes of promoting, and when used to promote, tobacco
cessation</quote>.</text>
</paragraph></subsection><subsection commented="no" display-inline="no-display-inline" id="ID5CA65170120147F9AAAC86B34DC1F17A"><enum>(b)</enum><header>Effective
Date</header><text>The amendments made by subsection (a) shall apply to
services furnished on or after the date of enactment of this Act.</text>
</subsection></section><enum>IV</enum><header>Promoting
biospecimen collection to accelerate the genomic mapping of the most lethal
cancers</header>
<section id="idE7E0CB587ACB4F8486A8265E6AB568D4"><enum>401.</enum><header>Adoption of
National Cancer Institute guidelines for biorepositories</header>
<subsection id="id505CD98019D14D9E8C8ABB455614C4C9"><enum>(a)</enum><header>In
general</header><text>A biorepository may adopt the First-Generation Guidelines
for NCI-Supported Biospecimen Resources, published by the National Cancer
Institute of the National Institutes of Health on November 21, 2006 (or any
successor guidelines), for the collection of biospecimens and any accompanying
data.</text>
</subsection><subsection commented="no" id="idE27D06F5188044A8B2D53A93CE1A1E7C"><enum>(b)</enum><header>Definitions</header><text>For
purposes of this section:</text>
<paragraph commented="no" id="idE7EB1B20F5BB42C2B1F0ADA1F99410CA"><enum>(1)</enum><header>Biorepository</header><text>The
term <term>biorepository</term> means a collection of biological materials
(which may include tissues, biomolecules, body fluids, and medical imaging)
derived from patients, stored under specifically-defined conditions, and
accessed for the purpose of scientific research or patient care.</text>
</paragraph><paragraph commented="no" id="id4A01A449E63645D686FAE0FE0096DB5E"><enum>(2)</enum><header>Biospecimen</header><text>The
term <term>biospecimen</term> means any material or medical images of material
that is biologically-derived, such as blood, tissue, and urine, and used for
diagnosis and analysis.</text>
</paragraph></subsection></section><section commented="no" display-inline="no-display-inline" id="idD139ECF8712C469FB5CE78789630AF14"><enum>402.</enum><header>MedPAC report
on payments for specimen collection</header>
<subsection id="ID05bac74096664f5f8d498294926a3c7d"><enum>(a)</enum><header>In
general</header><text>Not later than 1 year after the date of enactment of this
Act, the Medicare Payment Assessment Commission shall submit to Congress a
report (in this section referred to as the <quote>report</quote>) on approaches
to developing a payment system within Medicare for the collection and storage
of cancer and related tissues for use in research involving the application of
genomic or proteomic technologies.</text>
</subsection><subsection id="IDf4547ff03b96429cb030e118ef3e9600"><enum>(b)</enum><header>Report
details</header>
<paragraph id="ID605bfb798a0b47f3b358b11ab67374e2"><enum>(1)</enum><header>In
general</header><text>The report shall include recommendations on the
following:</text>
<subparagraph id="ID53f85e1b678c4252b2302b9cd1ac3c90"><enum>(A)</enum><text>Potential billing
code systems for the collection, storage, and pathological definition of cancer
and related tissues.</text>
</subparagraph><subparagraph id="IDd0473b952dfc45ce865abe06ef38379b"><enum>(B)</enum><text>Potential payment
systems for the collection, storage, and pathological definition of cancer and
related tissues.</text>
</subparagraph><subparagraph id="IDe064b54080a0493f81865a89edc04318"><enum>(C)</enum><text>The feasibility
of expanding the recommended payment system to cover tissue collection,
storage, and pathological definition for research on conditions unrelated to
cancer.</text>
</subparagraph></paragraph><paragraph id="ID40b0d97fb8dd4bbb8e55917e6c4d605a"><enum>(2)</enum><header>Payment
systems</header><text>Proposed payment systems referred to in paragraph (1)(B)
shall consider the following factors:</text>
<subparagraph id="ID6217c93d2b204e4ba2e8227f3c9572d6"><enum>(A)</enum><text>Numbers and types
of cancer tissues collected for the purpose of research involving the
application of genomic or proteomic technologies.</text>
</subparagraph><subparagraph id="ID942349cd54d24394bdbed64c5e6ef5e3"><enum>(B)</enum><text>Professional time
required for pathologists, surgeons, other experts to collect these tissues for
post-genomics research.</text>
</subparagraph><subparagraph id="IDf866eed2f4c04f03a42849ce26fa974d"><enum>(C)</enum><text>Specific
annotation of collected tissue required beyond normal diagnostic needs
currently in practice.</text>
</subparagraph><subparagraph id="IDd766263983c346ac870d324c9af3529f"><enum>(D)</enum><text>Numbers of
tissues collected on government sponsored clinical trials and method of
coverage for the collection of these tissues.</text>
</subparagraph><subparagraph id="ID2c680195c6a542d9b03c2ede70854576"><enum>(E)</enum><text>The cost of
maintenance of such highly annotated resources.</text>
</subparagraph><subparagraph id="ID31f24631149e4c79b3e3710804404443"><enum>(F)</enum><text>The cost of
overseeing the standards needed to ensure that the tissues collected for
molecular oncology research, including the certification and oversight by a
qualified professional body.</text>
</subparagraph></paragraph></subsection></section>