[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1056 Introduced in Senate (IS)]







110th CONGRESS
  1st Session
                                S. 1056

    To provide for a comprehensive Federal effort relating to early 
  detection of, treatments for, and the prevention of cancer, and for 
                            other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 29, 2007

Mrs. Feinstein (for herself and Mr. Brownback) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
    To provide for a comprehensive Federal effort relating to early 
  detection of, treatments for, and the prevention of cancer, and for 
                            other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``National Cancer 
Act of 2007''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
 TITLE I--EXPANSION OF CANCER-RELATED RESEARCH, PREVENTION, DETECTION, 
                         AND TREATMENT PROGRAMS

Sec. 101. Sense of the 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.

SEC. 2. FINDINGS.

    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.

 TITLE I--EXPANSION OF CANCER-RELATED RESEARCH, PREVENTION, DETECTION, 
                         AND TREATMENT PROGRAMS

SEC. 101. SENSE OF THE SENATE CONCERNING INVESTMENTS IN CANCER RESEARCH 
              FUNDING.

    It is the sense of the Senate that--
            (1) past investments in cancer research have resulted in 
        better health, an improved quality of life, and new 
        discoveries; and
            (2) 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.

SEC. 102. SENSE OF THE SENATE CONCERNING INVESTMENTS IN CANCER RESEARCH 
              TO DEVELOP TARGETED DRUGS.

    (a) Findings.--The Senate finds that--
            (1) all cells have molecular signatures, unique 
        identifiable characteristics related to a cells' function in 
        the body;
            (2) as a normal cell becomes malignant, its signature 
        changes and this change becomes a signal of the presence of 
        cancer; and
            (3) with new technologies, scientists are reading cancer-
        associated signatures and using this information to devise 
        treatments that target specific cells.
    (b) Sense of the Senate.--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.

SEC. 103. EXPANSION OF CANCER-RELATED RESEARCH, PREVENTION, DETECTION, 
              TREATMENT, AND SURVIVORSHIP PROGRAMS.

    Subpart 1 of part C of title IV of the Public Health Service Act 
(42 U.S.C. 285) is amended--
            (1) by inserting after the subpart heading the following:

   ``CHAPTER I--PURPOSE OF INSTITUTE AND NATIONAL CANCER PROGRAMS'';

            and
            (2) by adding at the end the following:

           ``CHAPTER II--PROGRAMS TO PREVENT AND TREAT CANCER

``SEC. 417E. STUDY AND STRATEGIC PLANS.

    ``(a) In General.--Not later than 6 months after the date of 
enactment of the National Cancer Act of 2007, 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:
            ``(1) Understanding the causes of cancer.
            ``(2) Research regarding cancer prevention.
            ``(3) Improving early detection and diagnosis of cancer.
            ``(4) Developing effective and efficient cancer treatments.
            ``(5) Understanding the factors that influence patient 
        outcomes.
            ``(6) Improving the quality of cancer care.
            ``(7) Research regarding the quality of life for cancer 
        patients and survivors.
            ``(8) Overcoming cancer health disparities.
    ``(b) Detailed Report.--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 
National Cancer Act of 2007, 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.
    ``(c) Priorities.--Not later than 6 months after the date of 
enactment of the National Cancer Act of 2007, 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.

``SEC. 417E-1. GRANTS FOR DEVELOPMENT OF TARGETED DRUGS.

    ``(a) In General.--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.
    ``(b) Duties of Director.--In carrying out the program under 
subsection (a), the Director of the Institute shall--
            ``(1) 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
            ``(2) not later than 6 months after the date of enactment 
        of the National Cancer Act of 2007, 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.
    ``(c) Limitations.--Amounts awarded under grants under this section 
shall not be used for the construction of facilities.
    ``(d) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section, such sums as may be necessary 
for each of fiscal years 2008 through 2011.

``SEC. 417E-2. CLINICAL TRIALS.

    ``(a) In General.--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--
            ``(1) information about how to access and use the National 
        Cancer Institute clinical trials database online;
            ``(2) information about the Food and Drug Administration 
        process for approving the use of drugs and biologics for a 
        single patient;
            ``(3) information targeted to populations of age and 
        cultural demographics that are frequently underrepresented in 
        clinical trials; and
            ``(4) recommendations regarding logistical support and 
        sources of funding for patients support costs.
    ``(b) Information Dissemination.--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.
    ``(c) Diversity Assurance.--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.
    ``(d) Sense of the Senate on a Central Institutional Review 
Board.--It is the sense of the Senate that--
            ``(1) 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;
            ``(2) 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
            ``(3) the research community should continue to streamline 
        the institutional review board process in order to bring 
        lifesaving treatments to patients as quickly as possible.

``SEC. 417E-3. CANCER CARE RESEARCHERS.

    ``(a) Supply of Cancer Researchers.--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.
    ``(b) Loan Repayment.--
            ``(1) In general.--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.
            ``(2) Service provisions.--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.
    ``(c) Authorization of Appropriations.--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.

``SEC. 417E-4. CANCER CARE WORKFORCE.

    ``(a) In General.--
            ``(1) Study.--The Secretary shall conduct a study on the 
        current and future cancer care workforce needs in the following 
        areas:
                    ``(A) Cancer research.
                    ``(B) Care and treatment of cancer patients and 
                survivors.
                    ``(C) Quality of life, symptom management, and pain 
                management.
                    ``(D) Early detection and diagnosis.
                    ``(E) Cancer prevention.
                    ``(F) Genetic testing, counseling, and ethical 
                considerations related to such testing.
                    ``(G) Diversity and appropriate care for disparity 
                populations.
                    ``(H) Palliative and end-of-life care.
            ``(2) Report.--Not later than 1 year after the date of 
        enactment of the National Cancer Act of 2007, the Secretary 
        shall submit to Congress a report that describes the findings 
        of the study conducted under subsection (a).
    ``(b) Program.--
            ``(1) Establishment.--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).
            ``(2) Recommendations.--The programmatic recommendations 
        described in paragraph (1) shall--
                    ``(A) set annual and long-term training goals to 
                assure an adequate cancer care workforce;
                    ``(B) 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
                    ``(C) be coordinated with existing programs to 
                prevent duplication.
    ``(c) Eligibility.--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.
    ``(d) Use of Funds.--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).
    ``(e) Authorization of Appropriations.--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.

``SEC. 417F-5. CANCER SURVIVORSHIP.

    ``(a) In General.--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.
    ``(b) Activities.--Activities that may be carried out under 
subsection (a) include--
            ``(1) 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;
            ``(2) 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--
                    ``(A) develop unique and innovative post-treatment 
                programs, services, and demonstrations designed to 
                support and advance cancer survivorship through--
                            ``(i) promotion of physical activity and 
                        healthy lifestyles;
                            ``(ii) educational outreach programs for 
                        health care providers;
                            ``(iii) support for innovative programs to 
                        improve the quality of life among cancer 
                        survivors;
                            ``(iv) home and community-based 
                        interventions;
                            ``(v) peer support and mentor programs;
                            ``(vi) public awareness and outreach 
                        campaigns; and
                            ``(vii) information dissemination to inform 
                        health care providers and cancer survivors of 
                        their health care options and available 
                        survivorship programs; and
                    ``(B) develop unique cancer survivorship 
                demonstration programs designed to address the needs of 
                underserved populations, including minorities, 
                children, and individuals residing in rural areas.
    ``(c) Coordination of Activities.--The Secretary shall ensure that 
activities carried out under this section are coordinated as 
appropriate with other agencies of the Public Health Service.
    ``(d) Report to Congress.--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.
    ``(e) Authorization of Appropriations.--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.

``SEC. 417G-6. MONITORING AND EVALUATING CANCER CARE IN CANCER 
              SURVIVORSHIP.

    ``(a) In General.--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.
    ``(b) Eligible Entities.--An entity shall be eligible for a grant 
under this section for a fiscal year if such entity--
            ``(1) operates a statewide cancer registry with funds from 
        a grant made under section 399B for such fiscal year; or
            ``(2) 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.
    ``(c) Contracting Authority.--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.
    ``(d) Application.--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.
    ``(e) Authority of Secretary Regarding Use of Grant Funds.--The 
Secretary shall determine the appropriate uses of grant funds under 
subsection (a) to achieve the purpose described in such subsection.
    ``(f) Authorization of Appropriations.--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.

``SEC. 417E-7. CANCER CARE GUIDELINES.

    ``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--
            ``(1) consensus protocols and guidelines for optimal cancer 
        treatments and prevention, including palliation, symptom 
        management, and end-of-life care; and
            ``(2) 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.

``SEC. 417E-8. OTHER ACTIVITIES TO IMPROVE OUTCOMES OF CANCER CARE.

    ``(a) In General.--
            ``(1) Research.--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.
            ``(2) Factors.--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.
    ``(b) Specific Requirements.--The Director of the Institute shall--
            ``(1) 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
            ``(2) 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.
    ``(c) Authorization of Appropriations.--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.''.

SEC. 104. NATIONAL INSTITUTE FOR ENVIRONMENTAL HEALTH SCIENCES.

    (a) In General.--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.
    (b) Authorization of Appropriations.--There is authorized to be 
appropriated to carry out this section such sums as may be necessary.

SEC. 105. NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES.

    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.

SEC. 106. COMPREHENSIVE CANCER CONTROL PLANS.

    Section 412 of the Public Health Service Act (42 U.S.C. 285a-1) is 
amended--
            (1) in the first sentence, by inserting ``, for 
        survivorship,'' after ``treatment of cancer'';
            (2) in paragraph (1)(B), by striking ``cancer patients'' 
        and all that follows and inserting the following: ``cancer 
        patients, families of cancer patients, and cancer survivors, 
        and''; and
            (3) in paragraph (3), by inserting ``and concerning cancer 
        survivorship programs,'' after ``control of cancer''.

SEC. 107. LUNG CANCER EARLY DETECTION AND RESEARCH DEMONSTRATION 
              PROJECT.

    Title XV of the Public Health Service Act (42 U.S.C. 300k et seq.) 
is amended by adding at the end the following:

``SEC. 1511. LUNG CANCER EARLY DETECTION AND RESEARCH DEMONSTRATION 
              PROJECT.

    ``(a) In General.--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.
    ``(b) Requirements.--
            ``(1) In general.--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.
            ``(2) Collection of imaging data.--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).
            ``(3) Relationship to items and services under other 
        programs.--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--
                    ``(A) under any State compensation program, under 
                an insurance policy, or under any Federal or State 
                health benefits program; or
                    ``(B) by an entity that provides health service on 
                a prepaid basis.
            ``(4) Records and audits.--To be eligible for a grant under 
        this section, an entity shall--
                    ``(A) 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
                    ``(B) 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.
            ``(5) Reports.--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.
    ``(c) Definition.--In this section, the term `high risk population' 
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.
    ``(d) Authorization of Appropriations.--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.''.

SEC. 108. COLORECTAL CANCER SCREENING.

    Title XV of the Public Health Service Act (42 U.S.C. 300k et seq.), 
as amended by section 106, is further amended by adding at the end the 
following:

``SEC. 1512. COLORECTAL CANCER SCREENING DEMONSTRATION PROJECT.

    ``(a) In General.--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--
            ``(1) screening asymptomatic individuals for colorectal 
        cancer as a preventive health measure according to scientific 
        evidence-based screening guidelines;
            ``(2) 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);
            ``(3) activities to improve the education, training, and 
        skills of health professionals (including allied health 
        professionals) in the detection and control of colorectal 
        cancer;
            ``(4) activities to evaluate the programs under this 
        section through appropriate surveillance or program monitoring 
        activities;
            ``(5) the development and dissemination of findings derived 
        through such evaluations through public and professional 
        education; and
            ``(6) activities to promote participation in the colorectal 
        cancer screening under this section.
    ``(b) Use of Certain Standards Under Medicare Program.--A grant may 
be awarded under subsection (a) only if the applicant involved agrees 
that--
            ``(1) 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;
            ``(2) 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
            ``(3) 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.
    ``(c) Requirements.--
            ``(1) Priority.--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--
                    ``(A) individual who is at least 50 years of age; 
                or
                    ``(B) individual at high risk for colorectal cancer 
                (as defined in section 1861(pp)(2) of the Social 
                Security Act) and is under 50 years of age.
            ``(2) Relationship to items and services under other 
        programs.--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--
                    ``(A) under any State compensation program, under 
                an insurance policy, or under any Federal or State 
                health benefits program; or
                    ``(B) by an entity that provides health service on 
                a prepaid basis.
            ``(3) Records and audits.--To be eligible for a grant under 
        subsection (a), an entity shall agree that the entity will--
                    ``(A) 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
                    ``(B) 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.
            ``(4) Reports.--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.
    ``(d) Authorization of Appropriations.--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.''.

SEC. 109. NATIONAL PROGRAM OF CANCER REGISTRIES.

    Part M of title III of the Public Health Service Act (42 U.S.C. 
280e et seq.) is amended by inserting after section 399B the following:

``SEC. 399B-1. ENHANCING CANCER REGISTRIES AND PREPARING FOR THE 
              FUTURE.

    ``Not later than 1 year after the date of enactment of the National 
Cancer Act of 2007 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 `SEER program') can share 
information to ensure more comprehensive cancer data. The report shall 
include ways in which the Secretary will--
            ``(1) standardize data between State cancer registries and 
        the SEER program;
            ``(2) increase the portability and usability of data files 
        from each registry for researchers and public health planners;
            ``(3) ensure data collection from the greatest number of 
        health care facilities possible;
            ``(4) maximize the use of State registry data and data from 
        the SEER program in State and regional public health planning 
        processes; and
            ``(5) promote the use of data to--
                    ``(A) improve the health status of cancer 
                survivors; and
                    ``(B) research quality of cancer care and access to 
                that care.

``SEC. 399B-2. NATIONAL CHILDHOOD CANCER REGISTRY.

    ``(a) In General.--The Director of the National Institute of Health 
(in this section referred to as the `Director') 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--
            ``(1) formalize the consent process by which pediatric 
        cancer patients enroll on to a clinical trial or receive 
        treatment within the multi-center infrastructure;
            ``(2) 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
            ``(3) evaluate the quality of pediatric cancer care, and 
        monitor long-term pediatric cancer survivorship.
    ``(b) Coordination.--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.
    ``(c) Authorization of Appropriations.--There is authorized to be 
appropriated, such sums as may be necessary to carry out this 
section.''.

SEC. 110. OTHER TRANSACTIONS AUTHORITY.

    Section 402(i) of the Public Health Service Act (42 U.S.C. 282(i)) 
is amended by adding at the end the following:
    ``(4) 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.''.

        TITLE II--EXPANDING ACCESS TO CANCER DRUGS AND TREATMENT

SEC. 201. DRUGS TO PREVENT CANCER.

    (a) In General.--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:

                  ``Subtitle G--Chemoprevention Drugs

``SEC. 581. RECOMMENDATIONS FOR INVESTIGATIONS OF CHEMOPREVENTION 
              DRUGS.

    ``(a) In General.--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--
            ``(1) it may be approved under section 505 for the high-
        risk condition that the drug is designed to treat; or
            ``(2) if the drug is a biological product, it may be 
        licensed under section 351 of the Public Health Service Act for 
        such condition.
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.
    ``(b) Regulations.--The Secretary shall by regulation promulgate 
procedures for the implementation of subsection (a).

``SEC. 582. DESIGNATION OF CHEMOPREVENTION DRUGS.

    ``(a) Designation.--
            ``(1) In general.--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--
                    ``(A) if an application for such drug is approved 
                under section 505; or
                    ``(B) if a license for such drug is issued under 
                section 351 of the Public Health Service Act,
        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.
            ``(2) Definitions.--In this subtitle:
                    ``(A) Chemoprevention drug.--The term 
                `chemoprevention drug' means a drug designed to treat a 
                high-risk condition.
                    ``(B) High-risk condition.--The term `high-risk 
                condition' means a medical condition that--
                            ``(i) has been diagnosed in individuals who 
                        have not been diagnosed with cancer or who do 
                        not currently have progressive, life-
                        threatening cancer; and
                            ``(ii) unless treated, could develop into 
                        progressive and life-threatening cancer
                    ``(C) Determination.--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.
    ``(b) Conditions of Designation.--A designation of a drug under 
subsection (a) shall be subject to the condition that--
            ``(1) 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
            ``(2) 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.
    ``(c) Notice.--Notice respecting the designation of a drug under 
subsection (a) shall be made available to the public.
    ``(d) Regulations.--The Secretary shall by regulation promulgate 
procedures for the implementation of subsection (a).

``SEC. 583. PROTECTION FOR CHEMOPREVENTION DRUGS.

    ``(a) In General.--Except as provided in subsection (b), if the 
Secretary--
            ``(1) approves an application filed pursuant to section 
        505(b); or
            ``(2) issues a license under section 351 of the Public 
        Health Service Act,
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.
    ``(b) Other Application Approval.--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--
            ``(1) 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
            ``(2) 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.
    ``(c) Market Exclusivity for Chemoprevention Drugs Designated for a 
High-Risk Condition.--If the Secretary designates a drug as a 
chemoprevention drug for a high-risk condition under section 582--
            ``(1)(A) 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
            ``(B) 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;
            ``(2)(A) if the drug is the subject of--
                    ``(i) 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
                    ``(ii) 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,
                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
            ``(B) 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
            ``(3) 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.

``SEC. 584. OPEN PROTOCOLS FOR INVESTIGATIONS OF CHEMOPREVENTION DRUGS.

    ``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.''.
    (b) Grants and Contracts for Development of Chemoprevention 
Drugs.--
            (1) In general.--The Secretary may make grants to and enter 
        into contracts with public and private entities and individuals 
        to assist in--
                    (A) defraying the costs of qualified clinical 
                testing expenses incurred in connection with the 
                development of chemoprevention drugs;
                    (B) defraying the costs of developing 
                chemoprevention devices; and
                    (C) defraying the costs of developing 
                chemoprevention foods.
            (2) Definitions.--For purposes of this subsection:
                    (A) Chemoprevention device.--The term 
                ``chemoprevention device'' means a device to be 
                approved to treat a high-risk condition.
                    (B) Chemoprevention drug.--The term 
                ``chemoprevention drug'' means a drug designed to treat 
                a high-risk condition.
                    (C) Chemoprevention food.--The term 
                ``chemoprevention food'' 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.
                    (D) High-risk condition.--
                            (i) In general.--The term ``high-risk 
                        condition'' means, with respect to a 
                        chemoprevention drug, chemoprevention device, 
                        or chemoprevention food, a medical condition 
                        that--
                                    (I) has been diagnosed in 
                                individuals who have not been diagnosed 
                                with cancer or who do not currently 
                                have progressive, life-threatening 
                                cancer; and
                                    (II) unless treated, could develop 
                                into progressive and life-threatening 
                                cancer.
                            (ii) Determination.--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.
                    (E) Qualified testing.--The term ``qualified 
                testing'' means--
                            (i) human clinical testing--
                                    (I) 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
                                    (II) 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
                            (ii) 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.
            (3) Authorization of appropriations.--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.
    (c) Studies.--
            (1) Medical devices or medical food for high risk 
        conditions.--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.
            (2) Chemoprevention products.--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.
    (d) Chemoprevention Products Board.--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:

``SEC. 229. CHEMOPREVENTION PRODUCTS BOARD.

    ``(a) In General.--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 `Board'). 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.
    ``(b) Definitions.--In this section:
            ``(1) Chemoprevention device.--The term `chemoprevention 
        device' has the meaning given such term in section 582 of the 
        Federal Food, Drug, and Cosmetic Act.
            ``(2) Chemoprevention drug.--The term `chemoprevention 
        drug' has the meaning given such term in section 582 of the 
        Federal Food, Drug, and Cosmetic Act.
            ``(3) High-risk condition.--The term `high-risk condition' 
        has the meaning given such term in section 582 of the Federal 
        Food, Drug, and Cosmetic Act.
    ``(c) Function.--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.
    ``(d) Duties.--In the case of chemoprevention drugs, the Board 
shall--
            ``(1) evaluate--
                    ``(A) the effect of subchapter G of chapter V of 
                the Federal Food, Drug, and Cosmetic Act on the 
                development of such drugs; and
                    ``(B) the implementation of such subchapter; and
            ``(2) 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;
            ``(3) 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;
            ``(4) assure appropriate coordination among all interested 
        Federal agencies, manufacturers, and organizations representing 
        patients, in their activities relating to such drugs;
            ``(5) 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;
            ``(6) 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;
            ``(7) 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
            ``(8) promote healthy competition to support the steady 
        movement of chemoprevention products through the research and 
        development process.
    ``(e) Consultation.--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.
    ``(f) Annual Report.--
            ``(1) In general.--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--
                    ``(A) identifies the drugs which have been 
                designated under section 582 of the Federal Food, Drug, 
                and Cosmetic Act as chemoprevention drugs;
                    ``(B) describes the activities of the Board; and
                    ``(C) contains the results of the evaluations 
                carried out by the Board.
            ``(2) Additional information for inclusion in annual 
        report.--
                    ``(A) Research activities.--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.
                    ``(B) Effect of provisions.--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 National Cancer 
                Act of 2007 for the development of chemoprevention 
                drugs.''.
    (e) Sense of the Senate on Chemoprevention Drugs.--It is the sense 
of the Senate that--
            (1) adequate chemoprevention drugs have not been developed;
            (2) 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
            (3) it is in the public interest to provide such changes 
        and incentives for the development of chemoprevention drugs.

SEC. 202. COMPASSIONATE ACCESS TO INVESTIGATIONAL DRUGS AND DEVICES.

    (a) In General.--Section 561 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360bbb) is amended by adding at the end the 
following:
    ``(f) Oncologic Compassionate Access Program.--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--
            ``(1) describes such compassionate access programs for 
        investigational drugs, biological products, and devices 
        intended to treat cancer;
            ``(2) 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
            ``(3) facilitates the contribution of safety and efficacy 
        data of investigational treatments from participants in such 
        compassionate access program.
    ``(g) Implementation of Compassionate Access Programs.--
            ``(1) Training of personnel.--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.
            ``(2) Policies, regulations, and guidance.--The Secretary 
        shall establish policies, regulations, and guidance designed to 
        most directly benefit seriously ill cancer patients.''.
    (b) Development of Surrogate Endpoints and Biomarkers.--The Federal 
Food, Drug, and Cosmetic Act is amended by inserting after section 561 
(21 U.S.C. 360bbb) the following:

``SEC. 561A. DEVELOPMENT OF SURROGATE ENDPOINTS AND BIOMARKERS.

    ``The Secretary shall--
            ``(1) establish a program to encourage the development of 
        surrogate endpoints and biomarkers, which shall include medical 
        images, that are reasonably likely to predict--
                    ``(A) clinical benefit for cancer-related 
                conditions for which there exist significant unmet 
                medical needs; and
                    ``(B) individual risk for cancer-related conditions 
                for which there exist unmet medical needs;
            ``(2) 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;
            ``(3) 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
            ``(4) 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.''.
    (c) Conforming Amendment.--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 ``Compassionate Access to Investigational Drugs 
and Devices for Cancer Patients.--''.

SEC. 203. ONCOLOGY DRUGS ADVISORY COMMITTEE.

    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:

``SEC. 566. MEMBERSHIP OF ONCOLOGY DRUGS ADVISORY COMMITTEE.

    ``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.''.

SEC. 204. TECHNICAL AMENDMENT.

    Section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360bb(a)(2)) is amended by inserting ``or targets and mechanisms 
of pathogenesis of diseases'' after ``disease or condition''.

      TITLE III--PAYMENTS FOR CANCER-RELATED SERVICES AND PRODUCTS

SEC. 301. COORDINATING CANCER CARE FOR PATIENTS.

    (a) Cancer Coverage Requirements.--Part B of title XVIII of the 
Social Security Act (42 U.S.C. 1395j et seq.) is amended by adding at 
the end the following:

                     ``cancer coverage requirements

    ``Sec. 1849.  (a) In General.--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.
    ``(b) Definitions.--In this section:
            ``(1) Cancer care coordinator.--
                    ``(A) In general.--The term `cancer care 
                coordinator' 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.
                    ``(B) Responsibilities.--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.
                    ``(C) Coordination and management.--
                            ``(i) In general.--The overall coordination 
                        and management under subparagraph (A) shall 
                        include the development of a plan of care 
                        that--
                                    ``(I) 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;
                                    ``(II) 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;
                                    ``(III) is furnished in a form that 
                                is appropriate for use by disparity 
                                populations, to the extent practicable; 
                                and
                                    ``(IV) is in accordance with 
                                standards determined by the Secretary 
                                to be appropriate;
                            ``(ii) Covered individual.--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--
                                    ``(I) is in accordance with 
                                subclauses (I) and (III) of such 
                                clause; and
                                    ``(II) 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.
                            ``(iii) Follow-up plan.--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--
                                    ``(I) describes the elements of the 
                                primary treatment, including symptom 
                                management, furnished to such 
                                individual;
                                    ``(II) provides recommendations for 
                                the subsequent care of the individual 
                                with respect to the cancer involved;
                                    ``(III) 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;
                                    ``(IV) is furnished in a form that 
                                is appropriate for use by disparity 
                                populations to the extent practicable; 
                                and
                                    ``(V) is in accordance with 
                                standards determined by the Secretary 
                                to be appropriate.
                            ``(iv) Revisions to follow up plan.--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--
                                    ``(I) is in accordance with 
                                subclauses (I), (II), and (IV) of such 
                                clause; and
                                    ``(II) 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.
                    ``(D) Standards.--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.
            ``(2) Individual.--The term `individual' means a person who 
        has been diagnosed with cancer and who is covered under the 
        insurance program established under this part.''.
    (b) Additional Payment.--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:
            ``(5) 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.''.

SEC. 302. ELIMINATION OF OPTIONAL EXCLUSION FROM MEDICAID PRESCRIPTION 
              DRUG COVERAGE FOR TOBACCO CESSATION MEDICATIONS.

    (a) In General.--Section 1927(d)(2) of the Social Security Act (42 
U.S.C. 1396r-8(d)(2)) is amended--
            (1) by striking subparagraph (E);
            (2) by redesignating subparagraphs (F) through (K) as 
        subparagraphs (E) through (J), respectively; and
            (3) in subparagraph (F) (as redesignated by paragraph (2)), 
        by inserting before the period at the end the following: ``, 
        other than agents approved by the Food and Drug Administration 
        for purposes of promoting, and when used to promote, tobacco 
        cessation''.
    (b) Effective Date.--The amendments made by subsection (a) shall 
apply to services furnished on or after the date of enactment of this 
Act.

 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.

    (a) In General.--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.
    (b) Definitions.--For purposes of this section:
            (1) Biorepository.--The term ``biorepository'' 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.
            (2) Biospecimen.--The term ``biospecimen'' means any 
        material or medical images of material that is biologically-
        derived, such as blood, tissue, and urine, and used for 
        diagnosis and analysis.

SEC. 402. MEDPAC REPORT ON PAYMENTS FOR SPECIMEN COLLECTION.

    (a) In General.--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 ``report'') 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.
    (b) Report Details.--
            (1) In general.--The report shall include recommendations 
        on the following:
                    (A) Potential billing code systems for the 
                collection, storage, and pathological definition of 
                cancer and related tissues.
                    (B) Potential payment systems for the collection, 
                storage, and pathological definition of cancer and 
                related tissues.
                    (C) The feasibility of expanding the recommended 
                payment system to cover tissue collection, storage, and 
                pathological definition for research on conditions 
                unrelated to cancer.
            (2) Payment systems.--Proposed payment systems referred to 
        in paragraph (1)(B) shall consider the following factors:
                    (A) Numbers and types of cancer tissues collected 
                for the purpose of research involving the application 
                of genomic or proteomic technologies.
                    (B) Professional time required for pathologists, 
                surgeons, other experts to collect these tissues for 
                post-genomics research.
                    (C) Specific annotation of collected tissue 
                required beyond normal diagnostic needs currently in 
                practice.
                    (D) Numbers of tissues collected on government 
                sponsored clinical trials and method of coverage for 
                the collection of these tissues.
                    (E) The cost of maintenance of such highly 
                annotated resources.
                    (F) 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.
                                 <all>