S.Amdt. 1248

1. Adds TITLE __--REDUCING LUNG CANCER at the appropriate place in division A

   Adds a title

   Inserted: TITLE __--REDUCING LUNG CANCER

   Inserted: SEC. __1. SHORT TITLE.

   Inserted: This title may be cited as the "Lung Cancer Mortality Reduction Act of 2009".

   Inserted: SEC. __2. SENSE OF THE SENATE CONCERNING INVESTMENT IN LUNG CANCER RESEARCH.

   Inserted: It is the sense of the Senate that--

   Inserted: (1) lung cancer mortality reduction should be made a national public health priority; and

   Inserted: (2) a comprehensive mortality reduction program coordinated by the Secretary of Health and Human Services is justified and necessary to adequately address and reduce lung cancer mortality.

   Inserted: SEC. __3. LUNG CANCER MORTALITY REDUCTION PROGRAM.

   Inserted: (a) In General.--Subpart 1 of part C of title IV of the Public Health Service Act (42 U.S.C. 285 et seq.) is amended by adding at the end the following:

   Inserted: "SEC. 417G. LUNG CANCER MORTALITY REDUCTION PROGRAM.

   Inserted: "(a) In General.--Not later than 6 months after the date of enactment of the Lung Cancer Mortality Reduction Act of 2009, the Secretary, in consultation with the Secretary of Defense, the Secretary of Veterans Affairs, the Director of the National Institutes of Health, the Director of the Centers for Disease Control and Prevention, the Commissioner of the Food and Drug Administration, the Administrator of the Centers for Medicare & Medicaid Services, the Director of the National Center on Minority Health and Health Disparities, and other members of the Lung Cancer Advisory Board established under section __6 of the Lung Cancer Mortality Reduction Act of 2009, shall implement a comprehensive program to achieve a 50 percent reduction in the mortality rate of lung cancer by 2016.

   Inserted: "(b) Requirements.--The program implemented under subsection (a) shall include at least the following:

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   Inserted: "(1) With respect to the National Institutes of Health--

   Inserted: "(A) a strategic review and prioritization by the National Cancer Institute of research grants to achieve the goal of the program in reducing lung cancer mortality;

   Inserted: "(B) the provision of funds to enable the Airway Biology and Disease Branch of the National Heart, Lung, and Blood Institute to expand its research programs to include predispositions to lung cancer, the interrelationship between lung cancer and other pulmonary and cardiac disease, and the diagnosis and treatment of these interrelationships;

   Inserted: "(C) the provision of funds to enable the National Institute of Biomedical Imaging and Bioengineering to expand its Quantum Grant Program and Image-Guided Interventions programs to expedite the development of computer assisted diagnostic, surgical, treatment, and drug testing innovations to reduce lung cancer mortality; and

   Inserted: "(D) the provision of funds to enable the National Institute of Environmental Health Sciences to implement research programs relative to lung cancer incidence.

   Inserted: "(2) With respect to the Food and Drug Administration--

   Inserted: "(A) the establishment of a lung cancer mortality reduction drug program under subchapter G of chapter V of the Federal Food, Drug, and Cosmetic Act; and

   Inserted: "(B) compassionate access activities under section 561 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb).

   Inserted: "(3) With respect to the Centers for Disease Control and Prevention, the establishment of a lung cancer mortality reduction program under section 1511.

   Inserted: "(4) With respect to the Agency for Healthcare Research and Quality, the conduct of a biannual review of lung cancer screening, diagnostic and treatment protocols, and the issuance of updated guidelines.

   Inserted: "(5) The cooperation and coordination of all minority and health disparity programs within the Department of Health and Human Services to ensure that all aspects of the Lung Cancer Mortality Reduction Program adequately address the burden of lung cancer on minority and rural populations.

   Inserted: "(6) The cooperation and coordination of all tobacco control and cessation programs within agencies of the Department of Health and Human Services to achieve the goals of the Lung Cancer Mortality Reduction Program with particular emphasis on the coordination of drug and other cessation treatments with early detection protocols.

   Inserted: "(c) Authorization of Appropriations.--There is authorized to be appropriated to carry out this section--

   Inserted: "(1) $25,000,000 for fiscal year 2010 for the activities described in subsection (b)(1)(B), and such sums as may be necessary for each of fiscal years 2011 through 2014;

   Inserted: "(2) $25,000,000 for fiscal year 2010 for the activities described in subsection (b)(1)(C), and such sums as may be necessary for each of fiscal years 2011 through 2014;

   Inserted: "(3) $10,000,000 for fiscal year 2010 for the activities described in subsection (b)(1)(D), and such sums as may be necessary for each of fiscal years 2011 through 2014; and

   Inserted: "(4) $15,000,000 for fiscal year 2010 for the activities described in subsection (b)(3), and such sums as may be necessary for each of fiscal years 2011 through 2014.".

   Inserted: (b) Food, Drug, and Cosmetic Act.--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:

   Inserted: "Subchapter G--Lung Cancer Mortality Reduction Programs "SEC. 581. LUNG CANCER MORTALITY REDUCTION PROGRAM.

   Inserted: "(a) In General.--The Secretary shall implement a program to provide incentives of the type provided for in subchapter B of this chapter for the development of chemoprevention drugs for precancerous conditions of the lung, drugs for targeted therapeutic treatments and vaccines for lung cancer, and new agents to curtail or prevent nicotine addiction. The Secretary shall model the program implemented under this section on the program provided for under subchapter B of this chapter with respect to certain drugs.

   Inserted: "(b) Application of Provisions.--The Secretary shall apply the provisions of subchapter B of this chapter to drugs, biological products, and devices for the prevention or treatment of lung cancer, including drugs, biological products, and devices for chemoprevention of precancerous conditions of the lungs, vaccination against the development of lung cancer, and therapeutic treatment for lung cancer.

   Inserted: "(c) Board.--The Board established under section __6 of the Lung Cancer Mortality Reduction Act of 2009 shall monitor the program implemented under this section.".

   Inserted: (c) Access to Unapproved Therapies.--Section 561(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(e)) is amended by inserting before the period the following: "and shall include providing compassionate access to drugs, biological products, and devices under the program under section 581, with substantial consideration being given to whether the totality of information available to the Secretary regarding the safety and effectiveness of an investigational drug, as compared to the risk of morbidity and death from the disease, indicates that a patient may obtain more benefit than risk if treated with the drug, biological product, or device.".

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

   Inserted: "SEC. 1511. LUNG CANCER MORTALITY REDUCTION PROGRAM.

   Inserted: "(a) In General.--The Secretary shall establish and implement an early disease research and management program targeted at the high incidence and mortality rates among minority and low-income populations.

   Inserted: "(b) Authorization of Appropriations.--There is authorized to be appropriated, such sums as may be necessary to carry out this section.".

   Inserted: SEC. __4. DEPARTMENT OF DEFENSE AND THE DEPARTMENT OF VETERANS AFFAIRS.

   Inserted: The Secretary of Defense and the Secretary of Veterans Affairs shall coordinate with the Secretary of Health and Human Services--

   Inserted: (1) in the development of the Lung Cancer Mortality Reduction Program under section 417E of part C of title IV of the Public Health Service Act, as amended by section __4;

   Inserted: (2) in the implementation within the Department of Defense and the Department of Veterans Affairs of an early detection and disease management research program for military personnel and veterans whose smoking history and exposure to carcinogens during active duty service has increased their risk for lung cancer; and

   Inserted: (3) in the implementation of coordinated care programs for military personnel and veterans diagnosed with lung cancer.

   Inserted: SEC. __5. LUNG CANCER ADVISORY BOARD.

   Inserted: (a) In General.--The Secretary of Health and Human Services shall establish a Lung Cancer Advisory Board (referred to in this section as the "Board") to monitor the programs established under this title (and the amendments made by this title), and provide annual reports to Congress concerning benchmarks, expenditures, lung cancer statistics, and the public health impact of such programs.

   Inserted: (b) Composition.--The Board shall be composed of--

   Inserted: (1) the Secretary of Health and Human Services;

   Inserted: (2) the Secretary of Defense;

   Inserted: (3) the Secretary of Veterans Affairs; and

   Inserted: (4) two representatives each from the fields of--

   Inserted: (A) clinical medicine focused on lung cancer;

   Inserted: (B) lung cancer research;

   Inserted: (C) imaging;

   Inserted: (D) drug development; and

   Inserted: (E) lung cancer advocacy, to be appointed by the Secretary of Health and Human Services.

   Inserted: SEC. __6. AUTHORIZATION OF APPROPRIATIONS.

   Inserted: For the purpose of carrying out the programs under this title (and the amendments made by this title), there is authorized to be appropriated such sums as may be necessary for each of fiscal years 2010 through 2014.

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   Original wording

   At the appropriate place in division A, insert the following:

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As printed