II 114th CONGRESS 1st Session S. 216 IN THE SENATE OF THE UNITED STATES January 21, 2015 Mr. Sessions (for himself and Mrs. Boxer ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To establish the National Prostate Cancer Council for improved screening, early detection, assessment, and monitoring of prostate cancer, and to direct the development and implementation of a national strategic plan to expedite advancement of diagnostic tools and the transfer of such tools to patients.

1. Short title This Act may be cited as the National Prostate Cancer Plan Act . 2. National prostate cancer council (a) Establishment There is established in the Office of the Secretary of Health and Human Services (referred to in this section as the Secretary ) the National Prostate Cancer Council on Screening, Early Detection, Assessment, and Monitoring of Prostate Cancer (referred to in this Act as the Council ). (b) Purpose of the council The Council shall— (1) develop and implement a national strategic plan for the accelerated creation, advancement, and testing of diagnostic tools to improve screening, early detection, assessment, and monitoring of prostate cancer, including— (A) early detection of aggressive prostate cancer to save lives; (B) monitoring of tumor response to treatment, including recurrence and progression; and (C) accurate assessment and surveillance of indolent disease to reduce unnecessary biopsies and treatment; (2) provide information and coordination of prostate cancer research and services across all Federal agencies; (3) review diagnostic tools and their overall effectiveness at screening, detecting, assessing, and monitoring of prostate cancer; (4) evaluate all programs in prostate cancer that are in existence on the date of enactment of this Act, including Federal budget requests and approvals and public-private partnerships; (5) submit an annual report to the Secretary and Congress on the creation and implementation of the national strategic plan under paragraph (1); and (6) ensure the inclusion of men at high-risk for prostate cancer, including men from ethnic and racial populations and men who are least likely to receive care, in clinical, research, and service efforts, with the purpose of decreasing health disparities. (c) Membership (1) Federal members The Council shall be led by the Secretary or designee and comprised of the following experts: (A) Two representatives of the National Institutes of Health, including 1 representative of the National Institute of Biomedical Imaging and Bioengineering and 1 representative of the National Cancer Institute. (B) A representative of the Centers for Disease Control and Prevention. (C) A representative of the Centers for Medicare and Medicaid Services. (D) A designee of the Director of the Department of Defense Congressionally Directed Medical Research Program. (E) A designee of the Director of the Office of Minority Health. (F) A representative of the Food and Drug Administration. (G) A representative of the Agency for Healthcare Research and Quality. (2) Non-federal members In addition to the members described in paragraph (1), the Council shall include 14 expert members from outside the Federal Government, which shall include— (A) 6 prostate cancer patient advocates, including— (i) 2 patient-survivors; (ii) 2 caregivers of prostate cancer patients; and (iii) 2 representatives from national prostate cancer disease organizations that fund research or have demonstrated experience in providing assistance to patients, families, and medical professionals, including information on health care options, education, and referral; and (B) 8 health care stakeholders with specific expertise in prostate cancer research in the critical areas of clinical expertise, including medical oncology, radiology, radiation oncology, urology, and pathology. (d) Meetings The Council shall meet quarterly and meetings shall be open to the public. (e) Advice The Council shall advise the Secretary, or the Secretary’s designee. (f) Annual report The Council shall submit annual reports, beginning not later than 1 year after the date of enactment of this Act, to the Secretary or the Secretary’s designee and to Congress. The annual report shall include— (1) in the first year— (A) an evaluation of all federally funded efforts in prostate cancer research and gaps relating to the development and validation of diagnostic tools for prostate cancer; and (B) recommendations for priority actions to expand, eliminate, coordinate, or condense programs based on the performance, mission, and purpose of the programs; and (2) annually thereafter for 5 years— (A) an outline for the development and implementation of a national research plan for creation and validation of accurate diagnostic tools to improve prostate cancer care in accordance with subsection (a); (B) roles for the National Cancer Institute, National Institute on Minority Health and Health Disparities, and the Office on Minority Health of the Department of Health and Human Services; (C) an analysis of the disparities in the incidence and mortality rates of prostate cancer in men at high risk of the disease, including individuals with family history, increasing age, or African-American heritage; and (D) a review of the progress towards the realization of the proposed strategic plan. (g) Termination The Council shall terminate on December 31, 2020. (h) Authorization of appropriations There are authorized to be appropriated to carry out this section $2,000,000 for the period of fiscal years 2016 through 2020.