II 114th CONGRESS 1st Session S. 2067 IN THE SENATE OF THE UNITED STATES September 22, 2015 Mr. Wicker (for himself, Mrs. Capito , Mr. King , Mr. Schatz , Ms. Ayotte , Ms. Collins , and Mr. Barrasso ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To establish EUREKA Prize Competitions to accelerate discovery and development of disease-modifying, preventive, or curative treatments for Alzheimer’s disease and related dementia, to encourage efforts to enhance detection and diagnosis of such diseases, or to enhance the quality and efficiency of care of individuals with such diseases.

1. Short title This Act may be cited as the Ensuring Useful Research Expenditures is Key for Alzheimer’s Act or the EUREKA Act . 2. Authorization of National Alzheimer’s and Dementia Research Breakthrough Prize Competitions Part B of title IV of the Public Health Service Act ( 42 U.S.C. 284 et seq. ) is amended by adding at the end the following: 409K. National Alzheimer’s and Dementia Research Breakthrough Prize Competitions (a) In general The Director of NIH, in consultation with the Director of the National Science Foundation, the Director of the Defense Advanced Research Projects Agency, the Commissioner of Food and Drugs, the Director of the Intelligence Advanced Research Projects Activity, and the heads of any other appropriate Federal agencies that have experience in prize competitions, shall establish prize competitions. The competitions shall be designed to achieve high-priority breakthroughs to achieve the national goals of preventing and treating Alzheimer’s disease by 2025, enhancing quality and efficiency of care for individuals with Alzheimer's disease, and expanding supports for individuals with Alzheimer’s disease and the family caregivers of such individuals. (b) EUREKA prize competitions (1) In general The Director of NIH, in consultation with the Director of the National Science Foundation, the Director of the Defense Advanced Research Projects Agency, the Commissioner of Food and Drugs, the Director of the Intelligence Advanced Research Projects Activity, and the heads of any other appropriate Federal agencies that have experience in prize competitions, and when appropriate, in coordination with private organizations, shall establish EUREKA prize competitions to accelerate breakthroughs in the area of Alzheimer’s disease and dementia that lead to the attainment of critical milestones set forth in the competitions. The competitions may be in any of the following areas: (A) Identification and validation of non-invasive biomarkers to inform therapeutic targeting. (B) Identification of scalable, non-invasive means of early detection and diagnosis of Alzheimer’s disease. (C) Repurposing of a drug approved by the Food and Drug Administration as a disease-modifying treatment for Alzheimer’s disease. (D) Innovations, including technological or telemedicine, to improve care of individuals with Alzheimer’s disease or dementia and to ease the burden of caregiving for such individuals, including cost burdens. (E) Breakthroughs to overcome a significant scientific barrier to understanding the pathology of Alzheimer’s disease. (F) Other Alzheimer’s disease and dementia needs, as appropriate and as determined by the Advisory Council described in subsection (c). (G) Other areas, as the Director of NIH determines appropriate. (2) Publication The Director of NIH shall publish each competition that is offered in the Federal Register, including the specific award amounts offered, applicable deadlines, and other eligibility criteria. (3) Eligibility To be eligible to win a prize under this section, an individual or private organization— (A) shall have registered to participate in the competition under any rules promulgated by the Director of NIH under paragraph (2); (B) shall have complied with all the requirements under this section; (C) in the case of a private organization, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States, unless the Director of NIH waives such requirement with respect to an organization or individual; and (D) may not be a Federal entity or Federal employee acting within the scope of their employment. (c) Advisory council Not later than 1 year after the date of enactment of the EUREKA Act , the Director of NIH shall convene an Advisory Council of nongovernmental experts in Alzheimer's disease and dementia to devise development of EUREKA prize competitions under subsection (b). The council shall be comprised of 8 members, including— (1) 2 experts from private organizations with expertise in managing multi-faceted prize competitions; (2) 2 experts in Alzheimer’s disease and dementia biomedical research; (3) 2 experts in Alzheimer’s disease and dementia therapy development, including individuals with expertise in designing and executing human clinical trials; and (4) 2 individuals from the caregiver or patient advocacy community. (d) Evaluation of submissions The Director of NIH, in consultation with the Advisory Council, shall appoint a panel of judges, from within or outside the National Institutes of Health, including from the private sector, to review and evaluate all submissions for EUREKA competitions. The judging panel shall forward recommendations to the Director of NIH and the Advisory Council. The Director of NIH shall evaluate all submissions recommended by the judging panel and select submissions for which the prize shall be awarded. In reviewing submissions and selecting awardees, the Director of NIH may seek technical assistance and expertise from other Federal agencies or external sources, as appropriate. (e) Administering the competitions The Director of NIH may enter into an agreement with a private organization to administer prize competitions, subject to the provisions of this section. (f) Applicability of other provisions Subsections (e), (h), (i), and (j) of section 24 of the Stevenson-Wydler Technology Innovation Act of 1980 shall apply to this section. In applying such subsection (h) to this section, the reference to subsection (g) shall be deemed to be a reference to subsection (b) of this section. Paragraphs (2) and (3) of subsection (k) of section 24 of the Stevenson-Wydler Technology Innovation Act of 1980 shall apply to the appointment and functioning of the panel of judges described in subsection (d). (g) Exemption from FACA The Federal Advisory Committee Act (5 U.S.C. App.) shall not apply to the advisory council established under subsection (c) or the judging panel appointed under subsection (d). (h) Private organizations In this section, the term private organizations means nongovernmental entities, including nonprofit and for-profit entities. (i) Funding (1) In general Support for a prize competition under this section, including financial support for the design and administration of a prize competition or monetary contributions or gifts of property for a prize purse, may consist of Federal appropriated funds, funds provided by private organizations, and individuals. The Director of NIH may solicit and accept funds from other Federal agencies, from private organizations, and individuals to support such prize competitions. The Director of NIH may not give any special consideration to any individual or private organization in return for a donation. (2) Authorization of appropriations To carry out this section, there are authorized to be appropriated not more than $10,000,000, for each of fiscal years 2017 through 2021. Any funds appropriated under this paragraph shall remain available until September 30, 2025. (3) Clarification Any funds made available through this section shall supplement, not supplant, other funding made available for research on Alzheimer’s disease and related dementia. .