Sec. 601. Medical Breakthrough Fund
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Section 402A of the Public Health Service Act ( 42 U.S.C. 282a ) is amended— by redesignating subsection
(e)as subsection (f); and by inserting after subsection
(d)the following: There is established a fund to be known as the Medical Breakthrough Fund to support biomedical research through the funding of basic, translational, and clinical research. There are authorized to be appropriated, and appropriated, to the Medical Breakthrough Fund out of any funds in the Treasury not otherwise appropriated, in addition to any amounts otherwise made available to the National Institutes of Health, the following amounts for the following fiscal years: For fiscal year 2017— $1,000,000,000 for the CV Prize (described in paragraph (5)) to remain available until expended; and $500,000,000. For fiscal year 2018, $1,500,000,000. For each of fiscal years 2019 through 2024, $2,000,000,000. Amounts in the Medical Breakthrough Fund shall not be available except to the extent and in such amounts as are provided in appropriation Acts. The Director of NIH shall allocate the amounts available in the Medical Breakthrough Fund for a fiscal year for research (not including the CV Prize) consistent with the following: 100 percent of such amounts shall be for research related to Alzheimer’s disease, cancer, heart disease, stoke, or diabetes. Not less than 35 percent of such amounts shall be for research by early stage investigators (as defined in paragraph (7)). Not less than 20 percent of such amounts shall be for research that pursues innovative approaches to major contemporary challenges in biomedical research that involve inherent high risk, but have the potential to lead to breakthroughs. Not more than 10 percent of such amounts may be for intramural research. No amount may be used for facilities and administration fees in connection with a research program or project in excess of 50 percent of the direct costs of such program or project provided under this subsection. Amounts in the Medical Breakthrough Fund are not subject to— any transfer authority of the Secretary or the Director of NIH under section 241, subsection (c), subsection (d), or any other provision of law; or the nonrecurring expenses fund under section 223 of division G of the Consolidated Appropriations Act, 2008 ( 42 U.S.C. 3514a ). Amounts appropriated and made available pursuant to this paragraph shall be used to supplement, not supplant, the funds otherwise allocated by the National Institutes of Health for biomedical research. Amounts in the Medical Breakthrough Fund established under paragraph
(1)may be used only to develop and implement the strategic plan under paragraph (6), to administer and award the CV Prize, or to conduct and support innovative biomedical research through the following: Research in which— a principal investigator has a specific project or specific objectives; and funding is tied to pursuit of such project or objectives. Research in which— a principal investigator has shown promise in biomedical research; and funding is not tied to a specific project or specific objectives. Research to be carried out principally by a small business concern (as defined in section 3 of the Small Business Act). In funding programs and activities through the Medical Breakthrough Fund, the Secretary, acting through the Director of NIH, shall— ensure coordination among the national research institutes, the national centers, and other departments, agencies, and offices of the Federal Government; and minimize unnecessary duplication. The Director of NIH shall award a Cure and Vaccine Prize (in this subsection referred to as the CV Prize ) consisting of the $1,000,000,000 appropriated under paragraph (2)(A)(i)(I) to the first applicant who the Director determines in accordance with this paragraph has developed a cure or vaccine for Alzheimer’s disease. Not later than 10 days after receiving recommendations under subparagraph (F)(ii)(I), the Director of NIH shall publish criteria for determining what constitutes a cure or vaccine of Alzheimer’s disease on the website of the National Institutes of Health. The Director of NIH shall— receive applications of applicants claiming to have developed a cure or vaccine that meets the criteria published under subparagraph (B); and send a copy of any applications so received to the CV Advisory Prize Board established under paragraph (F)(i). The Director of NIH shall— determine if a cure or vaccine for Alzheimer’s disease described in an application received under subparagraph
(C)meets the criteria published under subparagraph (B); and when making a determination under clause (i), take into consideration the recommendations submitted under subparagraph (F)(ii)(III)). If the Director of NIH determines under subparagraph
(D)that a cure or vaccine described in an application received under subparagraph
(C)meets criteria published under subparagraph (B), not later than 90 days after the date of such determination, the Director shall award the CV Prize to the applicant who submitted the application. Not later than 120 days after the date of the enactment of this subsection, the Director of NIH shall establish a CV Prize Advisory Board to advise the Director with respect to awarding the CV Prize. The CV Prize Advisory Board shall— not later than 180 days after the date of the enactment of this subsection, recommend to the Director of NIH criteria for determining what constitutes a cure or vaccine of Alzheimer’s disease; review applications of applicants claiming to have developed a cure or vaccine that meets the criteria published under subparagraph (B); and submit recommendations to the Director of NIH as to whether the cure or vaccine described in such application has met such criteria. The CV Prize Advisory Board shall consist of 14 members as follows: 8 members appointed by the Director of NIH. 1 member appointed by the Speaker of the House of Representatives. 1 member appointed by the majority leader of the Senate. 1 member appointed by the minority leader of the House of Representatives. 1 member appointed by the minority leader of the Senate. The Director of NIH, who shall serve ex-officio. The Secretary, who shall serve ex-officio. The Director of NIH shall ensure that scientifically based strategic planning is implemented in support of research priorities of the Medical Breakthrough Fund, including through the development, use, and updating of a strategic research investment plan that— is designed to increase the efficient and effective focus of biomedical research in a manner that leverages the best scientific opportunities through a deliberative planning process; identifies strategic focus areas in which the resources of the Medical Breakthrough Fund can address, and find more effective treatments for, Alzheimer’s disease, cancer, heart disease, stoke, and diabetes; includes objectives for each such strategic focus area; and ensures that basic research remains a priority. The Director of NIH shall appoint 18 members to an advisory council to offer recommendations to the Director on the strategic research investment plan implemented pursuant to subparagraph (A). The 18 members shall consist of— 3 members who specialize in Alzheimer’s disease; 3 members who specialize in cancer; 3 members who specialize in heart disease; 3 members who specialize in stoke; 3 members who specialize in diabetes; and 3 members who have broad experience in biomedical research. The Director shall review and, as appropriate, update the research strategic investment plan under subparagraph
(A)not less than often every 18 months. In this subsection, the term early stage investigator means, with respect to a research project or program funded under this subsection, an investigator who— is the principal investigator or the program director of such project or program; has never been awarded, or has been awarded only once, a substantial, competing grant by the National Institutes of Health for independent research; and at the time of initial funding for such project or program, is within 10 years of having completed— the investigator’s terminal degree; or a medical residency (or the equivalent). .
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