Sec. 1141. Council for 21st Century Cures
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Title II of the Public Health Service Act ( 42 U.S.C. 202 et seq. ) is amended by adding at the end the following: A nonprofit corporation to be known as the Council for 21st Century Cures (referred to in this part as the Council ) shall be established in accordance with this section. The Council shall be a public-private partnership headed by an Executive Director (referred to in this part as the Executive Director ), appointed by the members of the Board of Directors. The Council shall not be an agency or instrumentality of the United States Government.
The purpose of the Council is to accelerate the discovery, development, and delivery in the United States of innovative cures, treatments, and preventive measures for patients. For the purpose described in section 281A, the Council shall— foster collaboration and coordination among the entities that comprise the Council, including academia, government agencies, industry, health care payors and providers, patient advocates, and others engaged in the cycle of discovery, development, and delivery of life-saving and health-enhancing innovative interventions; undertake communication and dissemination activities; publish information on the activities funded under section 281D; establish a strategic agenda for accelerating the discovery, development, and delivery in the United States of innovative cures, treatments, and preventive measures for patients; identify gaps and opportunities within and across the discovery, development, and delivery cycle; develop and propose recommendations based on the gaps and opportunities so identified; facilitate the interoperability of the components of the discovery, development, and delivery cycle; propose recommendations that will facilitate precompetitive collaboration; identify opportunities to work with, but not duplicate the efforts of, nonprofit organizations and other public-private partnerships; and identify opportunities for collaboration with organizations operating outside of the United States, such as the Innovative Medicines Initiative of the European Union.
The Council shall have a Board of Directors (in this part referred to as the Board of Directors ), which shall be composed of the ex officio members under subparagraph
(B)and the appointed members under subparagraph (C). All members of the Board shall be voting members. The ex officio members of the Board shall be the following individuals or their designees: The Director of the National Institutes of Health. The Commissioner of Food and Drugs. The Administrator of the Centers for Medicare & Medicaid Services. The heads of five other Federal agencies deemed by the Secretary to be engaged in biomedical research and development. The appointed members of the Board shall consist of 17 individuals, of whom— eight shall be appointed by the Comptroller General of the United States from a list of nominations submitted by leading trade associations— four of whom shall be representatives of the biopharmaceutical industry; two of whom shall be representatives of the medical device industry; and two of whom shall be representatives of the information and digital technology industry; and nine shall be appointed by the Comptroller General of the United States, after soliciting nominations— two of whom shall be representatives of academic researchers; three of whom shall be representatives of patients; two of whom shall be representatives of health care providers; and two of whom shall be representatives of health care plans and insurers. The Chair of the Board shall be selected by the members of the Board by majority vote from among the members of the Board. The term of office of each member of the Board appointed under paragraph (1)(C) shall be 5 years. Any vacancy in the membership of the Board— shall not affect the power of the remaining members to execute the duties of the Board; and shall be filled by appointment by the appointed members described in paragraph (1)(C) by majority vote. If a member of the Board does not serve the full term applicable under subparagraph (A), the individual appointed under subparagraph
(B)to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual. Not later than 90 days after the date on which the Council is incorporated and its Board of Directors is fully constituted, the Board of Directors shall establish bylaws and policies for the Council that— are published in the Federal Register and available for public comment; establish policies for the selection and, as applicable, appointment of— the officers, employees, agents, and contractors of the Council; and the members of any committees of the Council; establish policies, including ethical standards, for the conduct of programs and other activities under section 281D; and establish specific duties of the Executive Director. The Board of Directors shall— meet on a quarterly basis; and submit to Congress, and make publicly available, the minutes of such meetings. The Board of Directors shall, not later than 3 months after the incorporation of the Council— issue an agenda (in this part referred to as the agenda ) outlining how the Council will achieve the purpose described in section 281A; and annually thereafter, in consultation with the Executive Director, review and update such agenda. Not later than 6 months after the date of enactment of the 21st Century Cures Act — the Comptroller General of the United States shall appoint the appointed members of the Board of Directors under subsection (a)(1)(C); and the ex officio members of the Board of Directors under subsection (a)(1)(B) shall serve as incorporators and shall take whatever actions are necessary to incorporate the Council. In carrying out this part, the Board of Directors shall establish such policies and bylaws, and the Executive Director shall carry out such activities, as may be necessary to ensure that the Council maintains status as an organization that— is described in subsection (c)(3) of section 501 of the Internal Revenue Code of 1986; and is, under subsection
(a)of such section, exempt from taxation. The Executive Director shall— be the chief executive officer of the Council; and subject to the oversight of the Board of Directors, be responsible for the day-to-day management of the Council. The Council shall establish a sufficient operational infrastructure to fulfill the duties specified in section 281B. The Council may accept financial or in-kind support from participating entities or private foundations or organizations when such support is deemed appropriate. The Council shall terminate on September 30, 2023. Not later than 1 year after the date on which the Council is established and each year thereafter, the Executive Director shall submit to the appropriate congressional committees a report on the performance of the Council. In preparing such report, the Council shall consult with a nongovernmental consultant with appropriate expertise. For the each of fiscal years 2016 through 2023, there is authorized to be appropriated $10,000,000 to the Council for purposes of carrying out the duties of the Council under this part. .
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Sec. 1141
Council for 21st Century Cures
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