Sec. 4. Establishment of Regenerative Medicine Coordinating Council
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The Secretary of Health and Human Services shall establish, within six months of the enactment of this Act, in the Office of the Secretary, a Regenerative Medicine Coordinating Council (in this section referred to as the Council ). The Council shall be composed of the following: The Secretary of Commerce. The Secretary of Defense. The Secretary of Health and Human Services. The Secretary of the Treasury. The Secretary of Veterans Affairs. The Administrator of the Agency for Healthcare Research and Quality.
The Administrator of the Centers for Medicare & Medicaid Services. The Commissioner of Food and Drugs. The Director of the National Institutes of Health. The Director of the National Institutes of Standards and Technology. The members appointed by the Secretary under subsection (d). The Secretary of Health and Human Services shall be the Chair of the Council. The Secretary shall appoint at least 5 persons to serve as members of the Council under subsection (b)(11). The members of the Council appointed under the preceding sentence shall include persons with expertise in third-party payment, regenerative medicine researchers from academic institutions, patient advocates, persons with expertise in drug discovery, persons with expertise in drug development, persons with expertise in basic research, persons with expertise in translational research, persons with expertise in medical device development, persons with expertise in biomaterials, clinicians, and persons with expertise in clinical research.
The Council shall— consult with, and provide information to, the Secretary of Health and Human Services for purposes of implementing any recommendations in the report required by section 3; prepare, and keep up-to-date, a national strategy to support research into regenerative medicine and the development of drugs, biological products, medical devices, and biomaterials for use in regenerative medicine; prepare a plan specifying priorities for research into regenerative medicine; not later than 1 year after the date of the enactment of this Act, establish priorities for the award of grants under sections 5 and 6 (relating to grants for basic or preclinical research into regenerative medicine and for development of drugs, biological products, medical devices, and biomaterials for use in regenerative medicine, respectively); identify sources of funding for research into regenerative medicine; identify areas where such funding is inadequate; make recommendations regarding Federal regulatory, reimbursement, tax, and other policies that will support development and marketing of regenerative medicine products; facilitate development of consensus standards regarding scientific issues critical to regulatory approval of regenerative medicine products; and determine the need for establishing centers of excellence or consortia to further advance regenerative medicine.
The Council shall adopt procedures to ensure the receipt of public input, such as holding public stakeholder meetings or creating advisory boards. The Council shall submit an annual report on its activities to the Congress, the Director of the National Institutes of Health, and the Commissioner of Food and Drugs. Each such report shall— provide details on progress in meeting goals identified by the Council for regenerative medicine; make recommendations regarding funding, regulatory, or other policies to achieve regenerative medicine goals identified by the Council; identify all regenerative medicine products currently on the market and those in development; identify regenerative medicine research and technological advances and discoveries that occurred in the previous year; and assess the impact of regenerative medicine on the Nation’s economy, including with respect to— the number of people employed in companies or research institutions working in regenerative medicine; the number of companies pursuing regenerative medicine products; increases in tax revenues; and the impact on national health spending.