Sec. 306. Establishment of additional Intercenter Institutes at the Food and Drug Administration
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Subsection
(c)of section 1014 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 399g(c) ) is amended to read as follows: Not later than the date that is one year after the date of the enactment of the Cures 2.0 Act or the end of the coronavirus disease 2019 (COVID–19) pandemic public health emergency under section 319 of the Public Health Service Act, whichever is later, the Secretary shall establish, in accordance with this section, at least two additional Institutes under subsection (a). . In establishing the focus of the two Institutes referenced in the amendment made by subsection (a), the Secretary of Health and Human Services shall ensure the following: One of the Institutes focuses on a group of diseases meeting the following criteria: Negatively affects at least one major body system. Represents a major disease burden in the United States. Represents a leading cause of mortality or disability in the United States. According to the National Institutes of Health, affects at least an estimated 50,000,000 Americans each year. Contributes to increasing health care (personal, familial, private sector, and governmental) expenditures and impacts the United States economy as a whole. For which the SARS–CoV–2 virus exacerbates symptoms or causes serious complications. For which medical products are approved by the Food and Drug Administration at a much lower rate than products for other disease areas, including in abbreviated pathways. One of the Institutes focuses on a group of diseases meeting the following criteria: Affects, individually, fewer than 200,000 people in the United States. Over 90 percent of such diseases have no therapy approved by the Food and Drug Administration. Affects, in total, over 30,000,000 Americans. Over 50 percent of patients are children. Not later than 2 years after the date of the enactment of this Act, and annually thereafter, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall submit a report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate on the activities of the Institutes established pursuant to this section.
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Sec. 306
Establishment of additional Intercenter Institutes at the Food and Drug Administration
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