Sec. 306. Report

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Section 565 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–4 ), as amended by section 305, is further amended by adding at the end the following: Not later than 180 days after the date of enactment of this subsection, and annually thereafter, the Secretary shall make publicly available on the Web site of the Food and Drug Administration a report that details the countermeasure development and review activities of the Food and Drug Administration, including— with respect to the development of new tools, standards, and approaches to assess and evaluate countermeasures— the identification of the priorities of the Food and Drug Administration and the progress made on such priorities; and the identification of scientific gaps that impede the development, approval, licensure, or clearance of countermeasures for populations with special clinical needs, including children and pregnant women, and the progress made on resolving these challenges; with respect to countermeasures for which a regulatory management plan has been agreed upon under subsection (f), the extent to which the performance targets and goals set forth in subsection (f)(4)(B) and the regulatory management plan have been met, including, for each such countermeasure— whether the regulatory management plan was completed within the required timeframe, and the length of time taken to complete such plan; whether the Secretary adhered to the timely and appropriate response times set forth in such plan; and explanations for any failure to meet such performance targets and goals; the number of regulatory teams established pursuant to subsection (b)(4), the number of products, classes of products, or technologies assigned to each such team, and the number of, type of, and any progress made as a result of consultations carried out under subsection (b)(4)(A); an estimate of resources obligated to countermeasure development and regulatory assessment, including— Center-specific objectives and accomplishments; and the number of full-time equivalent employees of the Food and Drug Administration who directly support the review of countermeasures; the number of countermeasure applications and submissions submitted, the number of countermeasures approved, licensed, or cleared, the status of remaining submitted applications and submissions, and the number of each type of authorization issued pursuant to section 564; the number of written requests for a regulatory management plan submitted under subsection (f)(3)(A), the number of regulatory management plans developed, and the number of such plans developed for security countermeasures; and the number, type, and frequency of meetings between the Food and Drug Administration and— sponsors of a countermeasure as defined in subsection (a); or another agency engaged in development or management of portfolios for such countermeasures, including the Centers for Disease Control and Prevention, the Biomedical Advanced Research and Development Authority, the National Institutes of Health, and the appropriate agencies of the Department of Defense. .

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21 USC 360bbb–4

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Sec. 306

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