Sec. 3. National Center of Excellence in Advanced Pharmaceutical Manufacturing
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Chapter X of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 391 et seq.) is amended by adding at the end the following: The Secretary shall designate institutions of higher education as National Centers of Excellence in Advanced Pharmaceutical Manufacturing, including continuous pharmaceutical manufacturing. To be eligible for designation under subsection
(a)an entity shall— be an institution of higher education; demonstrate— the physical and technical capacity for research and development of advanced pharmaceutical manufacturing; a record of transferring scientific knowledge to the marketplace; scalable manufacturing knowledge, which may be through collaborations of other institutions of higher education, biopharmaceutical manufacturers, or other entities; the ability to train a future workforce for research on and implementation of advanced pharmaceutical manufacturing; and the ability to support Federal agencies with technical assistance for advanced pharmaceutical technologies, with an emphasis on creating a secure national pharmaceutical stockpile and the ability to rapidly address drug shortages; and submit an application to the Secretary at such time, in such form, and in such manner as the Secretary may require. The Secretary may terminate the designation of an entity designated under subsection
(a)upon a determination that the entity no longer meets the requirements of subsection (b). Not later than 1 year after the date on which the first designation is made under subsection (a), and annually thereafter, the Secretary shall submit a report to Congress on the activities of the entities designated under such subsection. To carry out this section, there are authorized to be appropriated $100,000,000 for the period of fiscal year 2021 through 2025. .
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Sec. 3
National Center of Excellence in Advanced Pharmaceutical Manufacturing
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