; and (B) constructing, or entering into contracts to construct, manufacturing facilities, including the construction of advanced manufacturing technology, RNA vaccines, DNA vaccines, recombinant protein vaccines, viral vector-based vaccines, live attenuated vaccines, inactivated vaccines, or other therapeutics, after clinical data relating to such products have demonstrated strong positive indications of safety and efficacy, to ensure immediate production at-scale upon Federal approval. (2) Submission of applications For each applicable COVID–19 product, and for each applicable drug, biological product, or device that the Office determines should be manufactured, as provided for under this section, the Secretary shall— (A) submit an application under subsection (b) or (j) of section 505, or under section 515, of the Federal Food, Drug, and Cosmetic Act or subsection (a) or (k) of section 351 of this Act or submit a notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act (or enter into a contract with another entity to submit such an application or notification); (B) request an emergency use authorization of the product under section 564A of the Federal Food, Drug, and Cosmetic Act (or enter into a contract with another entity to submit an application for such use)