advanced research and development
(A)The term “advanced research and development” means, with respect to a product that is or may become a qualified countermeasure or a qualified pandemic or epidemic product, activities that predominantly— (i)are conducted after basic research and preclinical development of the product; and (ii)are related to manufacturing the product on a commercial scale and in a form that satisfies the regulatory requirements under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301et seq.] or undersection 262 of this title. (B)The term under subparagraph (A) includes— (i)testing of the product to determine whether the product may be approved, cleared, or licensed under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301et seq.] or undersection 262 of this titlefor a use that is or may be the basis for such product becoming a qualified countermeasure or qualified pandemic or epidemic product, or to help obtain such approval, clearance, or license; (ii)design and development of tests or models, including animal models, for such testing; (iii)activities to facilitate manufacture of the product on a commercial scale with consistently high quality, as well as to improve and make available new technologies to increase manufacturing surge capacity; (iv)activities to improve the shelf-life of the product or technologies for administering the product; and (v)such other activities as are part of the advanced stages of testing, refinement, improvement, or preparation of the product for such use and as are specified by the Secretary.