; and (C) a written determination by the Secretary, after review of all public comments received pursuant to subparagraph (B), that no previously generated data that could be substituted for, or otherwise determined sufficient to replace, the data expected to be produced through new animal testing is available for review by the Secretary; (3) conducted for any product or ingredient that is subject to regulation under chapter V of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 351 et seq. )