; (B) provide a period of at least 60 days for comment on the draft guidance; and (C) after considering any comments received and not later than one year after the close of the comment period on the draft guidance, publish final guidance. (c) Applicability Section 505(j)(3)(H) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies beginning on the date of enactment of this Act, irrespective of the date on which the guidance required by subsection (b) is finalized.