; and (2) not later than 18 months after the close of the period for receiving public comments on such draft guidance, publish final guidance on the topics described in paragraph (1). (c) Effective date The amendment made by subsection (a) applies with respect to applications, and supplements to applications, that are submitted or pending under section 505(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b) ) on or after January 1, 2017.