EFFECTIVE DATE.

SEC. 405. [21 U.S.C. 379j-51 note] EFFECTIVE DATE. (a) In General.—Except as provided under subsection (b), the amendments made by this title shall take effect on the later of— (1) October 1, 2012; or (2) the date of the enactment of this title. (b) Exception.—Fees under part 8 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, as added by this title, shall be assessed for all biosimilar biological product applications received on or after October 1, 2012, regardless of the date of the enactment of this title.