; (2) fully disclosed and enumerated to the group health plan sponsor; and (3) available for audit by the plan sponsor, or a third-party designated by a plan sponsor no less than once per plan year. . III Biosimilar biological product and generic drug competition and affordability 301. Ensuring timely access to generics Section 505(q) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(q) ) is amended— (1) in paragraph (1)— (A) in subparagraph (A)(i), by inserting , 10.31, after 10.30 ; (B) in subparagraph (E)— (i) by striking application and and inserting application or ; (ii) by striking If the Secretary and inserting the following: (i) In general If the Secretary