; and (II) the potential reduction in effectiveness could result in the benefits of the drug no longer outweighing the risks. . (b) Establishment of requirement Section 505(o)(3)(C) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(3)(C) ) is amended by striking such requirement and all that follows through safety information. and inserting the following: such requirement— (i) in the case of a purpose described in clause (i), (ii), or (iii) of subparagraph (B), only if the Secretary becomes aware of new safety information; and (ii) in the case of a purpose described in clause (iv) of such subparagraph, if the Secretary determines that new effectiveness information exists. . (c) Applicability Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(3) ) is amended by adding at the end the following new subparagraph: (G) Applicability The conduct of a study or clinical trial required pursuant to this paragraph for the purpose specified in subparagraph (B)(iv) shall not be considered a new clinical investigation for the purpose of a period of exclusivity under clause (iii) or (iv) of subsection (c)(3)(E) or clause (iii) or (iv) of subsection (j)(5)(F). . (d) New effectiveness information defined Section 505(o)(2) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(2) ) is amended by adding at the end the following new subparagraph: (D) New effectiveness information The term new effectiveness information , with respect to a drug that is or contains a controlled substance for which a listing in any schedule is in effect (on a temporary or permanent basis) under section 201 of the Controlled Substances Act, means new information about the effectiveness of the drug, including a new analysis of existing information, derived from— (i) a clinical trial; an adverse event report; a postapproval study or clinical trial (including a study or clinical trial under paragraph (3)); (ii) peer-reviewed biomedical literature