; 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: (E) 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; (iii) data derived from the post­mar­ket risk identification and analysis system under subsection (k); or (iv) other scientific data determined to be appropriate by the Secretary. . (e) Conforming amendments with respect to labeling changes Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(4) ) is amended— (1) in subparagraph (A)— (A) in the heading, by inserting or new effectiveness after safety ; (B) by striking safety information and inserting new safety information or new effectiveness information such