; (5) a description of Federal oversight, if any, of controlled substance packaging technologies, including— (A) identification of the Federal agencies that oversee such technologies; (B) identification of the technologies recommended by these agencies, including unit dose packaging, packaging that provides a set duration, or other packaging systems that may mitigate abuse or misuse; and (C) a description of the effectiveness of such recommendations at preventing the diversion of legally prescribed controlled substances; and (6) recommendations on— (A) whether site-of-use, in-home controlled substance disposal products and packaging technologies require Federal oversight and, if so, which agencies should be responsible for such oversight and, as applicable, approval of such products or technologies; and (B) the potential role of the Federal Government in evaluating such products to ensure product efficacy. W Postapproval study requirements 7221. Postapproval study requirements (a) Purposes of study Section 505(o)(3)(B) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(o)(3)(B) ) is amended by adding at the end the following: (iv) To assess a potential reduction in effectiveness of the drug for the conditions of use prescribed, recommended, or suggested in the labeling thereof if— (I) the drug involved— (aa) is or contains a 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; or (bb) is a drug that has not been approved under this section or licensed under section 351 of the Public Health Service Act, for which an application for such approval or licensure is pending or anticipated, and for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act