; (3) the manner in which the Food and Drug Administration will assess evidence to support the inclusion of opioid sparing data in the labeling of non-addictive medical products intended to treat pain, including— (A) data collection methodologies, including the use of novel clinical trial designs (consistent with section 3021 of the 21st Century Cures Act ( Public Law 114–255 )), and real world evidence (consistent with section 505F of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355g )), as appropriate, to support product labeling; (B) ethical considerations of exposuring subjects to controlled substances in clinical trials to develop opioid sparing data and considerations on data collection methods that reduce harm, which may include the reduction of opioid use as a clinical benefit; (C) endpoints, including primary, secondary, and surrogate endpoints, to evaluate the reduction of opioid use; (D) best practices for communication between sponsors and the agency on the development of data collection methods, including the initiation of data collection; and (E) the appropriate format to submit such data results to the Secretary; and (4) the circumstances under which the Food and Drug Administration considers misuse and abuse of drugs in making determinations of safety under paragraphs (2) and (4) of subsection (d) of section 505 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355 ) and in finding that a drug is unsafe under paragraph (1) or (2) of subsection (e) of such section. (c) Definitions In this section— (1) the term medical product means a drug (as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) )), biological product (as defined in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) )), or device (as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(h) ))