; (D) best practices for communication between sponsors and the agency on the development of such data collection methods, including the initiation of data collection; and (E) the appropriate format to submit such data results to the Secretary. (2) Final guidance Not later than 6 months after the close of the period for public comment on the draft guidance under paragraph (1), the Secretary shall finalize such guidance. (b) Risk of abuse and misuse (1) Draft guidance Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall issue draft guidance to clarify the circumstances under which the Food and Drug Administration considers misuse and abuse of drugs in making determinations of safety under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. (2) Final guidance Not later than 6 months after the close of the period for public comment on the draft guidance under paragraph (1), the Secretary shall finalize such guidance. (c) Definitions In this section— (1) the term medical product means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(g)(1) )), biological product (as that term is defined by section 351(i) of this Act ( 42 U.S.C. 262(i) )), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321(h) )); and (2) the term opioid sparing means reducing the use of opioids or other controlled substances.