1. Opioid sparing claims and indications (a) Opioid sparing (1) Draft guidance Not later than 1 year after the date of enactment of this Act, the Secretary, acting through the Commissioner of Food and Drugs, shall issue draft guidance to clarify how the Food and Drug Administration will assess evidence to support claims of opioid sparing for non-opioid or other non-addictive medical products intended to treat pain. Such guidance shall include— (A) data collection methodologies, including the use of innovative clinical trial designs (consistent with section 3021 of the 21st Century Cures Act ( Public Law 114–255 )), and real world evidence (as defined in section 505F(b) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355g(b) )), as appropriate, to support product labeling; (B) ethical implications of exposure to controlled substances in clinical trials to support opioid sparing claims and considerations on methods to reduce harm; (C) endpoints, including primary, secondary, and surrogate endpoints, to evaluate the reduction in opioid use; (D) best practices for communication between sponsors and the agency on the development of such data collection methods, including the initiation of data collection