; (D) the percentage of products in such review division which met the review goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 ( Public Law 115–52 ); (E) agency efforts to ensure consistency across review divisions in the metrics and processes by which new drug applications for non-addictive or non-opioid products intended to treat pain are reviewed; (F) a discussion and summary of the common reasons for applications which did not meet the review goals identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2017 ( Public Law 115–52 ), as applicable and appropriate; and (G) recommendations to better enable utilization of the accelerated approval pathway. 3. Breakthrough therapy status for pain and addiction therapies (a) Draft guidance (1) In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the Secretary ), acting through the Commissioner of Food and Drugs, shall issue draft guidance, clarifying the methods and processes by which the Food and Drug Administration may provide a breakthrough therapy designation for non-opioid or non-addictive drugs or devices developed to treat chronic or acute pain or substance use disorders. (2) Contents The guidance under paragraph (1) shall address— (A) eligibility requirements for such drugs and devices to receive breakthrough therapy designation; (B) opportunities for engagement with the Food and Drug Administration with respect to the breakthrough therapy pathway; (C) specific actions to ensure that the design of the clinical trials is as efficient as practicable, when applicable and scientifically appropriate, for such drugs and devices