; (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; and (D) the application of organizational commitment of the Food and Drug Administration to facilitating breakthrough designation for qualified drugs and devices, including involvement of senior managers of the Food and Drug Administration for such drugs and devices. (b) Final guidance Not later than 6 months after the close of the period for public comment on the draft guidance under subsection (a), the Secretary shall finalize such guidance. (c) Data in performance reports (1) In general As a component of the performance reports under sections 736B(a) and 738A(a) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 379h–2 , 379j–1), the Secretary shall include information, as appropriate, on policies and processes of the Division of Anesthesia, Analgesia, and Addiction Products of the Food and Drug Administration (referred to in this section as the DAAAP ) for the breakthrough therapy pathway, with respect to drugs and devices developed to treat chronic or acute pain or substance use disorders, during the previous fiscal year. (2) Contents Information provided as a component of the performance reports under sections 736B(a) and 738A(a) of the Federal Food, Drug, and Cosmetic Act may address— (A) the number of requests for breakthrough therapy designation submitted to the DAAAP; (B) the number of applications for breakthrough therapy designation that the DAAAP granted, and a description of the common reasons for granting applications for breakthrough therapy designation; (C) the number of applications for breakthrough therapy designation that the DAAAP denied, and a description of the common reasons for denying applications for breakthrough therapy designation; and (D) recommendations to better enable utilization of the breakthrough therapy designation pathway for non-addictive or non-opioid products intended to treat pain.