; (B) primary and secondary endpoints for the reduction of opioid use while maintaining adequate pain control; (C) use of real world evidence, including patient registries, and patient reported outcomes to support inclusion of opioid-sparing data in product labeling; and (D) how sponsors may obtain feedback from the Secretary relating to such issues prior to— (i) commencement of such data collection; or (ii) the submission of resulting data to the Secretary. (3) Public meeting Prior to updating or issuing the guidances required by paragraph (1), the Secretary shall consult with stakeholders, including representatives of regulated industry, academia, patients, and provider organizations, through a public meeting to be held not later than 12 months after the date of enactment of this Act. (4) Timing The Secretary shall— (A) not later than 12 months after the date of the public meeting required by paragraph (3), update or issue the one or more draft guidances required by paragraph (1)