; (B) the clinical hold should be issued for such other reasons as the Secretary may by regulation establish; or (C) any written request to the Secretary from the sponsor of an investigation that a clinical hold be removed shall receive a decision, in writing and specifying the reasons therefor, within 30 days after receipt of such request. Any such request shall include sufficient information to support the removal of such clinical hold. 587S. Collaborative communities for in vitro clinical tests (a) In general (1) For the purposes of facilitating community solutions and decision making with respect to in vitro clinical tests, the Secretary may participate in collaborative communities comprised of public and private participants that may provide recommendations and other advice to the Secretary on the development and regulation of in vitro clinical tests. (2) A collaborative community under this section shall have broad representation of interested private and public-sector stakeholder communities and may include patients, care partners, academics, healthcare professionals, healthcare systems, payers, Federal and State agencies, entities responsible for accrediting clinical laboratories, international regulatory bodies, test developers, or other interested entities or communities. (b) Guidance The Secretary shall issue a draft guidance not later than 180 days after the date of enactment of the Verifying Accurate Leading-edge IVCT Development Act of 2020 , addressing the participation process and framework to build consensus, and how the Secretary may consider, review, and implement recommendations under subsection (c). (c) Recommendations A collaborative community for in vitro clinical tests may make recommendations to the Secretary on matters including— (1) mitigating measures for in vitro clinical tests; (2) standards development activities and performance standards for in vitro clinical tests or groups of such tests; (3) scientific and clinical evidence to support new claims for in vitro clinical tests