the product approved, licensed, or authorized under the animal rule. (2) The consistency of the application of the animal rule among and between review divisions within the Food and Drug Administration. (3) The flexibility pursuant to the animal rule to address variations in countermeasure development and review processes, including the extent to which qualified animal models are adopted and used within the Food and Drug Administration in regulatory decisionmaking with respect to medical countermeasures. (4) The extent to which the guidance issued under section 565(c) of the Federal Food Drug and Cosmetic Act ( 21 U.S.C. 360bbb–4(c) ), entitled, Product Development Under the Animal Rule: Guidance for Industry (issued in October 2015), has assisted in achieving the purposes described in paragraphs (1), (2), and (3). (b) Consultations In conducting the study under subsection (a), the Comptroller General of the United States shall consult with— (1) the Federal agencies responsible for advancing, reviewing, and procuring medical countermeasures, including the Office of the Assistant Secretary for Preparedness and Response, the Biomedical Advanced Research and Development Authority, the Food and Drug Administration, and the Department of Defense