for specific tools or technologies (including platform technologies) that have the potential to support and advance the development or manufacture of security countermeasures, qualified countermeasures, and qualified pandemic or epidemic products. The Secretary, acting through the Commissioner of Food and Drugs, shall publish the final guidance not later than 3 years after the enactment of this Act. 604. Animal rule report (a) Study The Comptroller General of the United States shall conduct a study on the application of the requirements under subsections (c) and (d) of section 565 of the of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 360bbb–4 ) (referred to in this section as the animal rule ) as a component of medical countermeasure advanced development under the Biomedical Advanced Research and Development Authority and regulatory review by the Food and Drug Administration. In conducting such study, the Comptroller General shall examine the following: (1) The extent to which advanced development and review of a medical countermeasure are coordinated between the Biomedical Advanced Research and Development Authority and the Food and Drug Administration, including activities that facilitate appropriate and efficient design of studies to support approval, licensure, and authorization under the animal rule, consistent with the recommendations in the animal rule guidance, issued pursuant to section 565(c) of the Federal Food Drug and Cosmetic Act ( 21 U.S.C. 360bbb–4(c) ) and entitled Product Development Under the Animal Rule: Guidance for Industry (issued in October 2015), to resolve discrepancies in the design of adequate and well-controlled efficacy studies conducted in animal models related to the provision of substantial evidence of effectiveness for 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