133 STAT. 957  PUBLIC LAW 116–22—JUNE 24, 2019  SEC. 604. ANIMAL RULE REPORT.  (a) STUDY.—The Comptroller General of the United States shall  conduct a study on the application of the requirements under sub- sections (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 counter- measure 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 Bio- medical 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 guid- ance, 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 substan- tial 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 address  variations in countermeasure development and review proc- esses, 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 counter- measures.  (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 Depart- ment of Defense;  (2) manufacturers involved in the research and develop- ment of medical countermeasures to address biological, chem- ical, radiological, or nuclear threats; and  (3) other biodefense stakeholders, as applicable.  (c) REPORT.—Not later than 3 years after the date of enactment  of this Act, the Comptroller General of the United States shall  submit to the Committee on Health, Education, Labor, and Pensions  of the Senate and the Committee on Energy and Commerce of  Recommenda-  tions.  Examination. 