## 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 

(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 

(3) other biodefense stakeholders, as applicable. 

Examination. 

Recommenda- tions. 

