Frontmatter -- Acknowledgments -- Contents -- Summary -- 1 Introduction -- 2 Evaluation of Current and Future TMT-Used Animal Models -- 3 Ethical and Regulatory Challenges in the Development of Countermeasures -- 4 Developing New Animal Models for Biodefense Research -- 5 Alternative Approaches to Animal Testing for Biodefense Countermeasures -- Appendix A: The Animal Rule -- Appendix B: Draft Guidance for Industry -- Appendix C: Developing Animal Models for Use in Animal Rule Licensure: The NIAID Approach -- Appendix D: Presentations to the Committee -- Appendix E: Statement of Task -- Appendix F: About the Authors.