Front Matter -- Preface -- Reviewers -- Contents -- Figures, Tables, and Boxes -- Abbreviations and Acronyms -- Executive Summary -- 1 Introduction -- 2 Background -- 3 The CDC Anthrax Vaccine Research Plan -- 4 Proposed Studies on the Efficacy of the Anthrax Vaccine -- 5 Proposed Studies on the Safety of the Anthrax Vaccine -- 6 Proposed Studies on the Acceptability of the Anthrax Vaccine -- 7 Summary Assessment of the CDC Anthrax Vaccine Research Plan -- Appendix A Biographical Sketches -- Appendix B Information-Gathering Meeting Agendas -- Appendix C Anthrax Vaccine Safety & Efficacy Research Plan -- Appendix D Food and Drug Administration Final Rule: New Drug and Biological Drug Products -- Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible -- Appendix E Department of Defense Memorandum: Reintroduction of the Anthrax Vaccine Immunization Program -- Appendix F Institute of Medicine: CDC Anthrax Vaccine Safety & Efficacy Research Program. Interim Report Findings and Recommendations1 -- Appendix G Institute of Medicine: The Anthrax Vaccine: Is It Safe? Does It Work? Findings and Recommendations1.